SESLHD PROCEDURE COVER SHEET NAME OF DOCUMENT Single Use Medical Devices TYPE OF DOCUMENT Procedure DOCUMENT NUMBER SESLHDPR/346 DATE OF PUBLICATION June 2014 RISK RATING Medium LEVEL OF EVIDENCE NSW Health Policy Directives National Safety and Quality Health Service Standard No. 3 „Preventing and Controlling Healthcare Associated Infections‟ (Criteria 3.1, 3.3, 3.9, 3.16.1 and 3.18.1) REVIEW DATE June 2017 FORMER REFERENCE(S) Former „Single Use Medical Devices‟ SESLHNPD/110 EXECUTIVE SPONSOR or Prof George Rubin EXECUTIVE CLINICAL SPONSOR Director Clinical Governance AUTHOR Infection Control Working Party POSITION RESPONSIBLE FOR THE DOCUMENT Infection Control Working Party KEY TERMS Single use, single patient use, cleaning, Manufacturer, reprocessing. SUMMARY To outline the requirements related to the remanufacture of medical devices marked by the manufacturer as „single use‟ or „single patient use‟ [email protected] COMPLIANCE WITH THIS DOCUMENT IS MANDATORY This Procedure is intellectual property of South Eastern Sydney Local Health District. Procedure content cannot be duplicated. Feedback about this document can be sent to [email protected] SESLHD PROCEDURE Single Use Medical Devices 1. PR 346 POLICY STATEMENT This Procedure instructs clinical staff across SESLHD on how to use single use medical devices correctly within a healthcare setting in line with the NSW Ministry of Health „Infection Control‟ Policy Directive PD2007_036 and National Safety and Quality Health Service Standard No. 3 „Preventing and Controlling Healthcare Associated Infections‟. It also ensures compliance to related NSW Legislation, which is outlined in the following section. 2. BACKGROUND Single use medical devices (SUDs) and single patient use devices, irrespective of the level of risk associated with their use, must not be reused unless there is compliance with the regulatory requirements for a manufacturer of medical devices as described in the Therapeutic Goods Act 1989 (Documents available from http://www.comlaw.gov.au/Series/C2004A03952 ), Therapeutic Goods (Medical Devices) Regulations 2002 (Documents available from http://www.comlaw.gov.au/Series/F2002B00237 ) and The Therapeutic Goods Regulations 1990 (Documents available from http://www.comlaw.gov.au/Series/F1996B00406 ) 2.1 Legal Issues The reuse of „single use‟ devices can affect their safety, performance and effectiveness, exposing patient staff to unnecessary risk Anyone who reprocesses or reuses a device intended by the manufacturer for use on a single occasion, bears full responsibility for its safety and effectiveness Anyone who reprocesses a single use device and passes it to a separate legal entity for use, has the same legal obligations under Medical Devices Regulations as the original manufacturer of the device 2.3 Technical Issues Single use devices may not be designed to allow thorough decontamination and, if applicable, re-sterilisation processes. Re-processing may affect the capabilities and/or the materials from which the device is made. 2.4 Definitions Cleaning: removal of soil / dirt / dust from a surface involving water and physical or mechanical action and a cleaning agent such as a neutral detergent Manufacturer: any natural or legal person who manufactures a product or has a product designed or manufactured, and markets that product "under his name or trademark." Opened-but-unused: a SUD whose packaging has been damaged/opened but the device was not used and/or did not come in contact with blood, tissue or body fluids Revision 6 Trim No. T14/12620 Date: June 2014 Page 1 of 4 COMPLIANCE WITH THIS DOCUMENT IS MANDATORY This Procedure is intellectual property of South Eastern Sydney Local Health District. Procedure content cannot be duplicated. SESLHD PROCEDURE Single Use Medical Devices PR 346 Reprocessing: all steps necessary to make a contaminated reusable medical device ready for its intended use. The steps include cleaning, functional testing, packaging, labelling, disinfection or sterilisation Single use device (SUD): intended to be used on an individual patient during a single procedure and then discarded. It 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. Various symbols are used on medical device packaging, to indicate “Do Not Re-use” and other information. This may replace wording Single patient use: Differentiation will be made with devices marked „Single Patient Use‟. Here re-use is permitted, but only with the same patient. The protocol for reprocessing the device between uses will be safe and a limit placed on the number of re-uses. This may include items such as disposable slings, nebulizer masks or urinary catheters for intermittent self -catheterisation 3. RESPONSIBILITIES 3.1 Employees will: Comply with management procedures for all single use and single patient-use medical devices 3.2 Line Managers will: Ensure adequate amounts of appropriate stock of medical devices are available for staff to comply Ensure all staff are aware of, and comply with this procedure 4. PROCEDURE 4.1 Devices designated for “single use” will never be reused. 4.2 Single use medical devices must be safely discarded after being used once on an individual patient. 4.3 Devices designated for single-patient use will be used, and re-used, as per manufacturer‟s instructions on one patient only, then safely discarded. 4.4 For devices that have been opened but unused: The Regulation does not include those SUDs that have been opened but unused The original manufacturer must state on the label if the device is reusable if it has been opened but unused. If no reprocessing instructions are provided by the original manufacturer, the open but unused SUD must be discarded Revision 6 Trim No. T14/12620 Date: June 2014 Page 2 of 4 COMPLIANCE WITH THIS DOCUMENT IS MANDATORY This Procedure is intellectual property of South Eastern Sydney Local Health District. Procedure content cannot be duplicated. SESLHD PROCEDURE Single Use Medical Devices PR 346 4.5 Staff who provide advice to patients on reusing SUDs Staff providing advice regarding cleaning / reprocessing and reuse of SUDs may be professionally liable for any harm to the patient related to the cleaning and re-use of the device 5. DOCUMENTATION Manufacturer‟s instructions for all SUDs are required to be available to clinicians. 6. AUDIT As required in individual settings. 7. REFERENCES NSW Health Policy Directive 2007_036 Infection Control Policy 2007, http://www0.health.nsw.gov.au/policies/pd/2007/pdf/PD2007_036.pdf Australian Guidelines for the prevention and control of infection in healthcare, 2010 http://www.nhmrc.gov.au/guidelines/publications/cd33 Australian Government, Department of Health and Ageing, Therapeutic Goods Administration, Medical devices, http://www.tga.gov.au/industry/devices-basics.htm Australian regulatory guidelines for medical devices (ARGMA), http://tga.gov.au/industry/devices-argmd.htm Australian Government, Department of Health and Ageing, Therapeutic Goods Administration, Australian Regulatory Guidelines for Medical Devices http://tga.gov.au/pdf/devices-argmd-01.pdf Medicines and Healthcare Products Regulatory Agency, Single-use medical devices : implications and consequences of re-use http://www.mhra.gov.uk/Publications/Safetyguidance/DeviceBulletins/CON2024995 8. REVISION AND APPROVAL HISTORY Date Revision No. Author and Approval May 2003 0 IAHS Infection Control Coordinators May 2005 1 Revised by IAHS Infection Control Coordinators Feb 05 2 Approved by Area Policy and Procedure Committee on 10 Feb 2005 and ratified by Executive on 21 Feb 2005 for a six month period – review August 05 June 2006 3 Former IAHS policy reviewed and merged for SESIAHS in collaboration with SESIAHS Infection Control Manual Working Party. Contact:: Yvonne demain. Approved by the Area Executive Management Committee, 13 June 2006 Sept 2008 4 Infection Control Manual- Section S- S4 Apr 2011 5 Updated to reflect change to Local Health Network Apr 2014 6 Reviewed by SESLHD Infection Control Consultants Forum May 2014 6 Re-formatted and revised by District Policy Officer. Only minor amendments made by Infection Prevention and Control Working Revision 6 Trim No. T14/12620 Date: June 2014 Page 3 of 4 COMPLIANCE WITH THIS DOCUMENT IS MANDATORY This Procedure is intellectual property of South Eastern Sydney Local Health District. Procedure content cannot be duplicated. SESLHD PROCEDURE Single Use Medical Devices Date Revision No. PR 346 Author and Approval Party June 2014 Revision 6 6 Approved by Prof George Rubin, Executive Clinical Sponsor Trim No. T14/12620 Date: June 2014 Page 4 of 4 COMPLIANCE WITH THIS DOCUMENT IS MANDATORY This Procedure is intellectual property of South Eastern Sydney Local Health District. Procedure content cannot be duplicated.