June 2015 Assessment of Reprocessing Practices for Neonatal ...€¦ · Neonatal Resuscitation...

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Assessment of Reprocessing Practices for Neonatal Resuscitation Equipment June 2015 MAILING ADDRESS PO Box 900922 Seattle, WA 98109 USA ADDRESS 2201 Westlake Avenue Suite 200 Seattle, WA, USA TEL: 206.285.3500 FAX: 206.285.6619 www.path.org

Transcript of June 2015 Assessment of Reprocessing Practices for Neonatal ...€¦ · Neonatal Resuscitation...

Page 1: June 2015 Assessment of Reprocessing Practices for Neonatal ...€¦ · Neonatal Resuscitation Equipment . June 2015 . MAILING ADDRESS. PO Box 900922 . Seattle, WA 98109 . USA . ADDRESS.

Assessment of Reprocessing Practices for Neonatal Resuscitation Equipment

June 2015 MAIL ING ADDRESS PO Box 900922 Seattle, WA 98109 USA ADDRESS 2201 Westlake Avenue Suite 200 Seattle, WA, USA TEL: 206.285.3500 FAX: 206.285.6619 www.path.org

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Table of Contents Acknowledgments ........................................................................................................................... iii

Acronyms ........................................................................................................................................ iv

Executive Summary ......................................................................................................................... v

1. Introduction ............................................................................................................................. 1

2. Methods ................................................................................................................................... 5

3. Results ..................................................................................................................................... 7

4. Discussion ............................................................................................................................. 27

5. Conclusion ............................................................................................................................. 30

References ...................................................................................................................................... 56

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Acknowledgments Support for this project is made possible by the generous support of the American people through the United States Agency for International Development (USAID) under the terms of the HealthTech Cooperative Agreement # AID-OAA-A-11-00051. The contents are the responsibility of PATH and do not necessarily reflect the views of USAID or the US Government.

This project was also made possible by the generous support of Save the Children USA.

We would like to extend special thanks to Dr. Jesca Nsungwa-Sabiiti and her team at the Uganda Ministry of Health for providing review of and consultation to this study. We also thank Dr. Linda Wright (National Institutes for Health), Dr. Goldy Mazia (PATH), and Dr. Magdalena Serpa (PATH) for their input on the study protocol; the PATH Uganda office for their participation in conducting data collection; and the Helping Babies Breathe Global Development Alliance members for providing us with key contact information.

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Acronyms

AAP American Academy of Pediatrics

HBB Helping Babies Breathe

HLD high-level disinfection

ICC infection control committee

PPE personal protective equipment

SNCU Special Newborn Care Unit

WHO World Health Organization

UNCoLSC United Nations Commission on Life‐Saving Commodities

USAID United States Agency for International Development

USFDA United States Food and Drug Administration

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Executive Summary

Background: Reusable neonatal resuscitation equipment must be reprocessed between uses to avoid infection. Reprocessing guidelines designed for neonatal resuscitation equipment in low-resource settings include selected components of the following process: decontamination, disassembly, cleaning, sterilization/high-level disinfection, reassembly, function testing, and storage. Anecdotally, Helping Babies Breathe country implementers had observed inadequate reprocessing in health facilities. The objectives of this study were to identify the factors leading to inadequate reprocessing of resuscitation equipment in a low-resource setting.

Methodology: Qualitative interviews and observations with health workers who perform reprocessing were conducted in March 2015 at all levels of care in public health facilities that had implemented Helping Babies Breathe training in central and eastern Uganda.

Results: Thirteen reprocessing areas in 9 health facilities were visited, and 16 interviews were conducted with health workers. In the units visited, not all reprocessing steps were consistently performed. Decontamination and cleaning were the steps most frequently followed for most resuscitation equipment; sterilization was done only in very few units and only for suction devices.

Several factors were identified during this study as either facilitating and/or hindering adequate reprocessing of neonatal resuscitation devices. Although only a few units sterilized suction devices, these were the only component of the equipment that regularly received full reprocessing in those units. Facilitating factors present in the units which consistently sterilized suction devices were:

- Perception of spread of infection risk posed by suction device. - Sufficient availability of suction devices meeting the needs of the units’ patient volume. - Consistent instruction transmitted from health worker to health worker on how suction devices

should be reprocessed. - Availability of a functional autoclave. - Sterilization done by a health worker specifically assigned to do so.

The inhibiting factors identified for reprocessing from all units visited were:

- Ineffective training and supervision, including lack of specific training on reprocessing neonatal resuscitation devices or training that did not emphasize sterilization or high-level disinfection for all devices; lack of uniform training in all units and for all shifts; low awareness on the purpose of each reprocessing step; low knowledge on the life-cycle, parts and functionality of resuscitation devices; minimal supervision.

- Lack of sufficient resuscitation equipment meeting the needs of the units’ patient volume (both in in terms of amount needed and functionality of equipment on hand).

- Varying perception regarding spread of infection risk posed by inadequately reprocessed resuscitation equipment; suction device perceived as “dirty,” but not bag and mask.

- Lack of reprocessing equipment and tools. - Lack of visual access to reprocessing guidelines. - Understaffed units with health workers lacking time to fulfill all responsibilities assigned to them.

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- Other environmental constraints, including limited space within unit to perform reprocessing and a dusty environment for air drying.

Conclusions: Factors leading to inadequate reprocessing are modifiable. The next step that can be taken at a global level is to work in collaboration with experts to form a consensus around reprocessing steps that are viable in a low-resource setting where health workers are constrained for time and resources. The approach will include improvement of the current practices in order to revise and simplify reprocessing guidelines and update Helping Babies Breathe training. Additionally, training must be improved and expanded, units should be fully supplied with needed equipment, and the health system must be strengthened overall.

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1. Introduction

Background

Birth asphyxia, defined as the failure of the newborn to establish breathing immediately after birth is a leading cause of neonatal death and kills 814,000 newborns every year, accounting for almost a quarter of all newborn deaths.1 More than 98% of these deaths occur in low‐ and middle‐income countries. Further, approximately 10 million babies do not breathe immediately at birth, and about 6 million require bag-and-mask resuscitation. This leading cause of neonatal death can often be prevented by providing basic neonatal resuscitation.

According to the World Health Organization (WHO), basic newborn resuscitation commodities include a bag‐and‐mask resuscitator for ventilation, a suction device, a source of warmth for thermal protection, and a clock. Each year, 60 million births occur in homes or community settings where most do not have access to any resuscitation resources.2 The key to reducing deaths due to birth asphyxia is to make “appropriate care for birth asphyxia”—both neonatal resuscitation skills and appropriate devices—available to all skilled birth attendants. In addition, a consistent program focused on ongoing training and local mentoring is needed to impact clinical management and patient outcome. In a recent effort to increase access to resuscitation equipment, the United Nations Commission on Life‐Saving Commodities (UNCoLSC) listed neonatal resuscitation devices as one of its 13 underutilized technologies. In addition to the efforts by the UNCoLSC, there are a several collaborative efforts aimed at increasing access to lifesaving resuscitation equipment and to developing and maintaining the skills required for neonatal resuscitation. Helping Babies Breathe (HBB) is an American Academy of Pediatrics (AAP) evidence-based educational program that teaches basic neonatal resuscitation techniques in low-resource settings. It is implemented by the HBB Global Development Alliance, a public-private partnership of the AAP, the United States Agency for International Development (USAID), the National Institute of Child Health and Human Development, and several other global health organizations. The objective of the HBB Global Development Alliance is to train birth attendants in developing countries in the essential skills of newborn resuscitation and strengthen health systems for its implementation.

Study objective

As with any reusable medical device, resuscitation equipment must be properly reprocessed (cleaned/disinfected or sterilized/stored) between patients to avoid the spread of infection. Despite the existence of formal guidelines and instructions for reprocessing, HBB implementers anecdotally observed that complete reprocessing of neonatal resuscitation equipment in low-resource settings was not occurring regularly, was being done improperly, or single-use devices were being used multiple times. Clean and functional commodities should be available in all delivery areas.3 Therefore, this study was undertaken as part of quality improvement efforts of basic newborn resuscitation in low-resource settings.

The general objective of this study was to characterize health facility reprocessing practices for neonatal resuscitation equipment in low-resource settings, specifically in a sub-Saharan African country like

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Uganda, where efforts to increase availability and use of neonatal resuscitation equipment have already begun.

The specific objectives of this study were:

• To identify the availability and characteristics of reprocessing instructions or guidelines for basic neonatal resuscitation equipment (bag-and-mask resuscitator and reusable suction devices) in health facility levels of care where deliveries are permitted.

• To identify actual reprocessing practices for neonatal resuscitation equipment taking place in described health facilities and determine if they are adequate.

• To identify the factors (national policy, infrastructure, work environment, device-specific, user-specific) that lead to inadequate reprocessing of neonatal resuscitation equipment in described health facilities.

Medical equipment reprocessing

To achieve infection prevention and control, consistent adherence to routine practices is necessary across the continuum of care. These practices may consider local factors, including type of facilities available, type of health care setting, and the level of education of the health care workers providing care.4

In terms of reprocessing of reusable equipment, determination of the appropriate reprocessing method must first take into account the level of infection risk posed by the object. The Spaulding Classification System which outlines the risk of transmission of infection posed by medical devices and equipment5,6 divides equipment and devices into three categories. These categories are critical items, semi-critical items, and non-critical items. Respiratory therapy equipment, including resuscitation equipment, is considered a semi-critical item which requires that it be free from all microorganisms, but a small number of bacterial spores are permissible. More detailed information about the Spaulding Classification system can be found in Appendix A.

Reprocessing guidelines have been developed by device manufacturers, federal oversight agencies (US Centers for Disease Control, country ministries of health), medical equipment specialty societies (Association for the Advancement of Medical Instrumentation), global technical agencies (WHO), nongovernmental organizations (Jhpiego), educational collaboratives (HBB), and hospital/clinic infection control committees. Most reprocessing guidelines are not developed for low-resource settings, but some efforts have been made to create reprocessing practices that allow for clean and safe equipment while taking into account what is feasible in a low-resource setting. Guidelines designed for neonatal resuscitation equipment in low-resource settings include selected components of the following process: decontamination, disassembly, cleaning, sterilization/high-level disinfection (HLD), reassembly, and storage. Although there is not perfect agreement on reprocessing steps in existing literature, the main steps for neonatal resuscitation devices are described in Table 1. Because there are so many guidelines available for reprocessing of resuscitation equipment, it may be difficult to discern the most appropriate steps to follow. Table 2 outlines steps included in a selection of reprocessing instructions for neonatal resuscitation equipment.

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Table 1: Reprocessing steps for neonatal resuscitation devices.6,7

PART I Decontamination

• Makes inanimate objects safer to handle by staff before cleaning by inactivating infectious diseases such as hepatitis B virus and HIV and reduces, but does not eliminate, a number of other microorganisms. For example, decontamination does not eliminate M. tuberculosis.7

• This step recognizes that in low-resource settings health workers may not have the personal protective equipment (PPE) they need.

PART II Disassembly

Allows for proper contact of the cleaning and disinfecting agents/methods to reach all surfaces.

PART III Cleaning

• Removes visible soil, both organic and inorganic material, from objects and surfaces. • Necessary step for all medical equipment regardless of further reprocessing activities since any organic or inorganic material remaining on

the surface of the equipment will prevent equipment from being properly disinfected or sterilized.7

PART IV Sterilization/ Disinfection

It is vital that specific procedures be followed for disinfection or sterilization in regard to time, temperature, and appropriate chemical concentration. Otherwise, reprocessing may not be effective and/or equipment could be damaged. Sterilization: • Required for items classified on the risk scale as “critical” and may also be appropriate for some items classified as “semi-critical.” Most

instructions reviewed (including manufacturers’ instructions) recommend sterilization as ideal for neonatal resuscitation equipment. Table 2 lists all the instructions reviewed.

