Relatório especial: Comprando dispositivos médicos do lugar dos comitês na experimentação

por Diana Bradley, Staff Writer | October 15, 2012
From the October 2012 issue of HealthCare Business News magazine

From the moment a patient enters a hospital, he is placing not only his trust, but also his life in the hands of health care professionals and the equipment they use. For this reason, hospitals must consider patient safety long before even dreaming of purchasing a medical device. But to properly assess a product’s potential, hospitals must first entrust their own confidence in vendors and organizations like the Food and Drug Administration (FDA), which rigorously tests and approves medical products and devices.

Regardless of safety regulations and testing, defective and dangerous medical products still proliferate in the industry, contributing to approximately 29 million injuries and 22,000 deaths each year, according to the United States Consumer Product Safety Commission.

Furthermore, a recent report by Stericycle ExpertRECALL, a global leader in product recalls, notes a spike in medical device products affected by recalls, with numbers reaching an eight-quarter high in the second quarter of 2012, exceeding 100 million units for the first time since 2010. At least one recall affected more than 140 medical device companies, with one-third of those facing multiple recalls. And Class I recalls for dangerous or defective products that could result in severe health problems or death rose from 4 to 7 percent from the previous quarter.

This is where the purchasing committee (also known as the medical equipment committee, medical technology committee, or the capital budget committee) comes in. Their job is to review, coordinate and judge a hospital’s new equipment purchases – from stents to CT scanners. Of course, no device is guaranteed to be 100 percent safe in every situation. So the pressure is on the purchasing committee to endorse the medical device they ascertain to be the safest, top quality product for their targeted environment.

Evaluating and incorporating safety into the process
When rooting out the potential problems during the medical device purchasing process, health care institutions won’t look twice at equipment that is not FDA-approved. It is also commonplace for hospitals to look into any existing recalls or alerts on the device or technology in question, and to ensure clinical staff are already familiar with the device, or identify if additional educational training is required.

“We put faith in the fact that the FDA does their due diligence when new devices come onto the market,” says Dawn Griffin, Palm Coast, Fla.-based Florida Hospital Flagler’s materials management director. “Studies are normally provided by the vendors in regards to the safety of the devices and the end-users and clinicians look these over.”

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