Fw: FDA to boost reporting of medical device problems

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From: Ilena Rose <ilena@...>

Sent: Thursday, January 11, 2001 12:24 PM

Subject: FDA to boost reporting of medical device problems

> http://www.reutershealth.com/frame/eline.html

>

> FDA to boost reporting of medical device problems

>

> WASHINGTON, Jan 09 (Reuters Health) - In the next few months, the US Food

> and Drug Administration (FDA) will start enrolling hospitals in a pilot

> program to encourage more reporting of patient deaths and injuries from

> medical devices, said an FDA official here Monday.

>

> Currently, hospitals, nursing homes, outpatient surgery and medical care

> centers and dialysis centers account for only about 5% of the total

> adverse reaction reports made to the FDA each year, said Gardner,

> deputy director of the Office of Surveillance and Biometrics at the FDA's

> Center for Devices and Radiological Health.

>

> Gardner spoke at the Drug Information Association's workshop on

> post-marketing surveillance.

>

> Device manufacturers make about 90,000 reports to the FDA each year, while

> the actual users of the equipment--mostly hospitals and nursing

> homes--make only 5,000 such reports.

>

> Manufacturers are required by law to notify the FDA when they learn their

> product has caused a serious injury or death. Device users, such as

> hospitals, are required to report patient deaths to the FDA from devices,

> and deaths and injuries to the manufacturer.

>

> But device injuries are notoriously underreported, said Gardner, and her

> colleague Larry Kessler, director of the Office of Surveillance. Often,

> the device is not recognized as the cause of the problem. For instance,

> Gardner said, a sick patient's allergic reaction to materials in a

> catheter might instead be ascribed to the underlying illness.

>

> Through surveys and site visits, the Office of Surveillance has found that

> hospitals in particular are worried about reporting an injury to the FDA

> for fear that it may make them vulnerable to a lawsuit, Kessler said.

> Hospitals and outpatient facilities are also confused about when they need

> to report a complication and to which federal agency.

>

> In 1997, as part of the Food and Drug Administration Modernization Act,

> Congress ordered the FDA to come up with a plan to increase reporting,

> without requiring every single outpatient provider to participate.

> Building on a previous test run, the Office of Surveillance will now

> randomly select hospitals, starting with about 25 facilities, to take part

> in a pilot study to improve reporting.

>

> Hospitals will be asked to report any deaths, serious injuries or near

> misses that are thought to be caused by medical devices. The FDA will

> train hospital staff when to recognize the complications and give them

> access to aggregate data from their facility and other hospitals.

>

> The pilot will focus only on hospitals and medical devices initially. As

> the plan gets put into action, the FDA hopes to expand the revamped

> reporting program to all medical products, including drugs, and to all

> healthcare providers, except physician offices.

>

> Gardner said the agency would like to get better responses from nursing

> homes. In the earlier test run, nursing homes would not report adverse

> events. But the agency is convinced there are medical device problems at

> the facilities. In a recent FDA telephone survey of 53 nursing home

> workers over 3 months, the employees said they witnessed at least 101

> injuries or " near misses " involving medical devices. Most involved

> wheelchairs and bed rails.

>

>