FDA acknowldeges need for greater oversight of drug pumps More than 700 deaths over 5 years linked to defective medical devices

According to an Associated Press story, federal health regulators have announced steps to improve the design and safety of drug pumps that have been linked to more than 700 deaths in the past five years.

Acknowledging a “history of problems,” federal regulators said they see a need for “more careful infusion pump design and testing.”

Infusion pumps are used to deliver fluids — liquid nutrients and medicines like insulin, morphine, chemotherapy or anesthesia — into a patient’s body. They are used in hospitals as well as by patients at home.

Over the past five years, the FDA has received reports linking 710 deaths to infusion pump problems, and that likely is an underestimate, one regulator said.

In the past, many problems were attributed to human error, a doctor or nurse thinking they mistyped infusion directions. But FDA officials believe that software and design issues are actually at the root of many of them.

The FDA is working on new guidelines that call on manufacturers to provide more detailed design and engineering information to FDA for new pumps. The FDA also wants manufacturers to try out the devices in settings where they are commonly used, and when necessary, it wants to be able to inspect the manufacturing plant before approving the device.

Source: The Associated Press

If you or a loved one suffered serious illness or death after using a defective pain or drug pump, it is very important to contact a product liability lawyer since you may have grounds for a lawsuit. Please contact the product liability attorney at Cappolino Dodd Krebs LLP today for a free consultation and professional insight.