Holland & Hart Healthcare Law Blog

THE “AVIATION” MODEL IN HEALTHCARE AND AIR FRANCE FLIGHT 447

 In the 1980s the Commercial Aviation Safety Team (“CAST”) determined that eighty five percent of aviation accidents and fifty two percent  of all fatal aviation accidents were the result of cognitive error by pilots. CAST pushed for the use of systems, checklists and foolproof communication systems to reduce the human element in aviation. The result was a fifty percent decrease in aviation accidents. The success of the systems method in aviation led healthcare safety advocates to campaign for the application of the systems model to tamp down the impact of human frailty on adverse healthcare outcomes. The systems model is now a fact of life in high risk medical procedure, pharmaceutical administration and other healthcare delivery modalities.

 You can see it in the operating room when a nurse paints a sign “the other leg” on your healthy limb or where two nurses must sign off on a prescribed medication. The interest in the systems application to quality improvement continues unabated. See Kahn, et al. , “To Err Is Human: Building A Safer Healthcare System.” National Academy  Press. Washington, D.C. (2000); Stripe, et al. “Aviation Model Cognitive Risk Factors applied To Medical Malpractice Cases.” (JABFM.org.);Inglehart & Fleming, “New Patient Safety Uses Aviation System Model.” Health Affairs Blog, April 13, 2009.

 Since the 1980s and the onset of the digital age the aviation model morphed into a much more pervasive systems intervention through the surge in computer driven maintenance and operational applications, not unlike parallel developments in healthcare. The crash of Air France Flight 447 A330 Airbus over the Atlantic Ocean on May 31, 2009 thrust to the fore two separate, but related computer systems driving  both airplanes and healthcare, albeit to differing degrees. The Airbus utilized the Aircraft Communication Addressing and Reporting System (“ACARS”). The onboard computers sent ten automatic maintenance messages to Paris indicating failures in the plane’s electrical systems and decompression of air in the plane’s fuselage.

 The current proliferation of medical devices with direct internet monitoring and reporting capacity provide the potential and fact of real time reporting of human body systemic failure to medical record repositories. The healthcare mimicry of aircraft maintenance information technology is upon us and we will likely embrace the use of “wearable” computers with growing fervor in the future.

Despite the apparent differences between healthcare and aviation, the information exchange paradigm used to insure quality in the aviation industry can be implemented to reduce the impact of the aforementioned system errors in health care delivery system (sic).

Martin, Lance, “Reducing Medical Errors Using an Aircraft Maintenance Information Technology (IT) System Model,” Dartmouth undergraduate Journal of Science. Dujs.dartmouth.edu/2004s/healthcareit.pdf.

 Despite Mr. Martin’s optimism and enthusiasm there appears to two principal kinks in both the aviation and healthcare systems that need to be addressed. The first relates to the information systems. There is no question that computer monitoring systems can generate a great deal of useful data. The critical question is how to sort and present the data in a format and application that can realistically serve the needs of pilots and practitioners. There needs to be assurance that the data is correct and not affected by defective “pitot tubes” or other malfunctions and a means to sift and prioritize mountains of data so as to provide real time, meaningful input to those sitting at the controls.

 The second concern relates to the ultimate control of the mission. The Airbus A330 contains the latest in fly-by-wire technology that substantially limits the operational control of the aircraft by the pilots. This is an exclusively electric system, without manual or hydraulic features. There is a debate ensuing in the blogosphere as to the degree of control, if any can be wrested from the computers by Airbus pilots in the event of an emergency. (Think of HAL in 2010:A Space Odyssey. That would be next year.)  The issue is at what point should human beings be able to reassert control from computer systems, particularly where onboard computers are juggling conflicting information from various sensors?

 Did the computers aboard Flight 447 malfunction causing a crash or did a last ditch effort by the pilots to regain control interfere with the failsafe functioning the planes systems? Was it a combination of both or an unremediable "act of God?" We may never know the answer.

Remember, more often than not, an airliner goes down at the end of a long chain of unrelated, seemingly innocuous decisions, malfunctions, mistakes and external factors. Remove any single link (or even change their sequence) and you have an on time arrival. Miles O’Brien Uplinks, June 19, 2009. trueslant.com/milesobrien/2009/06/10the-paradox-of-simplicity/.

 In the future computer systems will have an ever increasing role in healthcare decision making and treatment as the incorporation of artificial intelligence applications into electronic medical records provides a whole new platform and paradigm for healthcare delivery. The healthcare industry will eventually face the conundrum of when and under what circumstances a physician will need to regain control over the treatment process. The crash landing of U.S. Airways Flight 1549 in the Hudson River earlier this year underscores some legitimate concerns to keep in mind. That crash also involved an Airbus with a similar air flight control system, which may have unnecessarily shut down the plane’s engines after the bird strike, causing the plane to lose all thrust. There may come a time when we need a doctor with the nerve, experience and professionalism of a Chesley B. “Sully” Sullenberger, III to seize the controls and manage a life threatening emergency.

