Decontamination of Equipment Prior to Service, Maintenance or Repair

Transcription

1 Decontamination of Equipment Prior to Service, Maintenance or Repair Guidelines and Procedures Introduction Responsibilities Decontamination documentation Advice for decontamination Decontamination procedures Internal services or repairs Equipment for repair or service by manufacturers Equipment impossible or not advisable to decontaminate Staff training Definitions Disposal of waste products References Appendix 1 Decontamination certificate Appendix 2 Decontamination label Review date: May 2009 Review by: Infection Control Team

2 Introduction Decontamination is the process that removes or destroys contamination and thereby prevents microorganisms or other contaminants reaching a susceptible site in sufficient quantities to initiate infection or any other harmful response. It includes the process of cleaning, disinfection and sterilisation and the overall decontamination process can include acquisition, inspection, packaging, transport, storage and use. The Health and Safety at Work Act, 1974 requires that employees who handle, service, repair or come into contact with medical devices must not be put at risk by contamination resulting from the use of such equipment. The Control of Substances Hazardous to Health (COSHH), 2002 is applicable to chemical and biological hazards. Items subject to inspection, maintenance, repair or disposal should be decontaminated beforehand (MHRA 2006). Anyone who uses, inspects, services, repairs or transports medical devices on the Trust premises or elsewhere, has the right to expect that such equipment have been appropriately treated to remove the risk of infection or any other hazard. This policy provides the management arrangements that need to be in place to oversee the process of decontamination prior to medical devices being sent for repair or maintenance. Responsibilities The Chief Executive is responsible for ensuring that decontamination procedures are in place. The Control of Infection Team will advise the Chief Executive on infection control issues and will be available to provide advice to other managers. The responsibility for the day-to-day operation of this policy rests with the Directors and Managers of Wards and Departments. Departmental managers of wards and departments are responsible for ensuring departmental/ward decontamination procedures are in place. Responsible organisations should keep patients, staff and visitors safe by having systems to ensure that all reusable medical devices are properly decontaminated prior to use or repair and that the risks associated with decontamination facilities and processes are well managed (Standards for Better Health, Core Standard C4c). Review date: May 2009 Review by: Infection Control Team

3 The repair and maintenance of equipment should be considered prior to purchase. Decontamination requirements should be considered before reusable medical devices are acquired to ensure that they are compatible with decontamination equipment available (Medicines and Healthcare Products Regulatory Agency MHRA 2006). Advice and assistance can be sought from Infection Control (01922) / Manufacturers of equipment should supply guidance on how the item of equipment can be decontaminated (MHRA 2006). Decontamination Documentation Appropriate documentation is required to be provided to indicate the contamination status of any items. All items sent for inspection, service, or repair either internally or externally must be accompanied by a certificate stating the decontamination status. Items sent for service or inspection to either internal or external service agencies without such documentation may be refused or delayed until such documentation is supplied. Decontamination certificates can be copied from the template in Appendix 1 to this policy. Alternatively a decontamination label (Appendix 2) can completed and attached to the item. These are available from the Patient Support Service on Bentley Lane. Advice for Decontamination Equipment can be divided into the following categories for decontamination purposes: Category 1 - equipment that can be readily decontaminated prior to inspection, service or repair. Category 2 - equipment that cannot be decontaminated without dismantling by an engineer. Category 3 - equipment that does not become contaminated under normal use. 3

4 Category 1 1. Staff should refer to the decontamination of medical devices policy for equipment contaminated with blood or body fluids. Care should be taken when handling contaminated equipment and standard precautions including use of personal protective equipment is required if contact with any body fluid is likely. 2. Non-disposable non-heat sensitive equipment should be sent to the H.S.D.U. for auto disinfection whenever possible. The H.S.D.U. manager should be notified and the method of transportation agreed when equipment is sent to H.S.D.U. The H.S.D.U manager can be contacted via the Manor Hospital switchboard on (01922) Category 2 1. The engineer should regard all equipment in this category as potentially infectious. 2. The engineer should take all appropriate precautions for handling such equipment, i.e. plastic aprons, appropriate powder free disposable latex / latex equivalent gloves, and where splashing or the production of aerosols may occur it is recommended that facial protection be worn and as provided for in the risk assessment. 3. The engineers must wear the appropriate protective equipment when dismantling or servicing equipment such as suction equipment, bedpan macerators, toilets and extract ventilation. 4. In cases of CJD contact the Infection Control Nurse. Category 3 1. Equipment which has not been used in invasive procedures or been in contact with blood or other bodily fluids and does not require decontamination should be visibly clean before inspection or servicing, e.g. sphygmomanometers, weighing scales etc. Decontamination Procedures Equipment for maintenance or repair must be cleaned/decontaminated in accordance with the following guidelines. Decontamination certificates must be completed, signed and attached to the equipment. Check manufacturer s instructions in relation to cleaning and 4

