FDA Concerns and Actions Re Infusion Pumps
05-07-2010
By Willie Bryant
During the past two months, FDA’s Center for Devices and Radiological Health (CDRH) has expressed considerable concern that data gathered over the past five years has identified what the agency considers to be an unacceptable number of problems associated with infusion pumps. Specifically, the agency recorded 18 recalls of insulin pumps over that five year period. This trend has attracted the Agency’s attention. Medical device manufacturers should heed the warning. The FDA is taking action to ensure consumers are protected.
Between January 1, 2005, and December 31, 2009, the FDA received over 56,000 Medical Device Reports, or MDRs, associated with the use of infusion pumps. Of those reports, nearly 17,000 identified adverse-events related to insulin pumps. These reports triggered those 18 recalls. The recalls were a result of a pump malfunction in which the proper amount of insulin is not administered, resulting in over- or under?infusion, which may lead to seizures, unconsciousness, diabetic ketoacidosis, or even death. The FDA says that these problems have been found across all manufacturers. The most frequently reported external infusion pump device problems include software error messages, human factors (which include but are not limited to use error), broken components, battery failure, alarm failure, over infusion and under infusion.
The FDA has taken several actions in response to these trends.
In March, the FDA convened an advisory panel of outside medical experts to discuss the type of recall actions that have or might be taken to “minimize risks associated with the devices in the recall situations”. On April 23, 2010, FDA notified infusion pump manufacturers by letter of the agency’s concerns and offered guidance and support in helping mitigate current risks and reducing future risks associated with infusion pumps.
The agency has scheduled a public meeting to discuss key challenges related to the infusion pumps, focusing on the following areas: (1) issues commonly related to external infusion pumps; (2) issues associated with filing Medical Device Reporting (MDRs); (3) issues related to human factors; and (4) issues related to improving the pre- and post-market regulatory process. CDRH has published on its website “Infusion Pump Strategies” for Clinicians, Pharmacists, Clinical and Biomedical Engineers and Health Information Technology Professionals, Facility Administrators and Managers, Home Health Nurses and for Patients Using Infusion Pumps at Home.
Recall management for devices used in the home environment, especially devices worn through the day, presents significant challenges to manufacturers from a recall logistics and consumer safety standpoint. Consider the following:
- Is your patient product registry a sufficient means of locating all device users, or must you use other sources to locate and contact users?
How do you document that your instructions were clear, understandable and followed by the user?
If a replacement unit is to be provided, how do you handle return of the defective units? How will you handle disposition?
Is your complaint program an efficient and adequate way to receive and track inquiries from consumers who receive your recall notice?
It is extremely important for any device manufacturer to have a recall plan and strategy in place. It is also critical that the plan be tested against the worst case scenario.
The FDA is not finished examining this issue. As a medical device manufacturer you must be prepared for whatever may emerge from this FDA initiative. Even if you aren’t an insulin pump manufacturer, be aware that FDA is closely watching for recall trends across the entire medical device industry. And the agency will demand recalls and institute new standards and policies if it spots what it considers a significant risk to health.
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[...] mind, some corporate executive is going to be the first in a long line,” Blumberg said. With the recent increase in recalls of FDA-regulated products, it is difficult to predict who the agency may want to single out as an [...]