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Top 5 medical device pitfalls to avoid

19 Nov 2015

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There have been a considerable number of serious recalls related to ventilators, including the Class I recall of the 248 Hamilton Medical AG ventilators, circuit board glitches related to a Covidien device, and non-functioning buttons on a GE ventilator.

Infusion pumps have been one of the most recall-plagued medical devices in the past decade. From 2005 through 2009 alone, FDA received roughly 56,000 reports of adverse events linked to infusion pumps. In those four years, medical device companies recalled 87 infusion pumps in the U.S. for safety reasons.

5. Gamma camera defects

FDA has received multiple reports of mechanical failures linked to gamma cameras, which can threaten patients and hospital staff members.

Gamma camera

Modern Healthcare revealed that Gamma cameras have been linked to at least five injuries of patients and hospital staff members in the past year.

In the past two years, there have been more than 40 recalls linked to the devices, which are used in nuclear medication applications. The cameras are typically very heavy, which has resulted in some patients being crushed. Many of the problems were linked to mechanical problems and sensor failures in the devices.

The devices, which are found in most hospitals in the U.S., have been linked to at least five injuries of patients and hospital staff members in the past year, according to Modern Healthcare. The devices are used for cardiac stress tests, brain imaging, bone scans and for imaging a variety of organs.

In 2013, a patient was crushed to death by the gamma camera on the GE Healthcare Infinia Hawkeye 4 system, which ultimately triggered a Class I recall of the product.


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