Over the last five years, the U.S. FDA has received more than 56,000 reports of adverse events attributed to the use of infusion devices. Critical to patient care, these medical devices are embedded in our healthcare system, which has prompted the FDA to launch a major initiative on exploring their safety, including a website dedicated to the topic.
Back in March, an Association for the Advancement of Medical Instrumentation (AAMI) committee met to address infusion device safety. In May, the FDA sponsored an infusion pump workshop as part of the initiative. Earlier this month, I made it a priority to attend the joint AAMI-FDA Infusion Device Summit, which took place October 5–6 at the FDA’s Rockville, MD campus. The main goal of this summit was to identify specific actions that can be taken by all the various stakeholders to improve infusion safety.
The summit attracted a very diverse group of well over 300 stakeholders: clinicians and other users of the devices, clinical/biomedical engineers, hospitals and other healthcare organizations, FDA officials, device manufacturers, product development firms (like Farm), associations, academicians, safety organizations, and many others. The summit received an overwhelming turnout—more than the FDA had anticipated—but the logistics were handled very well and the two days went smoothly. We met in a huge room with several projection screens and listened to a number of presenters on topics such as standardizing the user interface; issues with the drug libraries programmed into “smart” pumps; and the shortcomings in processes for collecting, compiling, and reporting on infusion device incidents.
The outcome of the summit was a list of the top 13 priorities for infusion device safety, which can be found at http://www.aami.org/news/2010/101410.press.infusion.priorities.html. These issues will be addressed in an upcoming action plan.
It is important for me to note that as part of their initiative, the FDA has published a new document titled Draft Guidance to Industry and FDA Staff—Total Product Life Cycle: Infusion Pump Premarket Notification [510(k)] Submissions. The draft guidance asks manufacturers to include additional information in their premarket submissions for infusion pumps, above and beyond what has traditionally been provided. 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 post-market reporting requirements. The expectation is that this guidance will be turned into a requirements document.
At the same time, the IEC has drafted a standard for infusion pumps, which AAMI reviewed and commented on earlier this year (“AAMI/IEC 60601-2-24, Medical Electrical Equipment—Part 2-24: Particular Requirements for Basic Safety and Essential Performance of Infusion Pumps and Controllers”). According to Jennifer Moyer at AAMI, “We are waiting on IEC right now to see how the comments were addressed. It is the ‘hurry up and wait’ stage of things. The draft document that had been circulated to the committee is out of date and not available anymore.”
I look forward to seeing the action plan and being part of the solution to this patient safety issue.