Tagged Medical Devices

FDA Announces Sweeping Plan To Review Safety Of Surgical Staplers

The Food and Drug Administration announced a sweeping plan on Friday to review and address the safety of surgical staplers, including a new examination of seven years’ worth of hidden reports highlighted Thursday in a Kaiser Health News investigation.

In a letter sent to health care providers Friday, the FDA said it will convene an advisory meeting on the safety of the devices and signaled that it might reclassify surgical staplers to put them under tighter control. The agency also said it plans to issue proposed recommendations to companies that make the devices, which are used in countless surgeries.

The FDA also acknowledged in its letter that “we are aware that many more device malfunction reports during this time frame” were submitted as “summary reports,” which go to the FDA but are not included in the public database known as MAUDE (the Manufacturer and User Facility Device Experience). The agency said it “is conducting an analysis” of those summary reports and the results will be made available to the public.

The KHN investigation found that in 2016 alone nearly 10,000 surgical stapler malfunction reports flowed into the internal FDA database that few patient-safety experts who were contacted knew existed. The public database that year disclosed fewer than 100 injuries or malfunctions.

The secretive reports on staplers were part of a much broader FDA program, collectively called “alternative summary reporting.” Since the start of 2016, more than 1.1 million serious injury or malfunction reports went into the internal database instead of being disclosed in detail in MAUDE, which is widely used by doctors and researchers to track problems.

The FDA has said “about 100” devices have had special exemptions to report incidents that way but confirmed the identity of only a few devices to KHN. The agency said it revoked most of the reporting exemptions in 2017 as a new summary-reporting program took shape and asked device makers to file reports noting publicly that summary data was being submitted in addition to data that would be kept inside the agency.

After Dr. Douglas Kwazneski witnessed a surgical stapler malfunction, he surveyed leading surgeons and discovered that more than two-thirds had experienced a stapler malfunction, or knew a peer who did.(Kendra Stanley-Mills for KHN)

The news report highlighted the work of Dr. Douglas Kwazneski, who experienced a stapler malfunction then turned to FDA data and saw “there was nothing” — a surprise that at the time “seemed like a cover-up,” Kwazneski said.

Surgical staplers cut and seal blood vessels and tissue, often during minimally invasive surgeries. When the staplers fail to fire, patients have bled profusely and suffered dire injuries or death. The FDA said stapler malfunctions or misuse can lead to “bleeding, sepsis, tearing of internal tissues and organs, increased risk of cancer recurrence, and death.”

The FDA has granted reporting exemptions over the years for both surgical staplers and staples, agency records show.

Stapler maker Medtronic confirmed that its reporting exemption for surgical staples ended in mid-2017. FDA records show that its public reports of injuries and malfunctions soared, from about 1,000 in 2015 to 11,000 last year. Ethicon, which also makes staplers, said it has not used the reporting exemption.

In the agency’s Friday announcement, Dr. William Maisel, chief medical officer in the FDA’s Center for Devices and Radiological Health, said the agency’s review of stapler incidents is ongoing. “But we know these devices provide important benefits for patients undergoing surgery, so it’s important for us to continue to educate providers about the devices’ safety and risk.”

“Improving the safety of surgical staplers and implantable staples is a top priority for the FDA, and we believe our forthcoming draft guidance to industry and planned advisory committee meeting will advance those efforts,” Maisel said.

The agency’s announcement said that public reports of harm by staples and staplers show “that from January 1, 2011 to March 31, 2018, the FDA received more than 41,000 individual medical device reports for surgical staplers and staples for internal use, including 366 deaths, more than 9,000 serious injuries, and more than 32,000 malfunctions.”

The agency also said that changing the classification of surgical staplers could allow the agency to require “performance testing of various mechanical features” and special labeling.

When Doctors Have Conflicts of Interest

My mother-in-law is an impressive woman.

At the age of 77, she still maintains a garden the size of my entire backyard, on the three acres of land she and my father-in-law, now 81, share in rural western Pennsylvania.

She does not tolerate stasis, and anytime my father-in-law collapses into his plaid armchair in front of the television, she appears on the scene within a minute or two, barks at him that there will be plenty of time to rest when they’re in the old age home, grabs the remote control, and turns the television off while simultaneously giving him another task to perform.

