According to a latest study many medical devices recalled in recent years by the Food and Drug Administration (FDA) because they posed a high risk to patients were not rigorously studied before being approved for patient use. The study, appearing on the web site of The Archives of Internal Medicine, said that most medical devices that were the subject of high-risk recalls from 2005 to 2009 had been cleared through a regulatory pathway with little testing. This included external heart defibrillators, hospital infusion pumps and mechanical ventilators.
There has been a strong reaction to the study with the FDA describing it as unoriginal, and a trade group representing medical device makers called the research flawed. But this study appears at a time when the Obama administration appears to be stepping back from what initially appeared to be a more aggressive approach to the regulation of medical devices.
Authors Diana M. Zuckerman and Paul Brown are two officials from the consumer group the National Research Center for Women and Families. Joining them is Dr. Steven E. Nissen, a cardiologist at the Cleveland Clinic, who was among the first physicians to raise questions about the drug Vioxx.
They write, “The standards used to determine whether a medical device is a high-risk or life-sustaining medical product prior to approval are clearly very different from the standards used to recall a medical device as life-threatening…Our findings reveal critical flaws in the current FDA device review system and its implementation that will require either Congressional action or major changes in regulatory policy.”
Dr. Nissen said that he was concerned that the administration had failed to take a more aggressive posture toward tightening the regulation of medical devices. In recent years, thousands of patients have been injured and some have died because of failed medical devices that were cleared for sale with little testing. “This is an area where the F.D.A. has failed the public,” Dr. Nissen said.
FDA in its statement said that the data was not new and reflected a similar analysis that had been presented last year at a public meeting held at the Institute of Medicine. Ms. Zuckerman retaliated saying she was the one who presented data at that meeting. The FDA uses one of the two regulatory pathways. In one pathway, typically used for critical, life-sustaining products like implanted heart defibrillators, manufacturers must often run clinical trials to show that a product is safe and effective. The other, known as the 510K process involves showing that a new product is equivalent to one already on the market. Some devices implanted in the body like artificial hips and knees, external defibrillators and infusion pumps fall into this category.
Karen Riley, an FDA spokeswoman, said that “while even one recall is too many, the 80 recalls should be kept in perspective and represent a small number of the devices cleared via this program.” She said in the study timeframe the FDA cleared more than 19,000 devices using the 510(k) process. And tens of thousands of devices previously cleared via 510(k) remain on the market. And while the analysis focuses on "high-risk" recalls, Riley said a 2010 Institute of Medicine review found that the annual recall rate for all 501(k) -cleared devices was actually just 1 percent to 1.5 percent a year.
Authors here have reported that of the 113 high-priority recalls initiated by the FDA from 2005 to 2009, 80 of the recalls, or 71 percent, involved devices cleared through the 510K process. Today the 501(k) process is by far the more common method of clearance for new devices, with only 1 percent of new medical device reviews subject to the more rigorous pre-market testing standard, the researchers found.
An industry trade group, the Advanced Medical Technology Association, described the findings as misleading. Among other things, the group said that it was not surprising that 510K devices accounted for the most recalls since most devices that FDA allowed for sale went through that process.
Dr. Jerry Avorn, a professor of medicine at Harvard Medical School in Boston expressed his concern at the state of affairs. He said approval for the FDA device branch were much looser than those for its drug branch adding, “And this paper documents the results of that worrisome difference in approach.” Avorn continued, “The current FDA leadership has been trying to improve the carefulness of device review, and that is very good for patients… But those attempts have been met by self-serving complaints from the device industry that better review and surveillance will somehow stifle innovation, which is not the case…We ought to be able to have reasonable standards of safety and effectiveness for devices and innovate at the same time.” “There’s no need to trade off the welfare of patients,” he concluded.