INTERNET MEDICINE PART II: PHYSICIAN CHAT ROOMS

One of the growing phenomena related to the practice of medicine and the internet is the introduction of physician chat rooms in real time on the web. In new forums like Sermo, approximately 90.000 physicians can currently log on line and discuss clinical issues in real time and obtain broad based input and support and advice from other physicians with respect to clinical issues. This is a form of social networking for physicians. Among the potential benefits of the forum is the ability to compare notes and to alert others to sudden distortions in the health of local populations due to flu or other causes, and the sharing of what works and doesn’t work in clinical practice. 

Stem Cell Research on Again, Time to Celebrate [Guest Editorial]

Among many other things that the Obama administration addresses --one of the most important far reaching actions in my opinion is the go-ahead to stem cell research. This was important scientific research that can help prevent diseases and in the development of better medicine to give a second chance at life to millions of human beings alive today.

"Socially Assistive" Robots: New Care Givers?

On March 10, the Washington Post ran a stimulating piece by Anita Slomski “I’m here to Make You Feel Better,”  about the development of interactive robots that have the potential to assist in the care of patients afflicted with autism, stroke, dementia, Alzheimer’s and other conditions that require a caretaker or a companion. Ms. Slomski’s article appeared earlier under the title of the “Sociable Robot” in the Winter, 2009 edition of Proto, a publication of Massachusetts General Hospital. Ms Slomski underscores that people become attached to robotic personalities. Consider the people who worry that when they send in their Roombas, a robotic vacuum cleaner, in for repair, they might not get their original back.  They have become attached to a particular vacuum personality. I for one have tried to disassociate myself from our vacuum cleaner for just that reason. Helps maintain the old objectivity you know.

Pfizer's "Double Blind" Bextra Bind -The Value of Clinical Data

Shortly before Christmas a Santa Clara County, California jury entered a $38 Million Dollar Judgment Against Pfizer, Inc. for allegedly stealing clinical data from the Ischemia Research and Education Foundation ("IREF"), concerning its acute arthritic pain drug, Bextra. Pfizer pulled Bextra from the market in 2005, followig concerns about its safety for heart patients. Not long ago Pfizer entered into a $900,000,000.00 product liability settlement for Bextra and for Cerebrex, both Cox 2 inhibitor drugs that raised safety concerns. IREF filed its suit in 2004, claiming that Pfizer obtained access to the clinical data developed by IREF after its negotiations with IREF collapsed through the device of a contract with an IREF employee and statistican, Ping Hsu. IREF is a non-profit research organization founded by Dr. Dennis Mangano, PhD, M.D., in 1987.IREF has developed a substantial data base of clinical information through the cooperation and participation of over 300 research centers around the world in the twenty plus years of its existence. There was apparently some evidence presented to the jury that Pfizer and Mr. Hsu destroyed or otherwise attemped a coverup of the use of the IREF information. Pfizer asserts that it has been unjustly caught up in the dispute between Mr. Hsu and IREF and denies any theft of the IREF information. It will likely appeal.

Ketek Attack At FDA.

In the April 19, 2007 edition of The New England Journal of Medicine, David B. Ross, M.D., Ph.D.,, a clinical assistant professor at George Washington University School of Medicine and Health Sciences took the FDA to task for its approval of Ketek, a ketolide antibiotic manufactured by Sanofi-Adventis, for use in respiratory tract infections.  The drug underwent three rounds of review by the FDA and followed an unusual structure of review and approval that may suggest outside interference in the process.

Second Circuit Finds 1986 HHS Rule Excluding Medical Coverage for Surgical Transplantation of Experimental Medical Devices Arbitrary and Capricious.

In Yale-New Haven Hospital, et al. v. Michael O. Leavitt, U.S. Department of Health and Human Services, ___ F.3d___, 2006 WL 3317691 (2nd Cir. 2006), Yale-New Haven Hospital and 48 implantees of cardiovascular-defibrillator devices ("ICDs"), sued to recover H.H.S.’s set-off recoupment of $1,500,000.00 in payments for the ICDs implanted in 1994 and 1995. The case turned on the validity of an "interpretive" rule promulgated by HHS in the 1986 Medical Reimbursement Manual. The provision directed all fiscal intermediaries to reject any and all claims for medical devices that had not received pre-approval by the FDA.

MEDICAL CLINICAL ALGORITHMS: BACK-UP OR FIRST LINE IN DIFFERENTIAL DIAGNOSIS.

What if your doctor was right 98% of the time in his or her differential diagnosis?  A genius?  Perhaps our expectation is that our doctor should score 100%, but that would not only be “aggressive,” it would be wildly inaccurate – after all doctors are human.  That begs the question of the likely future use of medical clinical algorithm’s to aid in the improvement of medical diagnosis.  Medical Clinical Algorithms’ incorporate a method of using medical tests such as The Oxford Text Book of Medicine and hundreds of medical journal articles into a differential diagnosis decision tree model to computer diagnose an illness through the symptom presented by a patient.

Brain Transplants: New Ethical Frontier?

There is the standard joke—a man walks into his doctor’s office and is advised he needs a brain transplant.  He is given two choices.  One brain costs $50.00 and the other $10,000.00.  The first belonged to a university professor.  (The second belonged to a woman, a man, a Democrat, a Republican or insert your favorite target.)  The punch line is the second is so expensive because it was unused.  The recent, successful face transplant in France has raised again some interest in whether a brain transplant would be technically feasible and ethical in the future.