The permissible re-use of medical devices requires that they can be efficiently cleaned and disinfected and/or sterilised. Equipment used to decontaminate reusable medical devices is carefully controlled to ensure the effectiveness of the decontamination process.
The HTM 01-06 (formerly CFPP 01-06) Guidelines issued by the Department of Health and the now archived standard HTM2030, cover the testing of Endoscope Washer Disinfectors (EWD’s) to ensure that they are operating within the required parameters for effective decontamination of medical devices. HTM 01-01 (formerly CFPP 01-01) and HTM2031 cover the requirements for sterilising re-useable medical devices using heat and steam.
Routine and periodic testing of both the equipment during use and of the final rinse water is designed to highlight where failure may occur which could result in the ineffective decontamination of re-useable devices putting patients at risk.