Community Equipment Loan Stores Guidance on Decontamination BULLETIN

Transcription

1 Community Equipment Loan Stores Guidance on Decontamination BULLETIN MHRA DB2003(06) September 2003

2 The Medicines and Healthcare products Regulatory Agency (MHRA) was formed from a merger of the Medical Devices Agency (MDA) and the Medicines Control Agency (MCA) on 1 April The Medicines and Healthcare products Regulatory Agency (MHRA) protects and promotes public health and patient safety by ensuring that medicines, healthcare products and medical equipment meet appropriate standards of safety, quality, performance and effectiveness, and are used safely. The MHRA is an executive agency of the Department of Health.

3 Contents 1 Executive summary Introduction Safe systems of work Decontamination of items After decontamination Guidance on decontamination Cleaning Disinfection Legal and other requirements Antibiotic resistant bacteria and other infectious agents Glossary References and bibliography Appendix 1 Certificate of decontamination DB2003(06) September /15

4 1 Executive summary This document provides general advice for staff dealing with community equipment in loan stores. There is a small risk of cross infection from the reuse of medical equipment issued by community equipment loan stores for use in the home setting. This risk can be minimised by some simple precautions. We provide advice on the handling of devices and equipment returned from use and give guidance on the nature of decontamination required and the generic methods to be used. Putting safe systems in place to manage the decontamination of equipment will contribute to meeting the requirements of the Department of Health's Integrating Community Equipment Services (ICES) initiative [1]. 2 Introduction Decontamination is the combination of processes used to make an item safe for handling by staff and for further use. The effective decontamination of reusable items is essential in reducing the risk of transmission of infectious agents. The aims of decontamination are to make reusable items safe to be handled or used by: loan store staff subsequent patients, carers or the patient's family maintenance staff. Decontamination is also important because subsequent users of equipment expect to receive equipment that both looks and is clean. There are three levels of decontamination: cleaning cleaning followed by disinfection cleaning followed by sterilization The decision about the level of decontamination required depends not only on how the item is used, but also the risk of the equipment transmitting infection or acting as a source of infection. The vast majority of loan equipment will not require much more than cleaning and occasionally disinfection. Given the nature of its use, it is unlikely that equipment loaned for use in the community will require sterilization. DB2003(06) September /15

5 3 Safe systems of work A local protocol for decontamination activities should be established with technical input, as required, from the following: equipment manufacturers infection control team clinical nurse specialist / equipment provision risk manager health and safety officer You may also wish to get advice from: appropriate government bodies e.g. MHRA, ICES, Health Protection Agency (HPA) appropriate professional bodies e.g. Infection Control Nurses Association (ICNA), National Association of Equipment Providers (NAEP), Hospital Infection Society (HIS), Institute of Sterile Service Managers (ISSM). Staff handling used medical equipment should assume that it may be contaminated and take precautions to reduce the risk of transmission of infectious agents through contact with blood and other body fluids. Personal protective equipment should be used, in accordance with local policy, for the handling of potentially contaminated and soiled equipment. A local policy for the management and transport of equipment from the point of use to the store should be implemented. Vehicles used for the delivery and collection of loan equipment should ideally be adapted to allow for segregation of those items being collected from those being delivered. The interior of the vehicle should be capable of being cleaned and disinfected. The walls and floors should be impermeable and should be compatible with cleaning and disinfection agents. It should be cleaned and disinfected on a weekly basis and also when visibly soiled. The store should maintain a one-way flow of equipment from receipt to issue in order to prevent cross-contamination and returned items being put into storage without first being decontaminated and inspected. DB2003(06) September /15

6 3.1 Decontamination of items Devices that are obviously contaminated with blood, body fluids or faeces should be handled with care and subjected to cleaning followed by disinfection in accordance with the manufacturer's instructions. Devices in contact with intact skin or not in contact with the user at all are generally considered to present a low risk of infection to those handling the equipment. These devices usually require cleaning only. Items of equipment that come into contact with intact mucous membranes or are obviously contaminated with blood or other body fluids present an increased risk of infection and therefore require cleaning followed by disinfection. Appropriately trained personnel who are provided with suitable equipment and personal protective equipment should carry out decontamination activities in accordance with the equipment manufacturer's instructions. Decontamination should be carried out in dedicated facilities that are fit for their intended purpose. Further information on decontamination is available in the MAC manual [2]. Table 1 illustrates the categories of risk and provides some examples of reusable equipment along with a suggested method of decontamination in between each patient use. This list is not exhaustive and staff decontaminating equipment should always first refer to the equipment manufacturer's instructions. DB2003(06) September /15

