Regulatory Compliance

“The labeling for reusable medical devices should inform the user as to how many times the device can be reused, based on testing data. Reuse life may also be addressed by validating the number of times the product can be reprocessed and reused, and providing this specification in the labeling.” – FDA Guidance Document on Reprocessing Medical Devices in Health Care Settings: Sec L, 2015 (revised 2017)

“The characteristics and performance of a device shall not be adversely affected to such a degree that the health or safety of the patient or the user and, where applicable, of other persons are compromised during the lifetime of the device, as indicated by the manufacturer when the device is subjected to the stresses which can occur during normal conditions of use and has been properly maintained in accordance with the manufacturer’s instructions.” – EU MDR 2017/745, Annex 1, Ch 1, Sec 6

“The manufacturer’s labeling must provide information to identify when the device should no longer be reused (e.g., signs of material degradation or the maximum number of uses).” – EU MDR 2017/745, Annex 1, Ch 3, Sec 23.4(n)

“Devices that are reusable must bear a UDI [Unique Device Identifier] carrier on the device itself. The UDI carrier for reusable devices that require cleaning, disinfection, sterilization or refurbishing between patient uses shall be permanent and readable after each [reprocessing treatment].” – EU MDR 2017/745, Annex 6, Pt 3, Sec 4.10

“For re-usable medical devices, biological safety shall be evaluated for the maximum number of validated processing cycles by the manufacturer.” – ISO 10993-1:2018, Sec 4.8

“The medical device manufacturer shall have objective evidence available that validation of the processing procedures has been undertaken to confirm that the specific medical device will be clean, disinfected, and/or sterilized when processed as directed.” – ISO 17664-1:2021 Sec 4.2

“If a manufacturer supplies a number of different medical devices that share common attributes, then validation studies may be performed as a product family. If this approach is taken, the medical device manufacturer shall demonstrate commonality between the different medical devices and the validation studies shall address the worst-case attribute(s) of the product family.” – ISO 17664-1:2021 Sec 4.3

“If the processing of a medical device in accordance with the medical device manufacturer’s instructions is known to lead to degradation that might limit the service life of the medical device, for example, functionality, biocompatibility or suitability for effective processing, then the medical device manufacturer shall provide such information regarding limitations and restrictions to the processor.” – ISO 17664-1:2021 Sec 6.3.1

“If the service life of the medical device is limited by the number of processing cycles or some other end-of-life indicator(s), this information shall also be provided.” – ISO 17664-1:2021 Sec 6.3.2

SteriLogix advocates for following Standardized Clinical Reprocessing Cycles for lifecycle studies of reusable surgical instruments released in the United States, Canada, and the European Union/UK.