Decontamination and infection control

A listing of publications produced by the MHRA and formerly by the Medical Devices Agency relating to decontamination and infection control.

Medical Device Alerts

Title
Summary
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.

MDA/2004/022 May 2004
Cidex® OPA ortho-phthalaldehyde high level disinfectant solution

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.

MDA/2004/044 September 2004
Lancing devices for obtaining blood samples

Inappropriate use of some lancing devices with the risk of:

  • Cross infection between patients.
  • Needlestick injury to healthcare and care workers.

MDA/2005/006 January 2005
SP10 Drug Tariff dressing packs

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.

MDA/2005/052 September 2005
Johnson & Johnson Wound Management Sterile Ray-Tec™ X-Ray Detectable Swabs - recall.

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

Title
Summary

SN 9825 June 1998
Latex medical gloves (surgeons' and examination) powdered latex medical gloves (surgeons' and examination).

Some people are allergic to the natural proteins or the chemical additives found in latex medical gloves, resulting in a wide range of allergic reactions varying from contact dermatitis to anaphylactic shock.

SN 1999(32) September 1999
Storage of sterile medical devices.

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.

SN 2000(17) October 2000
Use of spirit-based solutions during surgical procedures requiring the use of electrosurgery equipment.

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.

SN 2001(28) November 2001
Compatibility of medical devices and reprocessing equipment with decontamination agents

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
Little Sister 3 and SES2000 benchtop steam sterilizers (long chamber versions)

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
Steam penetration tests in vacuum benchtop sterilizers

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

Title
Summary

DB 2006(05)
Managing Medical Devices

 Includes guidance on the  sale, transfer of ownership and disposal of used medical devices.
DB 9804 June 1998
The validation and periodic testing of benchtop vacuum steam sterilizers.

This bulletin provides guidance on the validation and periodic testing of vacuum benchtop steam sterilizers. These sterilizers are equipped with a pre-sterilization active air removal (vacuum) stage and are not connected permanently to main services.

DB 2006(04)
Single-use medical devices: implications and consequences of reuse.

Replaces DB 2000(04)

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.
DB 2002(05) July 2002
Decontamination of endoscopes.

Replaces DB 9607

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.

DB 2002(06) October 2002
Benchtop steam sterilizers - guidance on purchase, operation and maintenance

Replaces DB 9605 and DB 2000(05)

This bulletin provides guidance on the purchase, operation and maintenance of benchtop steam sterilizers.
DB 2003(05) June 2003
Management of medical devices prior to repair, service or investigation

Replaces Department of Health's HSG(93)26 and MDA Safety Notice SN 9516

This device bulletin provides advice on setting up safe systems of work and outlines the various legal requirements associated with decontamination activities. It should be consulted as part of the process of establishing a decontamination regimen.

DB 2003(06) September 2003
Community Equipment Loan Stores - Guidance on Decontamination

This Device Bulletin is aimed specifically at community equipment loan stores. It provides generic guidance on the handling and decontamination of loan equipment.

One Liners

Title
Summary
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.

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.

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.

Department of Health. Health Service Circular HSC 1999/178 Variant Creutzfeldt-Jakob Disease (vCJD): Minimising the Risk of Transmission (August 1999)
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'.
HSC 1999/179 Controls Assurance in Infection Control: Decontamination of Medical Devices (August 1999).
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.



Page last modified: 14 September 2005