A Reusable Surgical Instrument is defined as: “an instrument intended for surgical use in cutting, drilling, sawing, scratching, scraping, clamping, retracting, clipping or similar procedures, without a connection to an active device and which is intended by the manufacturer to be reused after appropriate procedures such as cleaning, disinfection and sterilisation have been carried out.” – 2.3, Chapter I, Annex VIII.
It should be noted that only devices without a connection to an active medical device can be defined in this manner, otherwise they will be given a higher classification. Examples of devices falling into this class include:
- Scalpels and scalpel handles
- Drill bits
- Saws, that are not intended for connection to an active device
- Retractors, forceps, excavators, and chisels
- Sternum retractors for transient use.
Considerations in the Medical Device Regulation
Under the current Medical Device Directive, these devices fall under Class I, with no Notified Body (NB) involvement (unless sold sterile). Similarly, the Medical Device Regulation also classifies these devices as Class I, however will now require Notified Body involvement with respect to the following aspects relevant to the reuse of the device:
- Maintenance and functional testing
- Related instructions for use.
In line with point 7 of Article 52 of the MDR, the manufacturer will be required to:
- Issue a Declaration of Conformity
- Establish and maintain the technical documentation in accordance with Annexes II and III
- Apply the procedures laid out in either Chapter I and III of Annex IX, or in Part A of Annex XI.
Conformity assessment with respect to Annex IX will be based on a Quality Management System and on the assessment of technical documentation, whilst a conformity assessment with respect to Annex XI will be based on product conformity verification.
This situation is very similar to that of Class I devices supplied in a sterile condition, or with a measuring function. It is evident that a vital part of conformity with the Regulation will be to provide detailed procedures for the processes involved in preparing the device for reuse. The manufacturer must also supply information on the validated method of re-sterilisation appropriate to the Member State in which the device is placed on the market.
Furthermore, the manufacturer must provide the end-user with information indicating the limitations of reuse so as to maintain device safety and performance. Such information could include the maximum allowable number of reuses, or guidance on how to recognise the signs of material degradation which could indicate that the device is no longer safe to use. Information on the maximum amount of times the device can be reused will eventually need to be provided to the UDI database. In addition to this, it is also required that any traceability, or safety information present on the device should remain legible after every preparation for reuse.
If you require any assistance on bringing your Reusable Surgical Instruments into conformity with the MDR, please do not hesitate to contact us at firstname.lastname@example.org.