Tag Archives: medical devices

Medical device investigation unearths conflicts, regulatory issues

Andrew Van Dam

About Andrew Van Dam

Andrew Van Dam of The Wall Street Journal previously worked at the AHCJ offices while earning his master’s degree at the Missouri School of Journalism.

The latest investigation from the Chicago Tribune’s Jason Grotto and Deborah L. Shelton focuses on a single medical device, yet still hits many of the health beat’s biggest narratives, primarily conflicts of interest and government regulation. In their centerpiece, they dig into the tale of a cardiologist who may or may not have tested a device he invented on patients without consent or regulatory approval. It’s in those gray areas that the story takes shape.

The device in question is an annuloplasty ring, which in 2001 was reclassified from class III to class II. In practical medical device terms, this means that new models don’t need clinical trials if they’re similar enough to devices that have already been approved. The reporters write that the rings earned this change of status in part because of the relatively low number of adverse events reported between 1991 and 1995 (465). Unfortunately, as their use has increased, so have the events.

Carpentier-McCarthy-Adams IMR ETlogix annuloplasty ring

Now that you have some idea of what they were up against, here’s a healthy excerpt from their “how we did it” sidebar, which is almost always Covering Health’s favorite part of a major investigative package.

The first hurdle in stories like these is understanding the medical science behind the device in question, which required us to gather up dozens of studies and reports on annuloplasty rings and the heart valve disease the device is intended to cure. We sifted through government documents and researched regulations as well as the history of the rings.

But writing about heart valve repair rings involves more than researching a disease and a device.

We also spent a lot of time with the patients in our stories because there is a level of trust that must be built up before people are willing to share personal information about their health. The same goes for Northwestern Memorial Hospital and surgeon, Dr. Patrick McCarthy.

We had to assure each of them that their viewpoint would be reflected in the stories. It’s a difficult balancing act that we tried to buttress with reams of documents, studies and interviews with independent sources.

For more on how Grotto and Shelton reported the story, watch for a “How we did it” article on the AHCJ website in the next couple of weeks.

If the issue sounds familiar, the storyline is similar to a 2005 investigation from The Wall Street Journal‘s David Armstrong, which found a partnership between the Cleveland Clinic – and some prominent staff members – and companies manufacturing devices used in clinical trials there.

Alarm fatigue hurts patient care, overwhelms nurses

Andrew Van Dam

About Andrew Van Dam

Andrew Van Dam of The Wall Street Journal previously worked at the AHCJ offices while earning his master’s degree at the Missouri School of Journalism.

In the wake of several high-profile incidents, The Boston Globe‘s Liz Kowalczyk has assembled a thorough investigation of alarm fatigue in hospitals. Alarm fatigue, for the record, is the idea that the huge arsenal of patient monitors in any given hospital floor are going off so often that nurses become slower in their responses to the alarms. For example, in one 15-bed unit at Johns Hopkins, staff found that, on average, one critical alarm went off every 90 seconds throughout the day.

With the help of ECRI, Kowalczyk has managed to attach some numbers to the issue.

The Globe enlisted the ECRI Institute, a nonprofit health care research and consulting organization based in Pennsylvania, to help it analyze the Food and Drug Administration’s database of adverse events involving medical devices. The institute listed monitor alarms as the number-one health technology hazard for 2009. Its review found 216 deaths nationwide from 2005 to the middle of 2010 in which problems with monitor alarms occurred.

But ECRI, based on its work with hospitals, believes that the health care industry underreports these cases and that the number of deaths is far higher. It found 13 more cases in its own database, which it compiles from incident investigations on behalf of hospital clients and from its own voluntary reporting system.

Kowalczyk also looks at potential solutions to the problem and how some institutions are trying to make changes to eliminate alarm fatigue, including cutting back on unnecessary monitors and having monitor warnings appear on nurses’ pagers or cell phones.

To back up the numbers, Kowalcyzk got some telling quotes from frustrated nurses.

“Yes, this is real, and, yes, it’s getting worse,’’ said Carol Conley, chief nursing officer for Southcoast Health System, which includes Tobey Hospital. “We want to keep our patients safe and take advantage of all the technology. The unintended consequence is that we have a very over-stimulated environment.’’

“Everyone who walks in the door gets a monitor,’’ said Lisa Sawtelle, a nurse at Boston Medical Center. “We have 17 [types of] alarms that can go off at any time. They all have different pitches and different sounds. You hear alarms all the time. It becomes . . . background.’’

Kowalcyzk’s investigation points out that, while alarms do tend to go off when there’s a real problem, it appears that they do so at the expense of also going off when there isn’t.

Monitors can be so sensitive that alarms go off when patients sit up, turn over, or cough. Some studies have found more than 85 percent of alarms are false, meaning that the patient is not in any danger. Over time this can make nurses less and less likely to respond urgently to the sound.

For more specifics on device design issues, see the final subheading, titled “Looking for solutions.”

For a one year, the Joint Commission made routine alarm testing and training part of their accreditation requirements, but dropped the stipulation in 2004 when it felt the problem had been solved.

Other parts of the series:

AHCJ asks FDA to re-evaluate embargo policy

Pia Christensen

About Pia Christensen

Pia Christensen (@AHCJ_Pia) is the managing editor/online services for AHCJ. She manages the content and development of healthjournalism.org, coordinates AHCJ's social media efforts and edits and manages production of association guides, programs and newsletters.

The Association of Health Care Journalists has sent a letter to FDA officials asking them to re-examine a policy that prohibits reporters from sharing embargoed materials with sources before the embargo lifts for the purpose of obtaining outside comment and context. As AHCJ notes, this highly unusual policy severely limits the ability of reporters to give readers the full story of a federal agency.

From the letter:

The restriction imposed on the medical-device announcement rewrote a longstanding compact between reporters and various public and scientific organizations. It also hampered or delayed reporters’ ability to fully inform the public about what the FDA is doing with taxpayers’ money. The early reports on the medical device approval process were brief and uninformative as a result.

Read the complete letter.

We will be sure to update readers if AHCJ receives a response from the FDA.

Fauber: FDA to review data on jaw implants

Andrew Van Dam

About Andrew Van Dam

Andrew Van Dam of The Wall Street Journal previously worked at the AHCJ offices while earning his master’s degree at the Missouri School of Journalism.

The Milwaukee Journal Sentinel‘s reporter John Fauber reports on the FDA’s order to review the long-term performance of certain joint implants. Fauber’s story on the agency’s failure to adequately test and regulate these products came out in late November.

lower-jaw

Photo by Jacob Enos via Flickr

The implants in question treat certain ailments affecting the joint that connects jaw and head, a disorder Fauber says “affects more than 10 million Americans, including a small number who undergo radical surgery to implant an artificial jaw joint.” And those people, Fauber reported and the FDA now acknowledges, have had a rough time in the long term.

Among the medical device reports it has reviewed, 52% of the devices that had to be removed were taken out less than three years after they were implanted, the agency said in an e-mail to the Journal Sentinel.
Device problems included the need for removal or replacement, loosening, difficulty removing, noise, fracture and breaking, the FDA said.
Patient problems included pain, surgical procedure or repeat surgical procedure, additional therapy and nonsurgical treatment or treatment with medication, infection, swelling, hospitalization and headache, it said.

At this point, the FDA isn’t talking about taking the devices off the market, but it is reviewing the existing data and beefing up its repeated requests that device makers supply long-term market data about the implants they’ve sold.

Beginning in 1999, the FDA approved four such devices made by three companies. At the time of approval it ordered the firms to collect the market data it now is reordering.
That data was inadequate, the agency said, noting that it did not show why or how soon the devices were being replaced. In addition, the companies had lost contact with many of the patients who had received the devices.
Without knowing that information, the agency cannot determine the true safety and effectiveness of the products or whether any of them should be removed from the market.

