SN 2001(34) - Matachana Miniclave Model 21Le Vacuum Benchtop Steam Sterilizer

 

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December 2001

MANUFACTURER/SUPPLIER
Matachana/Prospect Medical

PROBLEM
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.

For the attention of:

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

ACTION

• Do not use these sterilizers (autoclaves) as vacuum benchtop steam sterilizers.
• Do not use them for processing any wrapped, hollow, or tubular devices.
• Use these sterilizers only for solid, unwrapped devices. (The term wrapping includes pouches and sterilization bags)
• Test these sterilizers in accordance with HTM2010 Part 3.

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

TRUSTS to:

• Liaison Officers (for onward distribution)
• Accident and Emergency Departments
• Infection Control Doctors
• Infection Control Nurses
• Managers of all Departments using benchtop (transportable) steam sterilizers (autoclaves)
• Medical Directors
• Nurse Executive Directors
• Theatre Managers

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:

• Liaison Officers (for onward distribution)

BACKGROUND
Pressurised steam is an effective sterilizing agent provided that air has first been removed from the sterilizer chamber and load. Residual air can prevent direct contact between the steam and the devices to be sterilized. An effective vacuum air removal stage is required to remove air from loads that are wrapped, hollow or tubular. Well designed sterilizers incorporate systems that are able to detect residual air, and air leaking into the chamber while under vacuum, which will prevent sterilization. The Miniclave 21Le does not have such systems.

Vacuum steam sterilizers should also be tested at the start of each day the sterilizer is used in order to check that the air removal stage is effective. This is the steam penetration test, which has to be validated to demonstrate that it can detect air that is present in sufficient quantity to interfere with sterilization. Matachana do not provide an acceptable test method for doing this. (Note - the Bowie and Dick test is the steam penetration test that is used on large porous load sterilizers in hospitals' SSDs.)

In the absence of such systems and tests there can be no certainty that the sterilizer is achieving sterilizing conditions. Therefore the Matachana Miniclave 21Le should be treated as a traditional benchtop steam sterilizer, applying the appropriate daily, and other periodic test procedures to ensure that it is capable of sterilizing unwrapped solid devices.

The user instructions for validation and periodic testing, using chemical and biological indicators, are inadequate to ensure that the sterilizer will consistently produce sterile product. Benchtop steam sterilizers will consistently produce sterile product. Benchtop steam sterilizers should be tested according to the protocols provided in Health Technical Memorandum (HTM) 2010, Part 3 Validation and verification, which are summarised in MDA's device bulletin DB9605 - The purchase, operation and maintenance of benchtop steam sterilizers.

ENQUIRIES
Enquiries to the MDA should quote reference number 20000816.012-14

© Crown Copyright 2001