[youtube]http://www.youtube.com/watch?v=00wx9NaGA8g[/youtube]
Medical Devices and Patient Safety: A Promising Path Forward
In an era of sophisticated information technology and rapid communication, the medical device community lags far behind other fields in its ability to alert patients about safety concerns.
For example, auto manufacturers and government regulators are able to quickly identify potential safety concerns by linking reports of crashes, malfunctions and defects with individual vehicle identification numbers (VINs).
They can then communicate recalls to affected customers by using their VIN. Manufacturers will issue notifications via mail or e-mail, or offer customers the ability to search the manufacturer’s website using their VIN.
In health care, drugs are tracked using a system established in the 1970s called National Drug Codes (NDCs). The 10-digit NDCs are assigned to all manufactured medications. The code tracks the vendor, product, and package code, which can then be captured in electronic health records and the FDA’s national database.
Unfortunately, we do not yet have a similar national system that can identify and communicate potential concerns for the tens of millions of patients with implantable devices such as pacemakers, glucose meters, artificial joints, and defibrillators.
Patients are bombarded by news stories about device recalls, but unless they have access to information about the exact make and model of their device, they have no way of knowing if they should be concerned. Since most medical device procedures take place in a hospital, a patient’s health care providers may also lack this critical, sometimes life-saving information.
The patient is then burdened with the task of tracking down their specialist or surgeon, in hopes that they documented the specific device information.
Clearly, the current health care information infrastructure does not yet support a robust surveillance system.
Placing Diagnosis Errors on the Policy Agenda
“Not everything that counts can be counted, and not everything that can be counted counts.”
This aphorism has been deliciously, but, alas, incorrectly attributed to Albert Einstein (the saying actually has mixed origins, but credit properly might be given to sociologist William Bruce Cameron, writing in 1963).
But, whatever its provenance, the saying is particularly appropriate in describing the woeful lack of attention paid to the long-standing problem of diagnosis errors in the provision of health care services.
Last week academic researchers from Baylor and the University of Texas published important research estimating that one in 20 adults in the U.S., or roughly 12 million people every year, receive an error of diagnosis—a wrong, missed or delayed diagnosis—in ambulatory care.
This likely represents a conservative estimate of the incidence of such errors in ambulatory care and does not attempt to include inpatient hospital care or care provided in nursing homes and post-acute care facilities, such as rehab hospitals.
The news media correctly decided that this peer-reviewed finding deserved prominent attention—it was a lead story on “NBC Nightly News” and other national news programs.
It seems that attaching a large number to the prevalence of such errors provided the needed news hook to give the problem the attention it has long deserved. Surveys reveal that the public is worried as much about a misdiagnosis or missed diagnosis as any other quality and safety issue in health care.
Autopsy studies performed over time find that unacceptably high rates of diagnosis errors persist; similarly, diagnosis errors continue to represent a leading cause of medical malpractice suits.
But even without newsworthy body counts, the problem of diagnosis errors has been known to clinicians for decades, if largely ignored by stakeholders and policy-makers as a major quality and safety problem.
Things That Make Me Worry About My Colonoscopy
Sorry to get all Katie Couric on you, but I’m going to have a colonoscopy on Friday. I turned 40 last October and I have some family history that leads my doctor to get one done now rather than at 50.
Unlike Katie, I won’t be broadcasting mine live, but I’ll share some articles and reflections on the process and, being process focused, what could go wrong. It’s a very necessary procedure, but there are, sadly, some very unnecessary and preventable risks.
According to Dr. Wikipedia (backed by journals):
This procedure has a low (0.35%) risk of serious complications
That’s about 1 in 300 patients, put another way.
For those of you who speak Six Sigma, that’s a 99.65% first time yield and a 4.2 sigma level.
That’s not going to scare me away.
Maybe I should have asked what my physician’s complication rates are. What are the complication rates at the surgical center where this will be done? Is this safer than being at a full-blown hospital or doesn’t it matter? Should I be more of an “engaged patient?”
Should I have asked more questions of my primary care provider? Why did she refer me to this GI specialist? Is he a “Best” doctor? Does that matter?
If I treat them as a supplier (respectfully), should I be able to walk the process and see what they do to prevent, say, instrument or scope disinfection errors?
Should I have asked:
- Show me how you disinfect the equipment
- Show me your training records for the people doing this work
- Show me your equipment maintenance records
- How do you verify that the work is being done properly?
- Have you had any complaints or incidents in the past?
I had my pre-procedure phone call on Monday. Maybe I should follow up and ask a few of these questions, even if I can’t go “walk the gemba” to check things out myself. What would you do?
Of course, I didn’t have data or information available to me to know:
- Which specialist is best at this?
- Who has the highest or lowest complication rates?
- What are the prices for different doctors or locations?
I don’t know how a busy person makes an informed decision.
Health IT: The Coming Regulation
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.
How a Washing Machine Inspired Me to See the Future of a Safer ICU
Berg, the company the brought along fun internet-connected concepts and products such as the Little Printer released this interesting video recently.
[vimeo=87522764 W=900&H=325]
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.
The Dangers Of Quality Improvement Overload
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.
What the Work of the Inspector General Tells Us about Patient Safety…
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.
CDC: Together We Can Provide Safer Patient Care
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.
Google Glass: A Paradigm Shift in Assessing Procedure Competency?
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?
