The upcoming EU Medical Device Regulation brings with it several new device classification and one specifically involves Class I Reusable Surgical Instruments. Which are defined as:
“an instrument intended for surgical use by cutting, drilling, sawing, scratching, scraping, clamping, retracting, clipping or similar procedures, without connection to any active medical device and which are intended by the manufacturer to be reused after appropriate procedures such as cleaning, disinfection and sterilisation have been carried out” – Article VII Part I 2.3
It should be noted that only devices without any connection to an active medical device can be defined is this manner, otherwise they will be given a higher classification. Examples of this class include:
- Scalpels and scalpel handles
- Drill bits
- Saws, that not intended for connection to an active device
- Retractors, forceps, excavators, and chisels
- Sternum retractors for transient use
Under the current Medical Device Directive, such devices would have fallen under the Class I classification, with no Notified Body (NB) involvement. On the other hand, the new Regulation gives specific conformity routes for these devices:
Conformity assessment based on a quality management system and on assessment of the technical documentation – Annex VIII, excluding Chapter II
Conformity assessment based on product conformity verification – Annex X, Part A
In all cases, the NB involvement will be limited to the aspects of reuse, in particular:
- Maintenance and functional testing
- Related instructions for use
Therefore, a vital part of conformance with the Regulation will be to provide detailed procedures for the processes involved in allowing the reuse of the device. This Information for Reuse will include the validated method of re-sterilisation appropriate to the Member State in which the device is placed on the market.
Furthermore, the information provided should also indicate the limitations of reuse such that the device remains safe to use. A maximum allowable number of reuses, could be provided to the user who would need to keep track of how many times that particular device has been used. Alternatively, the user can look out for signs of material degradation which could indicate that the device is no longer safe to use.
It is also required that any traceable, or safety information present on the device should remain legible after every preparation for reuse.
The Unique Device Identifier (UDI) will be required to be present on the device itself. In the case that the technology to include the UDI on the device is too expensive, does not exist, or if marking adversely affects safety or performance, the DI may be omitted. However, the UDI must be present on the label, and higher levels of packaging.