Medical Device Sterilisation White Paper

Nosocomial (hospital-acquired) infections are a major but often preventable threat to patient safety. One significant source of such infections is contaminated medical devices used during surgeries and other clinical procedures, where opportunistic biofilm organisms such as Pseudomonas aeruginosa and Staphylococcus aureus are able to quickly colonise medical devices and thus establish infection in those exposed to the instruments. In an attempt to minimise this particular source of infection, regulatory authorities require medical device manufacturers to ensure that the recommended cleaning and sterilisation procedures used in the reprocessing of such devices are fully validated and shown to be effective.

The US Food and Drug Administration (FDA) published clear guidelines on this topic in March 2015 with European authorities also recognising the need to legislate and are currently developing their recommendations. The Association for the Advancement of Medical Instrumentation (AAMI) have also developed useful documentation both to aid manufacturers in developing their products and laboratories carrying out the validation work. Relevant standards for this work include ANSI/AAMI ST98:2022, ISO 17665-1, ISO 17664, ISO 14937, ISO 11138-1, ISO 15883-1, ASTM E1766-15.