Infusion Pump Improvement Initiative
Like all medical devices, infusion pumps present benefits and risks. These devices have allowed for a greater 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. As part of a balanced public health approach, the U.S. Food and Drug Administration (FDA) seeks to support the benefits of infusion pumps while minimizing the risks.
Through the Infusion Pump Improvement Initiative, FDA is taking broad steps to prevent infusion pump problems:
- Establish additional requirements for infusion pump manufacturers;
- Proactively facilitate device improvements; and
- Increase user awareness.
This comprehensive approach will foster the development of safer, more effective infusion pumps, and support the safe use of these vital medical devices.
Components of this initiative include:
- Draft Guidance to Industry and FDA Staff – Total Product Life Cycle: Infusion Pump Premarket Notification [510(k)] Submissions. The new draft guidance requests that additional information be included in premarket submissions for infusion pumps, above and beyond what has traditionally been provided. 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. The 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. FDA intends to undertake rulemaking to convert the guidance into requirements (special controls) that will apply to pumps under development and already on the market.
- 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 suggests that “manufacturers may need to conduct additional assessments of new products or changes to products currently being marketed,” and recommends that they meet with FDA early in the development process to discuss evolving premarket submission requirements. Finally, the letter offers 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, FDA will discuss infusion pump problems and possible future actions. Specific topics of discussion will include the nature, scope, and impact of the problems currently being experienced; steps 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.
- Generic Infusion Pump Project. One of several ongoing collaborative research projects, the Generic Infusion Pump project is aimed at creating new tools and methods for manufacturers to use to develop software that is provably correct.
- Infusion Pump Website. FDA launched this website to provide information for patients, users, and other stakeholders about infusion pump problems, and to present potential strategies for reducing pump-related risks.