The new article highlights aspects related to sterility and reprocessing for both sterile and non-sterile.
Table of Contents
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published draft guidance dedicated to orthopedic non-spinal bone plates, screws, and washers in the context of premarket notification (510(k)) submissions. Once finalized, the guidance will provide an overview of the applicable regulatory requirements as well as additional clarifications and recommendations to be considered by medical device manufacturers and other parties involved. At the same time, it is important to mention that the provisions of the guidance documents issued by the FDA are non-binding in their legal nature, and are not intended to introduce new rules or impose new obligations. Moreover, the authority explicitly states that an alternative approach could be applied, provided such an approach is in line with the existing regulatory framework and has been agreed upon with the authority in advance.
The document describes in detail the way specific aspects related to the products in question should be addressed in the respective submissions in order to ensure the completeness of the information provided.
Sterility
Under the general rule, the products falling within the scope of the present guidance should undergo proper sterilization in order to mitigate the risk of infections being transmitted. In this respect, the authority refers to a separate guidance document named “Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile” for further guidance.
Reprocessing
The document also addresses aspects related to reprocessing medical devices (including those that are single-use and supplied non-sterile assuming additional sterile processing). First of all, the authority acknowledges that many of the products described in the guidance could be reused, hence, they require proper cleaning and sterilization between uses in order to ensure the risks associated with potential infection transmission are duly mitigated while preventing degradation of the device itself due to the respective procedures the device undergoes. Furthermore, such products could be supplied non-sterile – should that be the case, they would require additional processing before initial use. According to the guidance, cleaning instructions in the labeling should clearly identify their applicability for reprocessing soiled reusable instruments or their applicability to new and uncontaminated implants and instruments before sterilization. Thus, the authority recommends providing detailed enough instructions describing the way the device should be processed or reprocessed in order to ensure the safety of patients, as well as the proper performance of the device itself. The appropriate information should be included in the labeling used for the product. The authority additionally emphasizes that the instructions for cleaning should be designed and validated for the type of contamination anticipated on the device, based on its intended use; accordingly, there may be separate, dedicated cleaning instructions; for new, uncontaminated single-use devices prior to sterilization, as well as separate, dedicated instructions for routine cleaning of contaminated reusable medical instruments prior to sterilization. It is also important to mention that, in accordance with the recommendations provided in the guidance, single-use devices, such as implants, should be cleaned separately from soiled reusable devices to prevent cross-contamination.
As further explained in the guidance, all the residues of the manufacturing process should be duly removed in the course of the manufacturing process itself, in line with the Good Manufacturing Practice. The above is important as, in most cases, this cannot be performed by healthcare institutions due to numerous organizational and/or technical reasons. The aspects related to cleaning necessary to remove all the manufacturing residues and contaminants are also addressed in the Quality System Regulation. In this respect, the document also refers to a separate guidance document named “Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling”.
Apart from the above, the guidance also provides examples of additional considerations to be reflected in the labeling used for medical devices described in the guidance. These aspects include, inter alia, the following ones:
- The quality of the water used for the final rinse could be important as well, hence, the appropriate specifications should be provided by the medical device manufacturer.
- The labeling should also contain a warning addressing the use of a product that is potentially damaged or contaminated. In particular, the said statement should notify the customer that in the event of any concerns about a medical device being damaged or contaminated, it should not be used. Moreover, should reprocessing be required before the initial use due to the device being supplied non-sterile, the appropriate validation instructions should be provided as well. In this respect, the authority expects medical device manufacturers to:
- Explicitly define “contaminated” and characterize the conditions under which a device would be considered “unused”.
- Provide validated reprocessing instructions for “Opened-but-Unused” products that are consistent with definitions as recommended above.
- Reprocessing instructions described in the labeling should be consistent with the relevant validation activities.
In summary, the present FDA guidance highlights certain specific aspects related to the information to be included in marketing submissions for bone plates, screws, and washers in order to accommodate the specific needs of such products and also the risks associated. The document describes in detail the approach to be applied when proving information about sterilization and reprocessing activities the products should undergo before they are used.
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