Infusion pumps provide a high level of control, accuracy, and precision in drug delivery, thereby reducing medication errors and contributing to improvements in patient care. At the same time, infusion pumps have been associated with persistent safety problems that can result in over- or under-infusion, and missed or delayed therapy.
To address safety issues associated with infusion pumps, the FDA undertook the Infusion Pump Improvement Initiative in 2010 to support the benefits of infusion pumps while minimizing the risks. The initiative involved three broad actions:
- Establishing additional requirements for infusion pump manufacturers;
- Proactively facilitating device improvements; and
- Increasing user awareness.
Through stakeholder collaboration and engagement, the FDA has been successful in carrying out these actions. Surveillance through adverse event monitoring and manufacturer inspections will continue to be an important part of identifying safety issues with pumps currently on the market.
FDA’s accomplishments include:
- Final Guidance for Industry and FDA Staff: Infusion Pump Total Product Life Cycle The final guidance requests that manufacturers include additional safety information in premarket submissions for infusion pumps. The guidance recommends that submissions include detailed engineering information concerning the product design and a more comprehensive discussion of steps the manufacturer has taken to mitigate risks in the design of the product and associated processes for its manufacture, servicing and maintenance, and use. This guidance recommends that manufacturers present this information as a safety assurance case that shows the connection between certain design elements, necessary safety mitigations, and the methods and reasons those mitigations are appropriate.. guidance also recommends additional design validation testing specific to the environment in which the device is intended to be used, alerts manufacturers that FDA may conduct pre-clearance inspections in certain circumstances, and emphasizes postmarket reporting requirements.
- Safety Assurance Case Pilot Program. The FDA initiated this pilot to gather information about industry concerns with safety assurance cases and how the FDA can provide more clarity on the development of safety assurance cases. The pilot program included 30 510(k)s submitted between April 2010 and August 2012. In addition to informing the final guidance, the FDA found that safety assurance cases increased the number of days the manufacturers took to address FDA’s questions and resulted in more infusion pump clearances, less withdrawals of 510(k) submissions, and no significant change in FDA review time.
- Letter to Infusion Pump Manufacturers. On April 23, 2010, FDA sent a letter to infusion pump manufacturers, describing reported problems and noting that many of these are associated with design deficiencies. The letter suggested that “manufacturers may need to conduct additional assessments of new products or changes to products currently being marketed,” and recommended that they meet with the FDA early in the development process to discuss evolving premarket submission requirements. Finally, the letter offered manufacturers the opportunity to voluntarily submit their software for review by FDA software experts prior to premarket review.
- Infusion Pump Workshop. In a public workshop on May 25-26, 2010, the FDA discussed infusion pump problems and possible future actions. Specific topics of discussion included the nature, scope, and impact of the problems currently being experienced; steps the FDA is taking to improve the current premarket and postmarket regulatory processes; and opportunities for FDA, members of the academic community, industry, and others to work together to improve infusion pump design.
- Infusion Pump Software Safety Research. The FDA’s Laboratory for Software Engineering is researching model-based engineering for infusion pumps and software verification techniques. The Generic Infusion Pump Project is one of several ongoing collaborative research projects aimed at creating new tools and methods for manufacturers to use to develop infusion pump software.
- Infusion Pump Website. FDA launched the Infusion Pump website to provide information for patients, users, and other stakeholders about infusion pump problems, and to present potential strategies for reducing pump-related risks.
- Infusion Pump Manufacturer Inspections. To help facilitate infusion pump safety, the FDA began inspections of FDA-registered infusion pump manufacturers in November 2011.
- The FDA inspected all 20 manufacturers that were manufacturing infusion pumps and registered with the FDA in November 2011. Manufacturers with inspection findings that require them to take official action are subject to continual surveillance or re-inspection until the deficiencies are corrected. Manufacturers with inspection findings that require no official action or voluntary action are inspected every two years.
- Overall, the FDA has seen an improvement in the inspection findings for infusion pump manufacturers. Inspections show the firms are proactively working with FDA and continuously initiating corrective actions as a result of the FDA inspections.
- As noted in the final guidance, the FDA may require a pre-clearance inspection prior to clearing an infusion pump. When determining if a pre-clearance inspection is necessary the FDA would consider a number of factors, including the manufacturer’s current inspection status, when the manufacturer was last inspected.
- Stakeholder Engagement. The FDA has worked with industry, standards associations, and other stakeholders to increase user awareness about infusion pumps and to facilitate the development of better designed pumps. FDA’s stakeholder engagement activities include the following: