Tag Archives: devices

Draft guidance signals FDA seeks to foster innovation in digital health sector

Rebecca Vesely

About Rebecca Vesely

Rebecca Vesely is AHCJ's topic leader on health information technology and a freelance writer. She has written about health, science and medicine for AFP, the Bay Area News Group, Modern Healthcare, Wired, Scientific American online and many other news outlets.

The FDA’s new guidance on digital health paves way for more tools that aim to support physicians and patients.

Expect to see a slew of new software programs and tools aimed to support clinicians and patients to make informed treatment decisions, after the Food and Drug Administration released its long-awaited draft rule last week on clinical decision support (CDS) systems. Continue reading

New tip sheet outlines what reporters should ask about security risks of medical devices

Rebecca Vesely

About Rebecca Vesely

Rebecca Vesely is AHCJ's topic leader on health information technology and a freelance writer. She has written about health, science and medicine for AFP, the Bay Area News Group, Modern Healthcare, Wired, Scientific American online and many other news outlets.

Photo: Dennis Skley via Flickr

The global ransomware attack involving WannaCry earlier this month exposed the vulnerabilities of computer systems worldwide.

But there’s one area even more at risk: medical devices. And that risk is growing, experts warn.

In a new AHCJ tip sheet, I describe how medical device security has become a growing concern and why journalists should pay attention. Continue reading

Illnesses, injuries linked to medical devices a ripe area for investigation #ahcj15

Paul Sisson

About Paul Sisson

Paul Sisson covers health care for U-T San Diego. He attended Health Journalism 2015 on an AHCJ-California Health Journalism Fellowship, which is supported by The California HealthCare Foundation.

CDC/ James ArcherAn outbreak of carbapenem-resistant enterobacteriaceae (CRE) was linked to dirty duodenoscopes.

CDC/ James ArcherAn outbreak of carbapenem-resistant enterobacteriaceae (CRE) was linked to dirty duodenoscopes.

Most medical devices marketed in the United States do not need formal approval from the U.S. Food and Drug Administration.

Members of a panel at Health Journalism 2015 on medical device coverage provided a variety of advice for reporters covering and of the implants, instruments and diagnostic tools common to the modern medical machine.

Moderator of the session was Chad Terhune, a Los Angeles Times reporter who recently found himself chasing an outbreak of carbapenem-resistant enterobacteriaceae (CRE) linked to dirty duodenoscopes. Contributing to the discussion were panelists USA Today investigative reporter Peter Eisler and Scott Lucas, associate director of accident and forensic investigation at the ECRI Institute. Continue reading

Researchers ‘owe’ the public information about financial ties #ahcj14

Blythe Bernhard

About Blythe Bernhard

Blythe Bernhard reports on health and medicine for the St. Louis Post-Dispatch and serves on AHCJ's Right to Know and Contest committees. She attended Health Journalism 2014 as an AHCJ-Missouri Health Journalism fellow, a program supported by the Missouri Foundation for Health.

When writing about medical studies, reporters should always ask researchers about any financial relationships with drug companies or device manufacturers. That was one of the main lessons from a panel on conflicts of interest on Saturday at Health Journalism 2014.

Starting in September, sunshine provisions in the Affordable Care Act will require drug companies to disclose most payments to doctors. Some companies have already started to publicize their financial relationships with doctors. But most medical journal articles do not give accurate information on researchers’ potential conflicts of interest, said panelist Susan Chimonas of the Institute of Medicine as a Profession at Columbia University.

“You shouldn’t be uncomfortable asking these questions,” Chimonas said. “They owe you this information. They owe everyone this information.” Continue reading

Lack of regulation of dental labs leaves plenty to be reported

Mary Otto

About Mary Otto

Mary Otto, a Washington, D.C.-based freelancer, is AHCJ's topic leader on oral health and the author of "Teeth: The Story of Beauty, Inequality, and the Struggle for Oral Health in America." She can be reached at mary@healthjournalism.org.

Image by mrrobertwade via flickr.

Image by mrrobertwade via flickr.

The piece that aired recently on WSYX-Columbus, Ohio, struck an ominous tone. It featured images of a shadowy basement workshop, cluttered with cooking pans and trays of artificial teeth.

The reporter, Tom Sussi, explained the place was a dental lab. The small operation certainly did not fit the spic-and-span image that might first come to mind when one hears the word “laboratory.” But under Ohio law, it was a perfectly legal place to manufacture dentures, Sussi learned as he did his interviews.

While Ohio beauticians, manicurists and masseuses are all “required to be licensed and properly trained,” the story concluded, the people who “who make things that go into your mouth, like crowns and dentures, are not.”

The situation is similar in a number of other states, as Kiera Butler of Mother Jones pointed out, in her own take on the issue, inspired by Sussi’s story. Continue reading

Newer technology not always more effective

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.

Joe Rojas-Burke reported in The Oregonian on what he called “a widespread problem in the health care system: the tendency to embrace new technology without waiting for proof that it’s better than older, cheaper, time-tested solutions.”

Some examples from Rojas-Burke’s report:

  • A Duke University study found that men who received robot-assisted prostate surgery experienced about the same rate of harmful side effects as those who went under a traditional surgeon’s knife and that, furthermore, the men who received robotic surgery felt three to four times as much post-surgery regret as those who chose the traditional option, probably due to heightened expectations.
  • Two Finnish researches reported in the British Medical Journal that falling, not osteoporosis, was the greatest risk factor for bone breaks among the elderly, casting doubt on the effectiveness of scanning bone density and prescribing drugs. “By one estimate, more than 80 percent of low-impact fractures occur in those who don’t have osteoporosis, which means that bone-density tests can’t reliably predict which patients are likely to break bones,” Rojas-Burke reports.
  • He cites the use of electronic fetal heart monitoring, computer-aided mammography devices, blockbuster drugs such as Vioxx, Zelnorm and Avandia as other cases in which newer may not be better.

The Columbia Journalism Review‘s Trudy Lieberman blogged that Rojas-Burke’s findings are particularly important when considered alongside the government’s proposed stimulus package, the Senate version of which “includes $1 billion for research on the comparative effectiveness of medical treatments.”

Lieberman, president of AHCJ’s board of directors, said the proposed “bill has already sparked concern that some patients may not get expensive treatments that they or their doctors want,” and recounted the cautionary tale of the National Center for Health Care and Technology, created in 1978 with a similar purpose. Lieberman said the center met an early demise during the Reagan administration thanks to the efforts of the American Medical Association and the Health Industry Manufacturers’ Association, which “argued that the Center was redundant because doctors were the ones best equipped to evaluate new technology.”