Articles Posted in Medical Device Safety

cdc-logo-300x226When it comes to the nation’s health, the Trump Administration and the GOP-dominated Congress seem determined to prove they know how to do penny-wise and pound-foolish. They’re amply demonstrating this with proposed slashes in the nation’s basic budget for public health. They’re calling for a $1 billion cut for the Centers for Disease Control and Prevention, notably in the agency’s funding to combat bioterrorism and outbreaks of disease, as well as to battle smoking and to provide critical medical services like immunizations. Their target is the Prevention and Public Health Fund, set up under the Affordable Care Act, aka Obamacare. With the ACA under fire by partisans who want to repeal and replace it, the fund was already imperiled. GOP lawmakers, determined to cut domestic spending, seem disinclined to come up with substitute sums.

Andy Harris, a Maryland Republican congressman, physician, and House appropriations health subcommittee member, has been quoted as calling the public health money, “a slush fund.” He argued that, “It’s been used by the secretary [of health and human services] for whatever the secretary wants. It’s a misnomer to call it the Prevention and Public Health Fund, because it’s been used for other things, and it’s about time we eliminated it.”

The Obama Administration did embarrass Congress by tapping the fund to provide emergency aid last summer to Florida, Puerto Rico, Hawaii, and other states battling tropical infections, including Zika and dengue fever. Congress took a long recess vacation, as states clamored for help for mosquito eradication and vaccine development to deal with Zika, a virus that can cause severe birth defects and other harms.

http://www.protectpatientsblog.com/wp-content/uploads/sites/69/2016/09/Food_and_Drug_Administration_logo.svg_-300x129.pngTo hear some powerful proponents tell it, Uncle Sam needs to really hurry up the government’s approval of drugs and medical devices. He’s got to make oversight over them easier, lighter, and less complex.

But consider just some of the health news in recent days:

skepticism-image-197x300At one point, medical experts recommended that physicians aggressively treat patients 60 and older so the top number of their blood pressure readings ran as close as possible to 140. Maybe not so, anymore. For a while, physicians were told to treat patients so their “good cholesterol” increased significantly. But maybe this approach doesn’t protect against heart disease after all. Pediatricians once warned parents to protect newborns by not exposing them to certain allergens, especially peanuts. If you haven’t had your head buried in the sand, that counsel, of course, has just changed 180 degrees.

Thanks are due to Aaron E. Carroll, a pediatrician, health research and policy expert, and columnist with the New York Times “Upshot” feature, for reminding — yet again, as repetition is the Mother of Learning — that medical news must be taken in by patient-consumers with a “dose of healthy skepticism.” This he says is especially true about reports on nutrition.

I’ve written about the harms that result from hype and the many, sometimes dramatic reverses in health and medical news. I’ve pointed out that there are accessible resources, such as the excellent healthnewsreview.org, to watchdog coverage of medical science and so-called advances. I’ve suggested that patient-consumers look closely at key elements in research stories, including how the work was done, how long the study ran, whether its data is visible and if it was published in a reputable medical journal. This will help savvy readers look askance, even at pieces in quality news sites — such as recent articles touting turmeric or eating lots of hot peppers.

fireextinguisher-211x300They’re likely jammed into many of the toys and electronic gadgets that overflowed the house during the holidays. But they’ve also been linked to sufficient fires that products have been recalled because of them, and some devices with them have even been banned in the nation’s skies. Now federal regulators are warning hospitals and doctors’ offices to beware, too: Their many battery-laden medical carts may burst into flames or explode.

The federal Food and Drug Administration has written to caregivers nationwide with a new caution that, within the last three years, it has received a dozen reports of “smoke, fire, melting batteries, burning, and other hazards” with medical carts. No injuries have been recorded but facilities have been evacuated due to smoke and fire hazards from cart blazes or smoldering, the FDA says. The rolling stations have grown increasingly common so staffers can conveniently dispense medication, or carry equipment related to colonoscopes, ultrasound, and anesthesia machines.

They’re also prized because their electrical sources—lead acid or increasingly lithium batteries—pack the power needed, they’re portable, convenient, and they’re long lasting. But those batteries also can generate a lot of heat, and they have proven problematic in other uses.

VPJoeBiden_PresidentObamaPresident Obama is expected to sign the $6.3 billion 21st Century Cures Act, capping a rare, multi-year, bipartisan push to significantly improve the nation’s health care. The Senate, with Vice President Biden presiding and winning salutes from political colleagues and patient advocacy groupsapproved the act 94-5.

