Federal regulators are moving to tighten their oversight of medical devices, including automated pumps that intravenously deliver drugs, food and other solutions to patients. The FDA has issued preliminary guidelines that will require producers of the devices, known as infusion pumps, to supply the agency with more test data on them before they can be approved for sale. These devices have been the most ubiquitous and problematic pieces of medical equipment. The biggest makers of infusion pumps include Baxter Healthcare of Deerfield, Illinois; Hospira of Lake Forest, Illinois; and CareFusion of San Diego, California.
The FDA reports that it has received reports of 710 patient deaths over the last five years that were linked to problems with the devices. But officials at the agency believe the number of deaths could be significantly higher. Some of those deaths involved patients who suffered drug overdoses accidentally, either because a hospital worker entered incorrect dosage data into a pump or because the device’s software malfunctioned.
The FDA Center for Devices and Radiological Health oversees scores of critical products like heart implants, imaging equipment and infusion pumps. Along with reports of 710 deaths, the Center received more than 10,000 complaints about infusion pumps annually from 2005 to 2009. In that same time frame, manufacturers of infusion pumps issued 79 recalls, among the highest for any medical device.
Under FDA rules, life-sustaining devices like heart defibrillators must typically undergo clinical trials before they are approved for sale. But the agency clears the sale of many other critical devices like pumps without clinical testing based on a manufacturer’s claim that a new device is similar to a product already on the market. The FDA is sending a letter to all infusion pump makers to inform them of its findings and outline some proposed additional requirements companies must meet.
Source: New York Times
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