PhotoMakers of medical devices face such little scrutiny from the Food and Drug Administration that even a 2011 Institute of Medicine report, commissioned by none other than the Food and Drug Administration, described the agency’s medical device evaluation process as “fatally flawed.”

Even worse, the FDA has reportedly allowed device-makers to flout the few regulations that they are supposed to follow.  

Federal law requires pharmaceutical companies to report any injuries possibly related to medical devices within 30 days of learning about the so-called “adverse event.” But a Minneapolis Star-Tribune report, published last April, details how Medtronic, the world’s largest medical device company, waited years before telling the FDA about more than 1,000 adverse events related to one of its medical implants, Infuse.
 

The device, used in back surgery, is now the subject of thousands of personal injury complaints. “The FDA raised no issues about the late reporting and blacked out the total number of events from the three-sentence summary that became public,” the Star-Tribune report says. “That number was revealed just months ago, after the Star Tribune challenged an FDA decision to keep it secret.”

In a lengthy statement, the FDA tells ConsumerAffairs that it had granted an exemption to Medtronic and defended the company's actions.

"FDA’s allowance of a summary report in certain circumstances, under the relevant regulation, is both appropriate and in the best interests of the public health," the statement says in part. "Such summary reporting can create practical efficiencies by reducing data entry and FDA staff review time of information that is already well-understood about a particular device." 

Asked to comment, Medtronic referred ConsumerAffairs to a statement the company published online. 

Multiple companies

A follow-up report published this month details how the FDA similarly accepted late adverse event reports from multiple companies, not just Medtronic, without penalizing the companies.
 
“When patients have been horribly harmed by medical devices, they’ve notified the FDA. But nothing changes,” Dr. Diana Zuckerman, President of the Center for Health Research, tells ConsumerAffairs. “And, the FDA has not penalized companies that failed to report serious complications to the FDA, as required by law. The FDA’s track record could hardly be worse.”
 

Zuckerman’s complaints aren’t new. In 2014, three years after the FDA’s Institute of Medicine panel called its regulatory process for devices flawed, Zuckerman lead a separate study claiming that there is scant public research to back up the safety of many FDA-approved medical devices. The agency has repeatedly contested such critical findings.

Criticism invited

But recent actions by the FDA now suggest the agency may finally be taking some of the criticisms of its device regulation to heart. On October 21, the FDA launched a new online program to encourage anyone, from patients to doctors, to report misconduct by medical device-makers.

"The webpage is not in response to any recent news articles," FDA spokesman Stephanie Caccomo tells ConsumerAffairs via email. "The webpage was developed to provide the public with more information on allegations of regulatory misconduct related to medical devices and provide clear instructions for reporting to the FDA." For public health watchdogs like Zuckerman, whether the FDA’s new program will have teeth remains to be seen.

The FDA’s new site, “Reporting Allegations of Regulatory Misconduct,”  specifically singles out medical devices and instructs people to report anonymously if they wish to do so. “Anyone may file a complaint reporting an allegation of regulatory misconduct,” the FDA says, with instructions on how to submit complaints via email or hard mail.

The FDA’s website launch coincides with a separate agency crackdown on medical devices, this one relating to hospitals and their responbility in reporting device failures. The FDA on October 24 published an online report calling out 15 hospitals for failing to report adverse events related to medical devices in an appropriate manner or correct timeframe.

The hospitals include high-profile facilities with stellar reputations such as Cedars-Sinai in Los Angeles.  "On June 25, Cedars-Sinai voluntarily reported to the FDA and the manufacturer that a surgical stapler device had malfunctioned during a surgical procedure on June 5, resulting in bleeding and requiring that sutures--the traditional method for surgical closer--be used instead," the hospital says in a statement. But Cedars-Sinai only reported the incident through the FDA's form for voluntary reporting. Instead, they should have reported the problem through the FDA's form for mandatory reporting, or Form 3500A, because of the serious consequences such a device malfunction could have caused, the hospital says. 

Rather than punish the hospitals, the FDA explains that they want to work with them to develop better reporting procedures for device injuries. “FDA is looking to improve the way we work with hospitals to modernize and streamline data collection about medical devices,” wrote Dr. Jeffrey Shuren, the agency’s director for the Center for Devices and Radiological Health, in a recent blog post.

For watchdogs like Zuckerman, the FDA’s new site soliciting allegations of abuse in the medical device industry is an encouraging step, but only on paper for now.  Though the new policy “sounds great,” she says, “will it make a difference? Will the FDA finally stop treating device companies like their favorite customers and remember that patients and consumers are their most important customers? ...More importantly, will FDA finally decide that they will no longer allow device companies to ignore patient safety?”


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