According to the European Union’s Medical Device Regulation (MDR), a “reusable surgical instrument” is 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.
According to the MDR, “reprocessing” means a process carried out on a used device in order to allow its safe reuse including cleaning, disinfection, sterilisation and related procedures. This also includes testing and restoring the technical and functional safety of the used device.
During reprocessing, devices are subjected to high temperatures and pressure as well as chemicals. Since the devices are subsequently reused, functionality and biocompatibility must be ensured after each reprocessing procedure. If necessary, a maximum number of reprocessing cycles should be defined.
Niutec AG offers chemical analyses enabling you to determine the following characteristics:
- Accumulation of organic, inorganic or particulate residues
- Corrosion resistance of metal components
- Deterioration or alteration of plastic components (e.g., handles made of PPSU or POM)
Based on the data obtained, a device’s biological safety can be assessed after repeated reprocessing.
Niutec AG will gladly support you with the appropriate analytical Methods.
Maximum permitted reprocessing and reuse
In the case of reusable devices, information must be provided on suitable reprocessing methods, e.g., for cleaning, disinfection and packaging. It must be made clear how it can be recognized that a device should no longer be reused. This could be defined, for example, by describing signs of material wear, material alteration or by specifying the maximum number of permitted reuses.
These characteristics can be determined on the basis of a study with a predefined number of reprocessing procedures by means of chemical analysis in accordance with ISO 10993-12 and ISO 10993-18 and carrying out corresponding risk assessments.
UDI on reusable devices after reprocessing
Reusable devices bear a UDI carrier on the device itself. For reusable devices requiring cleaning, disinfection, sterilization or reprocessing prior to each use, a UDI carrier must be permanently affixed and legible throughout the expected lifetime of the device after any reprocessing procedure performed to prepare the device for subsequent use.
A visual inspection can be performed to determine legibility compared to an unprocessed device.
By means of chemical characterisation, it is possible to assess material alteration and thus the change in biocompatibility.
Niutec AG makes it possible for you to carry out a study to incorporate it into your technical documentation
- Reprocessing various numbers of reprocessing cycles
- Chemical characterization in accordance with ISO 10993-12 and ISO 10993-18
- Assessment of alteration after several cycles
Typical material alterations can thus be determined or excluded by determining the extractables & leachables compared to time zero (after single-use reprocessing). The surface of the device can also be assessed by means of chemical tests.
Contact us today to start planning a study tailored to your material and device.