Tag: Patient Safety

“Unaccountable” An Important, Courageous and Deeply Flawed Book

Nov 5, 2012• 16

By ROBERT WACHTER, MD

In his new book, Unaccountable: What Hospitals Won’t Tell You and How Transparency Can Revolutionize Health Care, Johns Hopkins surgeon Marty Makary promises a “powerful, no-nonsense, nonpartisan prescription for reforming our broken health care system.” And he partly delivers, with an insider’s and relatively unvarnished view of many of the flaws in modern hospitals. Underlying these problems, he believes, is an utter lack of transparency, the sunshine that could disinfect the stink.

The thesis is important, the honesty is admirable, and the timing seems right. Yet I found the book disappointing, sometimes maddeningly so. My hopes were high, and my letdown was large. If your political leanings are like mine, think Obama and the first debate.

Makary hits the ground running, with the memorable tales of two surgeons he encountered during his training: the charming but utterly incompetent Dr. Westchester (known as HODAD, for “Hands of Death and Destruction”) and the misanthropic “Raptor,” a technical virtuoso who was a horse’s ass. Of course, all the clinicians at their hospital knew which of these doctors they would see if they needed surgery, but none of the patients did. (Of HODAD, Makary writes, “His patients absolutely worshipped him… They had no way of connecting their extended hospitalizations, excessive surgery time, or preventable complications with the bungling, amateurish, borderline malpractice moves we on the staff all witnessed.”)

This is compelling stuff, and through stories like these Makary introduces several themes that echo throughout the book:

1) There are lots of bad apples out there.

2) Patients have no way of knowing who these bad apples are.

3) Clinicians do know, but are too intimidated to speak up.

4) If patients simply had more data, particularly the results of patient safety culture surveys, things would get much better.

Improving Patient Safety Through Electronic Health Record Simulation

Oct 31, 2012• 2

By William Hersh, MD

Most tools used in medicine require knowledge and skills of both those who develop them and use them. Even tools that are themselves innocuous can lead to patient harm.

For example, while it is difficult to directly harm a patient with a stethoscope, patients can be harmed when improper use of the stethoscope leads to them having tests and/or treatments they do not need (or not having tests and treatments they do need). More directly harmful interventions, such as invasive tests and treatments, can harm patients through their use as well.

To this end, health information technology (HIT) can harm patients. The direct harm from computer use in the care of patients is minimal, but the indirect harm can potentially be extraordinary. HIT usage can, for example, store results in an electronic health record (EHR) incompletely or incorrectly. Clinical decision support may lead clinician astray or may distract them with unnecessary excessive information. Medical imaging may improperly render findings.

Search engines may lead clinicians or patients to incorrect information. The informatics professionals who oversee implementation of HIT may not follow best practices to maximize successful use and minimize negative consequences. All of these harms and more were well-documented in the Institute of Medicine (IOM) report published last year on HIT and patient safety [1].

One aspect of HIT safety was brought to our attention when a critical care physician at our medical center, Dr. Jeffery Gold, noted that clinical trainees were increasingly not seeing the big picture of a patient’s care due to information being “hidden in plain sight,” i.e., behind a myriad of computer screens and not easily aggregated into a single picture. This is especially problematic where he works, in the intensive care unit (ICU), where the generation of data is vast, i.e., found to average about 1300 data points per 24 hours [2]. This led us to perform an experiment where physicians in training were provided a sample case and asked to review an ICU case for sign-out to another physician [3]. Our results found that for 14 clinical issues, only an average of 41% of issues (range 16-68% for individual issues) were uncovered.

A Coming Storm: FDA Regulation of Mobile Medical Applications

Oct 24, 2012• 14

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.

The New Bioterrorism? The Hacked Medical Device

Oct 23, 2012• 1

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.

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

Oct 11, 2012• 2

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.

Waste Not

Sep 21, 2012

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.]

Health Care’s Man on the Moon Moment?

Sep 12, 2012• 7

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.

Medical Apps: The Next Generation

Aug 23, 2012• 3

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.

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

Aug 20, 2012• 20

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.

See One, Do One, Harm One?

Aug 14, 2012• 28

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.