3M Webinar IP Role and SPD · regulatory agencies on the Central Sterile Department/Sterile...

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© 3M 2015. All Rights Reserved

3M Health Care AcademySM


Sterile Processing for the Infection Preventionist: What you need to know?November 19, 2015


Welcome!Topic: Sterile Processing for the Infection Preventionist: What

you need to know?

• Facilitators: Christophe de Campeau, 3M Sandra Velte, 3M

• Speakers: Jacqueline Daley HBSc, MLT, CIC, CSPDS

• For more information: www.3m.Com/3MSterileU

© 3M 2015. All Rights Reserved 3

House Keeping

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white arrow to expand your control panel (upper right-hand corner of your screen).

• Type a question in the question box and click send.

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House Keeping

Continuing EducationEach 1 hour web meeting is approved by IAHCSMM, CBSPD and is 3M Health Care Provider approved by the California Board of Registered Nurses CEP 5770 for one contact hour.

Post webinar email• Link to Course Evaluation• CS Tech CE Certificate Included• Forward eMail to others in attendance


•Jacqueline Daley HBSc, MLT, CIC, CSPDSManager Infection Prevention, Clinical Epidemiology and Vascular Access ServiceSharp Metropolitan Medical Center

• 3M Educational Consultant• Speaker’s Bureau Sage Products


Learning Objectives

• Identify the impact of standards, guidelines, recommended practices and regulatory agencies on the Central Sterile Department/Sterile Processing Department as it relates to Infection Prevention

• Review the role of the Joint Commission in the Sterile Processing Department (SPD) as it relates to Infection Prevention

• Discuss best practices for monitoring the sterilization process and why biological indicators are considered the most effective method for monitoring the sterilization process

• Understand the importance of procedures for recall of potentially contaminated equipment and supplies

• List three areas of concern in the Sterile Processing Department (SPD) that impacts infection prevention

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Role of Sterile Processing Department (SPD)

“The importance of this [SPD] role in the prevention of nosocomial [HAIs] is clear: reusable medical devices improperly handled, disinfected, or sterilized provide a source of contamination and increase the risk of transmission of infection to both patients and the staff involved in reprocessing procedures.”

Pugliese, Gina and Hunstiger. Central Services, Linens and Laundry. In Hospital Infections. Edited by John V. Bennett and Philip S. Brachman. 3rd ed.


Standard, Guidelines and Professional Bodies

• Association for Professionals in Infection Control and Prevention (APIC)• Position Statements

• Association of periOperative Registered Nurses (AORN)• Recommended Practices

• Society for Healthcare Epidemiology of America (SHEA)

• The Joint Commission (TJC)• Infection Prevention and Control Standards

• Association for the Advancement of Medical Instrumentation (AAMI)

• Society of Gastroenterology and Associates, Inc (SGNA)

• American Society for Gastrointestinal Endoscopy (ASGE)


Government and Regulatory Agencies• Center for Disease Control and Prevention (CDC)

• Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008

• Environmental Protection Agency (EPA)• Office of Pesticides Program-Antimicrobials Division (OPP-AD) is responsible for all regulatory activities

associated with antimicrobial pesticides.

• Regulates items used to sanitize and disinfect environmental surfaces and sterilants such as ethylene oxide

• Food and Drug Administration (FDA)• Medical instruments and device approval through the 510K process

• Approval of products used as sterilants and high-level disinfectants with general claims for reprocessing reusable medical and dental devices

• Center for Medicare Medicaid (CMS)• Conditions of Participation

• Hospital Infection Worksheet – Sec 3.A. Reprocessing Semi-Critical Equipment; Sec 3.B. Reprocessing of Reusable Critical Equipment, Instruments and Devices: Sterilization

• Local and state regulations

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Association for Professionals in Infection Control and Prevention (APIC)

• Impact on Sterile Processing• Endorses standards and guidelines through participation on committees such as AAMI and

Healthcare Infection Control Practices Advisory Committee (HICPAC), Centers for Disease Control & Prevention (CDC).

• Development of Position Statements• **Important information for infection preventionists regarding media attention on an outbreak

involving reusable surgical instruments.• “Infection preventionists can play an important role in collaboration with the perioperative team

and the facility’s sterile processing department (SPD)/surgical reprocessing professionals to ensure the proper cleaning and sterilization of surgical instruments.”

• Develops competencies for infection preventionists to ensure a clear understanding and management of risks in department to include the practices in Central Sterile / Sterile Processing• Allows for assessment of practices in this domain

http://apicweb.beta.deghosting.com/Resource_/TinyMceFileManager/Position_Statements/Dirty_Surgical_Instruments_TalkingPoints.pdf


• Supports initiatives that actively promote certification of sterile processing personnel

• Provides a course on “Disinfection and Sterilization: Best Practices in Reprocessing Surgical Instruments”

• Helps healthcare professionals in all settings ensure compliance with regulatory standards for sterile processing and adhere to recommended best practices.

