By Scott Hensley
Stung by two analyses that found weaknesses in the approval of high-risk medical devices, the Food and Drug Administration vows to beef up requirement for clinical tests.
Dr. Jeffrey Shuren, acting chief of the agency's device division, told the New York Times and the Wall Street Journal the agency has already taken steps to raise the standards for the studies of devices in humans and will do more.
Areas for action include better defined targets for device effectiveness and more diligent follow-up of patients taking part in clinical studies.
An analysis published in JAMA found most high-risk cardiovascular devices approved by FDA in recent years had only one clinical study to support the decision. The clinical evidence was also weakened by a lack of adequate comparisons to alternative treatments.
A second study, whose authors include an FDA official, reached similar conclusions, though the findings were a little less damning. Dr. William Maisel, a cardiologist and senior author of the second paper, told the Journal, "the unreliability of the data 'is why we have been pushing the FDA to raise its clinical trial standards for medical devices.' "
In a statement, Janet Trunzo, an official with the device trade group AdvaMed, said, the industry is "still reviewing the findings" of the JAMA paper. She noted that high-risk devices are evaluated and approved on the basis of a wide range of data. Clinical tests provide some of the information, but engineering testing is also important.
Update: For more on how the FDA evaluates devices and some of the recent problems with the process, see this video interview of Dr. Maisel by The Healthcare Channel.