December 11, 2018
In early November, CMDE has published a draft guideline for the reprocessing validation and labeling for reusable medical devices: Part 1 (hereinafter referred to as the "Guidelines") which solicited opinions from the public.
The purpose of the guidance is to support applicants in the preparation of reprocessing validation and labeling procedures for reusable medical devices during the product registration. (For purposes of this discussion, we define ‘reprocessing’ as cleaning, disinfection, or sterilization of reusable medical device after its use.) This guideline is divided into two parts. The first part mainly stipulates the six (6) requirements of the reprocessing instructions for the manufacturer. The second part sets out the requirements for validation method for the reprocessing instructions, providing a list of the confirmation plan thereof, along with the recommended reports for the reusable medical devices. The guideline currently for release comprises only the first part.
This guideline shall be considered when the product meets the following conditions:
1. A reusable medical device that is initially provided to the user in a sterile form which requires the end-user to reprocess after using.
2. Reusable medical devices that are initially provided to the user in a non-sterile form and require the user to sterilize, clean or disinfect only for first use.
3. Reusable medical devices used by only one patient and which needs to be reprocessed after each use.
4. Disposable medical devices that are initially supplied to the user in a non-sterile form and requires the end user to sterilize, clean or disinfect the device prior to its use.
The contents of this guideline cover the following points:
1. Basic requirements of reusable medical devices: This section describes the points that manufacturers must consider for the reprocessing verification during the design phase and requires manufacturers to ensure the safety of reusable medical devices;
2. Requirements for reprocessing instructions: The manufacturer shall provide the user with detailed instructions for reprocessing. The guideline mainly stipulates the six (6) requirements of the reprocessing instructions which should be provided by the manufacturer;
3. Definition of terms;
4. Sample of the reprocessing overview for reusable medical devices
Invalidated reprocessing methods, being the perpetrator for a number of adverse events associated with routine application of reusable medical devices, has been one of the on-trend regulatory topics in the recent years. From the guideline, the definition of reprocessing has been derived as “sterilization”, “cleaning” or “disinfection”. The guideline applies to most devices having a direct contact with patients, as well as for some consumable products. If your country does not have any requirements for this part, we recommend most companies to make all necessary documentations to prepare for this requirement in advance. The 《guidelines》 issued by China or 《the Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Guidance》 issued by US FDA in 2016 comprise a good regulatory references.