**http://www.apic.org/Resource_/TinyMceFileManager/Position_Statements/Dirty_Surgical_Instruments_TalkingPoints.pdf

Association for Professionals in Infection Control and Prevention (APIC)


• Recommended Practices• Cleaning and care of surgical instruments and powered equipment• Selection and use of packaging systems for sterilization

• Evaluating, selecting, and using packaging systems and for packaging the items to be sterilized and used in the perioperative setting

• Sterilization• Provides guidance for sterilizing items in the perioperative setting

Association of periOperative Registered Nurses (AORN)

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© 3M 2015. All Rights ReservedThe Joint Commission: 2015 Hospital Accreditation Standards


Top Standards Compliance Issues for 2014

• Ambulatory Surgery• 41% IC.02.02.01 The organization reduces the risk of infections associated with medical

equipment, devices, and supplies.

• 22% IC.01.03.01 The organization identifies risks for acquiring and transmitting infections.

• Office-Based Surgery Practices• 39% IC.02.02.01 The practice reduces the risk of infections associated with medical

equipment, devices, and supplies.

• 19% IC.01.03.01 The practice identifies risks for acquiring and transmitting infections.

• 17% IC.01.04.01 Based on the identified risks, the practice sets goals to minimize the possibility of transmitting infections independent practitioners and staff.

Joint Commission Perspectives®, April 2015, Volume 35, Issue 4


• LD.04.01.01, EP2• The hospital provides care,

treatment, and services in accordance with licensure requirements, laws and regulations

• LD.04.03.07• Patients with comparable needs

receive the same standard of care, treatment, and services throughout the hospital

• LD.04.04.07

• The hospital considers clinical practice guidelines when designing or improving processes.

• IC.02.02.01 - The organization reduces the risk of infections associated with medical equipment, devices and supplies.

• The hospital implements infection prevention and control activities when doing the following:• EP1- Cleaning and performing low-level

disinfection of medical equipment, devices, and supplies.

• EP2 - The hospital implements infection prevention and control activities when doing the following: Performing intermediate and high-level disinfection and sterilization of medical equipment, devices, and supplies.

The Joint Commission: 2015 Hospital Accreditation Standards

The Joint Commission

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• Evidence-based Guidelines• Standard IC.01.05.01, EP 1 - Lack of having—and/or lack of using—current evidence-

based guidelines for cleaning, disinfection, high-level disinfection, and sterilization practices is a frequently identified issue and includes knowledge of guideline content and accessibility of guidelines (electronic or manual) for staff use.

• Orientation, Training, and Competency• Standard IC.02.02.01 - lack of orientation, training, and competency (initial and ongoing)

of all staff involved in processing or handling semi-critical and critical devices that require high-level disinfection or sterilization.

The Joint Commission Perspectives February 2014

The Joint Commission – Issues with High-Level Disinfection (HLD)


• Quality Control and Quality Monitoring• Standard IC.01.05.01, EP 2 - lack of quality control for high-level

disinfection and the lack of quality monitoring for sterilization.

• Supervisory and Infection Prevention and Control Staff• Fourth most frequently identified issue involves the participation and collaboration of

staff in monitoring high-level disinfection and sterilization processes.

• Record Keeping• Fifth most frequently noted issue involves documentation.

The Joint Commission Perspectives February 2014

The Joint Commission – Issues with High-Level Disinfection (HLD)


Findings from non-complying organizations include:• Mistaken belief that the risk of passing bloodborne pathogens or bacterial agents to patients is low• Staff lack the knowledge or training required to properly sterilize or high-level disinfect equipment• Staff do not have access to or lack knowledge of evidence-based guidelines• Lack of leadership support• Frequent leadership and staff turnover makes sterilization or high-level disinfection of equipment a

low priority• Lack of a culture of safety that supports the reporting of safety risks• Processes for sterilization or high-level disinfection are not followed (i.e., staff take short-cuts)• Time frames for proper sterilization or high-level disinfection of equipment are not followed• No dedicated staff person to oversee the proper sterilization or high-level disinfection of equipment

http://www.jointcommission.org/assets/1/23/Quick_Safety_Issue_Two_May_2014.pdf

The Joint Commission’s Office of Quality Monitoring

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• Facility design or space issues prevent proper sterilization or high-level disinfection of equipment (e.g., processing takes place in a small room that is also used for storage)

• Lack of monitoring or documentation of sterilization or high-level disinfection of equipment, which makes it difficult to track the use of equipment on a specific patient, complicating the patient notification process when an outbreak occurs

• Equipment is spread throughout the facility and may be processed or stored in numerous locations, making it difficult to track the equipment for documentation purposes.

http://www.jointcommission.org/assets/1/23/Quick_Safety_Issue_Two_May_2014.pdf

The Joint Commission’s Office of Quality Monitoring (cont’d)


• EC.02.05.01 The hospital manages risks associated with its utility systems

• EP 6: In areas designed to control airborne contaminants (such as biological agents, gases, fumes, dust), the ventilation system provides appropriate pressure relationships, air exchange rates and filtration efficiencies

• Move from clean to dirty

• Decontamination – negative pressure

• Prep and Pack – positive pressure

• Sterile storage – positive pressure

Joint Commission Problematic Standards


• The Joint Commission will survey for:• Orientation, training and competency of the health care worker

(HCW) who process medical equipment, devices and supplies• Levels of staffing and supervision of the HCW who process medical

equipment, devices and supplies• Standardization of the process regardless of whether it is centralized

or decentralized• Ongoing quality monitoring• Observation against the manufacturers guidelines and the

organization procedures.