• Destroys or eliminates all microorganisms, including bacterial spores. Sterilization is required for all equipment that enters sterile tissue, a sterile cavity, or the vascular system.

OR Disinfection: • Types of disinfection are chemical and thermal (includes boiling, steaming, pasteurizing). • Eliminates many or all pathogenic microorganisms, except bacterial spores. The levels of disinfection described below include examples of

their effectiveness and limitations. • The three levels of disinfection are low-level, intermediate-level, and high-level. The level of disinfection required is dictated by the

equipment purpose. In the case of neonatal resuscitation equipment, most instructions reviewed indicate that high-level disinfection is required if sterilization is not done. All levels of disinfection are described in Appendix B. High level: This is the minimum disinfection required for items classified on the risk scale as “semi-critical,” but sterilization may also be appropriate for some semi-critical items. High-level disinfection destroys all microorganisms except some bacterial spores, particularly if there is heavy contamination. High-level disinfection can be achieved chemically by soaking equipment in the correct concentration of a disinfectant and during the correct time and temperature to achieve the appropriate level of disinfection. It can also be achieved by boiling the equipment for 10 to 20 minutes.7,8

PART V Reassembly

• Necessary step so that the equipment is ready for urgent use. • Should include inspection of individual parts and of functionality of reassembled device.

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PART VI Storage

• High-level disinfected equipment must be stored in a manner that protects it from environmental contaminants. • Sterilized equipment must be stored in a manner that maintains the sterility of the equipment. When equipment is packaged the integrity of

the wrap must be maintained and act as an effective bio-barrier during storage. The equipment must be stored away from environmental contaminants and must be used immediately upon unpacking.5 There are a variety of packaging materials indicated for sterilization, including wrapped instrument cassettes, paper bags, cloth, aluminum foil, and polyfilm plastic tubing. The selection of packaging material is guided by the type of sterilization equipment used.9 For example, a material that is suitable for steam autoclaving may not be appropriate for dry heat or chemical vapor sterilization.

• HBB recommends storing equipment in clean plastic bags or boxes used only for that purpose.10 Table 2: Examples of detailed reprocessing steps for resuscitation equipment by source.

Source Decontamination Disassembly Cleaning Drying after cleaning

Sterilization or HLD

Drying after HLD

Visual inspection and reassembly

Function testing Storage

Laerdal silicone resuscitator11

NO √ √ √ √ √ √ √ √

Laerdal NeoNatalie resuscitator12

NO √ √ √ √ √ √ √ √ (does not specify how to store)

Laerdal Upright resuscitator13

NO √ √ NO √ √ √ √ √ (does not specify how to store)

Jhpiego7 √ √ (loosely referred to in a different section of

the document)

√ √ NO N/A NO NO √ (loosely referred to in a different

section of the document)

Jhpiego14 √ NO √ √ HLD only (sterilization

indicated as “not necessary”)

√ NO NO √ (instruction found loosely in a

different section of the document)

WHO15 NO √ (partial)

√ NO √ √ √ √ NO

WHO5 NO NO √ √ √ NO NO NO √ (does not specify how to store)

WHO CC AIIMS16 NO √ √ NO √ √ NO √ √

HBB Flipchart10 NO √ √ NO HLD only √ √ √ √

HBB Clinical Reminder17

√ (recommended AFTER

disassembly)

√ √ NO √ √ NO √ NO

National Neonatology Forum (India)18

√ (unclear, contradictory

instructions)

√ √ NO √ √ √ (reassembly only)

NO NO

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In a variety of reprocessing guidelines and reprocessing training materials currently available in the public domain, the terms decontamination and disinfection are used interchangeably even though they are, in fact, different processes with different intentions. Throughout this report, “decontamination” refers to the process of making the device safer for the health care worker to handle before cleaning by inactivating infectious agents such as hepatitis B virus and HIV, while “disinfection” refers to the process of removing pathogenic microorganisms to make the device safe for use on a subsequent patient.

Any object in a health facility can become contaminated with pathogenic microorganisms and serve as a vehicle in transmission of nosocomial infections, including neonatal resuscitation equipment of which there are several examples in the literature.19,20,21 In developing countries, nearly 50% of early onset neonatal bloodstream infections are due to gram-negative bacteria, such as Klebsiella, Pseudomonas, and Acinetobacter. These gram-negative bacteria are known to cause common-source outbreaks because they flourish in multiple-use containers of medications, liquid soaps, and other solutions (including antiseptics and disinfectants), and on insufficiently reprocessed medical equipment.22 Respiratory therapy equipment, including bag-and-mask resuscitators and suction devices, are classified as semi-critical on the risk scale5,6 meaning that they require high-level disinfection. In general, resuscitation equipment does not require sterilization, but sterilization is preferred for neonatal resuscitation equipment if feasible and not harmful to the equipment. Lack of preexisting immunological memory makes both preterm and full-term infants more vulnerable to infectious agents than older children and adults.23 Therefore, additional precautions must be taken when reprocessing medical equipment that comes in contact with neonates.

Disinfectants recommended for decontamination and high-level disinfection

In low-resource settings, sodium hypochlorite (household bleach) and alcohol are recommended for decontamination of medical equipment. For HLD, the United States Food and Drug Administration recommends specific chemicals that are not frequently found in low-resource settings. Appendix C provides further information on the chemicals and dilution instructions relevant for this study.

2. Methods

This qualitative study employed individual in-depth interviews along with semi-structured observations to collect information from a sample of health care workers who were responsible for conducting the reprocessing of neonatal resuscitation equipment in central and eastern Uganda. Data collection took place in 13 reprocessing units within 9 health facilities in March 2015.

PATH received a non-research determination from the PATH Research Determination Committee (RDC #0682) as well as approval from the Mulago Hospital Research and Ethics Committee (Kampala, Uganda) and the Uganda National Council for Science and Technology. Further, the Uganda Ministry of Health provided permission and a letter of introduction for each heath facility that was visited.

Site selection and recruitment

HBB partners working in Uganda were asked for the contact information of facilities where HBB had been implemented. Sites were then selected in collaboration with the PATH Uganda office in locations

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that enabled efficient use of time allocated for data collection, aiming to include all levels of care in urban and rural settings. Uganda restricts deliveries to facilities classified as Health Centre III and above; therefore, it was not recommended to visit any Health Centre II locations.

Sample size

Purposive sampling was utilized. A total of 16 participants from 9 facilities (comprising 13 units total) were recruited to participate in the study. Observations were conducted as part of the interview process with all 16 participants in all 13 units.

Eligibility criteria

Facilities selected for this study were health care centers and hospitals in central and eastern Uganda, both in urban and rural settings, where deliveries are performed (Health Centre III level and above) and that had received training in the HBB neonatal resuscitation curriculum. Although reprocessing of neonatal resuscitation equipment is not the main focus of this curriculum, reprocessing of resuscitation equipment is described in the curriculum materials and taught in the course.

All participants recruited fulfilled the inclusion criteria. The study was open to both male and female participants, but the health workers responsible for reprocessing of neonatal resuscitation equipment at the sites visited were all female. All were over the age of 18, were fluent in English, and were directly responsible for reprocessing neonatal resuscitation equipment.

Study procedures

Facility characteristics were collected at the start of the interview/observation process from the in-charge nurse/midwife of the unit using a separate data collection form.

An in-depth interview guide and a separate semi-structured observation guide were initially developed for this study. Pre-testing of the tools was done at a nonprofit private health facility in Uganda that was not part of data collection. During pre-testing it was noticed that the health worker being interviewed would describe their process using certain materials and certain steps for reprocessing, but when asked to demonstrate them, the actual process was quite different. Moreover, it was clear that the units were very busy and did not have enough space for someone to remain there for an extended period of time or to pretend to be observing something other than the process of interest. Based on the above, it was decided to merge the existing items of the interview and observation guides into a single data collection tool. This allowed for improved accuracy and decreased time required to perform both activities and in that way allowing the interviewers/observers to visit all the selected facilities in the two geographic regions.

The semi-structured interview/observation guide explores the health workers’ perspectives and behaviors around reprocessing of neonatal resuscitation equipment. It collects information on described and demonstrated reprocessing practices and the environment where they occur. Data collection included photography of materials, facilities, and processes without capturing health workers faces or other personal identifiable features. The final interview/observation guide can be found in Appendix D.

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The selected health facilities were contacted beforehand to schedule a visit. All interviews/observations occurred during day time. Fixed interview times with specific health workers were not recommended by the facilities as their activities varied depending on patient and facility needs. On the day of the visit, health workers were selected from those present in the unit at the time of the visit and who were not performing a delivery or other urgent activities. Permission was obtained from the health workers to be interviewed and observed, and if agreed, a consent form was signed and they were provided with a copy of the consent form.

Interviews/observations were conducted in English by research team members with medical clinical background. Health workers were first interviewed sitting in whatever comfortable space was available in the unit (a separate office, a table and chair within the unit, etc.). Then, health workers were asked to show the reprocessing area, demonstrate the steps taken, provide access to the neonatal resuscitation equipment, and answer other questions that required visual confirmation. The interaction with the health worker ranged from 60 to 90 minutes and further observation/note taking required an additional 45 minutes in most cases. Data were entered directly into the printed data collection tool.

Data management and analysis

An electronic data repository was created by PATH in Microsoft Excel and Word to facilitate organization, security, quality control, maintenance, and analysis of study data.

Information obtained from the interviews/observations was analyzed using a qualitative, thematic approach. The analysis of data involved sorting, categorizing, and summarizing data manually to create table matrices framed by the key areas of inquiry. Descriptive and qualitative content analysis was performed using Microsoft Excel and Word.

3. Results

Facility characteristics

Nine facilities and 13 units were visited. Interviews and observations were conducted in the labour ward of each facility (total 9 units) and also in the Special Newborn Care Unit (SNCU) if one existed at the facility (total 4 units). Annual deliveries at the facilities in this study ranged from approximately 300/year (25/month) to almost 22,000/year (1,800/month). Table 3 outlines the types and numbers of facilities and units visited within each facility.

Table 3: Types and numbers of facilities and units visited.

ID Type Ownership Location Units visited

1 National referral Public Urban Labour ward, SNCU

2 District hospital Private not for profit Rural Labour ward, SNCU

3 Regional hospital Public Urban Labour ward, SNCU

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ID Type Ownership Location Units visited

4 Health centre III Public Urban Labour ward

5 Health centre IV Public Rural Labour ward

6 Health centre III Public Rural Labour ward

7 Health centre IV Public Rural Labour ward

8 Health centre IV Public Urban Labour ward, SNCU

9 Health centre III Public Semi-urban Labour ward

Facilities did not have records on number of HBB trainings received and date of last occurrence. In most cases, it was only possible to collect this information on an individual level, which is reported in the health worker section of the results.

Through the interviews it was determined that 8 out of the 9 facilities had an infection control committee (ICC). However, as outlined in Table 4, the participants’ perceptions of the level of activity was variable and nosocomial infections were perceived to be rare in most cases. Level of ICC activity or engagement did not appear to be related to type of facility or location (urban vs. rural).

Table 4: Types and numbers of facilities and units visited.