7 Table 1 Examples of equipment and categories of decontamination Example of equipment assistive listening device bed lever bedside rail blanket support communication aid for speech impediment domestic lighting fall alarm flashing doorbell gas escape alarm grab rail hoist lever tap liquid level indicator low vision optical aid special cutlery split leg table stool teapot tipper textphone transfer board trolleys walking aids 2- and 4-section bed frame bath board lift & seat bed pan commode hoist sling male & female urinal mattress and cover pressure relief mattress raised toilet seat shower chair & seat special seating toilet frame & seat wheelchair frame wheelchair seating Suggested method of decontamination * Cleaning Cleaning and disinfection * Suggested protocols for the methods of decontamination are provided in section 4 of this document. Note: Always follow the equipment manufacturer's instructions for decontamination. DB2003(06) September /15

8 Items subject to investigation, service or repair (either in the loan store or at the manufacturer's / suppliers premises) should be decontaminated prior to these activities (see DB 2003(05) [3]). Items requiring service or repair in the client's home should be safe to be handled by service personnel. The equipment may require to be cleaned and disinfection prior to service. Further advice should be sought from the manufacturer or service agent. Any loaned items being returned to a manufacturer or supplier should also be decontaminated. Organisations should have in place a system to enable adverse incidents involving equipment to be reported to the Medicines and Healthcare products Regulatory Agency (MHRA). This is a key ICES milestone. 3.2 After decontamination Once the decontamination process has been completed, items should be inspected and any maintenance carried out to ensure that they are safe and fit for reuse. They should then be labelled with a certificate of decontamination. An example of a certificate of decontamination is provided in Appendix 1. Whilst a certificate of decontamination for every single item processed may seem unachievable in reality, loan stores need to consider ways of documenting the processes undertaken. There may be other ways of recording this information and a local protocol should be established based on equipment throughput and resources available. A diagrammatic representation of the recommended workflow using a dirty in / clean out approach is given in Figure 1. The facilities and equipment required in each of these areas for the activity being undertaken is outlined in Table 2. DB2003(06) September /15

9 Figure 1 Workflow for community equipment loan store Collection from user Return to store Logging in Clinical waste disposal Segregation Disassembly Dirty area (see Table 2a) Equipment disposal Decontamination Complete certificate of contamination status Reassembly Inspection, testing, maintenance and/or repair Packaging Clean area (see Table 2b) Storage Record dispatch Delivery to user DB2003(06) September /15

10 Table 2a Facilities and equipment for the dirty area Dirty area Activity Collection of equipment from user Logging in of returned equipment Segregation of equipment to be sorted by level of decontamination required Disassembly of equipment where necessary Cleaning or cleaning & disinfection depending on the type of equipment and the nature of contamination Completion of certificate of decontamination Facilities suitable vehicle to allow segregation of clean and dirty items the inside of the vehicle should be able to be cleaned and disinfected on a regular e.g. weekly basis and when visibly soiled. the vehicle driver must have access to personal protective equipment and a first aid kit. The driver must be adequately trained to handle contaminated items. impermeable off-floor shelving which should be cleaned regularly dedicated hand decontamination facility e.g. hand wash basin foot operated pedal bin and black bags for domestic waste stream foot operated pedal bin and yellow bags for clinical waste stream personal protective equipment e.g. plastic aprons, latex/nitrile/vinyl gloves, and face visors personal protective equipment dedicated hand decontamination facility sharps bin equipment manufacturer's reprocessing instructions utility sink and drainer adequate ventilation appropriate drainage facilities lockable chemical storage cupboard appropriate cleaning / disinfection equipment personal protective equipment e.g. coveralls, latex/nitrile/vinyl gloves, non-slip footwear and face visors dedicated hand decontamination facility sharps bin pedal operated clinical waste bin COSHH assessments & material safety data sheets should be available. DB2003(06) September /15

11 Table 2b Facilities and equipment for the clean area Clean area Activity Reassembly of equipment following completion of decontamination process Inspection and testing for maintenance and / or repair as part of the quality control process Packaging of equipment as appropriate for storage or dispatch Storage of equipment prior to dispatch Record of dispatch of equipment for delivery to user Facilities A certificate of decontamination (or some other means to identify that it has been decontaminated) should accompany all equipment from here onwards. equipment manufacturer's instructions personal protective equipment dedicated hand decontamination facility personal protective equipment dedicated hand decontamination facility Impermeable off-floor shelving which should be cleaned regularly robust, secure outer door suitable vehicle to allow segregation of clean and dirty items the inside of the vehicle should be able to be cleaned and disinfected on a regular e.g. weekly basis and when visibly soiled 4 Guidance on decontamination Cleaning is an essential prerequisite for disinfection. In some cases, cleaning alone may be sufficient. Although mechanical methods of cleaning are generally preferred, some of the equipment handled by a community equipment loan store cannot be decontaminated using a mechanical washer-disinfector. If after cleaning it is necessary to disinfect the item, the chosen method of disinfection must be compatible with the equipment. Decontamination should be carried out in accordance with the equipment manufacturer's instructions. If there is no reprocessing information provided with the product, then you should contact the manufacturer for guidance. If the manufacturer is unable to provide this information or if it is believed to be inadequate, notify the MHRA. Reusable medical devices placed on the UK market after June 1998 must be provided with reprocessing instructions. Generic protocols for decontamination are provided in the MAC manual [2]. Listed below are suggested methods for dealing with community equipment. DB2003(06) September /15

