On Friday, the Food and Drug Administration 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.
Over the last five years, the agency says it has received reports of 710 patient deaths linked to problems with the devices, though F.D.A. officials say they think the number may 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.
An estimated two million infusion pumps are used in hospital and clinical settings and hundreds of thousands more are used by patients in their homes. The pumps use a variety of designs to intravenously deliver food, fluids and drugs like pain medications, insulin and cancer treatments.
The pump-related initiative comes as the Obama administration tries to reinvigorate the F.D.A. after years of criticism by lawmakers and others that it was a rubber stamp for industry. The F.D.A. Center for Devices and Radiological Health, which oversees scores of critical products like heart implants, imaging equipment and infusion pumps, has come under particular scrutiny.
A few years ago, for example, several top scientists at the center contended in letters to lawmakers that their superiors had ignored both their recommendations and policy guidelines in approving the sale of devices. Along with reports of 710 deaths, the center also received more than 10,000 complaints annually about infusion pumps from 2005 to 2009. In that same time frame, manufacturers of infusion pumps issued 79 recalls, among the highest for any medical device.
The center’s new director, Dr. Jeffrey E. Shuren, who has headed the center since August, said in an interview this week that pump manufacturers would soon be required to provide more data about their devices before offering them for sale. He added that the agency had determined that pumps could be made far safer.
He also said that the categorywide approach that the agency was taking toward infusion pumps might soon be extended to other types of medical devices, though he declined to elaborate.
“We need to ratchet up the expectations for medical device manufacturers,” Dr. Shuren said.
The biggest makers of infusion pumps include Baxter Healthcare of Deerfield, Ill.; Hospira of Lake Forest, Ill.; and CareFusion of San Diego.
Representatives of all three companies said the firms were reviewing of the agency’s initiative and could not comment on the specifics. However, they said their pumps were safe and that they looked forward to cooperating with regulators.
“We are committed to partnering with the agency to advance and complete the process for issuing new guidelines for the enhancement of the device review process,” Eric Floyd, Hospira’s vice president for global regulatory affairs, said in a statement.
Under the infusion pump proposal, which could be completed by the end of the year, producers would be required to provide additional data to support the procedures they used to determine the effectiveness and safety of their devices. In addition, companies would have to conduct limited clinical trials to ensure their pumps were not susceptible to misuse or had design elements that could create errors.
Pump producers now typically conduct “simulated” testing of its devices by users to identify bugs. Dr. Shuren indicated that the agency was seeking real-world testing as well.
Infusion pumps normally use software to automatically control both the rate and volume of a medication’s flow. To set a pump for an individual patient’s needs, a doctor, a nurse or other health care worker enters information by using the buttons on a pump’s keypad, which resembles that of a phone.
Pump manufacturers say that most problems occur when a nurse or health care worker enters the wrong data accidentally. F.D.A. officials said, however, that based on their review of pump complaints they thought many deaths and injuries related to the devices were less the result of user error than of product design and engineering.
For example, agency officials said that some pumps were prone to key bounce, a problem in which defective software interprets a single keystroke as two separate presses of that key. For example, instead of dispensing two units of a drug, a pump would dispense 22 units.
Under F.D.A. 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.
Agency officials said Friday that they were sending a letter to all infusion pump makers to inform them of their findings and outline the proposed additional requirements companies were be required to meet.
Dr. Shuren said he expected that the new requirements would initially slow down the rate of the agency’s approval for new pumps that manufacturers are seeking to market.
The agency also said it had developed an open-source software code that manufacturers of pumps can use to test the validity of the software they use in their devices.
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