Facility ID

ICC Participant’s perception on ICC’s level of activity

Participant’s perception of nosocomial infection rate at facility

1 Yes Very active Does not know

2 Yes Meets monthly None in SNCU, but participant doesn't know about rest of facility

3 Yes Not active Not doing well

4 Yes Does not know Not tracked

5 Yes Not functional. Meets only when there is need. Rare cases

6 No About to form a committee Rare cases

7 Yes Does not meet regularly. Over one year since last meeting.

Not common

8 Yes There is a committee, but unaware if committee meets. Have never seen them visit labour ward.

Not common

9 Yes Meets every 2 months Not common. Maybe once per month.

Health worker training and experience

Sixteen health workers were interviewed, some of which belonged to the same unit. The cadres responsible for reprocessing neonatal health equipment in these health facilities were nurses (4), midwives (9), nurse/midwives (2) and student nurse (1). Several participants were also in supervisory or management roles within the unit or health center. Of the 16 health workers, three were nursing/midwifery officers and five were the in-charge or deputy in-charge nurse/midwife of the unit.

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The nursing/midwifery experience of the 16 participants, including a student nurse, ranged from 2 years to 25 years. All but two health workers had received specific training on reprocessing of neonatal resuscitation equipment. The source of the initial training (in general or specifically for neonatal resuscitation equipment) varied from receiving the training at school (25%), from a colleague or supervisor when joining the unit (44%), or through HBB training (19%). Twelve percent of participants did not receive any training specific to the reprocessing of neonatal resuscitation equipment.

At the time of the study, 11 of the 16 health workers (69%) reported that they had received refresher training on reprocessing of neonatal resuscitation equipment. Most of the refresher trainings took place within the past two years and 64% of them received it during HBB training, while the rest received it from visiting staff or a senior colleague. It is important to note that the content of the refresher training could encompass a wide variety of information and may not necessarily be focused solely on reprocessing of neonatal resuscitation equipment.

For the five health workers who indicated that they had not received refresher training, this was not necessarily associated with length of employment or location. The years of experience in their position ranged from 2.5 years to 13 years in the same facility. Four of these health workers were at facilities located in urban areas and one was at a rural health facility. Regular training schedules for reprocessing of neonatal resuscitation equipment were not common. One health worker noted that she received regular training when the HBB mentor visited the facility every few months. Otherwise, training occurs haphazardly or when new nursing staff or students begin working in the unit.

All health care workers interviewed were aware of nosocomial infections and of the importance of reprocessing neonatal resuscitation equipment. However, they perceived certain pieces of the resuscitation equipment to be dirtier than others, such as the suction device, and therefore considered them to be more important to clean than other pieces. Interviewees did not have in-depth knowledge about the level of nosocomial infections in their unit or in the facility.

More than 50% of the health workers interviewed in this study reprocessed neonatal resuscitation equipment at least once a week, while the rest engaged in this activity more sporadically. Table 5 outlines frequency of reprocessing of neonatal resuscitation equipment. This variability was desirable for sampling purposes and reflecting the number of births at the facility requiring resuscitation per month.

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Table 5: Frequency of neonatal equipment reprocessing by participant

Frequency Number of participants

Daily 3

Twice per week 4

Once per week 2

Once or twice per month 2

Once every two or three months 4

Very infrequently 1

TOTAL 16

Health worker supervision

Minimal supervision occurred with the reprocessing of neonatal resuscitation equipment in facilities visited. Ten (62.5%) of the 16 participants indicated that they receive no supervision in regard to reprocessing. However, of these ten, 2 stated that because they are the in-charge nurse/midwife for their respective units, they provide supervision for reprocessing of neonatal resuscitation equipment rather than receiving supervision. Of the remaining 6 (37.5%) health workers who stated that they receive supervision, only two received supervision with any regularity. One stated that she received daily supervision by the in-charge nurse, and one stated that she received supervision from the HBB mentor every three months. All others indicated that they received occasional supervision, but the frequency of this supervision is uncertain. There is some discrepancy; however, in regard to level of supervision provided. Examples of this discrepancy include:

- An in-charge nurse/midwife participating in the interview process stated that she provided supervision for reprocessing, but another staff member in the same unit and from the same shift stated that no supervision was provided.

- In another hospital, staff members in the same unit and same shift provided different responses regarding reprocessing supervision. One nurse stated that the senior nurse was keen to observe how staff clean the equipment while another nurse in the same unit stated that there was no supervision and explained that it was assumed that once a staff member had been given instruction then they knew what to do.

When asked who they would speak to with questions about reprocessing, most respondents stated that they would ask a senior colleague, the in-charge nurse/midwife, or the HBB trained staff either in their unit or another unit within the hospital. One respondent stated that she did not know who to ask if there was a question, and another stated that there was no one to ask and further stated, “…those providing bags should teach us.”

Availability of guidelines

When asked what guidelines or instructions the health worker followed, 15 (94%) said that they did not have any guidelines. However, in 3 of the 13 units visited (within 2 facilities), there were posted

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guidelines. Further, health workers were not referencing manufacturer reprocessing instructions for the devices.

In terms of the three units where there were posted guidelines, only 1 of the 16 participants was aware that the guidelines were posted. In the other two cases it was observed that guidelines were posted, but the participants were not aware of them. In one of those two units, the posted guidelines were specifically focused on the reprocessing of neonatal resuscitation equipment and were posted over the resuscitation table, a few feet from the area where the equipment is reprocessed. Further, the instructions described reprocessing using Cidex®, a brand of high-level glutaraldehyde disinfectant that the unit did not have access to. In the other unit that had guidelines posted, the reprocessing instructions were part of the HBB resuscitation poster in which the reprocessing instructions appear in small font underneath the resuscitation instructions. In the latter instance, two nurses interviewed from the same unit were not aware that the HBB poster contained instructions for reprocessing. Further, because the main focus of the poster was resuscitation, it was posted next to the resuscitation area, not the reprocessing area. Finally, in two other units visited it was indicated by the participants that the guidelines had been posted in the past but had been removed and were not reposted. Per new policy in that facility, posting directly on the wall was forbidden but was permitted on a designated board, which they did not have during the study visit.

Photograph 1: Reprocessing Instructions focused on Cidex,

which was unavailable in the unit.

Photograph 2: Reprocessing instructions in the lower-half of

the HBB poster. Health workers were unaware of the

reprocessing instructions on the poster.

Reprocessing areas

The space where reprocessing took place in each unit was generally small, cramped and of variable cleanliness. Conditions varied even between units in the same facility. Only one of the 13 units visited appeared to have sufficient space for health workers to reprocess equipment, and this space was located outdoors. However, due to the space being outdoors, leaves and other debris had blown into uncovered

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reprocessing buckets and the sun directly hit those buckets at a certain time of the day, which can degrade the bleach. In contrast, the other unit visited within the same facility had a small, cramped reprocessing space indoors. In most cases there was not a separate room for reprocessing, and the work was done immediately adjoining to the labor or resuscitation space or in a public area of the facility, such as a hallway. While most reprocessing spaces were clean, some were found to be dusty and/or disorganized. Further, one reprocessing space had trash on the floor, one had blood on the floor, and one did not have a working sink. In the latter case, water had to be obtained from a sink in another room and brought to the reprocessing space. The reprocessing areas were never marked as such. In all cases, the decontamination and cleaning steps for reprocessing were conducted using buckets or containers for liquids. In cases where the buckets/containers were located on the floor, the health worker was required to bend over or crouch to clean the equipment.

Photograph 3: Debris in uncovered bucket.

Photograph 4: Reprocessing buckets in public hallway.

Equipment

In the cases where there was both a labour ward and a SNCU in a health facility, the units within the same facility had variable access both to reprocessing equipment and resuscitation equipment. This could be based upon perceived need, but equipment forecasting was not being done, so it was unclear how the amount of equipment for each unit was determined.

Reprocessing equipment

Per existing guidelines, equipment required for reprocessing neonatal resuscitation equipment includes:

• Disinfectant (for decontamination) • Mild detergent or soap (for cleaning) • An autoclave for sterilization; or glutaraldehyde (“Cidex”) or sodium hypochlorite (0.1%+boiled

water or 0.5%+tap water7), or boiling apparatus for high-level disinfection • High-level disinfection logbook • Buckets or containers for liquids • Clean water

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• Sink • Clock • Scrub brushes or other method of providing friction to scrub equipment • Towels for drying or a clean, protected space for air drying • Clean, covered storage containers • Personal protective equipment. This includes gloves, eye protection, apron/gown, mask, cap,

closed-toed shoes)

Table 6 describes whether health workers had access to the required reprocessing equipment and their expressed needs for it.

Table 6: Access to necessary reprocessing equipment.

Equipment Access

Disinfectant (for decontamination)

All facilities had access to JIK®, a brand of sodium hypochlorite (NaClO, household bleach) that is popular in Africa, in either 3.85% or 6% concentration; one unit also used calcium hypochlorite (CaCl2O2) granules that were pre-packaged by the hospital pharmacy. In the facility where the calcium hypochlorite was used, there was a discrepancy between health worker interviews as to which equipment it was used for. One health worker said it was only for decontaminating the suction bulbs and they used JIK for disinfecting other pieces of the equipment. While another health worker in the same unit said that calcium hypochlorite was used for all resuscitation equipment and JIK was only used to decontaminate surfaces or when they ran out of calcium hypochlorite. Multiple participants noted that their unit occasionally runs out of JIK. Two health workers in different facilities specifically stated that if there was a better disinfectant than bleach they would use it.

Mild detergent or soap While all facilities had access to soap/detergent, there was one unit that had no soap/detergent while another unit in the same facility had soap/detergent. Interviewees noted that their unit occasionally runs out of soap/detergent and they would prefer to have a reliable stock of it.

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Equipment Access

An autoclave for sterilization, or glutaraldehyde (“Cidex”), or sodium hypochlorite (0.1%+boiled water or 0.5%+tap water) for HLD or boiling apparatus for HLD

Sterilization: Three units (in two facilities) always autoclaved suction devices but no other components of the resuscitation equipment. In two other units health workers noted that they had access to an autoclave but very rarely used it for resuscitation equipment. Further, in six units there was an autoclave either in the unit or in the facility, but the staff did not use it for resuscitation equipment. In one of these instances, the autoclave could not be used because it was a donation that had a North American plug. In one instance, the health worker noted that they do not have enough resuscitation equipment that could withstand the autoclaving process (referring to single-use devices). High-level disinfection: Only one unit out of the 13 visited had access to Cidex, but it was an infrequent supply and was rarely used even when in stock because only the matron knew how to mix it and they did not like it because it discolored the silicone masks. Within the same facility, another unit did not have access to Cidex, but wished they could use it. Even though sodium hypochlorite (household bleach) was available at all facilities, none used it for HLD. Two units had boiling machines or solar stoves for boiling, but rarely used them for resuscitation equipment (one of these units also had an autoclave, but it was never used for resuscitation equipment). A further three units had access to boiling machines or solar stoves used for boiling but did not use them for resuscitation equipment. Two units that regularly autoclaved the suction devices also had boiling machines in case the autoclave was not functioning.

HLD logbook Only 1 of the 13 units visited had an HLD logbook. Another unit within the same facility did not have an HLD logbook.

Buckets or containers for liquids

The containers for liquid preparations (disinfectant, detergent, or clean water) were either metal or plastic. In the cases where metal was being used, the containers often had rust spots. In most units plastic buckets were used for the JIK solution since chlorine corrodes metal. However, in one unit it was specifically noted that metal containers were being used for the JIK solution. While all units had containers for reprocessing, participants often expressed a wish for more buckets. One participant noted that sometimes there are not enough buckets to clean the equipment properly, so the same bucket is used for multiple reprocessing steps.

Clean water Clean tap water was available in all facilities, but a few days per month running water was unavailable. Units plan for this and always store water in advance in large containers so that it can be used when running water is not available.

Sink All but one unit had a working sink.

Clock Clocks were generally available. In cases where there was either no clock or a non-functioning clock, a personal watch was used. However, during visits it was observed that time was not always tracked during decontamination.

