A guide to the decontamination of reusable surgical instruments

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Transcript of A guide to the decontamination of reusable surgical instruments

A guide to the decontamination of reusable surgical instrumentsFor queries on the status of this document contact info@whe.wales.nhs.uk or telephone 029 2031 5512
Status Note amended March 2013
A guide to the decontamination of reusable surgical instruments
reusable surgical instruments
© Crown copyright 2003
reusable surgical instruments
instruments Infection control policies Decontamination training
page 11
4.0 CLEANING page 15
5.0 DISINFECTION page 21
page 23
7.0 PACKAGING page 25
page 33
page 37
APPENDIX 1 – Processing of flexible endoscopes
page 39 APPENDIX 2 – References page 41 APPENDIX 3 – Glossary page 45
Acknowledgements page 48
The aim of this guide is to provide information on the decontamination of surgical instruments. It can be applied to any healthcare setting where reusable surgical instruments are reprocessed.
This guide covers the broader issues relating to the reprocessing of re-usable surgical instruments (for example trays), and is intended for people working in multi-disciplinary healthcare fields who are involved in any aspect of the management of surgical instruments and equipment. This may involve the actual cleaning and sterilization of surgical instruments and equipment, or their transportation, storage and use.
It is written for a wide audience, and whilst reflecting the basic principles of decontamination, it should not be used as a replacement for legislative documents or detailed guidance issued by the Department of Health and other recognised bodies.
Since the National Decontamination Initiative began in 1999, NHS Estates have issued a number of CD-ROMs to the NHS, which have contained decontamination guidance documents relating to decontamination standards and their application. The latest edition
was issued in July 2003. References to guidance contained on the CD-ROM are given throughout this guide to allow for more detailed information to be obtained by the reader as required. A full description of these references is listed in Appendix 2. These documents can also be accessed through the NHS Estates website.
The guide is divided into specific sections for ease of reference following the order of the “decontamination life-cycle” shown in Figure 1. This allows healthcare workers involved in particular areas of decontamination to focus directly on those topics that are of interest to them.
The decontamination life cycle model highlights the extent to which decontamination affects the whole of an organisation and not just those areas processing equipment.
Traditionally, decontamination has been the responsibility of the departmental heads of specialist units, for example sterile services, endoscopy units, theatre suites etc. Management arrangements within organisations often divided these functions and made it difficult for a totally co-ordinated approach to the application of decontamination standards and practices to be achieved. However, regardless of the location, the same
standards should be applied to decontamination practices throughout an organisation.
Figure 1 highlights each stage of the decontamination process through which surgical instruments pass before every use. Effective decontamination requires the attainment of acceptable standards at all stages of the life cycle. Failure to address issues in any of these stages will result in inadequate decontamination.
At all stages of reprocessing, the following issues need to be taken into account:
1. the location and activities where decontamination takes place;
2. facilities and equipment at each location;
3. ensuring that equipment used is validated, maintained and tested in accordance with manufacturer’s guidelines and legislation;
4. the existence of effective management arrangements;
5. the existence of policies and procedures for all aspects of decontamination work.
Decontamination is the combination of processes (including cleaning, disinfection and sterilization) used to render a reusable item safe for further use on patients and handling by staff. The effective decontamination of reusable surgical instruments is essential in minimising the risk of transmission of infectious agents.
In maintaining and developing organisation-wide decontamination standards and practices, the following should be included:
• an effective management control system must be in place to cover all aspects of the decontamination life- cycle;
• every organisation should have a nominated lead with responsibility for decontamination, either at director level or someone who has line management responsibility to a senior responsible person at that level;
• documented robust and comprehensive policies and procedures to ensure that decontamination processes are undertaken in a controlled manner to protect the health and safety of patients and staff;
• a procurement policy which ensures that all purchased instruments are compatible with decontamination processes available within the organisation;
• manual cleaning of devices to be restricted to those items deemed incompatible with automated processes;
• reprocessing of surgical instruments to be undertaken in dedicated facilities and outside the clinical/patient environment, preferably in central facilities;
• equipment used to decontaminate surgical instruments and associated equipment must be fit for purpose, validated and tested in accordance with current recommendations;
• organisations should have systems in place to trace instrument sets and endoscopes through decontamination processes and to the patient (see below; see also HSC 2000/032 and HSC 1999/178);
• a documented training scheme must be in operation with individual training records for all personnel, including management involved in decontamination activities.
