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 the regulatory requirements for reprocessing medical devices in healthcare settings.

It is important to mention that due to its legal nature, the guidance does not introduce new rules and requirements the parties involved should follow but provides additional clarifications on how the provisions of applicable legislation should be interpreted, as well as recommendations to be considered by medical device manufacturers, healthcare institutions using medical device subject to reprocessing, and other parties involved. The Agency additionally states that an alternative approach could be applied, provided such an approach complies with the applicable regulatory requirements and has been approved by the authority in advance.

Validation of Reprocessing Methods 

First, the document describes the main points related to the validation of reprocessing methods in accordance with the Quality System Regulation. In particular, it is stated that in accordance with the applicable legislation, for Class II and Class III devices and select class I devices, the manufacturer must establish and maintain procedures for validating the design of their device, which shall ensure that the device conforms to defined user needs and intended uses. Additionally, medical device manufacturers are obliged to develop and implement procedures for monitoring and control of process parameters for validated process to ensure that the specified requirements continue to be met. 

Hence, medical device manufacturers should validate the design of the device, as well as the instructions for use accompanying it. The authority additionally emphasizes that the aforementioned requirements should be applicable even with regard to medical devices that are exempted from 510(k).

In order to reduce the regulatory burden, medical device manufacturers are allowed to group their products subject to validation into product families consisting of medical devices similar in terms of design or materials used. According to the FDA, in such cases, it may be possible “to establish that validation data for the most difficult to reprocess devices in a family (i.e., the worst-case device or “master device”) covers devices that present an equivalent or lesser reprocessing challenge.” However, when following such an approach, the manufacturer will have to demonstrate that the differences among medical devices that exist are not significant enough to impact the effectiveness of reprocessing. Moreover, if the manufacturer implements some changes to the design of the device or the materials used, and such changes could impact reprocessing, revalidation would be required. 

The authority also states that if the medical device in question is subject to design control, design validation would be required in order to ensure the final product meets the needs of users. In the course of such validation, it is necessary to consider the factors related to the intended user population, as well as the environment in which the device is intended to be used. 

The scope of validation should cover the processes and procedures associated with cleaning, disinfection, and sterilization. 

Validation of Cleaning Process: Key Points 

The document further describes the approach to be applied by medical device manufacturers in order to achieve and sustain compliance with the applicable requirements related to the cleaning of a reusable medical device after use. In this regard, the guidance also refers to the appropriate FDA-recognized voluntary consensus standards the manufacturers may use for demonstrating compliance with the respective regulatory requirements. As it is stated by the FDA, the manufacturer should carry out validation activities in order to demonstrate that:

  • The methods (manual or mechanical) are adequate to allow the device to undergo further processing and to eventually be reused safely; and
  • Reprocessing instructions are effective in conveying the proper reprocessing methods to the user.

In particular, the validation activities to be performed by the medical device manufacturer should include the validation of the cleaning process using worst-case testing. This should be performed in order to ensure that the device in question could be reprocessed after being used and then used in a safe and efficient way after such reprocessing is performed strictly in accordance with the instructions and recommendations provided by its manufacturer. The authority also mentions that at least two quantitative test methods should be applied. As in the case with other types of testing, it is necessary to determine the cleaning test endpoints in advance in order to use them further when evaluating the results. 

Under the general rule, in the course of such testing, the manufacturer should create conditions that are similar to those in which the device is intended to be used. This aspect is especially important as it ensures the accuracy and reliability of testing results. In certain cases, artificial soil could be used. 

Validation Protocols 

The document also provides additional recommendations regarding the documentation of methods designed to test the cleaning process. In particular, the manufacturer should provide the authority with detailed enough validation protocols containing important information regarding the testing performed, including details on main parameters (e.g., time or temperature). It is also important to mention that the principle of worse-case testing should be applied here as well. For this purpose, the manufacturer should conduct a rigorous analysis of the instructions for use accompanying the device when supplied to the customers in order to identify the worst-case conditions. The authority also provides some examples of such scenarios, namely:

  • If the cleaning instructions recommend a 10 to 20 minute pre-soak, the validation protocols should specify 10 minutes;
  • If the cleaning instructions advise the user to manually clean at 45ºC (plus/minus 5ºC), the validation protocol should specify cleaning at 40ºC;
  • If a device consists of lumens, ports, or channels that must be flushed during cleaning, the validation protocol should include minimal flushing specifications, such as time, flush volume or flow rate, and number of repetitions. 

Apart from the aspects described hereabove, the document pays attention to test types and protocols. In particular, the guidance describes the approach to be applied by a medical device manufacturer as a party responsible for validation when determining the particular test type to be applied. 

In summary, the present FDA guidance provides a brief overview of the most important aspects to be taken into consideration by medical device manufacturers with regard to validation activities. The document describes the approach to be applied in order to ensure compliance with the applicable regulatory requirements and provides additional recommendations based on existing legislation. 


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