Scrub brushes or other method for scrubbing

Only one unit out of 13 visited had access to scrub brushes, and within the same facility another unit did not have access to scrub brushes. In general, clean (unsterile) gauze or towels were used for scrubbing, but it was observed that the towels did not appear to be clean. Interviewees frequently expressed a wish for scrub brushes of varying sizes to facilitate cleaning of equipment.

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Equipment Access

Towels for drying equipment or clean, protected space for air drying.

Four units used gauze to dry equipment following reprocessing. The remaining nine units allowed equipment to air dry. In all cases where equipment was air drying, it was left in the open. Locations were often dusty and were often crowded with other equipment or close to areas with equipment that had yet to be reprocessed.

Clean, covered storage containers

While 9 of the 13 units (69%) stored reprocessed equipment in dry, covered containers, in only 3 of these were the containers also clean and free of debris, rust, and/or dust. In the remaining units, the equipment was stored on trays next to the resuscitation area or in uncovered dusty/rusty containers.

PPE: gloves, eye protection, apron/gown, mask, cap, closed-toed shoes

Access to PPE was variable across and within facilities. No unit had all the types of PPE indicated. Only one unit had five of the six PPE items and within the same facility another unit only had two of the six PPE items. In all cases gloves were available but sometimes ran out. Respondents expressed a wish for heavy duty gloves, aprons, face masks, gum boots, and eye protection. In two units, eye protection, masks, and aprons were available but were not being used.

Eleven of 16 (69%) respondents identified lack of reprocessing equipment as a factor needing to be addressed. Items that were noted as lacking in eight of the nine facilities included scrub brushes of various sizes, goggles, aprons, gum boots, buckets, and adequate amounts of disinfectant and detergent/soap.

Resuscitation equipment

Facilities did not have aggregated information on the amount of neonatal resuscitation equipment available in the entire facility, so in most cases it was only possible to collect the unit-level information. However, most units did not seem to have a strict record of how many devices they had, and in many instances it was not clear if the equipment was available or in storage, was reusable or intended for single-use but was being reused. Further, in most cases the health workers were not aware of which brands of resuscitation devices they had in their unit, and upon inspection of the devices available in the unit it was not always possible to determine the brand.

Amounts of resuscitation equipment differed between the labour wards and SNCUs in the same facility, and in most cases SNCUs had more equipment than the labour wards did. It is possible that resuscitation equipment is expected to be used more frequently in the SNCU where unstable newborns are admitted and that may account for the decision to procure variable amounts of equipment. Moreover, it seemed that the department head (Pediatrics vs. Gynecology) made the decision on amounts of equipment needed, but it was not possible to explore this further.

Table 7 describes the amount of equipment reported as available by the staff interviewed. As mentioned above, these amounts are not to be considered accurate as no tracking report was available. Moreover, on several instances it was noticed that an amount was reported but then when gaining access to some of the equipment the amounts differed (more devices observed than reported by the staff in some cases).

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Table 7: Equipment reported as being available for neonatal resuscitation use. Note: Type of bags (single-use/reusable), size of masks, and type of suction devices are unknown unless specified.

ID Births per month Equipment type SNCU Labour ward

1 1,825 Bags 20 2

Masks 50 8

Suction devices 20 (bulb)

5

2 190 Bags 9 (plus more in storage)

7 (plus more in storage)

Masks 39 (plus more in storage)

23 (plus more in storage)

Suction devices 42 51 (50 bulb and 1 unspecified)

3 570 Bags 5 2

Masks 11 4

Suction devices 2 (penguin)

2 (1 penguin, 1 bulb)

4 30 Bags Unit not visited or does not exist in

facility

1 (reusable)

Masks 1 (size 1) NOTE: size 0 mask was missing.

Suction devices 1 (mechanical)

5 70 Bags Unit not visited or does not exist in

facility

3 (1 single-use, 2 reusable)

Masks 4 (two size 0, two size 1)

Suction devices 3 (2 penguin, 1 mechanical)

6 25 Bags Unit not visited or does not exist in

facility

2 (reusable)

Masks 4 (two size 0, two size 1)

Suction devices 3 (2 penguin, 1 bulb)

7 120 Bags Unit not visited or does not exist in

facility

5 (1 single-use, 2 reusable, 2 unspecified)

Masks 7 (three size 0, four size 1)

Suction devices 4 (2 penguin, 2 bulb)

8 480 Bags 1 (single-use)

3 (reusable)

Masks 5 2

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ID Births per month Equipment type SNCU Labour ward

Suction devices 1 (penguin)

1 (bulb)

9 100 Bags Unit not visited or does not exist in

facility

3 (1 single-use, 2 reusable)

Masks 3 (one size 0, one size 1, one size unspecified)

Suction devices 4 (1 penguin, 3 bulb)

During interviews and observations it was clear that few units had sufficient resuscitation equipment to meet their needs. In all units with high patient volume and births the staff were so busy caring for patients continuously that they did not have enough time to adequately reprocess each piece between uses. In other cases, the unit was less busy and technically had a sufficient amount of equipment to meet their patient volume needs, but when the equipment was inspected it was found to be broken or incomplete. In one unit, the disk membrane inside the device was disintegrating and tore upon inspection. In two units, in different facilities, the staff noted that the night shift would not reprocess neonatal resuscitation equipment after use, so it was not ready for use the next morning. The reason the night shift did not clean equipment was not clear.

When equipment was needed for resuscitation and it had not been reprocessed yet, participants noted that they either had to shorten or skip reprocessing steps, or they had to borrow equipment from another unit when possible. In some facilities, equipment was locked up to prevent loss, particularly with suction penguins.

In several instances, it was noted that equipment had been lost or that items had to be locked up to prevent loss. In one unit visited, there was only one bag-and-mask device available because the others had been lost when lending them for ambulance use during patient transfers. In several instances, the participants noted that because there were no replacement parts available entire devices had to be replaced, but the replacements took a long time. In such cases where a facility only has one or two bags available, it is problematic when a device breaks and requires a significant amount of time to receive a replacement.

Knowledge of the life cycle of resuscitation equipment appeared to be minimal. Single-use bag-and-mask devices were often used and reprocessed as reusable equipment and staff were unaware that there were both single-use devices and reusable devices or which type they were using. In two units visited, single-use masks were missing the air cuff, but the staff were unaware that the mask was incomplete and continued to use the mask.

Reprocessing practices

Health workers noted that they begin the reprocessing of neonatal resuscitation equipment immediately after use, once the mother and baby are stable. One health worker did note that while equipment was normally reprocessed immediately, there could occasionally be a delay of up to one hour. In such cases the equipment would be put into the sink so that it was not confused with clean equipment.

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The main steps described in current documents that consider the needs of low-resource settings include:

- Decontamination - Disassembly - Cleaning - Drying (air or towel) after cleaning - Sterilization or high-level disinfection (HLD) - Drying (air or towel) after HLD - Reassembly, inspection, and function testing - Storage

Although three units sterilized the suction bulbs, they did not use sterilization or HLD with any other piece of the resuscitation equipment. Therefore, in no facility did all of the reprocessing steps occur for every piece of equipment. While there was variation among the process that each participant followed, the most common procedure was:

- Removal of mask from bag only (note: many of the bag-and-mask devices observed were single-use devices being reused and are not designed for further disassembly).

- Wiping the outside of the bag with a gauze pad soaked in diluted bleach and returning to storage or tray.

- Decontamination of the mask and suction device by soaking them in a diluted bleach solution for approximately 10 minutes. If the health worker did not have sufficient time or needed to reuse the equipment immediately, the soaking lasted less than 10 minutes.

- Cleaning of mask and suction device in soapy water using clean gauze to scrub the items. Rinsing with clean water.

- Air drying if time allowed or drying with clean gauze or towel. - Return items to tray or storage area.

When asked how long it took them to reprocess the neonatal resuscitation equipment, the average time was 23 minutes [responses ranged from 15 to 30 minutes]. When considering the time that was required to reprocess a piece of equipment, the health workers were describing how long it took them to decontaminate, clean, and dry the equipment in units where drying was done by hand. When equipment was air dried it was noted as adding a further 1 to 3 hours to the process. It is clear that the answers reflect the process when there are no time constraints. One health worker noted that there have been times when resuscitation equipment in her unit has been cleaned in 2 minutes because it was needed for another patient. When asked what percentage of the time they were able to complete all the reprocessing steps that they had described and demonstrated at the time of the interview, it became clear that health workers’ time and resources are limited. Table 8 describes the frequency with which they were able to complete all steps (as defined by the health worker).

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Table 8: Percentage of time a health worker was able to complete each step of their particular reprocessing procedure.*

Percentage of time able to complete entire process* Number of health workers (%) (n= 15**)

100% of the time 5 (33%)

50% of the time 4 (27%)

Less than 50% of the time 6 (40%) *In most cases the health worker’s conception of “entire process” encompassed only the decontamination and cleaning steps. **Out of 15 health workers. One participant was not asked this question as the interview was cut short due to an interruption. When time was a constraint, health workers reported shortening or deleting steps from their reprocessing procedure (examples provided in the detailed sections below). Time constraints arose when the resuscitation equipment was needed for another infant or when the health worker was too busy with other tasks to devote time exclusively to reprocessing equipment.

Decontamination: Although decontamination was being performed, it was not always done for each piece of equipment. Discussion on ideal reprocessing procedures with the health workers suggested that they were not aware that the purpose of the decontamination step was to protect them, but rather they seemed to think this was a disinfection process. Instead of soaking all pieces of the bag-and-mask device in the bleach solution, most health workers soaked only the mask and suction device and wiped the bag with a gauze pad soaked with bleach solution. However, examples of exceptions to this process include the following:

- One participant decontaminated only the suction bulb by soaking it in the JIK (household bleach) solution and wiped the mask and bag with gauze pad soaked in JIK solution. This was a different process than what was done by her colleagues in the same unit, who were also interviewed and observed.

- Another participant, using only a small amount of JIK and water, scrubbed the bag and mask (still connected together) with a toothbrush that had just been used to scrub delivery instruments that were coated in blood.

Soaking time for decontamination was reported to be at least 10 minutes in most cases. In one facility, equipment was left soaking for 12 to 24 hours, in two units the equipment was only soaked for 5 minutes, and in one instance the health worker soaked the suction bulb, but only dipped the mask into a JIK solution. When reprocessing was rushed due to equipment need or time constraints of the health care workers, the soaking time was shortened. As noted, two health workers expressed frustration that their colleagues on the night shift were not reprocessing the resuscitation equipment after use. In these cases, it was not ready for use by the day shift, and time had to be spent reprocessing the equipment.

The bleach solution used for this step was prepared incorrectly by 11 of 15 health workers that were asked about this (73%). This error with dilution was largely due to confusion regarding the concentration of the sodium hypochlorite/JIK that is provided to the health facilities. None of the health workers had access to dilution instructions for sodium hypochlorite/JIK. In several instances it was noted that the instructions used to be posted but had been removed for some reason and were not replaced. Reasons for removal of the instructions included remodeling of the unit and the instructions were torn. In the facility that also used calcium hypochlorite crystals, one unit within that facility had posted dilution instructions for the

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calcium hypochlorite, but the other unit visited within the facility did not have any posted dilution instructions.

Health workers had received training from their peers, supervisor, or during their schooling on how to dilute JIK with 3.85% available chlorine to a 0.5% solution using 1 part bleach to 6 parts water (a 1:6 dilution ratio). However, although the 1:6 dilution ratio is intended to create a 0.5% chlorine solution using 3.85% sodium hypochlorite, none of the health workers were aware of what concentration of chlorine solution was intended to be created using the 1:6 rule.

