The Food and Drug Administration has spent decades refining its processes for approving drugs and devices (and is still refining them), so what would happen if they extended their scope to the exploding health software industry?
The FDA, and its parent organization, the Department of Health and Human Services, are facing an unpleasant and politically difficult choice.
Sticking regulatory fences into the fertile plains of software development and low-cost devices will arouse its untamed denizens, who are already lobbying Congress to warn the FDA about overreaching. But to abandon the field is to leave patients and regular consumers unprotected. This is the context in which the Food and Drug Administration, the Office of National Coordinator, after consultation with outside stakeholders, released a recent report on Health IT.
I myself was encouraged by the report. It brings together a number of initiatives that have received little attention and, just by publicizing the issues, places us one step closer to a quality program. Particular aspects that pleased me are:
- The suggestion that quality programs should start to look at electronic health records (p. 8). EHRs have been certified by various bodies, but usually just to check off boxes and declare that the systems comply with regulations–neither the quality of their user interfaces nor the quality of their implementations have been questioned. Reportedly, the FDA considered “safety and quality standards” for electronic health records in 2010 but couldn’t get them adopted. It also checks certain forms of clinical decision support, but only if they are built into a regulated device. The current HHS report refers back to aspirational documents such as a Health Information Technology Patient Safety Action & Surveillance Plan and a set of guidelines on the safety of EHRs.
- A call for transparent reporting and sharing of errors, including the removal of “disincentives to transparent reporting”–i.e., legal threats by vendors (p. 25). Error reporting is clearly a part of the “environment of learning and continual improvement” I mentioned earlier. A regulation subgroup stated the need most starkly: “It is essential to improve adverse events reporting, and to enable timely and broader public access to safety and performance data.” Vague talk of a Health IT Safety Center (p. 4, pp. 14-15) unfortunately seems to stop with education, lacking enforcement. I distinctly disagree with the assessment of two commentators who compared the Health IT Safety Center to the National Transportation Safety Board and assigned it some potential power. However, I will ask ONC and FDA for clarification.
- A recognition that software is part of a larger workflow and social system, that designing it to meet people’s needs is important, and that all stakeholders should have both a say in software development and a responsibility to use it properly.
Don’t imagine that the FDA is unused to regulating software. For quite some time they have instituted practices for the software used in some medical devices , and have tried to keep them up-to-date.
A waterfall-like process of risk assessment and testing called computer system validation has long been required for pharma and devices.
Continue reading “Health IT: The Coming Regulation”
Filed Under: Tech, THCB
Tagged: Andy Oram, Device software, EHR vendors, FDA, FDA regulations, HHS, HIT, Medical Devices, Patient Safety, software errors
Apr 14, 2014
Berg, the company the brought along fun internet-connected concepts and products such as the Little Printer released this interesting video recently.
The amazing part of this is that Cloudwash is foundational and will just be built on. It shows where the current state of the Internet of Things is and where it can go in the future. What Berg did was amazing to me.
It took a regular “dumb” appliance with software and electronics that were trapped in and made the interaction richer and its meaning and value richer.
In a way, they radically changed the way I viewed how devices could be connected and created the possibility for a new class of devices in our daily lives.
And in a way, I saw so many parallels to healthcare.
In the video, Berg mentioned how the action of washing clothes can be quite complicated. There are baroque symbols on how clothes should be treated and this in turn is reflected by different sets of complicated icons on machines
Healthcare delivery can be far more complex though.
“In any given hospital, as many as 15 medical devices, including monitors, ventilators and infusion pumps, are connected to an ICU patient, but because they are made by different companies, they don’t “talk” with one another. Patient-controlled analgesic pumps that deliver powerful narcotics, where a known side effect is respiratory depression, aren’t linked to devices that monitor breathing, for example.”Today’s ICU is arguably more dangerous than ever,” says Peter Pronovost.
