The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of medical devices and other healthcare products, has published a guidance document on infusion pumps.
The document addresses the most important regulatory matters associated thereto and provides additional clarifications and recommendations regarding the applicable regulatory requirements. The provisions of the guidance are non-binding and are intended to describe the approach suggested by the FDA. An alternative approach could be applied, provided such an approach has been approved by the authority in advance and complies with existing legislation. Apart from the general principles, the present guidance also provides clarifications regarding certain specific aspects to be considered by medical device manufacturers and other parties involved.
According to the guidance, when submitting a premarket notification, the party responsible for a medical device should also provide the proposed labels, samples of labeling, advertising materials to be used to promote the device, as well as details about its intended use and how it should be used. The appropriate requirement is also prescribed under the current legislation. In particular, it is stated that the instructions for use accompanying the device should provide comprehensive information regarding its features and how the device should be used in a safe and efficient manner.
With regard to labeling, the FDA emphasizes the following aspects:
- Directions for Use. Due to their specific nature, infusion pumps should be used only when supervised by a qualified healthcare professional. Moreover, the instructions for use should clearly prescribe how the device should be used for the purpose it initially intended. According to the applicable legislation, in the case of infusion pumps, the labeling used should contain information regarding the indications, effects, routes, methods, frequency and duration of administration, and any relevant hazards, contradictions, side effects, and precautions. The aforementioned information should be provided in a scope sufficient to ensure the use in a safe and efficient manner.
Apart from the scope of information required according to the applicable legislation, the authority also recommends including additional details on:
- Indications for use,
- Cleaning and disinfection (for reusable elements and in the context of agents available to intended users),
- Alarm limits and ranges,
- Basic (default) settings,
- User interface (especially in terms of screens and data fields),
- References to the particular administration sets the infusion pump is intended to be used with,
- Information about the factors that could impact performance of the device,
- Accuracy specifications,
- Indications on the fluid(s) the device in question could administer, including any applicable contradictions,
- Detailed instructions on the way the functions of the infusion pump should be used,
- Description of a calibration check,
- Description of messages the device could provide, as well as indications of the actions to be taken in such cases,
- Details regarding compatibility with diagnosing procedures,
- Information about the matters related to electromagnetic compatibility and radiofrequency technologies
- Home Use Labelling. The authority also encourages medical device manufacturers to indicate the particular environment in which the infusion pump is intended to be used. In particular, if the infusion pump subject to review is intended to be used at home by laypersons, this should be reflected in the instructions for use and how they are provided. As mentioned, such use should be supervised by a qualified healthcare professional. Additionally, for such devices, it is necessary to indicate the phone number that could be used to contact customer support operated by the manufacturer.
Should a hazardous situation occur, an infusion pump should issue an alarm to notify the person using it. In order to avoid confusion, medical device manufacturers should provide comprehensive information about any and all alarms the pump may issue. Such information should be duly communicated to users of the device. In this regard, the FDA refers to the applicable standard IEC 60601-1-8: Medical electrical equipment – Part 1-8: General requirements for safety – Collateral standard: Alarm systems. Moreover, the matters related to alarms should be addressed in the safety assurance case, including the aspects related to false positive and false negative alarms.
The guidance further provides examples of situations that could trigger an alarm. These situations include the following:
- Occlusion (supply side and patient side);
- Free flow / Improper flow of fluid;
- Depleted battery or No power;
- Defective battery;
- Low or Empty reservoir;
- No reservoir;
- Dose limit / Bolus limit exceeded;
- Drug library mismatch; etc.
Safety Control Mechanisms
As stated in the guidance, the manufacturer shall also develop and implement a safety control mechanism intended to detect and prevent hazardous situations. According to the guidance, such mechanisms include but are not limited to various tests (e.g., battery test, pump mechanism failure test) and checks (e.g., system checks, sensors checks). In order to ensure the aforementioned mechanisms operate as intended, the manufacturer should also perform the appropriate verification and validation. Moreover, the safety case for the device should cover the situations when the mechanism failed to perform in an efficient way, or the action resulting from it is unsafe itself, occurs too early or late, etc.
510(k) Pre-Clearance Inspection of Infusion Pump Manufacturers
Apart from the aspects described above, the present FDA guidance also addresses the matters related to pre-clearance inspections of infusion pump manufacturers the regulating authority is entitled to carry out in order to assess compliance with the applicable regulatory requirements. The appropriate procedure was introduced in response to a significant increase in the number of recalls and complaints related to infusion pumps marketed in the US. The analysis of these recalls and complaints demonstrated that the manufacturers failed to implement the appropriate quality system.
However, a pre-clearance inspection is not a mandatory procedure in any and all cases. The regulating authority may decide on applying it if deemed reasonably necessary to assess compliance with the Quality System regulations. The factors to be considered by the Agency when determining whether a pre-clearance inspection is needed include the following ones:
- The infusion pump subject to review employs novel technologies;
- There were no inspections for the particular facility within 2 years, or their scope hasn’t covered the process in question;
- The grounds for submitting 510(k) are related to failures or malfunctions to be addressed.
In summary, the present FDA guidance addresses the most important aspects related to the regulatory requirements to which infusion pumps are subject and also provides additional clarifications and recommendations to be considered. The document also describes the approach to be applied in the context of postmarket surveillance and reporting requirements with which the manufacturers should comply.
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