The Food and Drugs Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a guidance document dedicated to infusion pumps. The guidance highlights matters related to performance testing.
It is important to mention that due to its legal nature, the FDA guidance is not intended to introduce new rules and requirements the parties involved should comply with, but rather to provide additional clarifications and recommendations to be considered. Moreover, an alternative approach could be applied, provided such an approach complies with existing legislation and has been approved by the regulating authority in advance.
Performance Testing: Regulatory Basics
According to the guidance, performance testing to verify/validate the pump design should assure that the related safety case claims are satisfied. The authority additionally emphasizes carrying out the performance testing in a way the device would be actually used in order to ensure the accuracy and reliability of testing results. Should more than one configuration be available, each of them should be tested separately. The manufacturer may refer to the data collected in the course of testing other configurations, but such references should be accompanied by a justification of the reliability of such reference. The scope of information to be provided to support the claims made by the manufacturer should be determined on a case-by-case basis depending on the particular medical device subject to testing and specific features of its design and functionality.
The information to be included in the 510(k) premarket notification with regard to performance testing should cover the following aspects:
- A description of the device design requirement being verified, including why it is essential to the proper functioning of the device;
- A description of the unit under test and how it relates to the final, finished device;
- The justification for the use of prototype or “production equivalent” devices or components during the design verification activity, if applicable;
- An explicit statement of the acceptance criteria for the verification activity;
- A detailed description of the verification method, including drawings and descriptions of the test apparatus where appropriate;
- An explanation of how the verification test set up simulates actual clinical use conditions, if applicable;
- The results of the verification activity;
- An analysis of the verification activity results; and
- An explicit statement of any conclusions drawn from the verification activity.
Additionally, the information to be provided by the medical device manufacturer should contain details regarding the user population subject to testing, the environment in which the device has been tested. The aspects to be addressed are include the following:
- Details regarding the design requirements subject to validation;
- Additional information about the particular medical device used for validation, and indications of any differences in comparison to a final product that would be placed on the market;
- If a prototype has been used, the appropriate justification of such use should be provided as well;
- Information regarding the extent to which the testing conditions represent the intended use conditions in order to ensure the accuracy and reliability of the results;
- Information on the acceptance criteria applied;
- Details about the design validation method employed;
- The results of the design validation activity;
- A rigorous analysis of the above; and
- An explicit statement of any conclusions drawn from the design validation activity.
The Agency mentions that medical device manufacturers may refer to the applicable FDA-recognized voluntary consensus standards in order to demonstrate conformity to the relevant regulatory requirements. However, this is not something mandatory and remains at the discretion of the manufacturer. Moreover, there are no specific requirements regarding the format to be used – such flexibility is allowed under the applicable standard ISO 14971.
Operational Safety and Related Matters
The guidance further provides additional clarifications regarding the specific aspects medical device manufacturers should pay attention to in the context of performance testing. These aspects include the following:
- Infusion Delivery Accuracy. This parameter should be evaluated in the context of the intended use of the device, as well as the particular conditions in which the device is intended to be used. In this regard, the authority mentions that when developing and verifying the accuracy specification, [the manufacturer] should consider the flow rates and duration of time over which the accuracy specification is defined. As mentioned, each configuration should be subject to separate testing. The representativeness of the particular configuration should be based on the impact it causes on the performance of the device. For instance, the following key points should be taken into consideration:
- Infusion sets: Length, diameter, number and type of flow restriction devices on the set, number and relative location of access point;
- Drug reservoir: Size, position relative to pump;
- Pump model/configurations: Flow rate limits, volume limits.
- Environmental Safety. In terms of environmental safety, the Agency encourages medical device manufacturers to adhere to the applicable standards. The appropriate documentation demonstrating conformity to such standards should be submitted as a part of the 510(k) submission. The particular standards to be used should be determined based on the intended environment in which the device will be used. Hence, the manufacturer should duly carry out a rigorous assessment of environmental hazards associated with the device and implement the relevant measures in order to mitigate the appropriate risks. The information about environmental hazards, as well as the measures taken to mitigate them, should be included in the safety assurance case.
- Electrical Equipment Safety. Another important aspect to be considered by medical device manufacturers with regard to infusion pumps relates to electrical equipment safety. In particular, the device should comply with the standard ANSI/AAMI ES60601-1:2012 “Medical electrical equipment – Part I: General requirements for basic safety and essential performance.” Compliance with this standard should be demonstrated by including the appropriate data in the 510(k) submission.
- Electromagnetic Compatibility. In case the device subject to review contains any electromagnetic components, it would be also necessary to demonstrate conformity to the appropriate EMC requirements. The FDA also states that apart from the evidence, the manufacturer would have provided extensive information about the testing performed and the results achieved.
Apart from the aspects outlined above, the main points to be addressed by the manufacturer include those related to radiofrequency wireless technology, hardware safety, software safety, mechanical safety, biological safety, and use safety.
In summary, the present FDA guidance provides additional clarifications regarding the applicable regulatory requirements for testing the infusion pumps should be subject to in the context of verification and validation. The document also highlights the most important aspects to be considered with regard to the safety of infusion pumps and related matters.
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