Medical Device Safety

July 26, 2018

Watch this documentary before you let a surgeon use a robot to cut inside you

Robots are the shiny new toys of surgery in American hospitals. They promise ultra-precise, tiny cuts that give patients faster healing and better outcomes. Wherever you live, your local TV news outlets have likely run uncritical, gee-whiz stories about hospitals and surgeons bringing in these robots, featuring glowing patient testimonials.

So what’s not to like? You need to watch a new documentary airing Friday night on Netflix to get the other side of the story, and there’s plenty. And also about other medical devices that promise much but deliver more pain than benefit.

June 26, 2018

Why are advance directives so key? Look at tough stats on ventilator survival

by Patrick A. Malone

Grown-ups with the least bit of gray on them may want to step up their thinking on how they want to receive medical care under tough circumstances, especially if they consider a new, clear-eyed and hard-nosed study that dispels any myths about possible life-sustaining “miracles” of artificial breathing machines.

A research team with experts from Boston, San Francisco, and Dallas studied 35,000 cases in which adults older than 65 had undergone intubation and use of mechanical ventilators at 262 hospitals nationwide between 2008 and 2015.

They found that a third of patients intubated died in the hospital.

June 20, 2018

Lasik surgery: a study in medical risks, complications, lack of official followup

by Patrick A. Malone

Caveat emptor, federal officials are reminding patients anew about an eye surgery that tens of millions of Americans already have undergone and all too many may believe ── wrongly ── is all but risk-free.

In fact, significant numbers of the 9.5 million Americans who had laser-assisted operations, the so-called Lasik procedure, may show vision improvements, but they also may be under-reporting problems connected with their surgeries, the New York Times reported.

The federal Food and Drug Administration approved Lasik in the 1990s, but the agency only recently has supported the gold-standard of medical research, a randomized clinical trial, to check in on long-running complaints about the surgery.

May 29, 2018

Heart doctors under fire over their pricey practices

by Patrick A. Malone

It’s one thing when modern medicine becomes so hidebound that it struggles over shedding a bit of traditional doctors’ garb. But new information emerging about cardiology’s entrenched reliance on maverick surgeons and evidence-light therapies in treating heart problems raises real questions: Exactly what’s going on in this costly area of care?

Haider Warraich ── a cardiology fellow at Duke and author of “Modern Death,” a book exploring how technology and modern mores are changing patients’ end-of-life experiences ── deserves praise for raising major concerns about the too easy acceptance by doctors and surgeons of existing, device-based treatments for heart conditions. The headline on his Op-Ed in the New York Times summarizes well his tough point: Don’t Put That in My Heart Until You’re Sure It Really Works.

He, of course, points to recent challenges about the effectiveness of cardiac stents. They have been commonly used for years now ── in hundreds of thousands of surgeries ── supposedly to relieve blockages in patients with stable chest pain. But recent research has started to show they provide no benefit over drugs, and it was only after further study showed that a new kind of dissolving stent contributed to increased heart attack risks that the device maker pulled the already in-use product, Warrich notes.

May 27, 2018

Let’s bust this myth now: Don’t expect insurers to help cut medical bills

by Patrick A. Malone

Patients who expect their health insurer will work in their interests to contain costs by medical providers might just as well hope for assistance from leprechauns, unicorns, or the tooth fairy.

Marshall Allen, a reporter for the Pulitzer Prize-winning investigative site ProPublica, has just penned a strong myth-busting piece, cross-posted on the National Public Radio site, about health insurers, writing:

The United States spends more per person on health care than any other country does. A lot more. As a country, by many measures, we are not getting our money’s worth. Tens of millions remain uninsured. And millions are in financial peril: About 1 in 5 is currently being pursued by a collection agency over medical debt. Health care costs repeatedly top the list of consumers’ financial concerns. Experts frequently blame this on the high prices charged by doctors and hospitals. But less scrutinized is the role insurance companies — the middlemen between patients and those providers — play in boosting our health care tab. Widely perceived as fierce guardians of health care dollars, insurers, in many cases, aren’t. In fact, they often agree to pay high prices, then, one way or another, pass those high prices on to patients — all while raking in healthy profits.

May 6, 2018

Medical hype can be lethal, as ‘minimally invasive’ chest surgery shows

by Patrick A. Malone

Doctors and hospitals have a right to blow their own horn a bit when they’re onto something good, don’t they? What’s the harm? Plenty, as reported by Healthnewsreview.org, an independent, nonpartisan health information watchdog site.