The Joint Commission Perspectives. October 2009 Vol 29 (10)

The Joint Commission Survey

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CDC Health Alert Network (HAN)

“The Centers for Disease Control and Prevention (CDC) and U.S. Food and Drug Administration (FDA) are alerting healthcare providers and facilities about the public health need to properly maintain, clean, and disinfect or sterilize reusable medical devices. Recent infection control lapses due to non-compliance with recommended reprocessing procedures highlight a critical gap in patient safety. Healthcare facilities (e.g., hospitals, ambulatory surgical centers, clinics, and doctors’ offices) that utilize reusable medical devices are urged to immediately review current reprocessing practices at their facility to ensure they (1) are complying with all steps as directed by the device manufacturers, and (2) have in place appropriate policies and procedures that are consistent with current standards and guidelines.

http://emergency.cdc.gov/han/han00383.asp September 11, 2015, 12:15 EDT (12:15 PM EDT) CDCHAN-00382


Our wake up call from the Joint Commission and CMS

Patient

TJC / CMS

HealthcareFacilities

http://www.komar.org/faq/churchill_polar_bear_tours/other-animals-fun-stuff/2009_11_09_5419-churchill-polar-bears.jpg


Under continuous review and maintenance.

ANSI/AAMI ST79:2010 & A1:2010 &A2:2011 & A3:2012 & A4:2013 (Consolidated Text)

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• CQI programs are used to assess and improve all components of the sterilization process

• Desired outcome of improving patient care by consistently delivering sterile product to the userNo single “right way” to implement CQI

• Team approach

Reprinted from ANSI/AAMI ST79:2010 & A1:2010 &A2:2011 & A3:2012 & A4:2013 Section 11

Continuous Quality Improvement (CQI) – AAMI ST 79 Section 11


• Cleaning and Decontamination

• Preparation and Packaging

• Sterilization

• Sterile Storage and Distribution• Record Keeping

• Recall Procedures

What are the key parts of the process?


• Instruments requiring extended cycles

• Original packaging changed for sterilization

• Flexible endoscopes not properly processed for patient use

• Late arrival of loaner instruments to allow for reprocessing according to IFU and quarantine implants for BI results

• Wrong BI process challenge device is run during routine testing

• Improperly reprocessed eye sets with improper reprocessing to prevent TASS

• Daily verification of mechanical cleaning equipment not done at least daily

• Manufacturer’s IFU for cleaning not followed

Young, Martha Top 10 Risk in Sterile Processing. AAMI Horizons Spring 2012

Risks in Sterile Processing

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“The sterilization risk analysis should be part of the overall infection prevention and control risk analysis in accordance with accreditation agency requirements.”

• Risk assessment (FMEA)

• Risk management (ANSI/AAMI ST79, Root cause analysis)

• Risk communication (Recall procedure)

“It should be performed annually and should be reevaluated whenever significant changes occur.”

Reprinted from ANSI/AAMI ST79:2010 & A1:2010 &A2:2011 & A3:2012 & A4:2013 Clause 11.2.2

Risk analysis = risk assessment + risk management + risk communication

Sterilization Risk Analysis


• Failure Modes and Effects Analysis (FMEA)

• Proactive risk assessment • Assess the relative impact of

different failures, in order to identify the parts of the process that are most in need of change.

• Root Cause Analysis• Reactive/Retrospective Process

• identify deficiencies or root cause for the error or adverse event

• Cause and effect fishbone diagram

• Answers the “Why” questions

• Based on analysis, identify improvements and implement to avoid recurrence

http://www.ihi.org

Sterilization Risk Analysis


CLEANING AND OTHER DECONTAMINATION PROCESSES

Manual or Mechanical? If you can’t clean it, you can’t sterilize it!

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• Liquid-resistant covering with sleeves

• Heavy-duty latex free or plastic gloves

• Surgical face mask (impervious to fluid and high filtration)

• Safety glasses that wrap around the eye or face shield

• Disposable hair covering• Proper footwear


Personal Protective Equipment (PPE) – Portal of Exit/Entry


The purpose of decontamination is to prevent the spread of infection.


