Source: http://abhi.org.uk/what-we-do/medical-device-regulation/decontamination-sterilisation/
Timestamp: 2017-11-22 20:00:17
Document Index: 122109182

Matched Legal Cases: ['art 1', 'art 2', 'art 3', 'art 4', 'art 5', 'art 6', 'art 1', 'art 2', 'art 3', 'art 1']

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:
Health Technical Memorandum (HTM) 01-01: management and decontamination of surgical instruments (medical devices) used in acute care. (including Part A: Management and Provision, Part B: common elements, Part C: steam sterilization, Part D: washer-disinfectors, Part E: alternatives to steam for the sterilization of reusable medical devices)
CFPP 01-06 Management and decontamination of flexible endoscopes
HTM 01-05: Decontamination in primary care dental practices
WHTM 01-01- Decontamination of medical devices within acute services, Part A: Management and environment
WHTM 01-01- Decontamination of medical devices within acute services, Part B: Common elements
WHTM 01-01 - Decontamination of medical devices within acute service, Part C: Steam sterilization and steam for sterilization
WHTM 01-01 - Decontamination of medical devices within acute service, Part D: Washer-disinfectors
WHTM 01-01 – Decontamination of medical devices within acute services Part E: Alternatives to steam for the sterilization of reusable medical devices
WHTM 01-05 - Decontamination in primary care dental practices and community dental services
WHTM 01-06 - Decontamination of flexible endoscopes, Part A: Policy and management
WHTM 01-06 - Decontamination of flexible endoscopes, Part B: Design and installation
WHTM 01-06 - Decontamination of flexible endoscopes Part C: Operational management (including guidance on non-channelled endoscopes and untrasound probles)
WHTM 01-06 - Decontamination of flexible endoscopes Part D: Validation and verification
WHTM 01-06 - Decontamination of flexible endoscopes Part E; Testing methods
SHTM 2010 (Part 1 of 6) Overview and management responsibilities Sterilization
SHTM 2010 (Part 2 of 6) Design considerations Sterilization
SHTM 2010 (Part 3 of 6) Validation and verification Sterilization
SHTM 2010 (Part 4 of 6) Operational management Sterilization
SHTM 2010 (Part 5 of 6) Good practice guide Sterilization
SHTM 2010 (Part 6 of 6) Testing and validation protocols Sterilization
SHTM 2030 (Part 1 of 3) Design considerations Washer-disinfectors
SHTM 2030 (Part 2 of 3) Operational management Washer-disinfectors
SHTM 2030 (Part 3 of 3) Validation and Verification Washer-disinfectors
SHTM 2031 (Part 1 of 1) Clean steam for sterilization
MHRA has published
Top 10 tips on benchtop steam sterilizers
Top 10 tips on endoscope decontamination
phil.brown@abhi.org.uk