There are no less than 9 concentrations of household bleach available worldwide. At the health care facilities visited in Uganda, each one used JIK brand sodium hypochlorite, but there were two possible concentrations. One contained 3.85% available chorine and the other contained 6% available chlorine. Health facilities do not consistently have access to the same concentration of JIK. The government supplies them with JIK, but patients are also asked to bring a small bottle of JIK for delivery, and they are not instructed of which concentration. To achieve a 0.5% bleach solution, these require different dilution ratios. Although health workers were aware that JIK bottles have different colored labels, only one health worker of those interviewed was aware that there are two concentrations of JIK and that she needed to adjust the dilution accordingly.

The JIK available in Uganda has three different label colors. Orange and yellow labels are on the bottles of 3.85% (orange indicates regular bleach, while yellow indicates lemon scented) and light blue labels are on bottles of JIK 6%. Although the concentration is printed on the bottle, as with bleach packaging in other countries, the concentration is in small font and might not be noticed unless one was specifically looking for it. In order to achieve a 0.5% chlorine solution, the JIK 3.85% requires a dilution of 1:6 while the JIK 6% requires a dilution of 1:11. Since a health facility does not always have access to the same concentration of bleach, it is possible that at some times the health workers are properly diluting the JIK as they use the same 1:6 dilution rule regardless of whether they have a bottle with an orange label, a yellow label, or a blue label. Of the four health workers that were properly diluting the JIK, only one was aware of the different concentrations and adjusted the dilution accordingly.

Photograph 5: JIK 3.85% available

chlorine.

Photograph 6: JIK 3.85% available

chlorine lemon scented.

Photograph 7: JIK 6% available

chlorine.

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Although the majority of the health workers used the 1:6 dilution ratio to prepare the chlorine solution, there were several health workers that used some other dilution regimen. In one unit, the health workers used a 1:6 dilution only to decontaminate resuscitation equipment used in babies considered as infectious, while the resuscitation equipment used on other babies was further diluted with more parts of water that resulted in a 0.05% chlorine solution when using JIK 3.85%. Even when they were actually starting with JIK 6% and creating a solution closer to a 0.1%, this would have been effective for decontamination only if they had prepared the dilution using boiled water, which was not the case. One health worker used a 1:1 dilution ratio, one was using a 1:2 dilution ratio, and one was adding half of a 250-ml bottle of JIK with just enough water to cover the equipment. However, in this last case, another health worker in the same unit was using the 1:6 dilution ratio. In another unit one health worker indicated that JIK is used for reprocessing of neonatal resuscitation equipment, while another health worker in the same unit indicated that the JIK solution is only used to wipe surfaces and that calcium hypochlorite was used for equipment reprocessing. In a third unit, a student nurse (who was not being interviewed) was observed adding only an unmeasured small amount of JIK to the water, and when asked about the dilution formula, she did not know about it. Some of these responses and observations demonstrate that there can be variability within the processes of health workers in the same unit and on the same shift. It is possible that the responses and actions of some health workers being interviewed may reflect a social desirability bias as they may have been describing or demonstrating the ideal situation.

In most cases, the bleach solution the health workers were preparing was over-concentrated and the efficacy of decontamination is not at risk if the solution is used as recommended. However, bleach can be corrosive if equipment is left soaking for more than 20 minutes.7 This can cause damage and shorten the longevity of medical equipment. This could be of particular concern in the instances when the staff leave the equipment soaking in a bleach solution for hours. However, when the solution prepared is less than 0.5% chlorine, it may not be effective for decontamination; the lower the concentration of chlorine, it becomes more important to use boiled water since tap water contains microscopic organisms that can inactivate chlorine.7

In one unit, JIK was mixed with detergent as a combined decontamination and cleaning step. In this case, the solution would only be useful for cleaning (if also scrubbing off organic material during this step), but the efficacy of bleach would likely be affected for the purposes of decontamination. Further, while most units kept the bleach solution in a covered container, five units (in four different facilities) left buckets uncovered, which might diminish the bleach solution strength due to oxidation and could permit organic debris to fall into the solution. Moreover, these uncovered solutions were often placed in close proximity to patients, including infants, exposing both patients and health workers to irritant fumes.

Bleach solution becomes unstable over time and, therefore, less effective and should be changed daily. All but two units reported preparing their bleach solution either daily or on demand at the time of a delivery. Of the two units that did not prepare it daily or on demand, they reported that they changed the solution when it became cloudy.

All units conducted reprocessing activities indoors, except one unit where it occurred outdoors and the container of bleach solution was exposed to the elements. Sunlight and heat both degrade sodium hypochlorite. Although the bucket was covered and the contents were not exposed to direct sunlight for long periods of time, the bucket was sitting in direct sunlight for hours, which caused the contents to

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become hot. It was not possible to take temperatures of the bleach solution so it is unknown if it had reached the temperature where heat-related degradation begins to occur.

Disassembly: In all cases where disassembly was done, it was done before decontamination and not after. In the cases where single-use bags were being reprocessed, it was only possible to remove the mask from the bag. In the cases where reusable bags were being reprocessed, full disassembly of the bag was rarely done, and only the mask was removed. In one unit, a health worker indicated that they only disassembled the bag when meconium was involved. A health worker in another unit stated that disassembly is part of the routine procedure. However, during demonstration it was observed that the health worker was unfamiliar with the device components and struggled to disassemble the device, which suggested that regular disassembly was likely not occurring. Moreover, while demonstration was taking place, a different health worker (not interviewed) in the same unit was observed following incorrect steps to reprocess a suction device. This suggests that the disassembly being demonstrated by the interviewed health worker was probably due to social desirability bias.

Cleaning: Cleaning was done using soapy water, except in the case of one unit that had no soap, so only the decontamination step was completed. As noted, another unit mixed the JIK and the detergent together. Items were scrubbed with clean gauze or a towel, although in some instances the towels did not appear to be clean. One health worker scrubbed the devices with her gloved hands rather than gauze or a brush.

Drying (air or towel) after cleaning: All items were air dried or dried with a clean (unsterile) gauze. However, it was reported that in a few instances the equipment would be used even if not dry. As noted previously, areas for drying were often dusty and/or crowded with other equipment. In some cases, the reprocessed equipment was drying close to equipment that had not yet undergone reprocessing.

Sterilization or HLD: This step was not done in the majority of units visited. Sterilization was only done by three units and exclusively for the suction device which was perceived as being dirty. In such cases, the suction device was sterilized along with the delivery kit by a health worker responsible for such activity. One unit reported performing HLD of all resuscitation equipment with glutaraldehyde (Cidex), but only rarely. Two units occasionally performed HLD by boiling for 20 minutes. No unit performed HLD with bleach solution. Even when most health workers were not aware of the life cycle of the bag-and-mask resuscitator, many did know that the resuscitators they had (single-use devices) could not undergo high-level disinfection or sterilization due to the materials they were made of (they had been instructed so). One health worker shared that some of their resuscitation devices had been autoclaved with metal instruments and had burst in the autoclave.

Noticing that in most facilities health workers only performed decontamination and cleaning, the research team reached out to a pediatrician in Uganda who is an HBB mentor to ask about reprocessing training. He noted that the training emphasizes decontamination, cleaning, and rinsing of equipment. However, while during training they state that sterilization and HLD can be done (boiling if no autoclave available), this step is not emphasized and is described as optional. He mentioned that this was true for the trainings he had been involved in but did not know how other trainings are conducted. (Two health workers specifically noted that reprocessing of neonatal resuscitation equipment was not included in their HBB training.)

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Drying (air or towel) after HLD: The two units that occasionally performed HLD by using a boiling apparatus would dry with gauze or leave equipment inside a closed container, which did not guarantee appropriate drying. Since most other units did not perform HLD, this step did not apply.

Reassembly, inspection, and function testing: Because disassembly was rarely performed for reusable bag-and-mask resuscitators, reassembly was not applicable. Inspection and function testing was rarely done following reprocessing, but function testing was described as done right before use.

Interviewees demonstrated how they check the functionality of the devices before use. From this demonstration it is clear that health workers appear to be unaware of the purpose of certain steps in the process. Depending upon the source, there are three to five steps involved in testing the functionality of the neonatal resuscitation device before use, as noted in Table 9.

Table 9. Steps indicated for testing functionality of resuscitation devices before use.

HBB clinical reminder (poster)17 Laerdal simplified NeoNatalie resuscitator guide12

1. Squeeze the ventilation bag and watch for the valve in the patient outlet to open as you squeeze. This shows the device is ready to deliver air to a patient.

Squeeze the bag and ensure the yellow lip valve opens with each squeeze. This indicates that air can be successfully delivered to a patient.

2. Seal the mask tightly to the palm of your hand and squeeze hard enough to open the pressure release valve. This shows that air which cannot be delivered through a blocked airway will escape through the pressure relief valve.

Squeeze the bag and ensure the yellow lip valve opens with each squeeze. This indicates that air can be successfully delivered to a patient.

3. Check the mask rim for any damage that could prevent an airtight mask seal to the face.

Seal the patient port connector to the palm of one hand. With the other hand press the index finger against the pressure release valve and squeeze the bag to ensure that no air escapes through the pressure release valve or from the bag.

4. __

Seal the patient port connector against the palm of one hand. With the other hand squeeze the bag and ensure that excessive air escapes through the pressure release valve.

5. __

Connect a patient mask to the patient port connector. Remove the bag from the patient valve. Press the bag into the mask opening to form a seal. Squeeze the bag to mimic the baby’s lungs and check that the bag can be squeezed without resistance.

Using the HBB instructions as guidance, health workers were observed while testing the functionality of the bag and mask resuscitator. Table 10 describes the results.

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Table 10: Observations of health worker actions and behavior when testing the bag-and-mask resuscitator.

Step outlined by HBB Participants completing this step (%) n=15*

Additional observations

Squeeze the ventilation bag and watch for the valve in the patient outlet to open as you squeeze. This shows the device is ready to deliver air to a patient.

7 (47%)

Seal the mask tightly to the palm of your hand and squeeze hard enough to open the pressure release valve. This shows that air which cannot be delivered through a blocked airway will escape through the pressure relief valve.

15 (100%) However, only 2 (13%) were observed to be listening for the sound that the air makes when it escapes from the pressure release valve. All others said that they were “feeling the pressure” or feeling the resistance of the bag.

Check the mask rim for any damage that could prevent an airtight mask seal to the face.

4 (27%) Only four participants actively noted that they check the mask as well as the device.

*The 16th participant was not asked to demonstrate as the interview was cut short due to an interruption.

Photograph 8: Function testing.

Although few health workers were listening for the air escaping from the pressure release valve, it is possible that they would notice if something was amiss with this valve but did not express it in such a way. When bags or other pieces of equipment were not functional, the health workers stated that they were removed from service and the matron or person in charge would obtain a replacement device since replacement parts were unavailable. However, some nonfunctional equipment was observed as still in use or included with the functional items. Health workers reported that there is often a long wait for replacement equipment.

Storage: In 9 out of 13 units (69%) the cleaned resuscitation equipment was stored in a dry, covered container, but in only 3 of these units were the containers clean and free of rust, dust, or other debris. These consisted of plastic boxes, metal boxes, plastic drawers, or a metal drum. Sometimes other medical equipment was also stored in the same container, such as a rusty speculum. In one unit, if equipment was boiled, it was left in the same boiling apparatus, covered, which prevented it from drying. However, if the equipment had only been decontaminated and cleaned, it was air dried and returned to the manufacturer’s box. In the remaining 4 units (31%), resuscitation equipment was stored on open trollies or another open

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surface. The frequency with which the storage container or storage space was cleaned varied. In two units it was cleaned daily while other units cleaned the storage container anywhere from a few times a week to when it appeared to be dusty. Generally the containers or spaces were wiped with JIK solution and soapy water or a combination of JIK and soapy water. All equipment was stored in the resuscitation area. However, two units stored the penguins in a locked space at night because they had a tendency “to disappear.”

