Medical Device Regulation

Decontamination and Sterilisation

Decontamination and sterilisation are key topics for many medical device companies, particularly those involved in the reusable surgical instrument, dental and endoscopy business. 

ABHI’s Sterilisation & Microbiology Working Group tracks the development of all the key medical device sterilisation standards, including those covering sterilisers, cleanrooms, disinfectants and antiseptics etc.  Further information on the work of this group is available to ABHI members in the members area.

On decontamination, we engage on an ad hoc basis with the Department of Health, medical device decontamination and sterilisation providers and medical device users. Issues include prion removal, healthcare acquired infections, and the logistics of moving medical devices along the decontamination chain.

The following decontamination guidance documents are currently in place:

England

Wales

Scotland

MHRA has published