Just last week, I had the privilege of shadowing the pain service team at work. The team had to go one by one to each patient while rounding throughout the hospital. At each patient, a nurse practitioner checked their PCA. These are supposed to the safest ways to deliver analgesics and are self-containing boxes that are locked except for their interface.
No one except the pain service team is supposed to even touch those boxes due to the level of training needed to even interface with them. But it relies on human systems to ensure that the correct concentration of drug is put in with the right dosage according to each patient.
Yet like Dr. Pronovost mentions, these pumps aren’t linked to devices that monitor breathing so that IF a wrong dosage is placed in the PCA, there is no way of stopping it before its too late.
Continue reading “How a Washing Machine Inspired Me to See the Future of a Safer ICU”
Filed Under: Uncategorized
Tagged: ICU, Kevin Wang, Patient Safety, patient-contolled analgesic pumps, Project EMERGE
Mar 25, 2014
Quality improvement (QI) and patient safety initiatives are created with the laudable goal of saving lives and reducing “preventable harms” to patients.
As the number of QI interventions continues to rise, and as hospitals become increasingly subject to financial pressures and penalties for hospital-acquired conditions (HACs), we believe it is important to consider the impact of the pressure to improve everything at once on hospitals and their staff.
We argue that a strategy that capitalizes on “small wins” is most effective. This approach allows for the creation of steady momentum by first convincing workers they can improve, and then picking some easily obtainable objectives to provide evidence of improvement.
National Quality Improvement Initiatives
Our qualitative team is participating in two large ongoing national quality improvement initiatives, funded by the Agency for Healthcare Research and Quality (AHRQ). Each initiative targets a single HAC and its reduction in participating hospitals.
We have visited hospital sites across six states in order to understand why QI initiatives achieve their goals in some settings but not others.
To date, we have conducted over 150 interviews with hospital workers ranging from frontline staff in operating rooms and intensive care units to hospital administrators and executive leadership. In interviews for this ethnographic research, one of our interviewees warned us about unrealistic expectations for change: “You cannot go from imperfect to perfect. It’s a slow process.”
While there is much to learn about how to achieve sustainable QI in the environment of patient care, one thing is certain from the growing wisdom of ethnographic studies of QI: buy-in from frontline providers is essential for creating meaningful change.
Frontline providers often bristle at expectations from those they believe have little understanding of the demands of their daily work.
Continue reading “The Dangers Of Quality Improvement Overload”
Filed Under: Physicians, THCB
Tagged: AHRQ, Burnout, Catherine van de Ruit, Charles Bosk, hospital acquired conditions (HACs), Hospitals, Joanna Brooks, Ksenia Gorbenko, Patient Safety, Providers, Quality improvement
Mar 9, 2014
March 2nd through the 8th were National Patient Safety Awareness Week – I don’t really know what that means either. We seem to have a lot of these kinds of days and weeks – my daughters pointed out that March 4 was National Pancake Day – with resultant implications for our family meals.
But back to patient safety and National Patient Safety Awareness Week. In recognition, I thought it would be useful to talk about one organization that is doing so much to raise our awareness of the issues of patient safety. Which organization is this? Who seems to be leading the charge, reminding us of the urgent, unfinished agenda around patient safety?
It’s an unlikely one: The Office of the Inspector General of the Department of Health and Human Services. Yes, the OIG. This oversight agency strikes fear into the hearts of bureaucrats: OIG usually goes after improper behavior of federal employees, investigates fraud, and makes sure your tax dollars are being used for the purposes Congress intended.
In 2006, Congress asked the OIG to examine how often “never events” occur and whether the Centers for Medicare and Medicaid Services (CMS) adequately denies payments for them. The OIG took this Congressional request to heart and has, at least in my mind, used it for far greater good: to begin to look at issues of patient safety far more broadly.
Taken from one lens, the OIG’s approach makes sense: the federal government spends hundreds of billions of dollars on healthcare for older and disabled Americans and Congress obviously never intended those dollars pay for harmful care. So, the OIG thinks patient safety is part of its role in oversight, and thank goodness it does.
