Mediclave or Medical Clave Steam Sterilisers - Inadequate Safety Locks

摘要

The Medical Devices Agency has been informed by the Health and Safety Executive (HSE) that there are shortcomings in the design and construction of the safety interlocks on Mediclave benchtop steam sterilisers. The HSE has found the safety interlocks to be inadequate and not designed to be fail-safe. As a result it is possible to remove the boiler from the base, and to remove the boiler end cap, while the chamber contains steam under pressure. Mediclave benchtop steam sterilisers are not considered safe for use unless they are modified to ensure that while the chamber contains steam under pressure the boiler and cap cannot be removed.