As part of a series on patient harm from misleading media, Joy Victory, the site’s managing editor, details the tragic results from superficial news stories, typically on smaller media outlets, that deceive patients and their families about the Nuss procedure, a surgery to correct a congenital condition that results in a concave or “funnel” chest (see photo).

This is a serious operation, as I know from my practice. But as Victory points out, this hard, cold fact somehow gets glossed over in glowing reports about the surgery, written by news services and by reporters at smaller papers in South Carolina, Virginia, and Myrtle Beach, Fla., and even in a larger daily in Kansas City, Mo.

March 20, 2018

Harsh new glare falls on fertility clinics’ booming business after major mishaps

by Patrick A. Malone

Equipment failures in two clinics in Cleveland and San Francisco not only resulted in the loss of thousands of frozen human embryos and eggs, the incidents also have raised new concerns about safeguards and regulation of booming and costly fertility programs.

Experts said the mishaps were uncommon, and they were hard pressed to explain how advanced refrigeration systems, with rigorous checks and back-ups, could have malfunctioned at large, respected facilities, leading to a likely boom of lawsuits by women and couples against the University Hospitals Ahuja Medical Center’s Fertility Center in Cleveland and the Pacific Fertility Center in San Francisco.

The centers serve different types of women and couples, with the San Francisco facility dealing with younger, career-driven, and international patients eager to freeze eggs and embryos in hopes of starting families later in life. It has attracted public notice, partly because high-tech firms in the nearby Silicon Valley offer financial assistance to women employees who want to freeze their eggs. The Cleveland center, meantime, seeks to assist women and couples in the city’s western suburbs with infertility issues, especially through in vitro fertilization.

March 9, 2018

Why are doctors operating, needlessly and so often, on frail seniors?

by Patrick A. Malone

Although patient advocates long have pressed Big Medicine to eliminate unnecessary care — waste in the health care system that some experts estimate adds as much as $765 billion annually in needless costs — it may be past due for a public condemnation of a notably extreme example of this practice: The all too frequent, unhelpful surgeries for the old, many of whom are at the end of life.

Liz Szabo of the independent, nonprofit Kaiser Health News Service, and National Public Radio deserve credit for their report, detailing how 1 in 3 Medicare patients undergoes a serious procedure, “even though the evidence shows that many are more likely to be harmed than to benefit from it.”

As the story explains:

January 23, 2018

Medical devices are an unregulated ‘Wild, Wild West,’ investigator warns

by Patrick A. Malone

Jeanne Lenzer, a seasoned medical investigative reporter, points out that 32 million Americans — about one in 10 of us — have at least one medical device implanted in our bodies. These include artificial joints, cardiac stents, surgical mesh, pacemakers, defibrillators, nerve stimulators, replacement lenses in eyes, heart valves and birth control devices.

Most patients — indeed most of the public — may think federal regulators subject all this hardware to rigorous quality and safety testing.

That’s a wrong assumption. And though medical devices may be helping change and save many lives, Lenzer also warns they are harming and even killing too many patients. In a new book (The Danger Within Us), interviews, and in a recent Op-Ed in the New York Times (“Can Your Hip Replacement Kill You?”), she has argued that:

January 9, 2018

Experts fret over how precise key basics may be in ‘precision medicine’

by Patrick A. Malone

Although billions of dollars and lots of positive public attention have been lavished on the promise of genetic-based “precision medicine,” this therapeutic approach to treating cancer and other serious diseases may need more scrutiny for basics of quality control.

National Public Radio deserves credit for airing some less-heard experts’ worries about the roles of at least two groups of little-seen and often-ignored medical specialists — pathologists and med techs — and how their common practices may undercut the potential of efforts to target disease treatments to individual patients based on maps of their genes.

Despite its powerful and progress-promising name, precision medicine relies on some old-fashioned, unchanged, and possibly problematic medical techniques, experts told NPR. Blood and tissue samples, which later will be analyzed with costly and supposedly state-of-the-art equipment, still get taken by med techs with limited training. Little attention typically gets paid to how they collect samples and how carefully they get handled before arriving in labs. They may sit on carts for hours, and they may be dragged through different parts of hospitals where temperatures vary widely and can hit extremes.