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Tag: Patient Safety

A Coming Storm: FDA Regulation of Mobile Medical Applications

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By Ryan Minarovich

I recently had the great fortune of attending Health 2.0 in San Francisco. The conference was abuzz with new medical technologies that are harnessing the power of innovation to solve healthcare problems including many new mobile medical application companies showcasing their potential. As I walked and talked around the exhibit floor, one thing caught my ear, or I should say one thing didn’t catch my ear. Among the chatter about these products, the concern about FDA regulation of this product segment, or even FDA regulation in general was noticeably absent. While many of the application developers are well aware of potential FDA involvement, most would be hard-pressed to outline the impact this would have on their companies and products.

Being labeled a medical device, which is the direction the FDA is leaning, could have a significant impact on business model organization, top-line revenue, and product deployment. For unprepared start-ups, FDA regulation could signal an end for their company. This is in stark contrast to well informed developers who are preparing themselves for the change and would most likely be able to leverage these regulations to their advantage.

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The New Bioterrorism? The Hacked Medical Device

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By Jane Sarasohn-Kahn

A time-and-technology challenged FDA, proliferation of software-controlled medical devices in and outside of hospitals, and growth of hackers have resulted in medical technology that’s riddled with malware. Furthermore, lack of security built into the devices makes them ripe for hacking and malfeasance.

Scenario: a famous figure (say, a politician with an implantable defibrillator or young rock star with an insulin pump) becomes targeted by a hacker, who industriously virtually works his way into the ICD’s software and delivers the man a shock so strong it’s akin to electrocution.

Got the picture?

Welcome to the dark side of health IT and connected health. Without strong and consistently adopted security technology and policies, this scenario isn’t a wild card: it’s in the realm of possibility. This is not new-news: back in 2008, a research team figured out how to program a common pacemaker-defibrillator to transmit a “deadly 830-volt jolt,” according to Barnaby Jack, a security expert.

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Risks and the Benefits: What Health Policy Can Learn from Clinical Medicine

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By Ashish Jha, MD

A few months back, we admitted a patient we’ll call Mr. Jones to the hospital for a severe gastrointestinal bleed.  We had discharged him two weeks earlier after he had come in with a heart attack and made sure he was on aspirin to prevent future cardiac events.  He dutifully took his aspirin and on the day of the readmission, had a massive bleed.  He made it to the hospital barely alive and an endoscopy in the ICU showed an active bleeding gastric ulcer.  For Mr. Jones, the gastrointestinal bleed, likely brought on by the aspirin, was an “unintended consequence” that almost killed him. Yet no one questioned whether we should have given him aspirin in the first place.  I felt terrible about what had happened but found solace in knowing that while for some patients the risks of aspirin are worse than the benefits, for the general population of people like Mr. Jones, the benefits are clearly worth the side-effects.

We do risk-benefit analyses every day in clinical care, knowing that for some patients, the benefits will be outweighed by the harm.  We try to be thoughtful about who might be hurt or not, but most of the time, we just can’t predict.  So, when the benefits appear to outweigh the risks, we move forward and try to learn from cases like Mr. Jones.

While this kind of risk-benefit analysis is common in clinical practice, it’s unfortunately not how we discuss health policy interventions.  No policy intervention is ever without risks, and it is rare that a new policy will have no side-effects at all.  Yet, every time policymakers put in a new initiative, they sell it as a panacea. Critics, upon finding an unintended consequence, then declare the whole thing a failure.

An excellent example of this is health information technology, a topic that I have blogged about in the past.  Proponents only talk about its benefits, allowing critics to highlight every shortcoming and failure.  Thank goodness I don’t have to deal with proponents and critics like that every time I consider prescribing aspirin to my patients.

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Waste Not

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By John H. Schumann, MD

In some ways, the Insititute of Medicine is like the famed “Academy” of Motion Picture Arts & Sciences. Having membership conferred is the ultimate accolade in a field full of brains, competition, money, and ego. A major difference is that the IOM doesn’t give out annual awards for best studies or best theories–the whole institute is comprised of lifetime achievement award winners.

That’s why when the IOM issues a report, it garners a lot of attention.

