April 15, 2011

DeLauro To FDA: Reform Medical Device Approvals

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U.S. Rep. Rosa L. DeLauro is pressing the Food and Drug Administration to change the process for federal approval of medical devices, calling it a “critical public health issue.’’

DeLauro’s comments came in the wake of testimony by government investigators that the federal approval process for medical devices still puts patients at risk. The FDA has made some changes but significant ones were delayed pending an Institute of Medicine study.

DeLauro, the 3rd District Democrat who has a hip replacement, expressed frustration with the pace of reviews of the current process while “more than 770,000 Americans have a hip or knee replaced each year.”

“It is simply unacceptable that their outcome should continue to rely on an inadequate approval process of the devices that are implanted during the surgery,” wrote DeLauro in a letter to Dr. Margaret Hamburg, FDA Commissioner.

She added that the agency process violates Congressional intent when it approves devices without stringent oversight. DeLauro is ranking Democrat on the Labor, Education, Health, and Human Services Committee, which has jurisdiction over FDA legislation.

DeLauro’s letter was prompted by testimony of Marcia Crosse, director of health care for the Government Accountability Office (GAO). Crosse told the Senate Special Committee on Aging that the FDA continues to approve high-risk devices without scrutiny and fails to monitor recalled products to determine if they are still being used.  In 2009, the GAO called on the FDA to review and reclassify 27 categories of high-risk devices to determine if they need to receive more intense scrutiny. So far, only one has been reviewed.

DeLauro asked for action before the Institute of Medicine review is complete. She also asked for specific answers to a series of questions. They include: how the FDA will protect the public from unsafe devices before the review is done; whether high-risk products continue to be allowed on the market without a stringent review process in violation of Congressional intent; whether the FDA needs more authority to deal with recall of bad products; and if a database of implanted medical devices would help insure that bad products are recalled.

The FDA plans to complete the evaluation of high-risk devices by the end of next year, William Maisel, deputy director for science in the FDA Center for Devices and Radiological Health, said at the hearing.

At present, the FDA system uses an expedited process for devices that are considered similar to ones already on the market. This is how a controversial hip implant system was approved that was eventually recalled by DePuy Orthopaedics, a subsidiary of Johnson & Johnson. Some 37,000 patients in the United States received that implant, the ASR XL Acetabular System, a metal on metal device. Worldwide, some 93,000 patients had received either the ASR XL or another system that had been used outside of this country.

The agency made some changes in its process which officials said were designed to balance the interests of patient safety and the medical device industry, which has complained that stronger oversight would deter innovation.

A joint replacement database is in the pilot stages.  The American Joint Replacement Registry is working on tracking patients, their devices and doctors to establish a permanent history for each procedure.  The hope is that problem devices will be detected sooner and the need for second replacement surgeries will be reduced.

One thought on “DeLauro To FDA: Reform Medical Device Approvals

  1. As long as FDA’s priority is protecting manufacturers of medical devices from regulatory overburdening instead of protecting public from defective medical devices, nobody can even dream of improving medical devices’ failure rate. FDA should be more open to introducing new testing processes which could eliminate faulty devices. The above statement is illustrated by Citizen Petition for Reconsideration of petition 2009-P-0362 recently filed with FDA. To read more please go http://www.regulations.gov/#!home and enter Keyword or ID: 2009-P-0362.

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