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Medical Equipment: Cleaning Services

Answer

The Department's guidance on the decontamination of medical equipment in the national health service is set out in ““Health Technical Memorandum 01-01: Decontamination of reusable medical devices Part A: Management and environment”” published in 2007 and ““A guide to the decontamination of reusable surgical instruments”” published in 2003. Copies of both documents have been placed in the Library.The Medicines and Healthcare products Regulatory Agency has a regulatory responsibility for the Medical Devices Regulations 2002 which control the reprocessing and re-use of medical devices CE marked for that status.The condition of surgical instruments for re-use is defined in BS EN ISO 13485:2003 which is described in executive letter EL(98) 05. A copy of this letter has been placed in the Library.The Department has an advisory committee in this area in the form of the Engineering and Science Advisory Committee (ESAC-PR) into the decontamination of surgical instruments, including prion removal. It has also worked with the National Institute for Health and Clinical Excellence (NICE) on decontamination. Both of these bodies have taken a special interest in the deactivation of prion infectivity on surgical instruments. The NICE guidance (November 2006) is available on NICE'S website at: www.nice.org.uk/guidance/index.jsp?action=byID&o=11332 and the ESAC-Pr 2006 annual report is available on the Department's website at:"www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_072443."

Secondary information

Type

Written question

Reference

191812; 474 c22W

Session

2007-08

Related items

Deposited Paper DEP2008-0832
Tuesday, 25 March 2008
Deposited papers
House of Commons

Subjects

Hygiene Medical devices

Link

View this Written question on www.publications.parliament.uk