12 4.1 Cleaning This is the removal of dirt by washing using a suitable detergent solution. Depending on the detergent manufacturer s instructions, the solution may be heated. Ideally devices and equipment should be immersed in the detergent solution and the equipment scrubbed or brushed. The detergent solution should be rinsed from the equipment with clean water. Cleaning can be done by hand or by using an automated washer. Brushes used for manual cleaning must be cleaned frequently and replaced regularly. Automated washers are available which allow equipment to be loaded into the machine and processed through a cycle of defined parameters resulting in cleaning to a consistent standard. This type of equipment is expensive and will require regular testing to demonstrate that it is still performing to specification. Consideration must be given to the ongoing costs of consumables, such as water and energy, which may be high. However, automated washers might enable a higher turnover of equipment and reduced operative hours. The use of an automated system can increase the level of quality assurance and reduce the risk to operatives. Loan stores should give serious consideration to whether an automated system would be appropriate for the equipment routinely being decontaminated and its cost-effectiveness. If you plan to use high-pressure jet washers and steam cleaners, an assessment of the risks to operators and staff should be undertaken beforehand. Splashes of water and aerosols (spray) could carry particles of soil from the device into the air, which could pose a risk to operators and staff in the vicinity. The risk assessment should identify any personal protective equipment necessary, including respiratory protective equipment. Equipment that cannot be immersed may be decontaminated by wiping with a cleaning cloth soaked in detergent solution and wrung out. Wipe all the surfaces of the equipment. The cloth should be reimmersed periodically and the detergent solution changed frequently. Disposable cloths should be used and discarded at the end of the shift or earlier if necessary. The detergent should be rinsed or wiped off using clean disposable cloths that have been immersed in clean water and wrung out. Equipment that has been cleaned should be dried prior to disinfection, inspection, maintenance, repair or storage. DB2003(06) September /15

13 4.2 Disinfection Equipment should first be cleaned using a method suggested above and then disinfected using either (a) moist heat (e.g. hot water or steam) or (b) a liquid chemical disinfectant. When using moist heat, the equipment should be held at 80 o C for a minimum of 1 minute in order to achieve disinfection. Other time/temperature relationships can also be used to achieve disinfection and the advice of the local infection control team should be sought on this issue. This can be more easily achieved using an automated processor where the water can be in continuous contact with the device. For equipment that cannot tolerate immersion in solution or exposure to high temperatures, manual disinfection using a clean cloth and a compatible liquid chemical disinfectant should be used. The solution should be wiped over the equipment's surface using a clean disposable cloth. When using a liquid chemical disinfectant, it is important to ensure that the disinfectant is at the correct concentration and is in contact with the device for the specified minimum contact time. The disinfectant solution should be removed from the equipment with clean water and the item dried prior to storage. Equipment that has been disinfected should be dried. Disinfectants should be used and stored in accordance with the manufacturer's instructions. The use of personal protective equipment when handling chemicals may be required. 5 Legal and other requirements The Health and Safety at Work etc. Act (1974) places a number of duties on employers and employees concerning the requirements of safe working practices [4]. The Management of Health and Safety at Work Regulations (1999) place a statutory duty of co-operation between employers and employees to provide each other with clear communication in health and safety matters including any hazards associated with their activities e.g. decontamination, transfer of material or equipment etc. [5]. In addition, the Control of Substances Hazardous to Health (COSHH) Regulations (2002) is applicable to both chemical hazards and biohazards [6]. DB2003(06) September /15

14 The Controls Assurance Standards programme was established in 1999 to ensure that boards of strategic health authorities, NHS trusts and primary care trusts have systems in place to ensure that risks are assessed and properly managed. Of the published Controls Assurance Standards several are relevant to this area: in particular Decontamination of medical devices, Infection control and Medical devices management [7]. 6 Antibiotic resistant bacteria and other infectious agents Some vegetative bacteria are resistant to antibiotics, but there is no evidence to suggest resistance to chemical or thermal disinfection. Organisms such as methicillin-resistant Staphylococcus aureus (MRSA) do not pose specific problems for loan store activities. The proper cleaning of equipment, even as the only method of decontamination, can minimise the risk of spreading infection via equipment to new hosts (people). Hand hygiene (regular washing and drying) is a key factor in the minimisation of transfer of infection from equipment to staff in the loan store. Further advice on antibiotic resistant bacteria and other infectious agents should be sought from the infection control team at your local NHS trust or primary care trust. 7 Glossary Cleaning A process which physically removes infectious agents and the organic matter on which they thrive but does not necessarily destroy all infectious agents. Cleaning is an essential prerequisite to ensure effective disinfection or sterilization. Contamination The soiling or pollution of inanimate objects or living material with harmful, potentially infectious or other unwanted material. Such contamination may have an adverse effect on the function of a medical device and may be transferred to a person during use and storage. Decontamination A process which removes or destroys contamination so that infectious agents or other contaminants cannot reach a susceptible site in sufficient quantities to initiate infection or any other harmful response. Differing levels of decontamination are used depending on the device and its intended use. The levels of decontamination are: Cleaning, DB2003(06) September /15