5 decontamination recommendations. Refer to policy the decontamination of medical devices for guidance on Cleaning equipment Always unplug electrical equipment before cleaning. Staff handling used medical equipment should assume that it is contaminated and take precautions to reduce the risk to themselves and to others (MHRA 2006). Gloves and aprons should be worn. Use disposable paper towels to clean and squeeze out excess water to avoid damaging the equipment. Use warm (40ºC) water and general-purpose detergent. Alternatively use a detergent wipe. DO NOT IMMERSE ELECTRICAL EQUIPMENT IN WATER. Rinse and dry thoroughly. Dispose of gloves and apron into household (black) waste bag Internal Service or Repairs All equipment must have attached a signed certificate (Appendix 1) stating that the equipment is safe to handle. The certificate will be attached to the equipment prior to despatch for repair or service. The Ward or Department Manager must ensure that decontamination procedures are undertaken by suitably qualified and equipped staff and must ensure that the appropriate decontamination certificates accompany all equipment to both internal and external agencies. The Manager should ensure that labels on equipment used on known cases of Hepatitis B or HIV state Biohazard and inform the engineers of the infection hazard. Do not include the patients/clients name. Internal repairs are made by EBME at the Manor or a contracted service. Contractors deal with all Arjo equipment and hospital beds. All other equipment should go via EBME. Equipment for Repair or Service by Manufacturers A written certificate of decontamination is required to accompany any equipment dispatched to manufacturers prior to repair or servicing of equipment. The certificate should be enclosed in an envelope affixed to the outside of the package. The envelope should be marked Examine enclosed documents before unpacking. 5

6 A copy of the Declaration of Contamination Status (Appendix 1) form should be kept in the ward or department when equipment is sent to an external organisation. The Supplies Department will arrange for the return to Supplier of equipment requiring repair or inspection. In the event that equipment proves to be defective and causes accident or injury, this information will be forwarded to the MHRA for investigation. This does not include items returned to HSDU. Equipment Impossible or Not Advisable to Decontaminate Any equipment deemed unfit for reuse should be decommissioned. Decommissioning aims to make equipment safe and unusable, while minimising damage to the environment. The manufacturer should be contacted for information on decommissioning and should be able to provide details of any environmental, disposal, recycling or structural requirements (MHRA 2006) If the manufacturer has ceased trading, contact the MHRA (see contact details) Contact the infection control team for further advice. It is illegal to send contaminated items through the post. Staff Training Inadequately trained staff may fail to decontaminate instruments properly, thus putting patients at risk. They may also risk their own health and safety if they are unaware of safe practice standards. All staff must be properly supervised and their performance monitored. Training should be appropriate to the equipment and practices within individual departments. The Chief Executive has the responsibility for ensuring that all staff involved in the use of medical devices has received appropriate training and instruction which is suitable and sufficient in the decontamination of medical equipment. Managers are responsible for ensuring that staff are trained during induction and receive the necessary updates. Managers must ensure that all staff use and are trained in the use of appropriate protective clothing and equipment during decontamination procedures. 6

7 Definitions Medical Device Any instrument, apparatus, appliance, material or other article whether used alone or in combination, intended by the manufacturer to be used for human beings for the purpose of: - Control of conception; Diagnosis, prevention, monitoring, treatment, alleviation of or compensation for any injury or Handicap; Investigation, replacement or modification of the anatomy or physiological process. Single Use Items Devices designated as single use items must not be reused in any circumstances The reuse of single use devices has legal implications: - Any one who reprocesses or reuses any device intended by the manufacturer for the use on a single occasion, bears full responsibility for its safety and effectiveness. Anyone who repossesses a single use device and passes it to a separate legal entity for use has the same legal obligations under the Medical Devices Regulations as the original manufacturer of the item. Disposal of Waste Products Waste products generated by decontamination processes are required to be disposed of in a safe manner and as prescribed in Trust Disposal of Waste Guidelines MHRA Contact details Telephone (Mon-Fri ) (other times) Fax info@mhra.gsi.gov.uk 7

8 References Health Technical Memorandum 2010 Health Technical Memorandum 2030 HSC (99) 178: Variant Creutzfeldt-Jakob Disease (vcjd): Minimising the Risk of Transmission HSG (93) 26 MDA DB 2000(04): Single-use medical devices: Implications and consequences of reuse MDA SN 9516 The Control of Substances Hazardous to Health (COSHH) Regulations, 2002 The Health and Safety at Work Act, 1974 The Management of Health and Safety at Work Regulations, 1999 The Management of Medical Equipment in NHS Acute Trusts in England. National Audit Office, June

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