Editorial: The FDA's Growing Pains to Enhance Postmarket Safety of Medical Devices

Jane Akre
November 24, 2018

Power morcellator, Contemporary ObGyn

Mesh Medical Device News Desk, November 24, 2011 ~ The FDA seems to be in a game of catch up when it comes to regulating medical devices, following the lead of manufacturers and relying on their promises rather than assuring a device is safe and effective before it is cleared for market.

In April the FDA released a plan to promote patients and public health by enhancing medical device safety. That has not been its legacy so far. The 510(k) clearance process has been a superhighway to the marketplace with very few speed bumps offering industry the “least burdensome” way to market.

The FDA in a release November 20 (here) now says

"After carefully considering public feedback, we’ll be announcing in a series of updates several important new actions that will help the FDA continue to enhance our nationwide post-market surveillance system: address new safety concerns that emerge once a device is on the market; and encourage innovations that lead to safer medical devices.”

Sounds like a good idea. But how will the FDA get there, especially when it has basically put its trust in industry to do its own calculations as to risk-benefit ratio before clearance through the “exchange of paperwork” 510(k)?

The week of November 26, the FDA says it will announce additional actions to fundamentally modernize medical device reviews, particularly as it relates to the 510(k) clearance process.

The agency admits it cannot possibly understand the full extent of the benefits and risks of a devices before they are marketed. However, the agency consistently believes promises of the med device industry, even one with a soiled reputation for consistently putting failed devices on the market that hurt patients.

Just how hard is the FDA trying to understand device risks? And what about devices that defy common sense? Does it make sense that a piece of polypropylene mesh, implanted permanently remain inert in the body? Does a morcellator that grinds unknown fibroids and whatever else exist in the abdomen make any sense, especially when cancerous tumor debris can be scattered?

Why continue to rely on the integrity of industry promises rather than raise the bar and require proof of safety?

Whatever the plan is, the FDA says it wants to be first among the world’s regulatory agencies, “to identify and act upon safety signals related to medical devices.”

That is a long-term goal at best.

So how could the FDA do a better job ensuring safety of medical devices?

Prolene Mesh

1) A Permanent Implant should NEVER undergo clearance through the 510(k). Permanent implants are just that and 510(k) is a sketchy review at best of safety and efficacy. Industry will not like a higher bar set, but for the sake of patients, 510(k) can never apply to a permanent implant.

Consider that the Essure birth control, did go through a premarket approval (PMA) and ended up harming thousands of women. What have we learned from the Essure device and PMA that should never be repeated?

2) A Permanent Implant must prove safety and efficacy.
That involves long-term, independent, third party testing, not studies that have a foregone conclusion because researchers are in financial conflicts with the device maker. This is a more expensive proposition and one that industry will fight because “least burdensome” provisions to the marketplace is what device makers have come to expect. Least burdensome does not necessarily work as well for patient safety.

3) An Enhanced Device Tracking and Reporting System for Adverse Events. The FDA admits its current reporting system is “passive” and voluntary, with notable limitations. It is easier to trace a car through its #VIN number than a medical device that is causing patient problems. There is supposed to be a sticker put on the device and on the patient records, but in real-life there are many that fall through this safety net. Stickers go missing or are never put on patient records. Most patients do not have their medical records and when they retrieve them, any mention of the type of medical device is lost or nonexistent.

In order to report a complication another hoop must be jump through.

Patients do not generally understand how to navigate the FDA’s website and what regulatory language applies to their particular device.

In 2011, the Institute of Medicine recommended the FDA develop a comprehensive medical device postmarket surveillance strategy and that 510(k) clearance that allowed clearance to the market was fundamentally flawed and should be abolished. The FDA says it’s been working on a way to collect data on medical devices postmarket to determine how they are doing, but practically speaking, in the seven years since then, the FDA has, if anything, made clearance of devices easier, not more difficult.

The Centers for Devices and Radiological Health (CDRH) which oversees medical devices describes actions it has taken to make devices safer (here).

4) Reporting to Device Registries Lax and Not Enforced.
If there is a complication it is supposed to be reported by the doctor or hospital to the FDA but that rarely happens and enforcement is spotty at best. Complications that are reported must first go to the device maker! That’s right Fox in the Henhouse dilemma, the fox get a first look-see at the complications AND it gets to decide if the complication is related to the device.

Look through the MAUDE database to see how many complications reported as related to a medical device are deemed by industry not to be related, therefore no follow-up required.

A doctor may choose not to report an adverse events in case it reflects badly on his surgical skills. What then? Where is the enforcement?

Additionally, MAUDE has exceeded its design capacity (as of six years ago) and is unable to handle the volume and complexity of device reports. It is incapable to taking reports using mobile aps, Electronic health records or registries. FDA is working on a new Adverse Event Reporting System (FAERS). What is the status?

Even when the FDA goes to retrieve complication reports from its MAUDE database, those made by lawyers are rejected as happened with morcellator injuries. The GAO has concluded that fewer than 1% of injuries from medical devices are reported.

Creating a registry is one thing, but meaningless unless it is used by patients and doctors and hospitals.

With the advent of electronic health records, which will presumably make reporting easier, but device registry is still in its infancy and the agency is still in discussion mode how to make the FDA more efficient.

5) The 522 studies take too long to be effective. Postmarket surveillance takes months even to enroll the first patient. Meanwhile more are injured rather than err on the side of caution and issue a Patient Safety Communication, at the very least, if not a recall. Voluntary recalls allow a device maker to reintroduce the device back onto the market at a later time. If a problem exists, it should be called out and a recall notice issued.

6) Expert Panels Free of Conflict. We have seen many examples of individuals the FDA consider experts to be in financial conflicts with the industry it is sitting in judgment of. Dr. Steven Brill is a recent example, he had taken more than $50,000 from J&J and was no longer eligible to be on the morcellator panel, however, Dr. Andrew Brill was on the Gynecological Mesh Panel of 2011. Another doctor on the mesh panel was the recipient of hundreds of thousands of dollars of grant money from Johnson & Johnson that reached her through a third party non-profit organization.

Additionally, there needs to be the presence of independent patient participants. They may be people who have undergone FDA training or are patient advocates or patients themselves injured by a particular medical device. Presently, we are aware of only one alleged patient group that has a pro-industry message and rejects members who do not share in the same positive attitude about mesh surgery.

Your thoughts on how the FDA could make medical devices safer?

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