Articles Posted in Medical Device Safety

precise-223x300Although 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.

spanking-187x300Kids can be a major part of what makes the holidays special. But if a house full of the little darlings hasn’t already driven the grown-ups around them to total distraction, parents, grandparents, and uncles, aunties may want to consider a few ways to ensure youngsters stay healthy and wise in the days ahead, including:

Spare the rod so children don’t get spoiled

If the kids get naughty during the winter break, their parents might find themselves agreeing with a controversial view: Two-thirds of Americans, when asked in surveys, say that misbehaving children younger than 7 need a “good, hard spanking” on occasion when they’re very bad.

gottliebThe  Food and Drug Administration has closed out the year by issuing a new white paper reaffirming the agency’s three-year-old warning to surgeons and women to avoid in general the use of a surgical device called a morcellator in “key-hole” or laparoscopic gynecological operations.

It wasn’t a surprise that the FDA retained this caution. That’s because the Wall Street Journal, back in 2014, had published a major investigative series linking morcellators to increased cancer incidences, recurrences, and risks in women. Researchers found that the popular surgical tool, by grinding up tissues such as those found in common female fibroid tumors, purportedly to permit their easier, faster removal, spread cancerous tissues throughout the body. The FDA has taken major, deserved criticism for failing for two decades to better protect thousands of women from harms caused by this medical device.

But what else did the agency do in its busy December? Scott Gottlieb, the FDA commissioner, also has reaffirmed that the FDA is motoring ahead with a stepped program to speed up an already loose approval and oversight process for medical devices like the morcellator.

soccerknee-300x97Here’s another painful reminder to grownups about youngsters and sports: Moderation matters, and youthful games are supposed to fun, diverting, and character building—and most definitely should not leave today’s aspiring athletes as tomorrow’s hobbled adults.

The New York Times has reported on what a pediatric sports medicine expert has described as a “dirty little secret” of orthopedics, which is “the chance of getting arthritis within a decade of tearing a tendon or a ligament in the knee is greater than 50 percent.” And more and more youths, as they participate aggressively and frequently in sports programs, are undergoing surgeries on damaged or torn anterior cruciate ligaments, a procedure well-known as the ACL repair.

The sports medicine doc says he is gathering data for a study that will show that patients at 26 children’s hospitals he has focused on underwent 500 ACL repairs in 2005, but by 2014, more than 2,500 youths had these surgeries.

epipen-300x119Big Pharma’s rapacious profit-seeking can seem to hit no bounds, even if it afflicts millions: Just consider what federal and state regulators are mulling about the makers of a popular anti-allergy therapy and those who supply a critical diabetes medication.

The federal Food and Drug Administration has replied to Bloomberg News Service that, so far, in 2017, it has recorded 228 reports of EpiPen or EpiPen Jr. failures, and the failure of EpiPens to deploy correctly has been cited in seven deaths through mid-September.

The agency said it is monitoring closely these “adverse event complaints.” These are unconfirmed reports that do not necessarily tie a product to a harm. But they might constitute sufficient grounds to investigate further and to potentially order product recalls, though, so far, the FDA says it believes patients can keep using EpiPens on the market without worry.

pacemaker-300x186Big medical device makers, like Big Pharma, have complained relentlessly that Uncle Sam hamstrings them with red tape and bureaucracy that slows or prevents innovative, life changing and lifesaving products from reaching the public. Most of this criticism has been targeted at the federal Food and Drug Administration, which under the Trump Administration, has promised to speed and ease its industry oversight.

But internal watchdogs for the Health and Human Services department have provided a rebuke to the move-faster crowd, detailing the costly cleanup—paid for by taxpayers like you and me— that results from defective medical devices.

The HHS inspector general’s office, in what some patient advocates are calling “a drop in the bucket” of the magnitude of this concern, has found that Medicare paid “at least $1.5 billion over a decade to replace seven types of defective heart devices [that] apparently failed for thousands of patients,” according to a story by Pro Publica, the Pulitzer Prize-winning investigative reporting web site.

IBM_Watson-300x201Watson_bruce-150x150Technology is  transforming medicine without a doubt, but its proponents—including one of the computing industry’s titans—may be getting ahead of themselves in boasting about their devices’ capacities.

Stat, the online health information news site that had a rocky week of its own, deserves credit for reporting  that IBM at present is overselling the medical capacities of its Watson super computer.

Big Blue’s “Dr. Watson,” promoted as an innovative, speedy, and influential diagnostician and medical advisor nonpareil, may be more like the Dr. Watson played by Nigel Bruce in black and white Sherlock Holmes movies starring Basil Rathbone. Watson’s pleasant, records what somebody more important is doing, and, occasionally, with bumbling good luck, he stumbles his way into valuable insight.

knees-300x81Although grandma and grandpa and even older ancestors before them didn’t live as long nor usually as well as many of us do, they still can provide valuable insights into how modern Americans can avoid painful debilitation that now leads to some of the most commonly performed surgeries on seniors.

Want to avoid an inconvenient, costly knee or hip replacement?

Keep your weight down and keep moving—two steps that researchers say may have helped reduce the prevalence of the joint rheumatoid arthritis (RA) that pushes tens of thousands of baby boomers each year to seek medical treatment, up to and including knee and hip procedures that cost taxpayers billions of dollars through the Medicare and Medicaid health programs.

fda-300x125Pro-business and anti-consumer  lawmakers in Congress are racing to slacken rules for medical device makers to report problems with their products. This move may imperil more patients, many of whom already have been harmed and some even killed already by defective and dangerous medical devices.

The dispute focuses on a provision to triple the time that companies would get to report product issues to the federal Food and Drug, giving medical device makers three months to do so, rather than 30 days as now required. They still must report to the agency immediately any incident in which a patient is harmed.

Although consumer safety advocates are decrying the oversight changes that GOP members of Congress are pressing, medical device makers are downplaying the regulatory shifts, saying they will eliminate needless bureaucracy. They say that if lawmakers don’t approve the rule changes it may sink the broader and crucial legislation they’re embedded in. The House has just approved and sent to the U.S. Senate the bigger FDA bill, which also provides 60 percent of the fee-based funds for agency drug and medical device reviews.

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