The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a guidance document dedicated to reprocessing medical devices in healthcare institutions. The document describes the validation methods to be applied, as well as the labeling for reprocessed devices. The guidance also outlines six criteria for reprocessing instructions to be provided by the manufacturer in order to ensure correct reprocessing, as well as the safety and proper performance of the reprocessed medical devices. The present article describes criteria 4-6, while criteria 1-3 are covered in the previous article dedicated to the topic.
It is also important to mention that FDA guidance documents are not intended to introduce new rules and requirements themselves, but rather to provide additional clarifications regarding current regulatory requirements, as well as additional recommendations to be considered by medical device manufacturers and other parties involved in order to ensure compliance thereto. Moreover, an alternative approach could be applied, provided such an approach is in line with the provisions of existing legislation and has been approved by the authority in advance.
Criterion 4. Scope and Feasibility
The fourth criterion states that reprocessing instructions should be technically feasible and include only devices and accessories that are legally marketed. The first part emphasizes that the procedures described in reprocessing instructions should be feasible in the context of the environment in which the device is intended to be reprocessed. Additionally, the instructions should contain a clear indication of the equipment and accessories required to follow them. Said equipment and accessories should be easy for the user to obtain. This becomes especially important in terms of sterilization methods recommended by the manufacturer. The Agency provides an example of radiation sterilization, which is an option only for manufacturing facilities, while for healthcare institutions, the most widely used sterilization methods include steam sterilization or, in certain cases, liquid chemical sterilization processes. Hence, the reprocessing instructions should clearly indicate the particular sterilization method to be applied and its main parameters. The authority additionally emphasizes that sterilization cycle parameters specified in the labeling for reprocessing a device should be consistent with validated sterilization cycle parameters for commonly available, legally marketed sterilizers, as this is vitally important to ensure the feasibility of the sterilization methods recommended for the intended users. The same approach should be applied with regard to accessories to be used – all the accessories mentioned in the reprocessing instructions should be legally marketed in the US and easily available for the parties involved. In most cases, such accessories are placed on the market as Class II medical devices under the premarket notification framework and are cleared by the FDA for the particular purpose (intended use). According to the guidance, the way the manufacturer recommends using the accessories should be aligned with the intended use for which such accessories (devices) are cleared. The guidance also refers to the list of FDA-cleared liquid chemical sterilants and high-level disinfectants maintained by the authority.
One of the most important concepts used in the context of reprocessing medical devices and sterilization is the concept of an “extended cycle.” According to the present guidance, it refers to any sterilization cycle that includes specifications that deviate from those found on commonly used, FDA-cleared sterilizers, and for which there are limited or no FDA-cleared sterilization accessories. As stated by the Agency, implementation of such cycles could be challenging for healthcare institutions. In most cases, extended cycles are needed to reprocess complex medical devices or increase the number of medical devices that could be reprocessed in the course of one operational cycle. Thus, when indicating the need for extended cycles in the reprocessing instructions, the manufacturer should make sure the accessories intended to be used are cleared for such extended cycles, which should be confirmed by the relevant testing data.
The Agency additionally recommends that manufacturers avoid referring to ranges when describing the temperature necessary to complete sterilization, as this suggests that all the values inside the range are acceptable. Instead, the manufacturer should specify the exact temperature, ensuring the efficiency of the sterilization process, provided that this will not impact the safety and performance of a medical device itself.
It is also stated that the Agency has accepted validated drying time specifications in the labeling that exceed those found on FDA-cleared sterilizers and that require manually setting the drying time controls.
Criterion 5. Comprehensiveness
According to criterion 5, reprocessing instructions provided by the medical device manufacturer should be comprehensive, allowing the intended user of a medical device to understand clearly how the procedure described therein should be performed. As stated by the FDA, in order to ensure comprehensiveness of reprocessing instructions, they should contain the following elements:
- Special Accessories. As mentioned, any and all accessories necessary to perform the procedures described in reprocessing instructions should be indicated clearly therein. Additionally, it is also necessary to describe in detail the appropriate protection measures to be taken during reprocessing. It is stated that the instructions should also provide sufficient detail so that the user can purchase the correct items, including any custom cleaning accessories, or identify a source for the purchase of such items.
- Point-of-Use Processing. The labeling for a medical device should contain the appropriate indications with regard to point-of-use reprocessing. For instance, it could be recommended to perform the initial cleaning of the device right after use to prevent the drying of soil in order to facilitate further reprocessing. The authority also states that delays between the steps of reprocessing procedures should be reduced to the maximum extent possible.
- Disassembly and Reassembly. If a medical device in question is comprised of several elements and parts that should be removed in the course of reprocessing, this should also be duly reflected in reprocessing instructions. Additionally, it is necessary to indicate the equipment required to perform this procedure. The reprocessing instructions should contain clear recommendations regarding the way this should be performed, as well as the particular step of reprocessing process when these procedures are required. The authority additionally emphasizes the importance of clarity of the wordings used: it is stated that the manufacturer shall avoid ambiguous language that could result in misinterpretation of the reprocessing instructions by the user. Additionally, it is important to provide information regarding how correct reassembly could be validated by the user once the procedure is completed. The Agency also states that disassembly and reassembly instructions should include information to visually inspect the device and components for wear and tear of components that cannot be assessed in the fully assembled configuration.
In summary, criteria 4 and 5 (sections A-C) describe how the information on recommended sterilization methods should be provided and also provides details regarding accessories, point-of-use reprocessing, and disassembly and reassembly procedures that could sometimes be required to ensure the effectiveness of reprocessing. The document provides recommendations to be followed by medical device manufacturers when creating reprocessing instructions or prodding the appropriate information in labeling.
How Can RegDesk Help?
RegDesk is a next-generation web-based software for medical device and IVD companies. Our cutting-edge platform uses machine learning to provide regulatory intelligence, application preparation, submission, and approvals management globally. Our clients also have access to our network of over 4000 compliance experts worldwide to obtain verification on critical questions. Applications that normally take 6 months to prepare can now be prepared within 6 days using RegDesk Dash(TM). Global expansion has never been this simple.