PROTOCOL FOR LOCAL DECONTAMINATION OF SURGICAL INSTRUMENTS
2. Management of Surgical Instruments
2.1 General Information
2.2 Acquisition and disposal of surgical instruments
3. Reprocessing of Medical Devices
3.1 Automated Cleaning
3.2 Manual Cleaning
3.3 Disinfection
3.4 Inspection
3.5 Packaging
3.6 Sterilization
3.7 Storage
3.8 Transportation
Recent work undertaken by a Working Group established by the Scottish Executive Health Department has shown that there is a significant amount of reprocessing of re-decontamination surgical instruments in clinical areas as opposed to central processing units. The Group's report, ‘The Decontamination of Surgical Instruments and other Medical Devices’, also states that wherever possible, decontamination processes should be automated.
Automated cleaning methods provide a number of advantages over manual methods. This includes the provision of efficient, reproducible processes, which can be more easily controlled and validated than manual methods. They provide protection for the user by reducing the exposure to chemicals and micro-organisms. Certain methods of automated cleaning also provide simultaneous cleaning and disinfection of items.
All reprocessing of surgical instruments should be undertaken outside of the clinical environment where possible, and preferably in Central Decontamination Units.
The preferred methods of decontamination, for the reasons stated above, are, in order of preference:
The above pre-supposes that all other good practice measures are in place.
This protocol has been developed to provide advice and guidance to ensure that decontamination, and in particular manual cleaning, is undertaken in a safe and effective manner.
The advice and guidance contained within this protocol is drawn from current published advice and is referenced throughout. This document should be read in conjunction with such other guidance as is necessary. It is not a substitute for published guidance.
2. Management of Surgical Instruments
2.1 General Information
Cleaning of re-useable surgical instruments is an essential pre-requisite to ensure effective disinfection and/or sterilization. The presence of organic matter on surgical instruments can inhibit disinfectant or sterilant contacting microbial cells and thereby reduce its activity and effectiveness. Surgical instruments and associated accessories should be decontaminated immediately following use, or as soon as is reasonably practicable. It is essential that, where devices have to be transported outside the clinical unit to the processing centre, regular collections are made and all items are appropriately containerised to prevent damage during transit, and to ensure staff safety.
All re-useable surgical instruments that are used in the clinical environment should be decontaminated without exception. For example, it is unacceptable to process only those instruments that come into direct patient contact. All instruments and instrument trays, opened in the clinical environment, should be decontaminated between uses.
The following pages contain key advice applicable to the reprocessing of surgical instruments where undertaken locally. Effective decontamination requires the control and monitoring of all stages of the life-cycle process shown in Figure 1.
Figure 1: Life-cycle of re-useable surgical instruments
At all stages, it is imperative that decontamination issues relating to the environment, equipment, facilities, management and policies/procedures are taken into account.
2.2 Acquisition and disposal of surgical instruments
Organisations should have a documented policy for the purchase of re-useable medical devices (including surgical instruments). This is to ensure that equipment purchased is fit for the intended purpose, compatible with existing equipment, easy to clean, and that the processes by which decontamination is to be achieved is available within the organisation. Advice is given in MDA DB 9801: Medical Device and Equipment Management for Hospital and Community-based Organisations. All manufacturers of CE marked re-useable medical devices (including surgical instruments) are required to provide ‘information on the appropriate processes to allow re-use, including cleaning, disinfection, packaging and, where appropriate, the method of sterilization of the device to be re-sterilized.’ (Medical Devices Directive 93/42/EEC Annex 1 ER 13.6h).
Users should refer to this information to ensure the compatibility of the processes employed in the cleaning of surgical instruments. Safety concerns relating to the compatibility of medical devices and their accessories with cleaning, disinfecting and sterilizing agents was issued as SAN (SC) 96/10. Devices designated for single-use must not be re-used under any circumstances. Further advice is given in MDA DB 2000(04).
The Advisory Committee on Dangerous Pathogens (ACDP) / Spongiform Encephalopathy Advisory Committee (SEAC) guidance, ‘Transmissible spongiform encephalopathy agents: Safe working and the prevention of infection’ and NHS MEL 1999 (65), ‘Variant Creutzfeldt Jakob Disease (vCJD): Minimising the risk of transmission’, recommends that where surgical instruments have been used on patients suspected of having Transmissible Spongiform Encephalopathies (TSEs), such as vCJD, the instruments should be quarantined in accordance with the above MEL, pending confirmation of diagnosis.
2.3 Processing environment and equipment requirements
The area to be used for manual cleaning should be dedicated for the purpose and not shared with other activities. This may be achieved by dedicating a zone to the cleaning process and segregating dirty from clean by appropriate work flow patterns and practices.
The following should be provided as appropriate:
The environment (i.e. air and surfaces) within which instruments are prepared for sterilization requires an appropriate level of particulate and microbiological control. The purpose of environmental control is to minimise the possibility of re-contamination and as such Microbiological/Infection control advice as to the appropriateness of the reprocessing environment should be sought in every case.
3. Reprocessing of Medical Devices
3.1 Automated Cleaning
Automated cleaning is preferred to manual cleaning due to the reproducibility and control of the process. This type of process is also more readily validated than manual cleaning. The process may involve a disinfection element such as in the use of a washer-disinfector or may consist of ultrasonic cleaning.
The process used should be appropriate to the equipment being cleaned and the
type of contamination being removed.
