The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of medical devices, has published a guidance document dedicated to reprocessing medical devices in healthcare settings.
In particular, the document provides additional clarifications and recommendations regarding the validation methods and labeling. It is important to mention that due to the legal nature of the document, the provisions set forth therein are not binding. Additionally, the Agency states that an alternative approach could be applied, provided it meets existing regulatory requirements and has been approved by the regulating authority in advance.
The latest version of the guidance was issued in March 2015, but some of its components were amended later in June 2017.
According to the FDA, the document provides recommendations for the formulation and scientific validation of reprocessing instructions for reusable medical devices, as well as recommendations with regard to the content of premarket applications.
The scope of the guidance covers the following types of premarket applications:
- Premarket notification 510(k) submissions;
- Premarket approval (PMA) applications;
- Humanitarian device exemption (HDE) applications;
- De novo requests;
- Investigational device exemption (IDE) applications.
In particular, the guidance provides additional clarifications with regard to labeling in the context of the aforementioned submissions. The authority additionally mentions that even if a medical device in question falls within the scope of an exemption from 510(k), it still should comply with the applicable regulatory requirements in terms of labeling or Quality Systems (QS) unless it is explicitly exempted from such requirements.
According to the present guidance, the medical device manufacturers responsible for reusable medical devices are obliged to ensure the labeling of such devices contains all necessary information (e.g., detailed instructions for use). The Agency additionally emphasizes the importance of the information the medical device manufacturer shall provide as this will have an impact on the safety and effectiveness of use.
It is important to mention that the scope of the present FDA guidance covers not only reusable medical devices intended to be used multiple times for different patients but also certain single-use medical devices which are supplied in non-sterile condition and thus need to be processed before use. Since most of the devices the recommendations provided herein apply to are multiple-use medical devices, the FDA uses the term “reusable devices,” while the scope of the guidance actually covers single-use medical devices as described above.
According to section 502(f) of the Federal Food, Drug, and Cosmetic (FD&C) Act, any medical device placed on the market shall have labeling containing sufficient information on how it should be used. In particular, it should describe how the device should be prepared for use. In the case of prescription devices, the directions for use could be less detailed. However, the labeling for such devices should still contain information for use, including indications, effects, routes, methods, and frequency and duration of administration, and any relevant hazards, contradictions, side effects, and precautions under which practitioner licensed by law to administer the device can use the device safely and for the purpose for which it is intended. Due to the fact that reprocessing constitutes an important element of the use process, the Agency states that the concept of “adequate directions for use” should cover the instructions on reprocessing as well for both prescription and non-prescription devices. In any case, the labeling of a medical device should meet any and all applicable requirements for labeling set forth under 21 CFR Part 801.
The authority also acknowledges that in recent years medical devices have become more complex and require more sophisticated reprocessing procedures. Moreover, the reprocessing technologies and methods are also facing improvement due to technological progress in general. The Agency also mentions that the present guidance could be subject to changes and amendments, should it be reasonably necessary due to the new information available.
As mentioned, the scope of the present guidance covers not only reusable medical devices themselves but also certain single-use medical devices that require processing before use. According to the guidance, the recommendations provided therein should be applied in the context of the following medical devices:
- Multiple-use sterile medical devices that should be subject to reprocessing after each use.
- Multiple-use non-sterile medical devices requiring reprocessing not only after use but also before the first use as well.
- Multiple-use medical devices that should be used by a single patient but still requiring reprocessing after each use.
- Single-use non-sterile medical devices requiring processing before use.
The Agency also describes cases that fall outside the scope of the present guidance. Such cases include the following:
- Processes that are used in industrial settings for the manufacture of single-use medical devices that are intended to be sold sterile.
- Processes intended to be used by reprocessors of single-use devices.
- Any process used for a sterile device provided without any reprocessing instructions from the original equipment manufacturer to permit use after the package has been opened.
- Processes regarding the removal or inactivation of transmissible spongiform encephalopathy agents from contaminated medical devices. The regulating authority explicitly states that, as of now, there are no medical devices approved for such removal or inactivation.
- Reusable medical devices that include a component that is not initially supplied as sterling and between uses cannot be adequately (1) cleaned and disinfected or (2) cleaned and sterilized.
The Agency mentions that if a medical device initially supplied sterile is not accompanied with the reprocessing instructions provided by its manufacturer, such device should not be reprocessed. Should its initial packaging ensuring sterility be damaged, such device should be neither used nor processed but should be returned to the manufacturer instead. It is also stated that the guidance provides general recommendations that could be applied to most of the medical devices falling within the scope of the guidance; however, in case there are device-specific recommendations in place, such recommendations should prevail. In terms of sterilization in general, the document refers to the appropriate guidelines issued previously by the FDA.
In summary, the present FDA guidance describes the current regulatory approach to reprocessing medical devices, including both reusable medical devices and single-use medical devices that should be processed before use. The document outlines the key points to be considered by the medical device manufacturer as the main responsible party, especially in terms of the information to be provided together with the device in order to ensure it will be used in a safe and efficient way. The guidance also clarifies how the general labeling requirements should be applied in the case of reusable medical devices that should be reprocessed between uses.
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