Risk assessment and release of new medical devices before investment and new procurement


Reprocessing Units for Medical Devices (RUMEDs) face continual challenges related to the risk assessment and subsequent purchase and release of new medical devices (MDs). As part of the decision-making process, in addition to the manufacturer’s instructions, the reprocessing demands arising from assignment of the respective medical device(s) to a risk category as per the KRINKO/BfArM Recommendation* must also be taken into account. Compliance between these two sets of demands is not always assured and it is not unusual for the manufacturer’s instructions to stipulate processes not available or feasible in the respective RUMED.
This means that the medical device(s) cannot be reprocessed using the available reprocessing process.
If problems arise in relation to reprocessing of the MDs, it should be established prior to purchase whether alternative MDs can be procured from another manufacturer.
The MD PROCUREMENT DECISION-MAKING PROCESS should be set out in the quality management (QM) system. Business management aspects will not be discussed in this present Recommendation.

Structured approach
1. Risk assessment and classification of MDs in accordance with the provisions of the KRINKO/BfArM Recommendation Factors such as medical device compatibility with the available reprocessing process, or the effectiveness of the latter, cannot necessarily be guaranteed. Accordingly, in addition to the functional requirements the MD manufacturer’s reprocessing instructions must also be evaluated (in accordance with DIN EN ISO 17664).
Pursuant to the provisions of the KRINKO/BfArM Recommendation (Item 1.2.1.), RISK ASSESSMENT AND CLASSIFICATION of the MDs as “Non-critical”, “Semi-critical“ or “Critical” is effected in line with the nature of their previous and subsequent use. The aim here is to ascertain the burden and nature of the pathogens anticipated in the area used as well as their resistance to the intended process.


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