Advice should be sought in relation to automated cleaning processes and procedures
from the Authorised Person (Sterilizers) and Microbiologist (Sterilizers).
3.2 Manual Cleaning
Manual cleaning would normally be undertaken either by employing immersion or
non-immersion techniques depending on the construction of the device.
Immersion Method — Procedure for manual cleaning
To minimise the risk to personnel undertaking manual cleaning, splashing and the creation of aerosols must be avoided.
The following is recommended:
cleaned and fully immerse it in the solution in order to displace trapped air and to ensure penetration of the lumen if hollow instruments are being cleaned. Consideration should be given to the use of a protein-enzyme dissolving solution when cleaning medical devices with lumens or complex parts;
and remove all visible soil, taking care to ensure the item remains under the surface of the water at all times to prevent the creation of aerosols;
|
NOTE: 1) The wash temperature is of particular importance when using enzymatic detergents. 2) If either the cleaning solution or the rinse water becomes obviously soiled or contaminated, it should be changed and the process repeated. 3) Cleaning materials should be disposed of, in the appropriate waste containers, following use, in accordance with local policy. 4) Jet guns should only be connected to the cold water supply. |
Non-immersion methods
This type of manual cleaning is appropriate for certain equipment where items
will become compromised by soaking in aqueous solution, e.g. electrical and
electronic equipment. These items should be cleaned in accordance with manufacturer’s
instructions. See also the advice given in ‘Sterilization, Disinfection
and Cleaning of Medical Equipment’, Part 2 Section 4, by the Microbiology
Advisory Committee (MAC).
Factors affecting manual cleaning
Due to the lack of acknowledged methods available to users to test the efficacy of manual cleaning processes, the following are important factors for successful cleaning;
Advice on assessing the efficacy of the cleaning process should be sought from the local Microbiologist/Infection Control Officer.
Over and above these factors is staff training and competency and this should be reflected in local policy statements.
3.3 Disinfection
Disinfection, as opposed to sterilization, is intended to reduce the number
of viable micro-organisms and may not necessarily inactivate certain viruses
and bacterial spores. Disinfection can be achieved by a number of means, dependent
upon the nature of the surgical instrument being cleaned but is usually achieved
by an automated washing process or by chemical means (reference SHTM 2030).
Chemical disinfection should only be employed where no practical alternative
exists. Disinfection is recommended for contaminated equipment prior to handling
and inspection, before packaging and sterilization.
3.4 Inspection
Following cleaning, all instruments should be carefully examined for organic material and/or damage (under magnification where appropriate). Inspection, maintenance or testing of items must be carried out by trained persons in accordance with the manufacturer’s instructions and/or local policy. Where practicable the inspection and functional testing of surgical instruments should be carried out by a person not responsible for cleaning the item. Those persons carrying out these tasks have a responsibility for ensuring that the items are fit for reuse. Records of all work performed, including functional testing, should be maintained.
3.5 Packaging
Where products are to be packaged, the materials used should be compliant with the relevant European Standards (BS EN 868) (Reference SHTM 2010). The methodology employed for packaging within the department should be documented.
3.6 Sterilization
Where items are to be sterilized following cleaning and/or disinfection the following should be taken into account:
Non vacuum benchtop sterilizers in which air is passively displaced by steam will only reliably sterilize devices that are not wrapped and are not hollow, e.g. cannulated items (refer to Medical Devices Agency guidance DB 9804 June 1998).
MDA DB 9605 states that ‘Dentists should note that benchtop steam sterilizers represent the best means available for prevention of cross-infection via dental handpieces in situations where porous load sterilization facilities are not available.’ Although handpiece lumens might not be sterilized, they will be subjected to disinfecting conditions that experts consider should be sufficient to inactivate HIV, HBV and HCV.
The sterilizer must be validated for the loads that the user intends to process, and only those loads should be processed in it, e.g. a sterilizer that is capable of sterilizing the lumen of a dental handpiece might fail to do so if the handpiece is wrapped.
3.7 Storage
The environmental conditions of the areas designated for storage and distribution should ensure the integrity of all materials and products, i.e. clean, dry, well ventilated and secure. The accommodation should afford adequate protection to prevent contamination or deterioration of the product. Items with damaged packaging should not be used. Stock rotation should be used for storage, i.e. FIFO (First in, First out).
3.8 Transportation
If the processed item is to be returned to the user it should be transported in a clean, secure transit container which protects the items from damage.
3.9 Record keeping
The Consumer Protection Act (1987)(6), in particular Product Liability, has implications for the reprocessing of devices used for patient care. In particular, it is essential to maintain adequate records that demonstrate how a particular device was processed, a description of the methods employed and details of available trained personnel with copies of training records. The organisation should have the ability to demonstrate how instruments have been processed e.g. a log of personnel involved in the cleaning and operation of the decontamination equipment, with cycle number (where applicable).
Sterilization, Disinfection and Cleaning of Medical Equipment: Guidance on Decontamination from the Microbiology Advisory Committee to Department of Health, Medical Devices Agency.
MEL 1999(65) Variant Creutzfeldt Jakob Disease (vCJD): Minimising the risk of transmission.
Medical Devices Directive 93/42/EEC Annex 1ER 13.6, h
SHTM 2010 Sterilizers.
SHTM 2030 Washer-disinfectors.
Safety Action Notice (SC) 96/10 Medical Equipment Compatibility with Johnson and Johnson NU-Cidex.
HDL (2001)10 Decontamination of Medical Devices.