Proponents say it has many benefits to go around, as I’ve written, providing:

  • a $4.8 billion boost to the National Institutes of Health to support an array of innovative research in its facilities, as well as at universities, medical schools, academic medical centers, and major hospitals;

fda hipThe pain and suffering that a flawed medical device can cause can last a long time. A Dallas jury provided a timely reminder of that, deciding six California plaintiffs should be paid more than $1 billion for the harm they suffered because of metal-on-metal hip replacement hardware made by Johnson & Johnson’s DePuy Orthopedics unit.

The Californians proved to jurors that they suffered tissue death, bone erosion, and other at times excruciating injury due to the faulty Pinnacle hip replacement product, which they said had been promoted as longer lasting and less risky than other alternatives. Jurors also heard that DePuy knew the products were defective and failed to warn patients.

Johnson & Johnson said it had acted appropriately and believed the verdict, which came in one of more than 8,000 Pinnacle-related lawsuits in Texas alone, would be overturned on appeal due to what the company said were errors by the presiding judge.

US_Congress_02It’s almost 1,000 pages,   culminates at least three years of work, and provides a $6.3 billion boost for an array of health-related agencies and initiatives. Will the U.S. Senate join the House in bipartisan passage of the 21st Century Cures Act, a sweeping measure that some say could affect American health care as much as the Affordable Care Act aka Obamacare?

After the bitterly divisive presidential campaign, House members surprised many with their swift consideration of the health funding bill, which passed 392-26. Congressional leaders then crowed about how they can work together and how the legislation will help. The act now has moved to the Senate for consideration. Senators, notably Massachusetts Democrat Elizabeth Warren, have been far more critical of components of the measure, particularly how Big Pharma and device-makers may benefit.

I’ve written how Congress, around this time last year, provided holiday cheer by approving the framework of the 21st Century Cures Act, an omnibus bill that took a year for funding details to get worked out. Because the legislation covers so many health areas and still must be acted on by the Senate and signed by the president, it still needs wary watching. Lobbyists for many different causes already have had a field day on this bill, and they will continue to do so.

prof-Madris-glasses-crop-2Instead of acting as a tough federal watchdog that protects and informs patients about problems with medical devices−from heart valves to drug pumps−the federal Food and Drug Administration all too often has served as an industry lap cat offering late, lax oversight in reporting safety woes, a new report finds. The Minneapolis Star-Tribune and former agency official Madris Tomes (photo right) deserve credit for blowing the whistle on the gaping bureaucratic loophole that lets device makers report problems almost at their leisure, and to do so in a way that hides issues from public view.

By law, the paper says, makers are supposed to file safety incident reports with the FDA within 30 days of occurrence. But the agency not only fails to enforce that requirement, it has created a process of Orwellian double-speak, allowing “retrospective reporting.” Device makers in this process tell the agency about hundreds of thousands of safety incidents, sometimes years after they occurred. Further, the FDA allows the companies to detail the incidents, in some cases tens of thousands of them, in confidential reports. The only notice the public gets is via terse summaries, “marker reports,” of the much longer documents.

Tomes, since leaving the agency, has created a search engine, Device Events, that helps outsiders track agency information on medical devices’ performance. Using that tool, it still took Star-Tribune reporters almost a year to pry from the FDA information barely hinted at in marker reports.

heatercoolerPost-op heart surgery patients who experience night sweats, muscle aches, weight loss, fatigue, or unexplained fever should contact their doctors, stat, federal officials say. They’re warning that a medical device, designed to keep organs and blood at a constant temperature, was contaminated with nontuberculous mycobacterium (NTM). Officials already have confirmed more than two dozen NTM infections in open heart patients, and thousands more may be at risk.

The federal Centers for Disease Control and Prevention flagged the potential patient risks linked to the Stöckert 3T, temperature-regulating surgical devices made by LivaNova PLC (formerly Sorin Group Deutschland GmbH).

Temperature-regulating devices are common in the 250,000 open heart surgeries performed annually in hospitals, officials say, and 60 percent of the procedures involve the German-made model. NTM infections may not develop immediately, and some cases were confirmed as many as four years after surgery. They typically are not fatal but can be problematic for immune-compromised patients, such as many open heart patients are. They respond well to antibiotics if detected.

ICUThe spots in hospitals where patients in the direst shape receive specialized treatment are themselves in need of urgent care, experts say, explaining that antiquated intensive care units (ICUs)

contribute to needless harm. But how exactly to yank them and the therapies they provide into the 21st century?

Usha Lee McFarling, a Pulitzer Prize winner, examines ICU reforms for the online health news site Stat, finding that these crucial and “heroic” hospital facilities fundamentally have changed little in a half century, although they now are jammed with new technology and devices. They serve almost 6 million Americans in grave condition, but in them, she says, “studies show serious and sometimes fatal medical errors are routine. And a recent review published in the journal Critical Care found no major advances in ICU care since the field’s inception in the 1960s.”

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