FDA In The News
FDA Tightening Its Oversight Of Infusion Pumps. On the front page of its Business Day section, the New York Times (4/24, B1, Meier) reported that Food and Drug Administration officials are “moving to tighten their oversight of medical devices, including one of the most ubiquitous and problematic pieces of medical equipment,” the infusion pump. Approximately “two million infusion pumps are used in hospital and clinical settings, and hundreds of thousands more are used by” home-bound patients who need their medication, insulin, morphine, or cancer treatments delivered intravenously. Yet, "over the last five years, the agency says it has received reports of 710 patient deaths linked to problems with the devices."
In fact, there were 87 recalls between 2004 and 2009, 14 of which were prompted by potentially life-threatening issues, according to the Wall Street Journal (4/23, Dooren). Apparently, the most frequent problem involved something referred to as “key bounce.” There have been instances when a healthcare worker enters one number into the key pad, but it is actually recorded twice, which may cause the release of too much medication. “When I punch 10 digits in my cell phone…I don’t get 11 or 12, and we should have that same expectation for infusion pumps…said,” Jeffrey Shuren, the director of the FDA’s device division.
Shuren added that, “in one instance, a nurse wanted to set an infusion pump to deliver 20 mL/h of heparin to a patient, but accidentally entered two zeroes instead of one, which infused the patient with 200 mL/h of the blood thinner,” MedPage Today (4/23, Walker) reported. After 56,000 such “reports of infusion pump malfunction” were received, “Shuren said the agency decided the 'old approach isn’t working.” So, instead of “dealing with individual device makers as safety problems emerge,” the FDA "is beefing up its premarket approval requirements for manufacturers of infusion pumps."
As part of the newly launched initiative, which “represents a major shift in FDA’s approach to medical device safety,” a “first draft of agency guidance” was released “recommending that manufacturers submit additional design and engineering information during premarket review of their devices,” Medscape (4/23, Lowes) reported. They also “should explain the steps they have taken to reduce the risk of their device at each stage of its life cycle, from design to actual operation, according to the preliminary guidance document.” In addition, "tests of infusion pumps should be conducted in the environment for which they are intended – hospital or home, for example – to account for real-life issues."
The AP (4/24, Stobbe), Reuters (4/24, Sherman), Modern Healthcare (4/23, Rhea), and HealthDay (4/23, Reinberg) also covered the story.
FDA In The News
Infusion pumps are a broad class of medical devices, of which insulin pumps are but on example. The quoted statistics of 56,000 incidents is for all devices. The submitted data also had 1% of those incidents reporting deaths as a result, but it is important to understand that almost “none” of those were deaths were incidents with insulin pumps. As one might imagine, things like pain medications can be extremely dangerous and the safety design of most infusion pumps is very archaic compared to insulin pumps.
I think having more stringent safety design, testing and oversight of insulin pumps is good, but one must not understand these things in context. This is for all infusion devices, many of which are crude instruments waiting for something to go wrong. I believe that Insulin pumps as a class have a much lower reporting rate and consequence rate.