SINGLE USE MEDICAL DEVICES POLICY First Issued by/date BWW /BKW March 2001 Issue Version Purpose of Issue/Description of Change Planned Review Date 2 Update May 2011 Named Responsible Officer:- Approved by Date Infection Prevention and Control Lead Infection Control Committee 18 th June 2008 Policy File:- Infection Control Policy No 6 Impact Assessment Screening Complete- July 2008 Full Impact Assessment Required - No Key Performance Indicator 1. Infection Prevention and Control audit 2. Attendance levels at Infection Control Training 3. Compliance with Code of Practice UNLESS THIS VERSION HAS BEEN TAKEN DIRECTLY FROM THE PCT WEB SITE THERE IS NO ASSURANCE THIS IS THE CORRECT VERSION
Contents Page Introduction 3 Policy Aim 3 Policy outcome 3 Target group 3 Specific responsibilities 4 Cross reference related PCT policies 4 Evidence to support policy 5 Legal Implications, negligence and regulatory requirements 5 Definition of a medical device 5 Definition of single use 5 Safety Issues 6 Single patient use 6 Use of Medicines 6 Prion disease 6 Disposal of single use equipment 7 Training 7 Audit 7 Archiving 7 Risk Assessment 7 References 8 List of those consulted in drafting process 8 Page 2 of 8
Wirral PCT Introduction The reprocessing and reuse of single-use medical devices is a long standing practice although the Medical Devices Regulatory Agency (MHRA) advises against this. Users often justify the reprocessing of such devices on the basis of economic and environmental benefits. These perceived benefits are questionable as many of the processes require to ensure that the device is safe and fit for its intended purpose cannot be undertaken by the reprocessor (a person who undertakes the reprocessing of a medical device). Many single-use devices are also reused without adequate evaluation of the increased risk to patients MHRA 2006. It is the Policy of this Trust that medical devices identified by the manufacturer as single use will never be reprocessed within a clinic or community setting and used for another patient. Policy Aim It is the aim of this policy to draw to the attention of staff hazards and risks associated with reprocessing and reusing single-use medical devices. It is the responsibility of each Independent Contractor to reduce Healthcare Associated Infection (HCAI) and ensure the Health and Safety of staff. The PCT recommends that contractors apply the principles of this policy as minimum standards within their practices to ensure their professional and contractual duties are discharged. Policy outcome Staff will use medical devices safely and appropriately. Single use items will not be reused. Target group PCT salaried staff. Shared as best practice with Independent General Practice staff, General Dental Practice staff, Independent Pharmacists and Optometrists. Page 3 of 8
Specific responsibilities Board The Board has collective responsible for ensuring assurance that appropriate and effective policies are in place to minimise the risks of health care associated infections. Director of Infection Prevention and Control It is the responsibility of the Director of Infection Prevention and Control to oversee the development and implementation of infection prevention and control policies. Infection Prevention and Control Team It is the responsibility of the Infection Prevention and Control Team to ensure this policy is reviewed and amended at the review date or prior to this following new developments in single use. Service Managers It is the responsibility of managers to ensure that staff have read the Single use policy and that staff have a suitable and adequate supply of single-use products appropriate to the care environment, Staff It is the responsibility of staff to ensure they follow the legal requirements as detailed in this policy. Cross reference related PCT policies Management of Healthcare Waste Policy Medical Devices Policy Waste Policy Nursing Non Medical Prescribing Standard Operating Procedure for Medicine Administration in Community Nursing NB: Always use most current versions of PCT policies as may be superseded at any time. Page 4 of 8
Evidence to support policy MHRA DB 2006(04) October 2006 Single-Use Medical Devices: Implications and Consequences of Reuse. Legal Implications, negligence and regulatory requirements The PCT acknowledges its responsibility to comply with the following legislation: Health and Safety at Work Act 1974 Part 1 of the Consumer Protection Act 1987 The General Product Safety Regulations 2005 The Medical Devices Regulations 2002 Standards for Better Health 2004 Definition of a 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 or alleviation of disease Diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap Investigation, replacement or modification of the anatomy or physiology process Definition of single use The medical device is intended to be used on an individual patient during a single procedure and then discarded. The device is not intended to be reprocessed and used on another patient. The labelling identifies the device as disposable and not intended to be reprocessed and used again. Page 5 of 8
Safety Issues Single use devices may not be designed to allow thorough decontamination processes. Reprocessing may alter its characteristics and performance may be compromised. Single use devices have not undergone extensive testing validation and testing for reuse. There may be the potential for cross-infection through design e.g. fine bores of tubes. Some materials can absorb certain chemical which can gradually leach from the material over time. Chemicals may cause corrosion or changes to the materials of the device. The material may experience stress during reuse and may fail stretch or break. Inadequately cleaned equipment can carry bacterial endotoxins which remain after bacterial are killed. Re-use of single use items may then transfer legal liability for that item from the manufacturer to themselves or their employer, unless reprocessing methods have been validated to prove the safety of both the process, and the end product. This Trust is not equipped to deal adequately with these requirements. Single patient use Some items of equipment are identified as suitable for single patient use i.e. urethral catheters supplied within the community for intermittent use and continence treatment equipment. A medical device may be used for more than one episode on one patient only; the device may undergo some form of reprocessing between each use. Advice must be sought from the manufacturer and the Infection Prevention and Control Team on appropriate decontamination methods. Use of Medicines Medicines including topical medical products must be considered as single use items unless the label and/or the supporting manufacturers guidelines clearly state that they have been prepared as multi-dose items. A risk assessment must be carried out (in conjunction with Medicines Management) for each individual product. Page 6 of 8
Prion disease Prions are infective agents which contain no nuclear material. Prions multiply by changing normal cellular proteins into abnormal proteins which then accumulate in the central nervous system, where they can trigger neurological symptoms. Chemical and heat sterilisation are only partially effective at inactivation prion protein. In order to reduce the potential risk of transmission of prions during procedures in contact with nervous tissue, single use instruments are recommended. Although the risk of Variant Creutzfeld-Jacob Disease (vcjd) in dentistry is low endodontic files and reamers should be treated as single use items. Disposal of single use equipment Single use equipment must be disposed of following the PCT waste disposal policies. Training Included in Essential training. Audit As part of the Infection Prevention and Control Audit programme. Archiving Hard and/or electronic copies of previous versions of this document will be held by the Infection Prevention & Control Team for the retention period required under current NHS guidance. Risk Assessment Included in service risk assessment, clinic and procedure risk assessment. Page 7 of 8
References Health Services Circular. HSC1999/178 variant Creutzfeldt-Jakob Disease (vcjd): Minimising the risk of transmission 1999. SEAC Position Statement vcjd and endodontic dentistry. Department of Health 2007 Primary care dental services: guidance on singleuse instruments for endodontic procedures. Department of Health 2007. Advice for dentists on re-use of endodontic instruments and variant Creutzfeldt-Jakob Disease (vcjd). List of those consulted in drafting process Infection Control Committee Page 8 of 8