A listing of publications produced by the MHRA and formerly by the Medical Devices Agency relating to decontamination and infection control.
Medical Device Alerts
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Title
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Summary
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|---|---|
| MDA/2003/019 July 2003 Re-usable stainless steel vaginal specula |
Inadequate decontamination of re-usable stainless steel vaginal specula can occur if manufacturers' instructions are not followed, resulting in the potential for cross infection. |
| MDA/2004/020 May 2004 Reusable nebulisers |
Potential risk of transmission of Legionella bacteria due to poor drying after cleaning. |
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MDA/2004/022 May 2004 |
Repeated exposure to Cidex® OPA high level disinfectant solution, following manual re-processing of urological instruments, may have resulted in hypersensitivity in some patients with a history of bladder cancer undergoing repeated cystoscopy. |
| MDA/2004/028 June 2004 Flexible and rigid endoscopes |
Risk of transmission of infection because of inadequate decontamination. |
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MDA/2004/044 September 2004 |
Inappropriate use of some lancing devices with the risk of:
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MDA/2005/006 January 2005 |
Some batches of Drug Tariff Specification 10 (SP10) dressing packs intended for community use have not been adequately sterilized and may present a risk of infection if used. |
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MDA/2005/052 September 2005 |
Johnson & Johnson Wound Management is conducting a voluntary recall of all Sterile Ray-Tec™ X-ray detectable swabs. A packaging defect means that the sterility of the swabs and the packaging may have been compromised. |
Safety Notices
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Title
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Summary
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|---|---|
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SN 1999(32) September 1999 |
Medical devices manufactured using plastics, polymer materials and latex compositions e.g. syringes, catheters, can deteriorate during storage and become unfit for use. This deterioration may be due to poor practice in storage management. |
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SN 2000(17) October 2000 |
The MDA continues to receive reports of the ignition of traces of spirit-based fluids during electrosurgical procedures; the fluids are mainly for skin cleaning/preparation. The resulting flames have led to serious patient burns, either directly or by setting light to flammable materials. |
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SN 2001(28) November 2001 |
Damage to reusable medical devices and/or reprocessing equipment due to incompatibility between the devices and the decontamination agents or processes. |
| SN 2001(34) December 2001 Matachana Miniclave model 21LE vacuum benchtop steam sterilizer |
The control systems and user instructions for the Matachana Miniclave 21Le are inadequate. The manufacturer does not provide an acceptable steam penetration test for this machine. This could lead to failure to sterilize loads. |
| SN 2002(02) January 2002 Dry heat (hot air) sterilizers |
Many dry heat sterilizers do not have appropriate controls to provide assurance that sterilizing conditions have been achieved in the load. There is evidence that they are seldom maintained or are not subjected to periodic testing necessary to ensure that they are achieving sterilizing conditions consistently. |
|
SN 2002(07) March 2002 |
Internal wiring on long chamber versions of Little Sister 3 and SES 2000 benchtop steam sterilizers (either with or without vacuum) can overheat. Acrid fumes or smoke might be emitted should the insulation melt or catch fire. |
| SN 2002(11) March 2002 Benchtop vacuum steam sterilizers - the "prion cycle" |
Users and potential purchasers of benchtop vacuum steam sterilizers should not be misled that a so-called 'prion cycle' alone will minimise the risk of prion transmission. |
|
SN 2002(24) August 2002 |
A daily steam penetration test is necessary to assist in the demonstration of the effectiveness of vacuum benchtop sterilizers that process wrapped, textile, hollow or tubular loads. Manufacturers of various sterilizers on the market do not provide information on the type of steam penetration test that is suitable and validated for their particular sterilizer. This could lead to failure to sterilize loads. |
Device Bulletins
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Title
|
Summary
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|---|---|
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Managing Medical Devices |
Includes guidance on the sale, transfer of ownership and disposal of used medical devices. |
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Single-use medical devices: implications and consequences of reuse. |