Photograph 9: Cleaned equipment ready for use.

Photograph 10: Clean equipment ready for use (close up

of Photograph 9).

Photograph 11: Cleaned equipment ready for use.

Photograph 12: Mask with spider and cobweb placed with

equipment ready for use.

Perception of significance: Fifty-three percent of health workers interviewed felt that the neonatal resuscitation equipment reprocessing steps they were following were not enough and noted that there is a need to do more, such as autoclaving, have more frequent and comprehensive training on reprocessing, and have access to adequate amounts of functioning equipment to allow them the time needed to complete the reprocessing before the equipment was needed again. Although 47% felt that the steps were adequate, many also noted that they needed more reprocessing equipment to accomplish these steps, such as buckets, brushes, detergent, and JIK. No one felt that the steps were excellent or unnecessary. On several occasions health workers noted that those who provide the equipment should also ensure that reprocessing training is conducted.

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Condition of resuscitation equipment

Resuscitation equipment that was present in units was inspected for cleanliness, appearance, and functionality. While the equipment appeared to be free from bodily fluids, many devices were dusty due to inappropriate storage. In one unit, a suction catheter that did not appear to be clean had been placed with the rest of the resuscitation equipment reported as clean. In units where health workers described that bags were generally only wiped instead of soaked during the cleaning process, many bags had droplets of clear liquid or white spots on the inside surface of the bag. This suggested that a cleaning method different from wiping was being performed by other health workers in the unit. A number of masks and penguins showed light brownish discoloration due to repeated use and cleaning. One suction penguin that showed dark brown discoloration had been boiled with other bloody metal objects, which could explain the dark discoloration (no glutaraldehyde solution was available in that unit). Even when discolored, the equipment was still functional, but this change in translucency may impact the health worker’s ability to determine if the devices have been thoroughly cleaned. While most equipment was functional, resuscitation equipment in some units was missing pieces such as connectors, membranes, or air cuffs. In four units broken or deteriorating equipment was mixed with functional equipment. Staff were not always aware that a device was broken or missing a component. For example, the masks that were missing their air cuffs were still in use because staff appeared to be unaware that the masks were incomplete.

Photograph 13: Condensation inside bag.

Photograph 14: Torn membrane on equipment still in use.

Photograph 15: Mask with missing air cuff. Mask still in use.

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Health workers suggestions for improving reprocessing practices

Health workers were asked if there was reprocessing equipment that they needed and did not have. In general, health workers expressed need for complete PPE, adequate numbers of buckets, access to soft scrub brushes of varying sizes, access to a disinfectant better than bleach, and adequate amount of disinfectants.

When asked what they thought was needed to improve reprocessing practices, the majority identified the need for more in-depth training on how to reprocess the neonatal resuscitation equipment. Other suggestions included the following:

- Improve access to reprocessing equipment. - Improve access to functional resuscitation equipment. - Improve the quality of the materials used in resuscitation equipment or obtain higher quality

devices that can withstand the sterilization or HLD process. - Provide safer suction devices (recommended by a unit that was using 10-ml syringes with a

suction bulb attached). - Better effort by health workers to perform reprocessing steps. - Larger reprocessing areas that would allow the buckets to be positioned so that the health worker

would stand up while reprocessing equipment.

4. Discussion

Reprocessing reusable medical devices poses various challenges in all settings,24 and as expected, this is even more the case in low-resource settings. There are several guidelines currently available for the reprocessing of respiratory equipment in general and some developed with the needs of low-resource settings in mind. There are also several guidelines specifically designed for the reprocessing of neonatal resuscitation devices. Considering the variety of guidelines currently available, we had expected to find that health workers in this particular low-resource setting would feel confused about the best way to reprocess neonatal resuscitation equipment. However, it was evident during interviews and observations that most health workers engaged in this study did not have demonstrable access to guidelines, and were, for the most part, following whatever general or specific instructions they had received from other health workers and working with the tools that they had available to them.

For the most part, complete reprocessing steps were not being followed in the units visited. Overall, only decontamination and cleaning were being performed, and in most instances, this was not followed completely as recommended due to time and resuscitation equipment constraints.

Several factors were identified during this study as either facilitating and/or hindering adequate reprocessing of neonatal resuscitation devices. Although only a few units sterilized suction devices, these were the only component of the equipment that regularly received full reprocessing in those units. Facilitating factors present in the units which consistently sterilized suction devices were:

- Perception of spread of infection risk posed by suction device.

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- Sufficient availability of suction devices meeting the needs of the units’ patient volume. - Consistent instruction transmitted from health worker to health worker on how suction devices

should be reprocessed. - Availability of a functional autoclave. - Sterilization done by a health worker specifically assigned to do so.

The inhibiting factors identified for reprocessing from all units visited were:

- Ineffective training and supervision including lack of specific training on reprocessing neonatal resuscitation devices or training that did not emphasize sterilization or HLD for all devices; lack of uniform training in all units and for all shifts; low awareness on the purpose of each reprocessing step; low knowledge on the life cycle, parts, and functionality of resuscitation devices; minimal supervision.

- Lack of sufficient resuscitation equipment meeting the needs of the units’ patient volume (both in in terms of amount needed and functionality of equipment on hand).

- Varying perception regarding spread of infection risk posed by inadequately reprocessed resuscitation equipment: suction device perceived as “dirty,” but not bag and mask.

- Lack of reprocessing equipment and tools. - Lack of visual access to reprocessing guidelines. - Understaffed units resulting in health workers lacking time to fulfill all responsibilities assigned

to them. - Other environmental constraints including limited space within the unit to perform reprocessing;

dusty environment for air drying.

Some of the identified inhibiting factors can be addressed in a shorter term than others. Clearly, uniform guidelines that are easy to understand and that match resources available need to be at hand and must be adequately explained as part of neonatal resuscitation training. Health workers interviewed were eager to receive more training. Almost half of them thought that the steps they followed were adequate, but half thought that what they were doing was not enough. Future HBB courses should provide comprehensive training on uniform reprocessing guidelines, and these guidelines should also be included in the orientation provided to health workers when joining a unit that cares for newborns, even if not receiving HBB training. In-charge nurses and HBB trainers will play a pivotal role in transmitting uniform guidelines since they were consistently identified as go-to persons in case of questions. Quality improvement efforts should also clearly assign them a supervisory role for this activity and establish a schedule for it.

Training methodology must also be improved by effectively conveying to health workers the infection risk that every piece of resuscitation equipment poses when not reprocessed properly. Moreover, the training should provide a clear rationale for each reprocessing step in order to enhance adherence to the complete process.

Guidelines should be posted next to the reprocessing area, but it should not be assumed that because they are posted health workers will know about them. Showing their location should be part of the orientation received when joining a unit that cares for newborns. For this, it will be necessary to consider facility restrictions as posting may be allowed in certain areas or on certain types of surfaces but not others.

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In terms of improving existing guidelines, they should include all necessary steps, provide rationale for their existence, and clearly describe how to execute them. In particular, during this study it was identified that instructions for diluting disinfectants should be included in the guidelines, and should point to different existing concentrations of those disinfectants. Moreover, a time log should be included into the decontamination and chemical HLD steps, aiming to serve as a reminder to prevent damage to equipment from soaking it for too long. It might also be necessary to simplify the way decontamination is done (by wiping instead of soaking) in order to decrease burden and time needed for the entire process. For the inspection/function testing step, the description on how to execute these steps needs to become easier for health workers to understand and learn what they should do by adding learning aids such as explaining how to use their senses during function testing (hearing air come out of the valve, etc.). It will also be necessary to indicate that broken equipment should be placed in a container or bag marked as “Broken/Do Not Use.” Appropriate administrative procedures to dispose of the equipment should be in place and occur as stated. The storage recommendation also needs to be strengthened in general but even more so accounting for dusty environmental conditions.

Recommendations on spatial minimum requirements for reprocessing areas could be ideally issued, but it is difficult to determine how useful these would be in settings where patient care space is limited. Moreover, given the infrastructure and the environmental conditions in which facilities are located, solutions for air drying after HLD must be developed which take into account that in certain climates, windows remain open and dust enters any space.

Reprocessing was mostly done immediately following the use of the resuscitation devices. However, this did not always happen when the health worker was busy with other activities. Assigning one health worker each day and in each shift to be responsible for the reprocessing of resuscitation equipment could allow the unit to prioritize this activity, particularly in high patient volume units.

Units should be adequately supplied with the necessary reprocessing and resuscitation equipment. As observed in this study, health workers need complete PPE. However, access to PPE does not guarantee that it will be used. Conveying the rationale for wearing PPE will likely enhance adherence. Several units in this study also needed more available options for conducting sterilization or HLD. Most importantly, units need to be supplied with enough resuscitation devices that match the patient volume typically received in the unit and that considers equipment that will become nonfunctional at a given point either due to breakage, general wear and tear, or because inadvertently misplaced. In line with this, forecasting of resuscitation equipment as well as tracking of existing functional devices should be part of the quality improvement efforts in facilities that care for newborns. An existing quantification tool 25can be used to provide estimates of product quantities for planning and cost simulations, but it is not intended for planning detailed distribution. Each facility must analyze the patient volume of each unit within the facility that cares for newborns including during transport within the facility or to other facilities and consider replacement needs.

Limitations of the study

This is a qualitative study which has inherent limitations in terms of being unable to establish causality or statistical association of events observed. Due to the busy schedule of health workers and the nature of the process of interest, it was not possible to conduct interviews/observations in private spaces. Thus, some of

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the participants’ answers were prone to social desirability bias. The study was conducted in a specific geographic setting and in specific health facilities, and as such, the generalizability of its findings may be limited.

5. Conclusion

Factors leading to inadequate reprocessing are modifiable. The next step that can be taken at a global level is to work in collaboration with experts to form a consensus around reprocessing steps that are viable in a low-resource setting where health workers are constrained by time and resources. The approach will include improvement of the current practices in order to revise and simplify reprocessing guidelines and update HBB training. Additionally, training must be improved and expanded, units should be fully supplied with needed equipment, and the health system must be strengthened overall.

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Appendix A. Spaulding Classification System for Medical Equipment Reprocessing5,6

Critical Items. Objects that enter sterile tissue or the vascular system and pose a high risk for infection if they are contaminated with any microorganism. This category includes surgical instruments, cardiac and urinary catheters, implants, and ultrasound probes used in sterile body cavities, among others.

Semi-Critical Items: Objects that come into contact with mucous membranes or non-intact skin. Such objects must be free from all microorganisms, but a small numbers of bacterial spores are permissible. This category includes items such as respiratory therapy (including resuscitation equipment) and anesthesia equipment, some endoscopes, esophageal manometry probes, cystoscopes, and diaphragm fitting rings, among others.

Non-Critical Items: Objects that come in contact with intact skin but not mucous membranes. Intact skin acts as an effective barrier to most microorganisms. This category includes items such as bedpans, blood pressure cuffs, crutches, bed rails, floors, and patient furniture, among others.

