SN 2001(28) - Compatibility of Medical Devices and Reprocessing Equipment with Decontamination Agents

Please note that contact names and/or numbers may have changed since this notice was published. If you need to contact us about a particular notice, email dts@mhra.gsi.gov.uk quoting the reference number and title of the notice.
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November 2001

MANUFACTURER/SUPPLIER
Various

PROBLEM
Damage to reusable medical devices and/or reprocessing equipment due to incompatibility between the devices and the decontamination agents or processes.

For the attention of:

Health Authorities (England) - Chief Executives
NHS Trusts (England) - Chief Executives
Primary Care Trusts (England) - Chief Executives

ACTION
Personnel responsible for reprocessing reusable medical devices should:

• Ensure that the decontamination agents used are compatible with both devices and reprocessing equipment.
• Consult the medical device and reprocessing equipment manufacturer/supplier before changing any decontamination process.
• Decontaminate reusable medical devices in accordance with the instructions provided by the device manufacturer.
• Ensure that appropriate decontamination facilities and compatible agents are available before purchasing new devices.
• Follow the instructions for use supplied by the manufacturer of the decontamination agent.

DISTRIBUTION REQUIRED
Please bring this notice to the attention of all who need to know or be aware of it. This will included distribution by:

TRUSTS to:

• Liaison Officers (for onward distribution)
• Medical Director
• Director of Nursing
• Theatre Manager
• Sterile Services Manager
• Supplies Manager
• Consultant Microbiologist
• Control of Infection Doctor
• Infection Control Nurses
• Estates Manager
• Risk Manager

HEALTH AUTHORITIES to:

• Liaison Officers (for onward distribution)
• Chairs of Primary Care Groups
• Registration Inspection Units
• General Medical Practitioners
• General Dental Practitioners
• Practice Nurses
• Nursing Homes
• Hospices
• Hospitals in the Independent Sector

PRIMARY CARE TRUSTS to:

• Chief Executives (for onward distribution)
• General Medical Practitioners
• General Dental Practitioners
• Practice Nurses

BACKGROUND
The Medical Devices Agency continues to receive reports about damage to medical devices or their components and to reprocessing equipment following contact with incompatible decontamination agents.

The damage is usually the result of reactions between the decontamination agent and the materials of construction of the device or reprocessing unit. Such damage may affect the performance or functionality of the device or the effectiveness of the decontamination procedure.

Manufacturers of reusable medical devices are required to provide information on how to decontaminate their devices. This information should include the types of decontamination agent that may be used, together with a warning of any agents or processes that are known to be detrimental to the device.

Never reuse devices designated for single-use.

This notice replaces MDA Safety Notice SN 9619.

DEFINITIONS

For the purpose of this Safety Notice, the following definitions apply:

Decontamination
A process that removes or destroys contamination and thereby prevents micro-organisms and other contaminants reaching a susceptible site in sufficient quantities to initiate infection or any other harmful response. Decontamination encompasses three processes - Cleaning, Disinfection  and  Sterilization.

Decontamination agent
A chemical agent or physical process used to decontaminate a medical device. Decontamination agents include detergents, disinfectants and  sterilants.

Reprocessing equipment
Equipment intended for the decontamination of medical devices and accessories such as automated endoscope disinfectors.

ENQUIRIES
Enquiries to the MDA should quote reference number AIM 71/01/002

© Crown Copyright 2001