Their most recent, “Best Care at Lower Cost: The Path to Continuously Learning Health Care in America” attracted the usual spate of headlines:

I’ve looked over the report–it’s been released in ‘pre-publication’ form on their website, and you can read the whole thing. It’s a worth a click over, because even if you can’t slog through 350+ pages, they’ve made several executive summary features (including a top ten list) andgraphics that do a great job of conveying the authors’ findings and recommendations. A few things jumped out at me:

  • $750 billion of our collective annual $2.3 trillion health care outlay does not improve health
  • we still have far too many errors in hospitals
  • too many patients discharged from hospitals are readmitted in less than a month (20%!)
  • which points to the lousy job we do ‘transitioning’ people from hospital to home
  • communication amongst medical personnel is abysmal

The report uses analogies from many industries. There’s the requisite comparison to aviation, since the safety record of commercial airlines is enviable. But there are also comparisons to hotels, manufacturing, general contractors, engineers, and even ‘mission control’ at NASA. [Health care does not compare favorably to NASA. Doctors should, but are not working for a common purpose like getting people to the moon.]

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Health Care’s Man on the Moon Moment?

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By Peter Pronovost, MD

On a snowy night in February 2001, Josie King, an adorable 18-month-old girl who looked hauntingly like my daughter, was taken off of life support and died in her mother’s arms at Johns Hopkins. Josie died from a cascade of errors that started with a central line-associated bloodstream infection, a type of infection that kills nearly as many people as breast cancer or prostate cancer.

Shortly after her death, her mother, Sorrel, asked if Josie would be less likely to die now. She wanted to know whether care was safer. We would not give her an answer; she deserves one. At the time, our rates of infections, like most of the country’s, were sky high. I was one of the doctors putting in these catheters and harming patients. No clinician wants to harm patients, but we were.

So we set out to change this. We developed a program that included a checklist of best practices, an intervention called CUSP [the Comprehensive Unit-based Safety Program] to help change culture and engage frontline clinicians, and performance measures so we could be accountable for results. It worked. We virtually eliminated these infections.

Then in 2003 through 2005, with funding from AHRQ, we partnered with the Michigan Health & Hospital Association. Within six months in over 100 ICUs, these infections were reduced by 66 percent. Over 65 percent of ICUs went one year without an infection; 25 percent went two years. The results were sustained, and the program saved lives and money, all from a $500,000 investment by AHRQ for two years.

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Medical Apps: The Next Generation

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By Kenny Lin, MD

Doctors of my generation have experienced dramatic changes in the way we access the information we need to care for patients.

As a medical student 15 years ago, my “peripheral brain” consisted of fat textbooks sitting on office bookshelves or smaller, spiral-bound references stuffed into the bulging pockets of my lab coat. As a doctor-in-training, I replaced those bulky references with programs loaded onto PDAs. Today, smartphone apps allow health professionals at all levels to access the most up-to-date medical resources such as drug references, disease-risk calculators, and clinical guidelines—anytime, anywhere.

Apps have several advantages over traditional medical texts. First, the information is always current, whereas many textbooks are already dated by the time they hit shelves. If I have a question, I can look up the answer on my smartphone without leaving my patient’s side. And unlike textbook chapters, many medical apps have interactive features that help doctors choose appropriate screening tests for patients, recognize when immunizations are due, or calculate a patient’s risk of developing heart problems.

Lastly, apps can enable remote monitoring of high-risk patients and reduce the need for office visits. In a small study published in PLoS ONE, for example, researchers found that patients hospitalized for heart vessel blockages were able to complete “supervised” rehabilitation exercise sessions in their homes with a portable heart monitor and GPS receiver that transmitted real-time data to doctors via smartphone.

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Why the Electronic Medical Record Needs to be Viewed as a Medical Device

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By WESTBY FISHER, MD

In our rush to establish a national electronic medical record (EMR) system as part of the American Recovery and Reinvestment Act of 2009, powerful silos of independent EMR systems have sprung up nationwide.

While most systems are being developed responsibly, like the Wild, Wild West, many have been developed without an objective eye toward quality and the potential  harm they may be causing our patients.

As most readers of this blog are aware, since 2005 the medical device industry in which I work has had widely publicized instances of patient deaths splashed all over the New York Times and other mainstream media outlets from defibrillator malfunctions that resulted in a just a few patient deaths.