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Appendix B. Disinfection levels for medical equipment reprocessing

Low-level: For items classified on the risk scale as “non-critical,” low-level disinfection can kill most vegetative bacteria (except M. tuberculosis), some fungi, and also inactivates some viruses. Examples of microorganisms that can be killed through low-level disinfection include Staphylococcus aureus, Salmonella typhi, Pseudomonas aeruginosa, HIV, herpes simplex, and hepatitis B & C viruses.26

Intermediate-level: For items classified on the risk scale as “non-critical,” selection of this level of disinfection depends upon purpose and use of the non-critical item. Intermediate-level disinfection inactivates M. tuberculosis, vegetative bacteria, most viruses, and most fungi but does not always kill bacterial spores. In addition to effectiveness against the same microorganisms that are killed by low-level disinfection, examples of microorganisms that are killed through intermediate-level disinfection include M. tuberculosis, polio virus, rhinovirus, Candida, and Aspergillus.26

High-level: This is the minimum disinfection required for items classified on the risk scale as “semi-critical,” but sterilization may also be appropriate for some semi-critical items. High-level disinfection destroys all microorganisms except some bacterial spores, particularly if there is heavy contamination. High-level disinfection can be achieved chemically by soaking equipment in the correct concentration of a disinfectant and during the correct time and temperature to achieve the appropriate level of disinfection. It can also be achieved by boiling the equipment for 10‒20 minutes.7,8,12

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Appendix C. Disinfectants recommended for decontamination and high-level disinfection

In low-resource settings, sodium hypochlorite (household bleach) and alcohol are recommended for decontamination of medical equipment. A 2003 Jhpiego infection control manual for limited-resource settings recommends wiping exposed surface of the equipment with a gauze pad soaked in sodium hypochlorite at a 0.5% solution as the most effective chemical method for decontamination in low-resource settings or 70% ethyl or isopropyl alcohol or 0.5%–3% phenolic compounds.7 The 2008 Jhpiego manual on respiratory infection control in health care facilities states that wiping the bag and mask with 60%–90% alcohol is suitable for decontamination except in cases where organic matter is present (i.e., blood or body fluids) as alcohol is not effective in the presence of organic matter. In such cases, a 0.5% chlorine solution must be used for wiping. Further, suction catheters must be soaked in 0.5% chlorine solution for 10 minutes prior to cleaning.14 As with all chemical disinfectants, sodium hypochlorite must be applied in the correct concentration and during the correct time and temperature to achieve the appropriate level of disinfection. However at the concentration required for high-level disinfection, sodium hypochlorite may be damaging to rubber27,28 and corrosive to metal.6,7

The United Stated Food and Drug Administration (USFDA) recommends glutaraldehyde, hydrogen peroxide, orthophthalaldehyde, and peracetic acid with hydrogen peroxide for HLD. Isopropyl alcohol and ethyl alcohol are excluded from the USFDA list of high-level disinfectants because of their inability to inactivate bacterial spores and inability of isopropyl alcohol to inactivate hydrophilic viruses (i.e., poliovirus and coxsackie virus). Three percent phenolic compounds have also been excluded from the USFDA list of approve high-level disinfectants due to unproven efficacy against bacterial spores, M. tuberculosis, and/or some fungi. Although sodium hypochlorite (household bleach, ClNaO) is not approved for use as a high-level disinfectant by the USFDA, it has been recommended in low-resource settings for this purpose since it is widely available and the most effective of the chemicals that are easily accessible.

Jhpiego recommends using a 0.1% sodium hypochlorite solution during 20 minutes for HLD but notes that boiled water must be used with this concentration of chlorine since tap water contains microscopic organic matter that can inactivate chlorine. Further, the decontamination and cleaning steps, along with appropriate rinsing and drying must be undertaken before a 0.1% chlorine solution would be effective for HLD. If using boiled water is not possible to prepare the 0.1% solution, then a 0.5% solution should be used for HLD.7

The formula7 recommended for making a dilute chlorine solution from any concentrated sodium hypochlorite solution is:

Total parts water = [% concentrate ÷ % desired dilute] -1

Based on the above formula, the table below describes the basic rules for diluting sodium hypochlorite for decontamination and for HLD. Worldwide there are no fewer than 9 concentrations of sodium hypochlorite commercially available. They range in concentration from 2.4% available chlorine to 15% available chlorine. The table below reflects the dilution for sodium hypochlorite concentrations found at healthcare facilities in Uganda.

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Chlorine available Parts water to 1 part bleach

0.5% solution 0.1% solution

3.85% 6 37

6% 11 59 As with any chemical, care must be taken to use sodium hypochlorite as directed both to achieve the desired results and to avoid hazardous situations. Bleach solution becomes unstable over time and for the purposes of decontamination must be changed daily, or if it becomes cloudy during the course of the day. Mixing sodium hypochlorite with anything other than water can cause dangerous fumes.29 When cleanser manufacturers mix bleach and detergent they do so using bleach-stable surfactants. However, it is problematic for consumers to mix bleach with detergent since the sanitation capacity of the chlorine is reduced or harmful compounds can be formed.30 If mixed with certain common chemicals—such as ammonia, vinegar, toilet bowl cleaner, drain cleaner, hydrogen peroxide—toxic gases are formed.31 Bleach is also sensitive to heat and light, and therefore bleach solution should be covered and kept in a non-transparent container.7 When exposed to sunlight or to temperatures of greater than 40°C (104°F) the degradation rate of the chlorine increases.32,33 Furthermore, chlorine fumes are an irritant to eyes and airway; although the fumes released by diluted bleach are less than with full-strength bleach, it should only be used in a well-ventilated area.

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Appendix D: Interview/Observation Guide

Interview/Observation guide for health care workers in Uganda health facilities.

Please use the Consent Form to obtain the health care worker’s consent before proceeding with the interview. Please introduce yourself: Thank you for meeting with me today. My name is and I work with PATH, a nonprofit organization based in Seattle, Washington, USA. Our mission is to improve the health of people around the world by advancing health technologies. I would like to talk to you today about reprocessing procedures for neonatal resuscitation equipment. Reprocessing is the term used for all the steps taken to prepare and maintain reusable medical equipment between patients, including cleaning, disinfection and storage. PATH and the Uganda Ministry of Health would like to better understand how basic neonatal resuscitation equipment is reprocessed in Uganda’s health facilities. Our main goal in conducting this work is to learn what procedures facilities are actually following and what makes it easy or difficult for health workers like you to do this. The information you provide today will help us come up with a reprocessing guide that is easy to follow, to provide recommendations for health facilities and to help you with this important process. To gather the most useful information, I would like to ask you to share with me and demonstrate the typical steps that you follow for reprocessing. Everything you say will be kept strictly confidential. The information you provide will be compiled with information given by other participants, and will be reported as a whole for all facilities, so nobody will be able to identify your answers. The interview will take about one hour and a half. I will ask you a series of questions. There are no wrong answers. We are very interested in learning from you and getting your opinion.

IDENTIFICATION INFORMATION

Facility Information:

Facility ID number (copy it from the corresponding Facility Information Form):

Facility Name:

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Health Worker Information (Interviewee)

Date: (DD/MM/YYYY)

Respondent ID number:

Years of experience in position (regardless of where employed):

Years at this facility:

HBB training received?: Shift (during visit):

N/A (not in patient care) Morning

No Afternoon

Yes. Date (Month/Year): Evening

Weekend Type of area being observed:

Sterilization room

Labour ward/delivery room

NICU

Other: Number of devices available in this area:

Bags: Masks: Suction devices: Manikin:

Interviewer Name:

Start time: End time:

Title Sex

Medical Officer Female

Clinical Officer Male

Matron Nurse

Nurse (Type: )

Midwife (Type: )

Nursing Assistant

Other:

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INTERVIEW/OBSERVATION GUIDE Reprocessing frequency/training/ supervision / schedule

Question 1: Frequency of reprocessing

As I mentioned earlier, reprocessing is the term used for all the steps taken to prepare and maintain reusable medical equipment between patients, including cleaning, disinfection and storage.

a. How often do YOU reprocess neonatal resuscitation equipment (bag, mask and suction device)?

Average births in a day/month?

b. Is there a fixed schedule for reprocessing neonatal resuscitation equipment or is the equipment cleaned immediately after use?

Yes, there is a schedule Please describe:

Immediately after use

Other Please describe:

Question 2: Training regimen a. How did you learn how to reprocess neonatal resuscitation

equipment?

b. Did you receive specific training to reprocess neonatal resuscitation equipment?

Yes When was the last time (month/year):

No

c. By who?

d. How many times have you received this specific training?

e. Is there a regular training schedule? Yes

No

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Question 3: Responsible parties a. What other health workers are responsible for reprocessing

neonatal resuscitation equipment in this facility? (if not obtained in the Facility Information Form)

Question 4: Guideline availability a. Which guidelines or instructions do you follow to reprocess the

neonatal resuscitation equipment? No guidelines/instructions Follows guidelines/instructions. Please show them if possible

(describe and take picture of them) Circle type of instructions: Manufacturer’s instructions, MoH instructions, HBB poster, Jhpiego or WHO instructions, other.

b. Where can you find them if you need to look at them? Posted in the reprocessing area Other

Please describe:

c. Are the guidelines clear and easy to follow? Yes No

Please describe:

Question 5: Supervision a. If you have a question about how to reprocess the neonatal

resuscitation equipment, what do you do? Who can you ask? Please describe:

b. Do you receive supervision in terms of reprocessing of medical equipment:

Yes. Please describe: How often? By whom?

No

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Space and equipment/materials necessary to conduct reprocessing

Question 6: Reprocessing area a. Where does reprocessing of the neonatal resuscitation

equipment take place? Please describe the area. Sterilization room

Please describe: Other separate room

Please describe: An area within the room where resuscitation takes place

Please describe: Is this area marked for reprocessing? Cleanliness/Number of people working in the space?

Other: Please describe:

Question 7: Water availability a. Please describe the source of water you use to reprocess

neonatal resuscitation equipment (for rinsing and for preparing dilutions).

Potable water line Tap water (not potable) No running water.

Please describe (ex: well water in regular bucket or veronica bucket):

Not sure b. How often is water available?

c. What do you do when there is no water?

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Question 8: Water purification/chlorine a. If there is no potable water line, do you prepare the

tap/well/other water before using it for reprocessing? No Yes. Please describe the process: If water is cloudy, the very first step s/he takes is filtering

water through four layers of moderately woven cotton cloth such as a cheese cloth or old sari material.

Then boils water for: 10min. 20min. Other:

OR treats water with household chlorine (prepare 0.001% solution by adding 10ml -2 teaspoons- of 0.5% chlorine solution to 20L of water).

OR treats water with high-test hypochlorite OR other; please describe:

b. What type/brand of chlorine do you use?

Household liquid bleach Name: Concentration:

Commercial liquid bleach Name: Concentration:

Other Name: Concentration:

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Question 9: Materials a. Mark the equipment and materials the health worker

typically uses to reprocess neonatal resuscitation equipment:

Autoclave Automatic cleaning machine Pot with a lid Sink Bucket or other container for disinfectant solution and /or

clean water Towels for drying Disinfectant: Household chlorine (3-5%) Other chlorine: % Glutaraldehyde (Cidex) % Other: Personal protective equipment: Gloves Eye protection/face shield Apron/gown Mask Cap Closed shoes Other: Mild detergent or soap Scrub brush High level disinfection log Clock Storage containers

Describe buckets (material, content, appearance of content, covered?) #1: #2: #3: #4: #5:

b. Do you ever run out of these materials? No Yes:

How often? Which materials?

c. Are there equipment/materials that you would need to reprocess neonatal resuscitation equipment but don’t have?

Please describe:

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d. Any issues with the equipment/materials you do have? Please describe:

Reprocessing procedure

Question 10 a. What happens to the equipment immediately after it is

used on a newborn?

• If interviewee says that the equipment is left somewhere for later cleaning, ask where the equipment is kept until it can be cleaned:

b. How long it takes before it is reprocessed on a typical

day?

c. Ask if there is only one bag available for the resuscitation area. If so, ask: What would a provider do if the bag was being cleaned and a baby who needed resuscitation was born at the time?