• “To be rendered safe to handle, some medical devices require only thorough cleaning; others, because of occupational exposure considerations, must be cleaned and subjected to a microbicidal process. Some devices can be prepared for patient reuse following the decontamination process, whereas others must be prepared and subjected to terminal sterilization (e.g., steam sterilization of surgical instruments).” (Clause 7.1)

• “The type of decontamination required for a particular contaminated device depends on the biohazard that the device presents.” (Clause 7.1)

• “The written [instructions for use] IFU of the device manufacturer should always be followed.” (Clause 7.2.2)

• “Surgical instruments and other items composed of more than one part or piece (e.g., metal tracheostomy tubes, procedure needles, dental handpieces, laparoscopic instrumentation, trumpet valves) should be disassembled to expose all surfaces to the cleaning process.” (Clause 7.4.1)

Reprinted from ANSI/AAMI ST79:2010 & A1:2010 &A2:2011 & A3:2012 & A4:2013 Sec. 7.1 & 7.2.2 & 7.4.1

Cleaning and other Decontamination Processes

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“For all reusable, the first and most important step in decontamination is thorough cleaning and rinsing.” (Clause 7.5.1) Reprinted from ANSI/AAMI ST79:2010 & A1:2010 &A2:2011 & A3:2012 & A4:2013 Clause 7.5.1

http://www.palmpressinc.com/product-tag/baby-in-sink/


Polling Question

How do you monitor the cleanliness of instruments after the decontamination process?a. Visual inspection onlyb. Visual inspection plus a cleaning monitoring productc. We do not monitor the cleaning process


PACKAGING

“The primary functions of a package containing a medical item are to allow the sterilization of the contents, to maintain the sterility of the contents until the package is opened, and to provide for the removal of the contents without contamination.”

Reprinted from ANSI/AAMI ST79:2010 & A1:2010 &A2:2011 & A:2012 & A4:2013 Clause 8.2 Rationale

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Paper-Plastic Pouches – “The plastic laminate used in paper–plastic pouches is impervious to the sterilant and, therefore, might prevent the sterilant from reaching the surface of anything with which the plastic side is in physical contact. Therefore, paper–plastic pouches should not be used within wrapped sets or containment devices unless the practice has been validated by the packaging manufacturer and verified by product testing in the health care facility.”

• ANSI/AAMI ST77:2013 Rigid Container Systems (Manufacturer Standard)

• Ergonomic issue• “The combined weight of the containment

device, the instruments, and any accessories or wrappers shall not exceed 25 pounds…”

• When containment devices, including their contents and any accessories or wrappers, are too heavy, sterilization and/or drying could be compromised in commonly available hospital sterilization cycles.

Reprinted from ANSI/AAMI ST79:2010 & A1:2010 &A2:2011 & A3:2012 &A4:2013 Clause 8.3.4 & 8.4.2 Rationale

Packaging Concerns


STEAM STERILIZATION

The first step in being able to monitor the steam sterilization process is to know the type of steam sterilizer that is used.


Steam Sterilization • Type of Steam Sterilization

Process• Gravity Displacement• Dynamic-Air-Removal

Prevacuum• Steam-flush pressure-pulse

(SFPP)

• Critical Parameters• Time • Temperature• Saturated Steam

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•Process designed for the steam sterilization of patient care items for immediate use

•High temperature (132-135°C / 270-275°F)• Gravity or dynamic-air-removal

• No dry time

• No storage

Immediate Use Steam Sterilization (IUSS) (Formerly Flash Sterilization)


Minimum cycle times at 121°C/250°F for gravity displacement steam sterilization cycles for sterilizers >2 cubic feet

Load Contents Time (Min)

Wrapped instruments 30

Textile packs 30

Wrapped utensils 30

Gravity Displacement - Cycle Time Examples

ANSI/AAMI ST79:2010 & A1:2010 &A2:2011 & A3:2012 & A4:2013 8.1 Table 4


Minimum cycle times for dynamic-air-removal steam sterilization cycles >2 cubic feet

Load Contents Temp Time (Min)

Wrapped instruments132°C/270°F135°C/275°F

43

Textile packs132°C/270°F135°C/275°F

43

Wrapped utensils132°C/270°F135°C/275°F

43

Unwrapped, non porous items (e.g. instruments)

132°C/270°F135°C/275°F

33

Unwrapped non‐porous/porous in mixed load

132°C/270°F135°C/275°F

43

Dynamic Air Removal - Cycle Time Examples


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Load Contents Temp Time (Min)

Unwrapped instruments on tray or glassware

132°C/270°F135°C/275°F ≥3

Wrapped trays of instruments,instruments in peel pouches

132°C/270°F135°C/275°F ≥5

Packs, wrapped 121°C/250°F ≥30

Table Top Gravity Steam Sterilizers



Minimum cycle times for immediate-use steam sterilization cycles >2 cubic feet – Gravity displacement

Load Contents TempTime (Min)

Unwrapped non‐porous items (e.g., instruments)

132°C/270°F135°C/275°F

33

Unwrapped non‐porous and porous items in mixed load

132°C/270°F135°C/275°F

1010

Gravity Displacement - Cycle Time Examples

ANSI/AAMI ST79:2010 & A1:2010 &A2:2011 & A3:2012 & A4:2013 8.6.2


Sterilization Monitoring - not as simple as it looks!

Is it done yet?