It is important to be able to trace products through the decontamination processes to which they have been subjected and also to the patient on whom they have been used. The ability to track and trace surgical instruments and equipment through the decontamination life-cycle enables corrective action to be taken when necessary. For example, in the unlikely event of a sterilization cycle failure, products can then be recalled.
HSC 2000/032 states:
“It is important that systems are in place to allow sets of surgical instruments to be tracked through decontamination processes in order to ensure that the processes have been carried out effectively. Systems should also be implemented to enable the identification of patients on whom the instrument sets have been used. This is important so that the relevant patients can be identified in the event of exposure to potential risk, and is relevant to both the primary and secondary care sectors. This requirement for traceability of
instrument is in addition to the measures for identification and tracking of flexible endoscopes set out in Health Service Circular 1999/178.”
Records should be maintained for all the sets cleaned, identifying:
• the cleaning and sterilization method used;
• the name of the person undertaking the decontamination; and
• details of the actual item being processed.
This information is required so that instrument sets can be traced, if required, in the event of a failure in the decontamination cycle or for infection control reasons.
Records relating to decontamination processes should be maintained by the organisation for a minimum of 11 years or in accordance with local data policies.
All organisations must have an infection control policy that contains:
• advice on decontamination and storage of surgical instruments;
• local policies on recommended disinfectants, their application, use, storage and disposal;
• protocols for the cleaning and disinfection of surgical instruments where instruments have to be processed in a local setting;
• protocols for the use of personal protective equipment (PPE);
• risk assessments for procedures used in the reprocessing of surgical instruments;
• spillage procedures;
• management and treatment of needle- stick/sharps injuries.
This policy should be written in collaboration with the infection control team.
Controls Assurance standards exist for the related issues of decontamination, the management of surgical instruments and associated equipment, and infection control. Organisations are legally required to undertake assessments and complete their returns as part of their risk management system.
Members of staff undertaking decontamination must be competent, properly trained and supervised. A national training scheme is currently being devised and will describe basic training for staff involved in all aspects of the decontamination of surgical instruments.
Individual training records, detailing an individual’s core competencies and any training received, must be maintained and updated regularly. Line managers are responsible for maintaining these records.
In the primary care setting, whoever owns or manages the practice is responsible for ensuring that systems are in place for ongoing staff training.
All used surgical instruments present a risk of infection. To minimise this risk, the instruments must be placed in closed, secure containers and transported to the decontamination area as soon as possible following use.
Transport containers must protect both the product during transit and the handler from inadvertent contamination and therefore must be:
• leak-proof;
• easy to clean;
• rigid, to contain instruments, preventing them becoming a sharps hazard to anyone handling the goods and to protect them against accidental damage;
• capable of being closed securely;
• lockable, where appropriate, to prevent tampering;
• clearly labelled to identify the user and the contents;
• robust enough to prevent instruments being damaged in transit.
Where decontamination takes place in the clinical setting, the above principles
can be modified to suit local circumstances. However, the methods used must ensure that the product and handler are protected at all times. It is recommended that wherever contaminated items are transported, risk assessments should be undertaken relating to the safe movement of the device. Staff handling contaminated instruments and equipment must wear PPE in accordance with local policy and be vaccinated against hepatitis B. Without exception after each use, transport containers must be cleaned, disinfected and dried, or discarded (as appropriate), using agreed methods.
Where contaminated instruments are to be transported outside of the healthcare premises onto a public highway, those responsible for such transportation must refer to the requirements of the Carriage of Dangerous Goods by Road Act 1992 and the Health and Safety at Work etc Act 1974. It is essential to use a method of transportation that ensures the segregation of contaminated product from clean/sterile instruments.
