Among the wide range of medical devices currently in use, the infusion pump has become one of the most commonplace–and most problematic. Over two million pumps currently operate in clinical settings, and hundreds of thousands more can be found in private homes. Over the last five years some 700 deaths have been linked to infusion pumps, and more than 40,000 related complaints have been made in that time. Because these devices administer the delivery of drugs and vital substances to patients, their risk of malfunction has become an industry concern. Although many of these incidents can be attributed to user error, the FDA has decided it’s not taking any chances on critical medical devices, and has issued a new set of guidelines requiring manufacturers to supply test data on their products.
As reported in the New York Times, current FDA policy requires manufacturers of life-sustaining devices to conduct clinical trials of new designs, however the agency is known to clear them for sale without testing based on their similarity to existing products. While infusion pumps are the immediate focus of these new guidelines, it is expected that other products will also be subject to more rigorous testing, and that this higher level of scrutiny will slow down the approval of new devices. The FDA has also supplied its own open-source testing software to manufacturers, in an effort to help them determine the effectiveness of their products.
But the problems plaguing the infusion pump market are creating more serious consequences for device manufacturers than just the delaying of new devices. As reported on Medical Device Network, the FDA has ordered Baxter Healthcare–a leading infusion pump manufacturer–to recall and destroy all of their “Colleague” model pumps due to the company’s failure to remedy a number of longstanding technical defects.
Tags: fda, infusion pump, medical devices, security