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Standardize the process

Checklists - outline all the steps

Automate the process

Reduce the number of steps and handoffs

Redundancy (double checks)

Design the sterilization process to prevent error and break the chain of infection? (SCARR)


• Monitoring and verifying the cleaning process• Sterilization process monitoring

• monitoring of every package and sterilization load • routine monitoring of sterilizer efficacy • qualification testing of the sterilizer after installation,

relocation, sterilizer malfunction, major repairs, and sterilization process failures

• periodic product quality assurance testing

Reprinted from ANSI/AAMI ST79:2010 & A1:2010 &A2:2011 & A3:2012 &A4:2013 Clause 10.4, Table 6, 10.6 – 10.9

Quality Control


• Probability

• Assurance level of 10-6

• Individual sterilization monitors does not indicate sterility

• Need the combination of all monitors to give an assurance of sterility

• Physical + Chemical + Biological = Probability of sterility

(1 in a million chance that an item is not sterile)

Sterilization Assurance

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Ensure probability of sterility of processed medical devices

Detect sterilization failure ASAP: quarantine medical devices until final BI result known

Verify a corrected failure ASAP…… get sterilizer back into service

Control costsRemove medical devices involved

in failures before patient useHelps determine if events during

sterilization process met parametersProvides verification of adherence

to policies/proceduresPromote patient safety and improve

outcomes

Reasons for Testing the Sterilization Process


• Each monitoring tool “plays a distinct and specific role in sterilization process monitoring, and each is indispensable to sterility assurance.”

• Physical monitors– time, temperature and pressure recorders, displays, digital printouts,

tapes and gauges

• Chemical indicators (CIs) - (Classes 1-6)

– external/internal CIs

– Bowie-Dick (BD) type tests

• Biological indicators (BIs)

Reprinted from ANSI/AAMI ST79:2010 & A1:2010 &A2:2011 & A3:2012 & A4:2013 Clause 10.4, Table 6 & 7

Sterilization Process Monitoring Devices


BIOLOGICAL INDICATOR MONITORING

Biological indicators provide the only direct measure of the lethality of the sterilization process.

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• Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008

• “Biological indicators are recognized by most authorities as being closest to the ideal monitors of the sterilization process because they measure the sterilization process directly by using the most resistant organisms (i.e., Bacillus spores) and not by merely testing the physical and chemical conditions necessary for sterilization.”

Ref: http://www.cdc.gov/ncidod/dhqp/pdf/guidelines/Disinfection_Nov_2008.pdf , page 76

CDC Guidelines


Routine load release

Testing of each non-implant and implant load

Routine sterilizer efficacy monitoring

Establishing a regular pattern of testing the efficacy of the sterilization process

Sterilizer qualification testing

Testing of the sterilizer after events occur which could affect the ability of the sterilizer to perform

Periodic product testing

Testing of routinely processed items to ensure the effectiveness of the sterilization process and to avoid wet packs

ANSI/AAMI ST79:2010 & A1:2010 &A2:2011 & A3:2012 & A4:2013 Clause 10.5.3, Table 7

Biological Indicator Monitoring


• Process challenge device (PCD)

designed to simulate the product to be sterilized

constitutes a defined resistance to a sterilization process and used to assess effective performance of the process

placed in the most challenging area in the sterilizer for sterilant penetration

• BI

• BI and a Class 5 integrating chemical indicator

• Class 5 integrating chemical indicator

• Class 6 Emulating Indicator


Sterilization Process Monitoring Devices

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• Routine load release • non-implant• implant load

• Routine sterilizer efficacy monitoring• Establishing a regular pattern of testing the

efficacy of the sterilization process for both gravity and dynamic air-removal testing.

• BI PCD• Every load • Daily plus every implant load• Weekly plus every implant load

• BD type test• Daily

• Immediate Use Steam Sterilizer (IUSS)• BI PCD representative of tray

routinely processed• Each type of tray configuration in

routine use should be tested separately• Perforated, mesh bottom, open surgical tray• Rigid sterilization container system• Protective organizing case• Single-wrapped surgical tray • Empty load on bottom shelf over drain

• BD type test if dynamic-air-removal• Daily

Reprinted from ANSI/AAMI ST79:2010 & A1:2010 &A2:2011 & A3:2012 & A4:2013 Clause 10.6.1, 10.6.2, Table 6 & 7

Routine Sterilizer Efficacy Monitoring


• Table-top sterilizers• BI PCD representative of package or tray routinely processed and

most difficult to sterilize

• BI PCD should contain items normally present during routine sterilization

• Full load in cold point (check with sterilizer manufacturer)

Routine Sterilizer Efficacy Monitoring


• Weekly, preferably daily

• Every load with an implant

• Some sterilization systems (e.g., Ethylene Oxide) require every load monitoring

• Why monitor every load?• Universal standard of patient care • Cost and impact of a recall• To be certain all implants, including

those in loaners, are appropriately monitored

• Ensure every type of sterilization cycle used is monitored

• Ensure every type of packaging used in flash sterilization is monitored

• Reduce risk and cost of healthcare-associated infections (HAIs)