This bulletin draws attention to the hazards and risks associated with reprocessing and reusing single-use medical devices. It covers the legal issues and regulatory requirements of such actions. It also considers the implications of damage to the materials of construction of the device and inadequate decontamination procedures. |
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This bulletin is concerned with problems associated with the decontamination of endoscopes and their accessories. It draws attention to areas of particular concern and offers advice and guidance to both users and manufacturers (of both the devices and the processing equipment) in resolving these issues. |
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Benchtop steam sterilizers - guidance on purchase, operation and maintenance |
This bulletin provides guidance on the purchase, operation and maintenance of benchtop steam sterilizers. |
One Liners
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Title
|
Summary
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|---|---|
| Issue 13 February 2001 | We have received a number of reports of patients who have had to be recalled for vaginal examination because vaginal speculae had not been adequately sterilised following cleaning. |
| Issue 19 October 2002 |
We have received a number of reports of cardiac catheters whose tips have broken off in the patient, with serious consequences. These cases occurred where the catheters had been resterilised and reused. |
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Issue 22 July 2003 |
The MHRA is aware that benchtop ultrasonicators, used as an important first step in the decontamination process, are not always being used appropriately. |
| Issue 24 October 2003 |
Recent reports have highlighted inadequate decontamination of reusable stainless steel vaginal specula. The consequences of this have, in some cases, led to patient recall and retesting. |
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Issue 28 July 2004 |
A recent case of Legionnaire's Disease has been associated with the use of nebulisers containing residual moisture after being cleaned in water contaminated with legionella bacteria. |
| Issue 29 September 2004 |
Flexible and rigid endoscopes are used increasingly throughout many hospital departments. A Medical Device Alert was recently issued (MDA/2004/028) as a result of inadequate endoscope decontamination practices. This special edition of One Liners attempts to highlight some of the issues relating to the safe use and decontamination in using endoscopes so as to minimise the risk of infection. |
|
Primary Care Issue 01 May 2005 |
Oxygen concentrators, benchtop steam sterilizers, chlamydia immuno-assay testing, blood glucose meters, foot injuries in wheelchairs. |
Advice from the Microbiology Advisory Committee (MAC)
Sterilization, Disinfection and Cleaning of Medical Equipment: Guidance on Decontamination from the Microbiology Advisory Committee to Department of Health, Medical Devices Agency (MAC manual).
This manual has been prepared and endorsed by the MHRA's Microbiology Advisory Committee to provide advice on all aspects of decontamination. It is in three parts.
Variant Creutzfeldt-Jakob Disease
| Guidance produced by the Advisory Committee on Dangerous Pathogens (ACDP) and the Spongiform Encephalopathy Advisory Committee (SEAC) Transmissible Spongiform Encephalopathy Agents: Safe Working and the Prevention of Infection (2003). This guidance gives advice on work with transmissible spongiform encephalopathy agents (TSEs) in experimental and clinical settings. It does not cover incidental exposure such as in farms, abattoirs or other work with animals. Separate information is available and is listed in the bibliography to this guidance. |
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Department of Health. Health Service Circular HSC 1999/178 Variant Creutzfeldt-Jakob Disease (vCJD): Minimising the Risk of Transmission (external link). This circular describes the present state of knowledge of the risks of transmission of variant Creutzfeldt-Jakob Disease (vCJD) from one patient to another. It details the action that health organisations and clinicians should already be taking to reduce the risk of transmission and recommends some further precautionary measures. It should be read in conjunction with HSC 1999/179 'Controls Assurance in Infection Control: Decontamination of Medical Devices and HSC 1999/123 'Governance in the New NHS: Controls Assurance Statements 1999/2000 : Risk management and Organisational Control' (external link). |
| HSC 1999/179 Controls Assurance in Infection Control: Decontamination of Medical Devices (external link). The purpose of this circular is to emphasise the importance of implementing existing guidance on the cleaning & sterilization of medical devices. A CD-ROM titled 'Decontamination Guidance', which draws together the extant Department of Health guidance on the complete process relevant to the decontamination of medical equipment, has been produced to assist those responsible for implementing best practice. |
