Inspection

Reprocessing of medical devices

  • Reprocessability of medical devices
  • Reprocessing instructions
  • Instructions for use from patient to patient
  • Medical Device Regulation (MDR)

In Germany, there are up to 1 million healthcare-associated infections per year - of which around 30,000 cases are fatal. Reprocessable medical devices should be made available and used with the same safety for every patient application especially to avoid serious cross-contamination. For reprocessable medical devices, the efficacy of the reprocessing procedure proposed by the manufacturer must be reproducibly demonstrated (validation of the reprocessing procedure).

On the one hand, this is necessary to ensure safe reprocessing while maintaining the required performance of the medical device. On the other hand, a risk to the patient, by using non-validated reprocessing methods, can be ruled out. The tests include the validation of the cleaning bar and disinfection bar in manual and machine procedures. Furthermore, the sterilizability of resterilizable products must be tested using different methods such as steam sterilization, hot air sterilization, or low-temperature process (FO, EO, H2O2/plasma). The European standards define that type tests are the basis of any quality assurance for medical devices. These are the responsibility of the manufacturer. Secure validations are the responsibility of the operator.

HygCen validates the reprocessability of various types of medical devices according to the applicable European, international, and American standards (e.g. EN ISO 17664, EN ISO 15883, EN ISO 17665, ANSI/AAMI ST79: 2010).

Subgroup: Reprocessing of health care products – information to be provided by the medical device manufacturer for the reprocessing of medical devices EN ISO 17664 specifies requirements for the information to be provided by the manufacturer for the reprocessing of a medical device requiring cleaning and subsequent disinfection and/or sterilization. They are designed to ensure that the product is safe and effective for its intended use. This includes information about reprocessing before the use or reuse of the medical device.

Testing and evaluation of information to be provided by the manufacturer
Instructions for the reprocessing of resterilizable medical devices (EN ISO 17664) include:

  • initial treatment at the place of use
  • preparation before cleaning
  • cleaning
  • disinfection
  • drying
  • inspection and maintenance
  • packaging
  • sterilization
  • storage
  • transport
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