ANSI/AAMI ST79:2010 & A1:2010 &A2:2011 & A3:2012 & A4:2013 Clause 10.5.4

Biological Indicator - Monitoring Frequency

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• Physical monitors

• External process indicator (Class 1) on every package

• Internal CI (Class 3, 4, 5 or 6) inside every package

• If desired, a PCD containing a

• BI

• BI and a Class 5 integrating chemical indicator

• Class 5 integrating chemical indicator

• Class 6 Emulating Indicator

• Evaluation of all data by an experienced, knowledgeable person

• Do not distribute load if any data suggests a sterilization process failure

• If desired, a PCD containing a • BI

• If a BI PCD is not used in each load• Do not know spores were killed

• Need to do a recall when a positive BI is obtained

• More frequent monitoring less to recall and reduce chance of patient receiving a non-sterile medical device

• Immediate Use Steam Sterilization Cycles (IUSS)

• Class 5 or Class 6 PCD for Releasing IUSS Loads

• Representative of load

• Open surgical tray

• Rigid sterilization container

• Protective organization case

• Use as internal CI and to release non-implant loads

ANSI/AAMI ST79:2010 & A1:2010 &A2:2011 & A3:2012 & A4:2013 Clause 10.5.4

Routine Load Release-Non-Implant Loads


What is an Implant?According to FDA, “device that is placed into a surgically or naturally formed cavity of the human body if it is intended to remain there for a period of 30 days or more. FDA may, in order to protect public health, determine that devices placed in subjects for shorter periods are also ‘implants.’ ” 21 CFR 812.3(d)

•Only BI results can be used to release implants

•“BIs within a PCD should be used to monitor every load containing implants (see 10.6.1).”•The PCD should include a Class 5 integrating CI

•“The load should be quarantined until the results of the BI testing are available (CDC, 2008).”

ANSI/AAMI ST79:2010 & A1:2010 &A2:2011 & A3:2012 & A4:2013 10.6.3

Routine Load Release-Implant Loads

• Immediate use steam sterilization (IUSS) should not be used for implantable devices except in cases of emergency when no other option is available.


• Name of

• Implant prematurely released

• Patient

• Surgeon

• Reason for premature release

• What could have prevented premature release

ANSI/AAMI ST79:2010 & A1:2010 &A2:2011 & A3;2012 & A4:2013 Annex L

Sample - Implant Exception Form

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Polling question

How often does your Sterile Processing Department monitor with a biological indicator?a. Every loadb. Once a dayc. Daily plus implantsd. Once a week


Other Required Testing

• Dynamic-air removal sterilizers

• Bowie-Dick type test –run three consecutive cycles in an empty chamber, one right after the other, with the each test result demonstrating sufficient air removal

• Table-top sterilizers• BI PCD representative

of package or tray routinely processed and most difficult to sterilize

• BI PCD should contain items normally present during routine sterilization

• Full load in cold point (check with sterilizer manufacturer)

• Three consecutive cycles

• For both gravity-displacement and dynamic-air-removal sterilizers

• Steam sterilizer installation, relocation, or repaired and the time it is released for use in the health care facility.

• Three consecutive cycles should be run, one right after the other, with a BI PCD

ANSI/AAMI ST79:2010 & A1:2010 &A2:2011 & A3:2012 & A4:2013 10.8.1, 10.8.2


Other Required Testing • Immediate Use Steam Sterilization (IUSS)

• BI PCD representative of tray routinely processed• Select a tray configuration to be tested

• Perforated, mesh bottom tray, open surgical tray

• Rigid sterilization container system

• Protective organizing case

• Single-wrapped surgical tray

• Empty load on bottom shelf over drain

• Three consecutive cycles

ANSI/AAMI ST79:2010 & A1:2010 &A2:2011 & A3:2012 & A4:2013 10.8.3 &10.8.4

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STERILE STORAGE

Sterile items should be stored in a manner that reduces the potential for contamination.


• Separate area with restricted access• Proper ventilation (at least 4 air

changes/hour, positive pressure to corridor) to protect against dust, moisture and extremes of temperature (~24ºC /75ºF) and humidity (<70%)

• Free of insects and vermin• Sterile items should be stored away from

outside walls (at least 2 inches), off the floor (at least 8-10 inches) and away from the ceiling (18 inches)

• Stored to prevent physical damage (dragging, sliding, crushing, bending, compressing or puncturing)

• Sterile packages should be minimally handled to reduce the risk of contamination of the contents

• Should not be stored next to sinks or under exposed water or sewer pipes or in locations where they may become wet

• Should not be stored on floor or windowsills

• Shelf life is event related• Sterile packages transported to the point

of use should be protected to prevent contamination

ANSI/AAMI ST79:2010 & A1:2010 &A2:2011 & A3:2012 & A4:2013 8.9

Sterile Storage

© 3M 2015. All Rights ReservedANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012, A4:2013 Section 8.9.2

Protect Clean and Sterile Supplies from Contamination

NO OUTSIDE SHIPPING CONTAINERS OR CORRUGATED CARDBOARD / CARTONS

* Photo courtesy of Department of Entomology, University of Nebraska-Lincoln.