Organisations must have a clearly stated policy outlining how the purchasing of medical devices will be managed. This should include a consultation process to ensure that all those involved in the purchase, decontamination, and use of the device are given the opportunity to discuss the suitability of an instrument or piece of equipment before a purchase is made. See the Microbiology Advisory Committee manual (MAC manual) and MDA DB 9801.
Lack of consultation has often resulted in devices being purchased which cannot be adequately decontaminated, as they are subsequently found to be incompatible with the decontamination processes available within an organisation. For example, devices manufactured outside the UK may require processes that are not routinely available within the UK, such as those that require sterilization temperatures other than the standard 121°C and 134°C cycles (see MDA SN 2001 (28)).
To help organisations in purchasing decisions, the NHS Purchasing and Supply Agency (PASA) has established framework agreements for purchasing a number of medical products and devices, for example washer-disinfectors, surgical instruments etc. Details are available from the PASA catalogue and their website.
Best practice suggests that automated washing processes are the preferred option. Therefore, devices that can be mechanically cleaned and thermally disinfected should be purchased whenever possible. Some devices are, however, incompatible with automated washing processes and are recommended for manual cleaning by the manufacturer.
When considering the purchase of instruments, the following issues should be taken into account:
• Does the instrument have lumens/can the device be easily cleaned? If not, is there an alternative reusable device which is easier to clean, or is a single- use device available as an alternative?
• Does the instrument need dismantling before cleaning? Are instructions provided by the manufacturer describing how this can be done?
• Does the instrument have electrical components? If yes, does the organisation have the capability to clean and sterilize them in the manner described by the manufacturer?
• Does the instrument have a limited life? Is this specified by the manufacturer?
• What method of cleaning does the manufacturer recommend and is this process available within the organisation?
3.0 Acquisition
• What cleaning agents are recommended and does this comply with local infection control policies, COSHH and health and safety requirements?
• If the instrument needs to be sterilized, is the preferred method of steam sterilization (134°C for a minimum of three minutes) recommended? If another method of sterilization is recommended, is this available within the organisation?
• If the product is heat- or pressure- sensitive, what alternative means of sterilization is recommended? Is this process available within the organisation?
• Has a risk assessment been undertaken to determine whether a single-use or a reusable product is more appropriate for the circumstances?
Manufacturers of re-usable surgical instruments are required to supply information on the appropriate decontamination process to allow reuse, including cleaning, disinfection and where appropriate the method of sterilization (Consumer Protection Act 1997; Medical Devices Regulations 2002).
It may sometimes be necessary to borrow equipment from another organisation or manufacturer: for example, for a trial, to treat a patient where equipment is not routinely available or where workload dictates that additional equipment is required on a temporary basis. All surgical instruments and equipment entering the organisation, regardless of the source, should be cleaned and sterilized before and after use in accordance with manufacturers’ instructions (see MDA SN 2000 (18)).
If staff are unfamiliar with on-loan equipment or newly purchased devices, it is essential to arrange training from the supplier/manufacturer to ensure equipment is decontaminated properly and to minimise the potential for damage. Items requiring disassembly during processing must be dismantled in accordance with manufacturers’ instructions.
Device loans should be so arranged to give adequate time for learning about the equipment and for decontamination of the device before it is required for use on a patient.
Effective cleaning of instruments (medical devices) before sterilization is of the utmost importance to reduce the risk of transmission of infectious agents. This may be achieved in a number of ways. Whenever possible, cleaning should be undertaken using an automated and validated process in preference to manual cleaning. Manual cleaning should be considered only where manufacturer’s instructions specify that the device is not compatible with automated processes. Where manual cleaning is undertaken, it should be carried out in accordance with the ‘Protocol for the local decontamination of surgical instruments’ issued by NHS Estates.
Research suggests that instruments cleaned as soon as possible after use are more easily cleaned than those left for a number of hours before reprocessing. Where instruments have to be transported from the point of use to the processing centre, collections should be made at frequent intervals throughout the day to ensure processing takes place as soon as possible after use.
It should be noted that certain solutions, in particular blood, saline and iodine, are corrosive to stainless steel instruments and will cause pitting and then rusting if allowed to remain on instruments for any length of time.
