The pressure from the FDA is long coming. In 1990, Congress ordered the more rigorous testing of medical devices before they became available for use, however the FDA never finished implementing the law, getting caught up in a federal loophole that allowed products that are “substantially equivalent” to combinations of other products marketed before 1976 to be sold. Thus, hundreds of new “Class C” devices were approved and made available for use. Class C is the FDA’s most risky category.

Products that currently fall in the Class C category include external heart defibrillators from Medtronic Inc., Royal Phillips Electronics NV and Zoll Medical Corp; dialysis catheters from Covidien Ltd.; hip joints from Zimmer Holdings Inc.; spinal screws from Medtronic and Johnson & Johnson; and a heart pump from Abiomed Inc.

The FDA’s recent action on the measure is spurred by the Government Accountability Office, which criticized the delay last January. The FDA will issue the regulations to the makers of the high-risk medical devices and based on the data, the agency will determine whether to reclassify devices to a less risky category or require the manufacturers to undergo further, more rigorous pre-market testing.

SOURCE: Sprint Fidelis Lead Recall › FDA to crack down on medical device manufacturers

And change is apparently what the FDA needs the most. On Thursday, the Government Accountability Office (GAO) said that from 2003 to 2007, the FDA cleared 228 medical devices for the market without a complete evaluation of their safety and effectiveness. Some of the devices were intended for sensitive and risky uses, such as pacemakers and heart valves, and a few have since been recalled because of malfunction or other problems.

“It all adds up to less-than-rigorous rigorous device review, and it’s placing tens of thousands of Americans at risk,” said Peter Lurie, deputy director of Public Citizen’s health research group, in a report by the Associated Press.

The GAO report (link to PDF of report) did not evaluate the number of people, if any, who were harmed by the hastily approved devices. Instead it focused on the approval process for medical devices, calling into question why FDA scientists are routinely pressured to approve of medical machinery against their professional judgment.

A factor that may be contributing to the FDA’s problem is the quickening pace of technology development. Manufacturers of high-tech medical devices have made giant strides in the past decade, and so the number of devices trying to enter the market has grown. The number of upgraded products up for review has also increased. As technology began to outpace the FDA’s approval process, which was established as a three-tier system in 1976, the Federal government pressured the FDA to speed things up.

With drug companies and medical device manufacturers seeking refuge in legal preemption, the current FDA approval system can be a formula for disaster for the American public. Last year, the U.S. Supreme Court ruled that federal (FDA) approval of medical devices could displace many laws on the state level. In other words, someone who has been harmed by an FDA-approved medical device may have little legal recourse in state courts.

SOURCE: Sprint Fidelis Lead Recall › FDA says approval of medical devices was rushed