Because in a world where patient safety gets a lot of discussion but much less action, the OIG keeps the issue on the front burner, reminding us of the human toll of inaction.
Continue reading “What the Work of the Inspector General Tells Us about Patient Safety…”
Filed Under: Physicians, THCB
Tagged: Adverse Events, Ashish Jha, Never Events, OIG, Patient Safety, skilled nursing facilities, To Err is Human
Mar 9, 2014
There are many stories of patients who suffer when we make errors prescribing antibiotics. 75-year-old Bob Totsch from Coshocton, Ohio, went in for heart bypass surgery with every expectation of a good outcome.
Instead, he developed a surgical site infection caused by MRSA. Given a variety of antibiotics, he developed the deadly diarrheal infection C. difficile, went into septic shock, and died.
A tragic story and, probably, a preventable death.
Today, we’ve published a report about the need to improve antibiotic prescribing in hospitals. Antibiotic resistance is one of the most urgent health threats facing us today. Antibiotics can save lives.
But when they’re not prescribed correctly, they put patients at risk for preventable allergic reactions, resistant infections, and deadly diarrhea. And they become less likely to work in the future.
About half of hospital patients receive an antibiotic during the course of their stay. But doctors in some hospitals prescribe three times more antibiotics than doctors in other hospitals, even though patients were receiving care in similar areas of each hospital.
Among 26 medical-surgical wards, there were 3-fold differences in prescribing rates of all antibiotics, including antibiotics that place patients at high risk for developing Clostridium difficile infections (CDI).
CDC has estimated that there are about 250,000 CDIs in hospitalized patients each year resulting in 14,000 deaths.
Continue reading “CDC: Together We Can Provide Safer Patient Care”
Filed Under: OP-ED, THCB, The Vault
Tagged: Antibiotic resistance, CDC, Clostridium difficile infections (CDI), Hospitals, MRSA, Patient Safety, Tom Frieden
Mar 4, 2014
I recently had the privilege of becoming a Google Glass Explorer. Basically, this means I walk around with a funky pair of glass frames and look strange – even for an urban hospital setting.
The Glass has a built in camera, and a small display that you can see with numerous apps ranging from GPS navigation to searching the Web. As cool as this the technology is – is there any utility in the healthcare setting?
There is the capability of video chat, where a consulting physician can see what I would be seeing in the operating room, and tell me what I may be looking at and what to do next. Pristine Eyesight, based in Austin Texas, is trialing this use of Glass in University of California, Irvine. Applications for nursing are being developed as well. Yet will this truly impact quality? I am not sure.
Yet one thing that intrigues me about the Glass is the perspective given when using the video function. I recorded some small surgical procedures and reviewed the video afterwards. I watched where I placed my hands, how I held the needle driver, where I took my bites, and in general – what I looked at during the case.
I felt like an NFL Coach reviewing game tape. For the first time in my surgical career, I was able to really see what I did, a perspective that I had never before experienced. This lightweight device with built in eye protection was far more comfortable than any helmet-cam I had used, and the line of sight was right in tune with my visual field. So I began thinking – is there a way this tool can improve outcomes in healthcare?
According to the American College of Surgeons, almost 5,000,000 central venous catheters are placed annually in this country. Complications including placement failure, arterial puncture and pneumothorax range from 15-33% in numerous studies. So how is this common procedure taught?
The classic “watch one, do one, teach one” methodology has been modified over the years. Now, after watching a few lines placed, house staff must perform a certain number of central line placements (usually 5) under the supervision of a senior resident, fellow or attending. Once the appropriate number is reached, the trainee is “competent” to perform the procedure on his or her own. Yet are they truly competent? Perhaps the high complication rates result from a flaw in this classic teaching methodology?
Continue reading “Google Glass: A Paradigm Shift in Assessing Procedure Competency?”
Filed Under: Tech
Tagged: David Stein, Google Glass, Maintenance of Certification, Patient Safety, PBETs, Quality, Surgery, Tech
Feb 5, 2014
The Cleveland Clinic is by far the best provider of cardiac care in the nation. If you have cancer there is no better place to be than Texas. Johns Hopkins is the greatest hospital in the America.