Many reusable items are manufactured in uncontrolled environments and some are handled extensively during this process. In addition, many manufacturers leave anti-corrosive agents such as oil and grease on the surface and in the joints of the item for protection during transit. New items should be cleaned and sterilized before being put into use. Manufacturer’s instructions should be followed, where available.
Under normal circumstances it should not be necessary to pre-treat surgical instruments at the point of use before being sent to the central processing unit (sterile services department).
Gross contamination may make decontamination more difficult if not removed immediately. In such circumstances it is suggested that instruments should be cleaned as soon as possible after use.
All staff undertaking pre-treatment cleaning of instruments should ensure their own safety by wearing appropriate PPE and carry out a risk assessment for the procedures being employed.
Equipment consisting of more than one component must be dismantled so that each part can be adequately cleaned. Advice on the methods for disassembly of surgical instruments should be sought from manufacturers. Training should be updated to take into account any new instruments introduced into the organisation to ensure that the equipment is dismantled and that adequate cleaning and sterilization takes place. Personal training records should reflect the range of devices upon which an individual has been trained and is competent to decontaminate.
All washer-disinfectors used for decontamination should be purchased against the Model Engineering Specification C30 and be capable of being validated in accordance with HTM 2030.
There are a number of different models of washer-disinfector that meet current standards. The size, model and type to be chosen should be considered against workload and throughput requirements, together with the availability of space.
Washer-disinfector logbooks and records should be kept by the designated “user” as defined in HTM 2030. Records should include a description of any loads processed, cycle parameters, product release together with details of routine testing and maintenance of the equipment used.
Each stage of the decontamination process should contribute to the reduction of bio-burden on the device being reprocessed. The recognised stages of the washing process may include a cool pre-wash (below 35ºC to prevent protein coagulation), main wash, rinse, thermal disinfection and post- disinfection rinse (where appropriate). The use of ultrasonic cleaners may be considered to assist the process (see next section).
Ultrasonic cleaners
Ultrasonic cleaners may be of the stand- alone ultrasonic bath type or may be washer-disinfectors of Type 1 (single chamber) or Type 2 (multi-chamber).
Many Type 1 washer-disinfectors do not incorporate a disinfection stage and are intended for use as a pre-cleaning process before final cleaning and disinfection in a washer-disinfector for surgical instruments.
Cleaning in the primary care setting is usually undertaken in a stand-alone bath filled with potable water (drinking quality) and a measured amount of detergent, as per manufacturer’s instructions. Instruments are placed in a basket and into the water where the ultrasonic action will remove gross soiling. This method of cleaning should be seen as a first-stage cleaning process, which would normally be followed by cleaning in a washer- disinfector or, where this is unavailable, a thorough rinse before sterilization.
Where such cleaners are used, the equipment manufacturer’s operating instructions must be adhered to and staff given adequate training in the use of the machine. Ultrasonic cleaning should be
used only if recommended by the instrument/device manufacturer.
Ultrasonic action is generated by transducers that agitate the water by creating bubbles. The bubbles implode and dislodge dirt from the surface and joints of surgical instruments.
Ultrasonic action helps to thoroughly clean devices with joints or multiple components that are difficult to clean manually.
Ultrasonic cleaners are not recommended for cleaning certain items, in particular rubber products which will absorb the ultrasonic waves and reduce the efficacy of the cleaning process.
Directions for use of ultrasonic cleaners
Staff must wear PPE at all times while handling contaminated instruments and working with the ultrasonic cleaner.
1. Fill the tank with potable water (drinking quality) to the manufacturer’s designated level. This ensures that the device being cleaned is not contaminated by water impurities.
2. De-gas the water as recommended by the machine manufacturer.
3. Add detergent, ensuring the manufacturer’s recommendations are followed. It is advisable to use a suitable enzymatic detergent that is effective at low temperatures.
4. If the tank has a heater, set the temperature control to be comparable with the detergent manufacturer’s recommendations.
5. When the specified temperature has been reached, place the opened/dismantled instruments into the basket.
6. Place the basket of instruments into the tank. Never put instruments directly onto the base of an ultrasonic washer.
7. Set the timer control to the…