Photographer: Jim Kalisch.

Mature Indian Meal Moth Larvae Pupating in Corrugated Cardboard*

Quality in the Sterile and Clean Storage Area

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RECORD KEEPING


Labeling on product•Lot or load control number

– Date of processing

– Sterilizer number

– Cycle number

Expiration date or statement:

“Contents sterile unless package is open or damaged. Please check before using.”

Electronic system• Reduction of human error

• Past records available with a touch of a finger

• Accessibility to all load records at any time

• All load information in one location

ANSI/AAMI ST79:2010 & A1:2010 &A2:2011 & A3:2012 & A4:2013 8.3.2

Documentation - Manual or Electronic


• Sterilizer and load records Load contents Date and time of cycle Exposure time and temperature Initials of operator Biological results Chemical indicator results

• Records of sterilizer repair, maintenance and calibration• Maintain records for time determined by risk manager

Documentation - Electronic or Manual

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RECALL PROCEDURES

Risk Communication


Recall Procedures• Written policies and procedures for the

recall of items from issued or stored loads should be developed in cooperation with the infection prevention and control committee and risk management of the individual health care facility.

• These policies and procedures should be documented, and records should be maintained.

• If cause of failure immediately identified and confined to one load or item

– e.g., using incorrect sterilization cycle

– No recall, correct problem and reprocess load

•If cause of failure not identified•Quarantine load, recall all items processed since last negative BI

•Determine cause of failure

ANSI/AAMI ST79:2010 & A1:2010 &A2:2011 & A3:2012 & A4:2013 10.11.1


Polling question

How many times in the last 12 months has your facility conducted a recall?a. 0b. 1-2c. 2 or mored. Not sure

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Areas of Concern


Areas of Concerns that Impact Infection Prevention

• Processing of endoscope• Inadequate processing

• Culturing of endoscope

• Cleaning verification • How clean is visibly clean?

• Immediate Use Steam Sterilization

• Toxic Anterior Segment Syndrome (TASS)• “Most cases of TASS appear to result from

inadequate instrument cleaning and sterilization”

• Loaner instrumentation• Timelines not met to allow for proper

processing

• Product testing• Product testing should always be performed

when major changes are made in packaging, wraps, or load configuration, such as dimensional changes, weight changes, or changes in the type or material of packaging or wrapper.”

ANSI/AAMI ST79:2010 & A1:2010 &A2:2011 & A3:2012 & A4:2013 10.9


• Infection Preventionist collaboration with the Sterile Processing Department (SPD) is key

• Include SPD in your Joint Commission tracer and rounding activities

• Ensure that all policies and procedures are evidence-based and up to date

• Quality does not automatically translate into patient safety

• Monitoring of the sterilization process is necessity for maintaining patient safety

• Be aware of publications in the media that impacts patient safety, healthcare environment and perioperative setting including the Sterile Processing Department

• Conduct regular risk assessments of the various processes and potential problems using tools such as FMEA and RCA when issues arise that impact patient safety

• Be aware of the concerns in the SPD

Summary

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CMSOSHA

The Joint Commission State Regulators

http://www.amusingtime.com/funny-dog-stuck-between-two-trees-2/

© 3M 2015. All Rights Reserved© 3M 2015. All Rights ReservedSM

77

Thank you!

Questions?


Next Month’s Webinar

Hot Topics from the 3M Sterilization Tech Line• December 10, 2015

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Acknowledgments

• SPD staff pictures used with permission.

• Reprinted from ANSI/AAMI ST79:2010, A1:2010, & A2:2011 & A3:2012 & A4:2013 with permission of Association for the Advancement of Medical Instrumentation, Inc. (C) 2011 AAMI www.aami.org. All rights reserved. Further reproduction or distribution prohibited.


AAMI Sterilization Standards• ST79 Comprehensive guide to steam sterilization and sterility assurance in health care facilities, 2nd edition (Incorporates Amendment

1:2010, A2,2011, A3:2012, and A4:2013)

• ST58 Chemical sterilization and high-level disinfection in health care facilities, 3rd edition

• ST91 Flexible and semi-rigid endoscope processing in health care facilities

• ST40 Table-top dry heat (heated air) sterilization and sterility assurance in health care facilities, 2nd edition

• TIR34 Water for the reprocessing of medical devices

• ST41 Ethylene oxide sterilization in health care facilities: Safety and effectiveness, 4th edition (Incorporates 2010 Erratum).