Question 11: Please demonstrate step-by-step how neonatal resuscitation equipment: the bag, mask, and suction device (bulb or penguin) are reprocessed. Please start describing right when you receive the used equipment. Mark the steps mentioned/demonstrated and describe if only some steps are followed.

a. Disassembly With gloves on?

Yes No

b. How many buckets or containers are used for the

complete procedure?

c. Decontamination By soaking all parts in 0.5% chlorine solution for 10 min. By wiping exposed surfaces with gauze pad soaked in 60-90%

alcohol or 0.5% chlorine solution. Other

Presept tabs 50% Troclosene Sodium (NaDCC)? How long does the equipment stay in the container?

BAG/MASK: SUCTION DEVICE: BAG: MASK: SUCTION DEVICE:

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d. Cleaning By manually washing all parts with scrub brush, with soap and

water, then rinsing with clean water. Use of automatic cleaning machine Other

Inspects for remaining debris?

Yes No

e. Drying after cleaning Air dry Towel dry. Type of towel used:

Describe area for drying cleaned equipment.

f. Sterilization/HLD By steam autoclaving all parts for 10-20 min. By chemical high level disinfection (HLD), soaking all parts in

activated glutaraldehyde (Cidex) for 60 min. at ambient temperature 25°C, then rinsing with boiled water for 2 min.

By chemical HLD, soaking all parts in 0.5% OR 0.1% chlorine solution for 20 min. at ambient

temperature, then rinsing with clean water for 2 min. By boiling all parts in water for: 10 min. 20 min. Other:

How long does the equipment stay in the container?

g. Is the equipment ever sterilized? Yes No

If boiling, what heat source is used?

h. Drying after HLD Air dry Other:

Describe area for drying disinfected equipment.

i. Inspecting/Reassembly With aseptic technique? (wearing face mask; hands, wrists and arms washed; wearing sterilized/HLD surgical gloves or new examination gloves)

Yes No

Describe how inspection is done:

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j. Storage (in between uses) In dry, HLD, covered boxes or plastic bags Other:

Question 12: Perceived completeness/time needed a. On a regular basis, how often are you able to implement

all of these steps? 100% of the time 50% of the time Less than 50% of the time

b. On average, how long does the whole process take you

(from disassembly to reassembly)?

c. If not doing it 100% of the time, what are your constraints?

d. If time is a constraint, which steps do you leave out?

e. What is the difference between a clean device and a sterilized device?

Question 13: If automatic cleaning machine is available at the facility a. Is it used for neonatal resuscitation equipment? If so,

how often?

b. What brand?

c. What year was this machine produced?

d. How often is it used?

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e. Is the automatic washer in working order at least 90% of the time?

Yes No

f. What process is followed if the automatic washer is not

working?

Question 14: If autoclave is available at the facility a. Is it used for neonatal resuscitation equipment? If so,

how often?

b. What brand?

c. What year was this machine produced?

d. How often is it used?

e. Is the autoclave in working order at least 90% of the time?

Yes No

f. What process is followed if the autoclave is not working?

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Question 15 If chlorine solution is used for decontamination:

Question 16 If a second chlorine solution is used for HLD:

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a. What strength of chlorine solution do you use for decontamination?

Not used Strength: % (0.1%, 0.5%) Doesn’t know

b. How often is new solution prepared?

Daily Covered container. Material: Uncovered container. Material: Every 14 days or earlier if cloudy Covered container. Material: Uncovered container. Material: Other: Covered container. Material: Uncovered container. Material:

c. Can you describe in detail how you prepare this

solution (how you measure chemical, kind of water you use, etc.)?

Uses the following formula to calculate parts of water: Total parts of water= % concentrate - 1 % dilute (To prepare 0.5% solution with JIK--which is sodium hypochlorite with 3.5% available chlorine--, add 1 part of JIK to 6 parts of water, in a plastic container).

Uses filtered/boiled water if preparing 0.1% solution

The water s/he uses for dilution is at ambient temperature or cold (not hot).

Other: d. Type of container (bucket, box, etc.):

e. Do you have access to the dilution instructions?

Yes No

f. If yes, where are these instructions posted?

a. What strength of chlorine solution do you use for HLD? Not used Strength: % (0.1%, 0.5%) Doesn’t know

b. How often is new solution prepared?

Daily Covered container. Material: Uncovered container. Material: Every 14 days or earlier if cloudy Covered container. Material: Uncovered container. Material: Other: Covered container. Material: Uncovered container. Material:

c. Can you describe in detail how you prepare this solution

(how you measure chemical, kind of water you use, etc.)?

Uses the following formula to calculate parts of water: Total parts of water= % concentrate - 1 % dilute (To prepare 0.5% solution with JIK--which is sodium hypochlorite with 3.5% available chlorine--, add 1 part of JIK to 6 parts of water, in a plastic container).

Uses filtered/boiled water if preparing 0.1% solution The water s/he uses for dilution is at ambient temperature

or cold (not hot). Other:

d. Type of container (bucket, box, etc.):

e. Do you have access to the dilution instructions? Yes No

f. Where are these instructions posted?

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Question 17: If glutaraldehyde is used for HLD: a. What strength of glutaraldehyde (Cidex) do you use for

HLD?: N/A (Cidex not available) Strength: % (2-4%) Doesn’t know

b. How often is new solution prepared?

Every 14-28 days or earlier if cloudy Covered container. Material: Uncovered container. Material: Other: Covered container. Material: Uncovered container. Material:

c. Can you describe in detail how you prepare this solution

(how you measure chemical, kind of water you use, etc.)? Adds activator. Health worker is aware that Cidex needs to be in approx.

ambient temperature 25°C (will not work if <20°C /68°F, unless otherwise stated by manufacturer).

Other: d. Type of container (bucket, box, etc.):

e. Do you have access to preparation instructions?

Yes No f. If yes, where are these instructions posted?

Question 18 Cleaning of storage containers

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a. How are the storage containers cleaned and how often? (Describe if only some steps are followed.)

Containers are decontaminated by soaking in 0.5% chlorine solution for 10 min.; rinsed; air or towel dried; then sterilized with dry heat or autoclave; OR HLD by boiling for 20 min. or soaked in 0.5% chlorine solution for 20 min.; then rinsed with boiled water and air dried.

Other:

Question 19 Inspection of bag function a. How do you inspect if the bag is functioning properly?

(See Bag Function Reference Sheet and describe if only some steps are followed.)

b. If you see that some part of the bag is not functioning,

what do you do? Replace defective parts Replace entire device Other:

Manikin/ storage of resuscitation equipment / estimated lifespan

Question 20: Equipment storage a. Where is the resuscitation equipment placed after it

is reprocessed?

b. Distance from resuscitation area?

c. Easy access for urgent use (unlocked)?

d. If locked, what is the process to access equipment?

e. Where else would the equipment be stored?

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Question 21: Manikin storage a. Where are training manikins for health worker use

located? And stored?

b. How often is the manikin used for training and practice? (Describe who cleans it, if not cleaned by health worker)

c. How often is the manikin cleaned?

d. How is it cleaned?

e. Have you had any problems with the performance of the manikin? (e.g., leaking neck)

f. Is there exclusive resuscitation equipment for simulation use?

Question 22: Replacement regimen a. Approximately, how long does the neonatal

resuscitation equipment last before it must be replaced?

Bag: Mask: Suction device (bulb/penguin): Manikin:

b. Do certain pieces of resuscitation equipment have to be replaced more often than others?

Yes No

c. If YES, which pieces?

d. Why do you think they need to be replaced that often?

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Factors facilitating or inhibiting adequate reprocessing

Question 23: Perception of significance e. In your opinion, do you think that the steps taken

in this facility to reprocess neonatal resuscitation equipment are:

Not enough Adequate Excellent Unnecessary

f. Please describe:

Question 24: Suggestions for improvement

g. What do you think is needed to help health workers like you reprocess neonatal resuscitation devices in a better way?

By manufacturers of the device By the MOH By the administration of the your health facility By personnel responsible for reprocessing By you

Awareness of hospital acquired infections

Question 25: General infection awareness a. Of all the types of equipment that you disinfect,

which do you consider are more important to disinfect? Less important? Where in these categories would you place neonatal resuscitation equipment?

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b. Why do you or don’t you think it is important to clean neonatal resuscitation equipment?

c. Do you think healthcare acquired infections are an issue in this facility? If so, how bad do you think is the problem?

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Condition of equipment (to be done if no observation will be conducted in this facility, and if time permitting)

Gain health worker permission to see and handle both clean and dirty basic neonatal resuscitation equipment (bag, mask and suction device, and include training manikin).

Use aseptic technique when handling the equipment (use a face mask, wash hands, and use two new pairs of examination gloves; double pair is for your own protection if the gloves are made out of vinyl).

Question 26: State of equipment a. Describe condition of equipment:

Reprocessed equipment Equipment awaiting reprocessing

Question 27: Resuscitation bag Question 28: Masks a. Bag size: ml

b. Reusable?

Yes No

c. Appearance of bag: Looks old Looks new

d. Opacity of bag:

N/A (colored or originally opaque) Transparent/Translucent Somewhat opaque Very opaque

e. Cleanliness of bag:

N/A (awaiting reprocessing) Clean Dirty (debris visible)

f. Feel of bag:

N/A (originally rough) Rough/uneven to the touch Smooth to the touch

a. Mask size(s) Size 0 Size 1

b. Reusable?

Yes No c. Appearance of mask(s): Size Size

Looks old Looks old Looks new Looks new

d. Opacity of mask:

Transparent/Translucent Somewhat opaque Very opaque

e. Cleanliness of mask:

N/A (awaiting reprocessing) Clean Dirty (debris visible)

f. Feel of mask rim:

Rough/uneven to the touch Smooth to the touch

g. Other mask observations (cracks, tears, rips):

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g. Bag function: Functional patient valve (squeeze the bag and

ensure the lip valve opens with each squeeze) Bag re-inflates quickly (squeeze bag; keep bag

squeezed and seal patient port connector against one hand; release bag checking that it re-inflates quickly after release)

No leakage (seal the patient port connector to the palm of one hand; with the other hand press the index finger against the pressure release valve and squeeze the bag to ensure that no air escapes through the pressure release valve or from the bag)

Functional pressure release valve (seal the patient port connector against the palm of one hand; with the other hand squeeze the bag and ensure that excessive air escapes through the pressure release valve)

Functional patient exhalation (connect a patient mask to the patient port connector; remove the bag from the patient valve; press the bag into the mask opening to form a seal; squeeze the bag to mimic the baby’s lungs and check that the bag can be squeezed without resistance)

h. Other bag observations (cracks, tears, rips):

Question 29: Suction device Question 30: Training manikin a. Suction device type and material:

b. Reusable?

Yes No

c. Appearance of suction device: Looks old Looks new

d. Opacity of suction device (just for penguin):

Transparent/Translucent Somewhat opaque Very opaque

a. Appearance of manikin: Looks old Looks new

b. Cleanliness of manikin

Clean Dirty

c. Manikin location/function: Set up/ready for use (water in it) Placed where health workers can practice Has its own set of bag and mask for practice Chest rises

d. Other manikin observations (cracks, tears, rips,

missing cords or squeeze bulb):

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e. Cleanliness of suction device: N/A (awaiting reprocessing) Clean Dirty (debris visible)

f. Feel of suction device:

Rough/uneven to the touch Smooth to the touch

g. Other suction device observations (cracks, tears,

rips):

Request permission to take photos of:

- Reprocessing area - Neonatal resuscitation equipment reprocessing in action - A reprocessed bag, mask, and suction device

REMINDER to observer: no employees, patients, or visitors are to be photographed.

Please go back to page 2 and enter time when interview ended.

THANK YOU!

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