Information to be provided by the medical device manufacturer for the processing of medical devices

Introduction
The information provided by the manufacturer serves as THE BASIS FOR PROCESSING each and every medical device (MD) and makes stringent demands on the organizational skills of a Reprocessing Unit for Medical Devices (RUMED) [1] with regard to the practicability and implementation of such processing measures.
The revision of EN ISO 17664:2017 is an opportune moment to examine the changes made to the standard as well as their implications for everyday practice.
This present publication also updates Recommendation 46 of the Quality Task Group.
Compared with EN ISO 17664:2004-07 [2] changes were made which are listed on page 2 of the standard (see Item “Amendments”):

  • The title of the standard has been expanded to include the entire medical device processing process and all medical devices (previously limited to the sterilization process and resterilizable medical devices)
  • The scope of the standard as reflected by the change of title includes the entire processing process (cleaning, disinfection and/or sterilization) and is no longer limited to reusable medical devices subject to terminal sterilization; the standard applies to invasive or other medical devices coming into direct or indirect contact with patients.

Compared with previously, the medical device manufacturer must provide information PURSUANT TO EN ISO 17664 for considerably more medical devices.
These include, in addition to the “resterilizable medical devices“ listed hitherto, all MDs [3] coming into direct or indirect contact with the patient, e.g. stethoscopes, flexible endoscopes, lamp holders, breathing equipment, tourniquets. Further instructions can also be found on this on page 2 and 3 (EN ISO 17664):

  • Definitions adapted to existing standards and following terms newly introduced: “medical device”, “reusable medical device”, “single-use medical device”, “processing”, “service life”, “packaging system”, “protective packaging”, “sterile barrier system” “, “sterility assurance level“, “terminal process” and “verification”
  • The requirements for validation of processes specified in the information to be provided by the medical device manufacturer (see Section 4) and requirements for risk analysis (Section 5) have resulted in a fundamental revision of the previous Sections 5 (Validation) and 6 (Risk analysis); the formation of medical device groups is now regulated by a standard

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