15 Cleaning followed by disinfection, and Cleaning followed by sterilization. Disinfectant A chemical agent that, under defined conditions, is capable of disinfection. Disinfection A process used to reduce the number of viable infectious agents but which may not necessarily inactivate some microbial agents, such as certain viruses and bacterial spores. Disinfection does not achieve the same reduction in microbial contamination levels as sterilization. Moist heat under defined conditions will also disinfect. Infectious agents The term includes micro-organisms and other transmissible agents, with the potential to cause an infection. Sterilization A process used to render an object free from viable infectious agents including viruses and bacterial spores [8]. 8 References and bibliography Website addresses and links correct at time of publishing. 1 Department of Health (2001) Integrating Community Equipment Services (ICES) 2 Sterilization, disinfection and cleaning of medical equipment: guidance on decontamination from the Microbiology Advisory Committee to Department of Health Medical Devices Agency (MAC manual) Part 1 Principles (published 1993, updated 2002) Part 2 Protocols (published 1996) Part 3 Procedures (published 1999, updated 2000 and 2002). 3 MHRA Device Bulletin DB 2003(05) Management of medical devices prior to repair, service or investigation. Web only publication: 4 Health and Safety at Work etc. Act HMSO; Statutory Instrument 1999 No The Management of Health and Safety at Work Regulations The Stationery Office. 6 Statutory Instrument 2002 No The Control of Substances Hazardous to Health (COSHH) Regulations The Stationery Office. 7 Controls Assurance Standards (Department of Health): DB2003(06) September /15

16 Decontamination of medical devices Health and safety Infection control Medical devices management Risk management system (core standard) Transport Waste management 8 BSI. BS EN 556-1: 2001 Sterilization of medical devices. Requirements for medical devices to be designated "STERILE". Requirements for terminally sterilized medical devices. Department of Health National Minimum Standards (National Care Standards Commission) [ provide requirements for independent health and social care providers. Guidance for Clinical Health Care Workers: Protection Against Infection with Blood-borne Viruses. Recommendations of the Expert Advisory Group on AIDS and the Advisory Group on Hepatitis Available at: PL CO(95)5 Advisory Committee on Dangerous Pathogens: Guidance on Protection Against Blood-Borne Infections In The Workplace: HIV and Hepatitis; Health Service Circular HSC2000/032 Decontamination of medical devices; Medicines and Healthcare products Regulatory Agency (MHRA) (Formerly Medical Devices Agency) Device Bulletin DB 9801 Medical device and equipment management for hospital and community-based organisations; Device Bulletin DB 2000(04) Single-use medical devices: Implications and consequences of reuse; Safety Notice SN 2001(28) Compatibility of medical devices and reprocessing equipment with decontamination agents; Medical Device Alert MDA/2003/001 Medical devices reporting adverse incidents and disseminating medical device alerts; Health and Safety Executive The publications below are on the HSE website: Five Steps to Risk Assessment. COSHH Essentials Easy Steps to Control Chemicals. DB2003(06) September /15

17 Appendix 1 Certificate of Decontamination Type of equipment Manufacturer Model Serial no Loan store inventory number Method of decontamination Please tick appropriate box Cleaning Cleaning followed by disinfection Other (please specify) Decontaminated by on Inspected & packaged by on Store location Notes This item has been prepared to ensure safe handling & transportation Name Signature Position Tel Date DB2003(06) September /15

18 DISTRIBUTION This device bulletin should be brought to the attention of staff working with community equipment in loan stores. It may also be of interest to infection control doctors, infection control nurses and consultant microbiologists. TECHNICAL ENQUIRIES Enquiries concerning the content of this device bulletin should be addressed to: Nathan Moore MHRA Hannibal House Elephant & Castle London SE1 6TQ Jonathan Plumb MHRA Hannibal House Elephant & Castle London SE1 6TQ Tel: Tel: Fax: Fax: CROWN COPYRIGHT 2003 Medicines and Healthcare products Regulatory Agency An executive agency of the Department of Health ISBN Sept