• ST81 Information to be provided by the manufacturer for the processing of resterilizable medical devices, 1st edition

• TIR12 Designing, testing, and labeling reusable medical devices for reprocessing in health care facilities: A guide for device manufacturers, 3rd edition

• TIR30 A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices, 2nd edition

• TIR55 Human factors engineering for processing medical devices

• TIR63 Management of loaned critical and semi-critical medical devices that require sterilization or high-level disinfection

• ST65 Processing of reusable surgical textiles for use in health care facilities, 2nd edition

• PB70 Liquid barrier performance and classification of protective apparel and drapes in health care facilities, 2ed

• TIR11 Selection of surgical gowns and drapes in health care facilities, 2nd edition


How to Purchase AAMI Standards for Your Reference Library

AAMI documents can be purchased through AAMI by credit card using the following four options:

Internet: http://marketplace.aami.org

Call: 1-877-249-8226

Fax: 301-206-9789

Mail: AAMI Publications, P.O. Box 0211, Annapolis Junction, MD 20701-0211

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References• The Joint Commission: 2015 Accreditation Standards• Joint Commission Perspectives®, April 2015, Volume 35, Issue 4• http://www.jointcommission.org/assets/1/23/Quick_Safety_Issue_Two_May_2014.pdf• CDC Health Advisory Immediate Need for Healthcare Facilities to Review Procedures for Cleaning, Disinfecting, and Sterilizing

Reusable Medical Devices. CDC Health Alert Network. September 11, 2015, 12:15 EDT (12:15 PM EDT) CDCHAN-00382• Association for the Advancement of Medical Instrumentation (AAMI). Comprehensive guide to steam sterilization and sterility

assurance in healthcare facilities. ANSI/AAMI ST79:2010 & A1:2010 &A2:2011 & A3;2012 & A4:2013• Association for the Advancement of Medical Instrumentation (AAMI). Containment devices for reusable medical device sterilization.

ANSI/AAMI ST77:2013• Recommended Practices for Sterilization in the Perioperative Practice Settings. In: Perioperative Standards and Recommended

Practices. Denver, CO: AORN, Inc, 2015• Rutala, William A, Weber, David J and HICPAC Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008

• Brachman, Philip S. Epidemiology of Nosocomial Infections. In Hospital Infections 3rd edition, edited by John V. Bennett and Philip s. Brachman. 1992 pp. 3-20.

• IAHCSMM Central Service Technical Manual, 7th Edition.• http://www.iahcsmm.org/current_issues_Joint_paper_loaner_instrumentation.htm• Seavey, Rose. AAMI Sterile Processing In Healthcare Facilities: Preparing for Accreditation Surveys. AAMI 2011.


References• Recommended Practices for Cleaning and Sterilizing Intraocular Surgical Instruments. From the American Society of Cataract and

Refractive Surgery and the American Society of Ophthalmic Registered Nurses. Special Report prepared February 16, 2007.• Occupational Safety and Health Administration. 29 CFR 1910.1030 Occupational Exposure to Bloodborne Pathogens ; Final Rule.

Federal Register December 6, 1991.• Archibald, Lennox K. and Hierholzer, Walter J. Principles of Infectious Diseases Epidemiology. in Hospital Epidemiology and Infection

Control 3rd edition. C. Glen Mayhall, Editor. 2004. Pp.1-17.• Sehulster, Lynn and Schultz, Janet. Central Sterile Supply. In Hospital Epidemiology and Infection Control 3rd edition. C. Glen Mayhall,

Editor. 2004. Pp.1301-1313.• Steam Sterilization – Update on The Joint Commission’s Position. June 16, 2009. • The Joint Commission Perspectives. October 2009 Vol 29 (10)• Reason, James Human error: models and management. BMJ 2000:768-70• Nick Mamalis, MD, Toxic Anterior Segment Syndrome Journal of Cataract and Refractive. Surgery 2006; 32:324-333.• AAMI / FDA Reprocessing Summit. October 2011.

http://www.aami.org/publications/summits/2011_Reprocessing_Summit_publication.pdf• Sterilization and Reprocessing – A Matter of Patient Safety. Horizons Spring 2012• Martha Young (2012) Top 10 Risks in Sterile Processing. Biomedical Instrumentation & Technology: Reprocessing, Vol. 46, No. sp12, pp.

15-19. • Standards of Infection Control in Reprocessing of Flexible Gastrointestinal Endoscopes. SGNA 2012• Guidelines for Use of High Level Disinfectants and Sterilants for Reprocessing Flexible Gastrointestinal Endoscopes. SGNA 2010• Multiple Society guideline on reprocessing flexible gastrointestinal endoscopes: 2011. American Society for Gastrointestinal Endoscopy

and the Society for Healthcare Epidemiology of America.


References• http://www.iahcsmm.org/current_issues_Joint_paper_loaner_instrumentation.htm• www.cdc.gov• www.fda.gov• www.epa.gov• www.ecri.org/2015hazards• https://www.ecri.org/Resources/Superbug/Culturing_Duodenoscopes_Key_Step_to_Red

ucing_CRE_Infections.pdf• http://www.cdc.gov/hai/pdfs/lab/interim-duodenoscope-culture-method.pdf• http://www.cdc.gov/hai/pdfs/cre/interim-duodenoscope-surveillance-Protocol.pdf• http://www.cdc.gov/hai/settings/lab/lab-duodenoscope-sampling.html#c

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