Why? Because US News and World Report suggests as much in its hospital rankings.
But which doctors at the Cleveland Clinic have the highest success rates in aortic valve repair surgeries? What are the standardized mortality rates due to cancer at University of Texas MD Anderson Cancer Center? Why exactly is Johns Hopkins the best?
We don’t have answers to these types of questions because in the United States, unlike in the United Kingdom, data is not readily available to healthcare consumers.
The truth is, the rankings with which most patients are familiar provide users with little. Instead, hospitals are evaluated largely by “reputation” while details that would actually be useful to patients seeking to maximize their healthcare experiences are omitted.
Of course, the lack of data available about US healthcare is not US News and World Report’s fault – it is indicative of a much larger issue. Lacking a centralized healthcare system, patients, news sources, and policy makers are left without the information necessary for proper decision-making.
While the United Kingdom’s National Health Service may have its own issues, one benefit of a system overseen by a single governmental entity is proper data gathering and reporting. If you’re a patient in the United Kingdom, you can look up everything from waiting times for both diagnostic procedures and referral-to-treatment all the way to mortality and outcome data by individual physician.
This is juxtaposed to the US healthcare system, where the best sources of data rely on voluntary reporting of information from one private entity to another.
Besides being riddled with issues, including a lack of standardization and oversight, the availability of data to patients becomes limited, manifesting itself in profit-driven endeavors like US News and World Report or initiatives like The Leap Frog Group that are far less well-known and contain too few indicators to be of real use.
The availability of data in the United Kingdom pays dividends. For example, greater understanding of performance has allowed policy makers to consolidate care centers that perform well and close those that hemorrhage money, cutting costs while improving outcomes. Even at the individual hospital level, the availability of patient data keeps groups on their toes.
Continue reading “Why Transparency Doesn’t Work.”
Filed Under: Tech, THCB, The Vault
Tagged: Alexander Chaitoff, consumer driven health, Data, Hospital rankings, NHS, Patient Safety, Transparency, US News and World Report
Jan 30, 2014
Besides the importance of physician happiness when using an EHR, using design principles that maximize user intuition and presentation of relevant information, there is one aspect of health care information systems that should never be overlooked…patient safety.
Scot Silverstein, MD, blogging at Health Care Renewal as InformaticsMD, frequently brings to light issues surrounding health care IT implementations that compromise patient safety. Reading his posts should be sobering and concerning to both medical professionals and the public alike. Like I’ve said, health care IT, in my opinion, is still in its infancy despite the number of years computers have been around and the existence of Meaningful Use legislation.
As a practicing physician as well as a software coder, I’ve used a number of EHR’s (and still currently using a well known EHR by my employer of my part time job) to know how some of these appalling user interfaces affect not just workflow and user happiness, but patient safety.
An example of one design element that most physicians may not be able to identify, ironically, is the one that is most harmful when it comes to patient safety. In this well known EHR, you are presented a medication list for a patient. As a physician, you assume that this list is a current medication list and is up to date. However, the reality is that this EHR system automatically removes a medication from the list when it is determined to be expired even if it should be appearing on the current medication list.
When a physician prescribes a medication from this system, it calculates the duration of usage of the medication based on the instructions, quantity of medication prescribed, and the number of refills. Once the duration exceeds the number of days that has elapsed since the prescription was made, the medication is taken off the current list automatically by the EHR. Now, taken at face value, this sounds like the logical approach to manage a medication list and utilizes the computing power that an EHR will gladly show off as a benefit to physicians.
Unfortunately, the EHR programmers failed to understand that medications are not taken regularly by all patients all the time. In fact, no physician assumes that at all. So why should an EHR make that assumption? Furthermore, there are plenty of treatments that are to be taken only as needed so how can an EHR account for that? Absolutely, impossible.
