FDA stepping up oversight of drug pumps

April 23, 2010 By MIKE STOBBE , AP Medical Writer

(AP) -- Federal health regulators on Friday 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.

"It's clear from the history of problems we're seeing that there is a need for more careful infusion pump design and testing," said Dr. Jeffrey Shuren of the U.S. . He announced the initiative Friday at a health journalists' conference in Chicago.

Infusion pumps are used to deliver fluids - liquid nutrients and medicines like insulin, , or - 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, said Shuren, the FDA's director of the Center for Devices and Radiological Health,

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.

shares

Related Stories

Recommended for you

Glucocorticoids offer long-term benefits for patients with Duchenne muscular dystrophy

November 22, 2017
Glucocorticoids, a class of steroid hormone medications often prescribed to patients with Duchenne muscular dystrophy (DMD), offer long-term benefits for this disease, including longer preservation of muscle strength and ...

Baby-boomers and millennials more afflicted by the opioid epidemic

November 21, 2017
Baby-boomers, those born between 1947 and 1964, experienced an excess risk of prescription opioid overdose death and heroin overdose death, according to latest research at Columbia University's Mailman School of Public Health. ...

Sensor-equipped pill raises technological, ethical questions

November 17, 2017
The first drug with a sensor embedded in a pill that alerts doctors when patients have taken their medications was approved by the Food and Drug Administration, raiding issues involving privacy, cost, and whether patients ...

New painkillers reduce overdose risk

November 16, 2017
Scientists on the Florida campus of The Scripps Research Institute (TSRI) have developed new opioid pain relievers that reduce pain on par with morphine but do not slow or stop breathing—the cause of opiate overdose.

Separating side effects could hold key for safer opioids

November 16, 2017
Opioid pain relievers can be extremely effective in relieving pain, but can carry a high risk of addiction and ultimately overdose when breathing is suppressed and stops. Scientists have discovered a way to separate these ...

US regulators approve first digital pill to track patients

November 14, 2017
U.S. regulators have approved the first drug with a sensor that alerts doctors when the medication has been taken, offering a new way of monitoring patients but also raising privacy concerns.

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.