SN 2002(07) - Little Sister 3 and SES2000 Benchtop steam sterilizers (long chamber versions)

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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March 2002

MANUFACTURER/SUPPLIER
Eschmann Equipment

PROBLEM
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.

For the attention of:

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

ACTION
Arrange for an upgraded wiring kit to be fitted. Eschmann can fit this, or supply the necessary parts to a competent service agent for them to fit. If you:

• have a service contract with Eschmann, they should fit the new wiring kit automatically. Check that this has been / will be done.
• do not have a service contract, contact Eschmann and they will fit the new wiring kit. You will be charged for this.
• have a service and maintenance contract with an independent contractor, ask them to fit the upgraded wiring kit.

(Note that Eschmann will supply the kit only to a suitably qualified person)

Consider taking unmodified units out of use until the new wiring kit has been fitted.

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

TRUSTS to:

• Liaison Officers (for onward distribution)
• Medical Directors
• Nurse Executive Directors
• Infection Control Nurses
• Infection Control Doctors
• Risk Managers
• Health and Safety Representatives
• Estates Departments
• EBME Departments
• Medical Physics
• Theatre Managers
• Accident and Emergency Departments
• Out Patient Departments
• Managers of all departments using benchtop (transportable) steam sterilizers

HEALTH AUTHORITIES to:

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

PRIMARY CARE TRUSTS to:

• Liaison Officers (for onward distribution)
• General Medical Practitioners
• General Dental Practitioners
• Infection Control Nurses
• Infection Control Doctors
• Practice Nurses

BACKGROUND
Eschmann Equipment and MDA have received a number of reports of acrid fumes or smoke being emitted from the casing of long chamber versions of Little Sister 3 and SES 2000 benchtop steam sterilizers. Investigation has shown that the problem is due to the crimped terminals connecting the power supply to the heater element. Only the long chamber machines are affected, because they have a higher wattage heater, and draw greater current, than the short chamber versions. The higher current generates more heat in the crimped terminals, which has caused them to deteriorate over time and to overheat.

Eschmann has produced a revised wiring kit with more resilient contacts. The kit can be fitted to the sterilizer in situ by a suitably qualified person.

Eschmann can trace machines that they have supplied direct, or if the owner has a service contract with Eschmann. They cannot trace some owners who bought their machine from a distributor and do not have a service contract with Eschmann. They have therefore asked MDA to issue this notice to alert owners that they cannot trace.

Eschmann will automatically modify machines that are covered by a maintenance contract with them. Owners whose machines are not serviced by Eschmann should ask them to fit the modification. They will charge for this. Alternatively, a suitably qualified person can also buy the kit (Part number 110223) from Eschmann and fit it for you.

ENQUIRIES

Enquiries to the MHRA should quote reference number 20000925.012-1

© Crown Copyright 2002