Diana Zuckerman, president of the National Research Center for Women & Families, credited Fauber’s reports in the Journal Sentinel and MedPage Today, a medical news website that partners with the newspaper, with prompting the FDA’s action.

Doctors tied to manufacturer report better outcomes, may influence spinal surgery

Andrew Van Dam

About Andrew Van Dam

Andrew Van Dam of The Wall Street Journal previously worked at the AHCJ offices while earning his master’s degree at the Missouri School of Journalism.

After using a FOIA request to obtain documents the Food and Drug Administration had labeled “confidential,” Milwaukee Journal Sentinel reporter John Fauber has found that conflicts of interest may have played a role in the outcomes of clinical trials for Medtronic’s much-debated spinal fusion product BMP-2.

In a review of the study’s summary data for the newspaper, researchers at Dartmouth-Hitchcock Medical Center found 91 of the 364 patients in the trial – 25% – were implanted by surgeons who had a financial connection with Medtronic. Those doctors reported an 80% overall success rate, compared with 63% for doctors with no ties to the company.

Fauber also notes Medtronic’s response, which was to simply point to comments the company had made for a previous Fauber story.

At the time, [Medtronic spokeswoman Marybeth Thorsgaard] said the company fully disclosed the success rates of the doctors with financial ties to the company to the FDA. She noted that those doctors also had better results with the patients in the trial who did not get BMP-2.

In a companion story Fauber writes that, much like in the clinical trials, the journal articles published to push BMP-2 (and its off-label use) were riddled with conflicts of interest. One of his sources even called one article “egregious” for “blowing off” complications.

Related

Bloomberg’s Peter Waldman and David Armstrong write about the “national boom in costly fusion surgeries” and how “surgeons have prospered from performing fusions, which studies have found to be no better for common back pain than physical therapy is – and a lot more dangerous.” The pair also look at Medtronic’s payments and other ties to doctors who perform the surgery, as well as some of the risks of the surgery.

WSJ details conflicts that drive spine fusion surgery

Andrew Van Dam

About Andrew Van Dam

Andrew Van Dam of The Wall Street Journal previously worked at the AHCJ offices while earning his master’s degree at the Missouri School of Journalism.

The Wall Street Journal‘s John Carreyou and Tom McGinty have taken advantage of their paper’s Medicare data stockpile to look at the conflicts of interest and piles of royalty money that drive the popularity of spine fusion treatments whose effectiveness has been disputed. Their work centers on Medtronic, which the Milwaukee Journal Sentinel‘s John Fauber also has written about.

spine

Photo by planetc1 via Flickr

For surgeons, the financial incentives to perform spine fusions can be strong. Though hospitals often lose money on the procedure when it’s performed on Medicare patients due to the high cost of the implants, the surgeons themselves can get paid as much as $12,000 per surgery.

Complex fusions … are reimbursed by Medicare at a sharply higher rate than decompressions, to account for the elaborate spinal devices used and the longer length of surgery. Complex fusions increased 15-fold among Medicare beneficiaries with spinal stenosis from 2002 to 2007, according to the JAMA study.

A big part of many surgeons’ income lies in their consulting and royalty arrangements with device makers, although disclosure of these arrangements remains piecemeal for now. Medtronic began releasing information about its payments to surgeons on its website in June, after coming under intense scrutiny from Sen. Charles Grassley (R., Iowa).

They’re required to keep some details under wraps, but the WSJ duo still manages to unleash anecdotes, including one about a surgeon who received “between $400,000 and $1.3 million in royalty, consulting and other payments from three spine-device makers.”

For reporters looking to understand the medical issues surrounding these procedures and why these conflicts can be detrimental to patients, see Janet Moore’s work in the Star Tribune.