Manufacturers of 25 medical devices have been ordered by the Food and Drug Administration to submit safety and effectiveness information so that the agency can assess the risk level for each device. The devices, which include pacemaker components, external defibrillators, female condoms, and hip joint metal, were marketed before 1976, before a law that authorized the FDA to review new medical devices. Manufacturers must submit the requested information within 120 days.

So, what’s taken the FDA so long? The potential for adverse effects from these medical devices is nothing new. Our previous analysis showed reports of deaths linked to medical devices were at an all-time high in 2006, with 2,712 fatality reports, more than double the number from 1997. Heart devices were cited in a high number of these reports.

Consumers Union’s policy analyst Bill Vaughan said companies should “put the data where the mouth is,” yesterday in Inside Health Policy. The FDA’s action is long overdue, given that Congress originally told the FDA to review so-called “legacy” devices in 1990, as part of the Safe Medical Devices Act. “This has been an embarrassment, or if it isn't it should be,” said Vaughn.