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Mikkael Sekeres, M.D.

Mikkael Sekeres, M.D.Credit

She has kept old age at bay through constant activity, sheer strength of will, and a splash of denial.

Her hip must have been bothering her for some time, then, before she let me and my wife in on her problem. At our insistence, she told one of her doctors, who sent her for X-rays and reviewed them with her, in his office, with my wife at her side.

“Ouch,” her doctor said, pointing at the image of her hip where her femur was scraping against the acetabulum of her pelvis, bone-on-bone. “That looks like it hurts.”

“Well, I do a few chores around the house in the morning and rest on the couch with a heating pad, and then I’m all right,” she told him.

My wife interjected. “Just so you understand, by ‘a few chores,’ she means that she plants five flats of flowers.”

Her doctor’s eyes widened. Recognizing that she is the type of person who would have to decide for herself when she was ready for surgery, he recommended she let the rest of us know when that time occurred. Earlier this summer, she decided it was time.

She met with the orthopedist who would perform her surgery, and the two quickly bonded. As it turned out, his wife is also a gardener, and like my father-in-law, he collects classic cars. He discussed the surgery he intended to perform, her likely recovery period, and then paused.

“Now, I have to tell you that the artificial hip I’m going to use is one that I had a hand in inventing, and although I will receive no royalties for implanting this hip in you, I do have a conflict of interest, and want to make sure you’re O.K. with that.”

I sit on our institution’s conflict of interest committee and this scenario, while not falling into the majority of doctor-patient interactions, is becoming increasingly common.

There are a number of different types of potential conflicts that can arise.

Like my mother-in-law’s surgeon, a doctor may invent a technology, or develop a drug, and receive payments every time that technology or drug is used – though, as my mother-in-law’s doctor told her, no royalties are received if the device is used at our institution. Still, you might wonder if his using that artificial hip influences other doctors who want to emulate him to use the same device, from which he would receive royalties.

Or, a doctor may provide advice to a company, for which she receives an honorarium, and conducts research (such as being an investigator on a clinical trial) using that company’s product. Will the payment she received influence her interpretation of the clinical trial results, in favor of the investigational drug? Or did she make the trial better because of the advice she provided?

What if, instead, the drug for which she provided advice is already commercially available. How much is her likelihood of prescribing this medication – what we call a conflict of commitment – influenced by her having been given an honorarium by the manufacturer for her advice about this or another drug made by the same company?

We know already that doctors are influenced in their prescribing patterns even by tchotchkes like pens or free lunches. One recent study of almost 280,000 physicians who received over 63,000 payments, most of which were in the form of free meals worth under $20, showed that these doctors were more likely to prescribe the blood pressure, cholesterol or antidepressant medication promoted as part of that meal than other medications in the same class of drugs. Are these incentives really enough to encroach on our sworn obligation to do what’s best for our patients, irrespective of outside influences? Perhaps, and that’s the reason many hospitals ban them.

In both scenarios the doctor should, at the very least, have to disclose the conflict to patients, either on a website, where patients could easily view it, or by informing them directly, as my mother-in-law’s doctor did to her.

More importantly, what do patients think of these conflicts? Back in the comfort of our family room, following her appointment, I asked my mother-in-law that very question.

“Oh, I was glad he told me.” I prodded her to go on, as she shifted in her chair, trying to get comfortable. “It made me trust him more. He must be an expert if he helped invent the hip. And of course I want him using the one he invented, he knows it better than anyone!”

It turns out, she’s not alone. In a study of over 600 surgical patients, about 80 percent felt it was both ethical and either did not influence, or actually benefited their health care, if their surgeons were consultants for surgical device companies.

It’s complicated. Certainly, the relationships doctors have with drug or device manufacturers drive innovation, and help make those products better for patients. But can we ever be sure these relationships aren’t influencing the purity of our practice of medicine, even a little?

Dr. Mikkael Sekeres is director of the leukemia program at the Cleveland Clinic. Follow him on Twitter @MikkaelSekeres.