The backlash in response to these deaths was significant: device registries were developed, software improvements to devices created, and billions of dollars in legal fees and damages paid to patients and their families on the path to improvement.  In addition, we also learned about the limits of corporate responsibility for these deaths thanks to legal precedent established by the Reigel vs. Medtronic case.

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See One, Do One, Harm One?

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By Peter Pronovost, MD

I recently cared for Ms. K, an elderly black woman who had been sitting in the intensive care unit for more than a month. She was, frail, weak and intermittently delirious, with a hopeful smile. She had a big problem: She had undergone an esophagectomy at an outside hospital and suffered a horrible complication, leading her to be transferred to The Johns Hopkins Hospital. Ms. K had a large hole in her posterior trachea, far too large to directly fix, extending from her vocal cords to where her trachea splits into right and left bronchus. She had a trachea tube so she can breathe, and her esophagus was tied off high in her throat so oral secretions containing bacteria did not fall through the hole and infect her heart and lungs. It is unclear if she will survive, and the costs of her medical care will be in the millions.

Ms K’s complication is tragic—and largely preventable. For the type of surgery she had, there is a strong volume-outcome relationship: Those hospitals that perform more than 12 cases a year have significantly lower mortality. This finding, based on significant research, is made transparent by the Leapfrog Group and several insurers, who use a performance measure that combines the number of cases performed with the mortality rate. Hopkins Hospital performs more than 100 of these procedures a year, and across town, the University of Maryland tallies about 60. The hospital where Ms. K had her surgery did one last year. One. While the exact relationship between volume and outcome is imprecise, it is no wonder she had a complication.

Ms. K is not alone. Of the 45 Maryland hospitals that perform this surgery, 56 percent had fewer than 12 cases last year and 38 percent had fewer than six.

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What We Talk About When We Talk About Nursing Shortages

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By David Glenn


Not so long ago, the air was filled with dire warnings of an impending nursing shortage. By 2020, according to one widely-cited analysis, demand might exceed supply by as many as 800,000 nurses.

That analysis was made in good faith, and it was based on not-crazy extrapolations from thirty years’ worth of economic data.

But in many local labor markets in 2012, there’s no sign of a shortage. In fact, in some regions there’s evidence of a glut. A few months ago, the California Institute for Nursing & Health Care announced that 43 percent of people who received nursing degrees in California and 2010 and 2011 were not working as nurses.

I’m going to try to make some dimly-informed comments about the nursing labor market in the next few posts. But first, a few words about what it means to say that there is (or isn’t) a nursing shortage.

In this context, “nursing shortage” is used in an unsentimental labor-economics sense. A nursing shortage exists when employers are actively trying to hire additional nurses but are rubbing against supply constraints, as evidenced by:

rapidly rising wages
mandatory overtime
heavy use of temporary “agency” nurses to fill gaps on units
a greater-than-usual willingness to hire nurses with little experience or limited training
new investments in nurse-replacing technology
desperate 3 am phone calls from hospital administrators to college presidents, begging them to launch new nursing programs

To say that there is no nursing shortage today is not to say that all hospital units are adequately staffed for patient safety and decent quality of care. There is plenty of reason to believe that patients would be better off if hospitals invested in stronger nurse-patient ratios.

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Gregory House, MD, RIP

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By Robert Wachter, MD

Dr. Gregory House hung up his stethoscope and cane for the last time last night and shuffled off into eternal life in the Land of Reruns. House — the brilliant, misanthropic, drug addicted, my-way-or-the-highway physician — has been an entertaining presence on FOX television for the past eight years. I enjoyed the series and even learned a little medicine. I also took some pride in the show, since House was television’s first hospitalist, a term I helped coin and now the fastest-growing specialty in modern medicine.

But as entertaining as he was, House was a throwback to an era in which the antisocial tendencies of some physicians were seen as irrelevant to their doctoring. As medical leaders strive to redefine “the great doctor” of today, House’s departure is both timely and welcome.

When I went to medical school in the 1980s, many of us valued nothing more than our autonomy. We saw medicine as an individual, not a team, sport, and interpreted professionalism as unwavering advocacy for our patients. While this was often healthy and noble, in some cases it crossed the line into obnoxiousness, even rage. (Today, we call doctors who cross this line “disruptive physicians.” Dr. House would certainly qualify.)

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