Continue reading “Why EHR Design Matters”
Filed Under: Tech, THCB
Tagged: Design, EHR, Michael Chen, Patient Safety, Physicians
Dec 18, 2013
Forget for a moment the familiar scenes of action and outraged reaction that are playing out in our long-running national debate over how best to provide access to health care for every American. Instead, ask one simple question: what happens in the doctor’s office or hospital once access is achieved.
I set out to write a book addressing that question almost twenty years ago. I thought myself well qualified: I’d written about health care for a decade for the Chicago Tribune while receiving various awards and other recognition. But it didn’t take long for a painful realization to set in of how naïve I really was.
Digging through hundreds of studies, articles and other first-hand sources stretching back for decades, I was stunned to discover that repeated evidence of unsafe, ineffective, wasteful and downright random care had had no effect whatsoever on how doctors treated patients. Literally none. Moreover, the few professionals who understood this truth couldn’t talk about it in public without endangering their careers or engendering vitriol from peers.
Fortunately, I had no academic or clinical career to imperil. In the conclusion to Demanding Medical Excellence: Doctors and Accountability in the Information Age, I gave vent to anger and indignation. I wrote:
From ulcers to urinary tract infections, tonsils to organ transplants, back pain to breast cancer, asthma to arteriosclerosis, the evidence is irrefutable. Tens of thousands of patients have died or been injured year after year because readily available information was not used – and is not being used today – to guide their care. If one counts the lives lost to preventable medical mistakes, the toll reaches the hundreds of thousands.
The only barrier to saving these lives is the willingness of doctors and hospital administrators to change.
Demanding Medical Excellence came out in October, 1997. What progress has been made since then, and where we have fallen short? I address that question in a short article, “The Long Wait for Medical Excellence,” in the October, 2013 issue of Health Affairs. The purpose of this blog entry is to recap some of what’s said there (for you non-subscribers) and to add a few impolite observations that don’t jibe with the rules of a peer-reviewed journal.
Continue reading “Still Demanding Medical Excellence”
Filed Under: OP-ED, THCB
Tagged: Demanding Medical Excellence, Hospitals, medical error, Michael Millenson, Patient Safety, Patients, Quality measurement, value-based care
Oct 8, 2013
My worst night as a doctor was during my residency. I was working the pediatric ICU and admitted a young teenager who had tried to kill herself. Well, she didn’t really try to kill herself; she took a handful of Tylenol (acetaminophen) because some other girls had teased her.
On that night I watched as she went from a frightened girl who carried on a conversation, through agitation and into coma, and finally to death by morning. We did everything we could to keep her alive, but without a liver there is no chance of survival.
Over ten years later, I was called to the emergency room for a girl who was nauseated and a little confused, with elevated liver tests. I told the ER doctor to check an acetaminophen level and, sadly, it was elevated. She too had taken a handful of acetaminophen at an earlier time. She too was lucid and scared at the start of the evening. The last I saw of her was on the next day before she was sent to a specialty hospital for a liver transplant. I got the call later that next day with the bad news: she died.
The saddest thing about both of these kids is that they both thought they were safe. The handful of pills was a gesture, not meant to harm themselves. They were like most people; they didn’t know that this medication that is ubiquitous and reportedly safe can be so deadly. But when they finally learned this, it was too late. They are both dead. Suicides? Technically, but not in reality.
For these children the problem was that symptoms of toxicity may not show up until it is too late. People often get nausea and vomiting with acute overdose, but if the treatment isn’t initiated within 8-10 hours, the risk of going to liver failure is high. Once enough time passes, it is rare that the person can be cured without liver transplant.
According to a recent ProPublica investigation, acetaminophen overdose is the #1 cause of liver failure in the US. And between years of 2001 and 2010, 1567 people in the U.S. were reported to have died by accidentally overdosing.
Continue reading “My Worst Night as a Doctor”
Filed Under: Physicians, THCB
Tagged: acetaminophen, painkillers, Patient Safety, Rob Lamberts, Tylenol
Oct 2, 2013