By Bill Toland
Pharmacy errors, hard-to-find clinical alerts, “farcical” training, and potentially life-threatening design flaws: Reading through the U.S. Food and Drug Administration’s catalog of electronic medical records malfunctions could be hazardous to your mental health.
If not yours, than that of the physicians and nurses who must work with the records systems, and who are reporting their experiences to the FDA’s adverse event database, otherwise known as MAUDE (the Manufacturer and User Facility Device Experience).
Most of the events submitted to the database involve misfiring medical equipment — broken aerosol compressors, faulty defibrillators — but as electronic records and computerized physician-order entry systems take hold at hospitals and clinics across the country, complaints about those systems are on the rise.
For decades, electronic patient records systems have been heralded as a potential game-changer for the health care industry, leading to improved patient health outcomes, fewer duplicate tests and, eventually, savings for the health care industry.
While most clinicians and academics still believe the promise is there, the systems are coming under increased scrutiny from doctors, nurses and some on Capitol Hill who say the technology is poorly regulated, often unproven and occasionally unreliable.
As such, the health records systems haven’t yet lived up the promise that was made when the Obama administration won passage its 2009 stimulus bill, which included $25.8 billion for health IT investments and incentive payments.
“Like with any new technology, there’s going to be unintended consequences,” said William M. Marella, director of Patient Safety Reporting Programs for the suburban Philadelphia Emergency Care Research Institute. He’s also director of the state’s Patient Safety Reporting System, which tracks adverse events and near-misses in Pennsylvania.
“In the long run, [electronic health records] will make us safer than we were” using paper records, Mr. Marella said. “But in the short term, we’ve got a lot of [implementation] issues that need to be addressed before [electronic health records] meet their promise.”
Last month, the nation’s largest union of registered nurses sent a letter to the FDA asking for broader and more stringent oversight of electronic records systems and of computerized physician-order entry systems, which allow clinicians to log treatment instructions for patients.
The National Nurses United, as part of its broader campaign highlighting the potential dangers of “unproven medical technology,” says FDA officials should test electronic medical records as rigorously as they might a new drug or an artificial hip implant.
“I don’t think that opinion is an outlier opinion,” Mr. Marella said. “Lots of clinicians are unhappy with the way these systems work, and are unhappy with the documentation burden we put on them.”
The nurses union also wants the U.S. Centers for Medicare and Medicaid Services to suspend its “meaningful use” program, which requires providers to start installing electronic medical records systems at the risk losing Medicare funding, “unless and until we have unbiased, robust research showing that [electronic health records] can and do, in fact, improve patient health and save lives.”
To date, since 2011, that CMS program has issued nearly $24 billion to hospitals and physicians clinics seeking to upgrade their electronic records systems and make the transition away from paper records.
Tracking the errors
The letter submitted by the nurses union to the FDA was part of the commentary related to the federal government’s proposed overhaul of its framework for regulating health IT. That draft proposal was published in April, a joint effort of the FDA, the U.S. Department of Health and Human Services, the Federal Communications Commission and the Office of the National Coordinator for Health IT.
Others offered their own responses. The College of Healthcare Information Management Executives and the Association of Medical Directors of Information Systems, in joint comments to the FDA, said that the government needs a retooled electronic health records certification program in order to “identify clear standards and require strict adherence to those standards.”
The report itself noted that “a nationwide health information technology infrastructure can offer tremendous benefits to the American public, including the prevention of medical errors, improved efficiency and health care quality, [and] reduced costs. … However, if health IT is not designed, developed, implemented, maintained, or used properly, it can pose risks to patients.”
Patient risk was a concern when, last summer, UnitedHealth Group Inc. recalled software that was used in hospital emergency rooms in more than 20 states “because of an error that caused doctor’s notes about patient prescriptions to drop out of their files,” according to Bloomberg News. There were no reports of patient harm, a UnitedHealth spokesman said, but the glitch illustrates the potential pitfalls for digital health records.
The MAUDE system, which accepts voluntary and anonymous incident reports from practitioners, and Mr. Marella’s own reporting have turned up plenty of other glitches. Some involve human error, others involve software and interoperability malfunctions, and many are simply design flaws, such as this example from a 2012 Pennsylvania Patient Safety Authority report:
Patient with documented allergy to penicillin received ampicillin and went into shock, possibly due to anaphylaxis. Allergy written on some order sheets [but] never linked to pharmacy drug dictionary.
And this one, from MAUDE:
Potassium chloride was prescribed twice per day as treatment for hypokalemia. The lab testing revealed a [bad] jump in the potassium level, but the result came to the EHR without alert or warning, and the nurses continued to give the patient potassium anyway [because] the nurse did not know that the potassium level was high. ... Though this patient did not die, others have from this type of defect.
Or this one, from 2013:
Patient’s medication list and other active orders did not appear on the doctor’s order section on the CPOE system, rendering it impossible for the doctor to confirm, alter, and reconcile the medication list. ... For obvious reasons, this defect in the CPOE is potentially life threatening when the doctor(s) do not have access to the current medication list.
And from April:
A patient [was] at risk for respiratory arrest due to a narrowing in the trachea. There is no place on the EHR to list such a life-threatening condition that would be visible to each and every care team member who opened the EHR for this patient. ... Care was delayed due to the above mentioned reasons, [and] the patient sustained a complete respiratory arrest that led to a cardiac arrest and anoxic brain injury.
While examples of electronic health records problems can be retrieved via various state and federal databases, many in the medical field say tracking the issues in a more comprehensive way will lead to better systems. Mandatory reporting would help, too, since only a fraction of adverse events related to electronic health records are actually reported to the FDA or state authorities.
But health IT vendors are against mandatory reporting, or any other system that would run afoul of the confidentiality clauses that are built into contracts with hospitals and clinics. Public, mandatory confessions of errors might also discourage such reporting, since the clinician who admits the error could be punished by his or her employer.
“We have felt that reporting by both providers and vendors should be voluntary. That is most consistent with the notion of a learning environment,” said Mark Segal, the chairman of the Electronic Health Records Association, told The Boston Globe.
Clinicians, too, are also wary about striking the right balance. “FDA oversight and regulation could slow innovation,” particularly if electronic health records and related systems are indeed scrutinized like other medical devices, according to a letter to the FDA from American Medical Association CEO James Madara.
And they have the FDA on their side. The agency does not intend to require the reporting of electronic health records-related adverse events, and does not intend to vet electronic health records in the same way that it reviews drugs and other medical devices.
But when push comes to shove, though, regulators should err on the side of safety, said Dean Kross, a cardiologist in private practice at the Allegheny Health Network and a longtime critic of electronic health record companies and the side effects of health IT adoption.
“The vendors have not been held accountable for the devices they are manufacturing,” he said. There is negligible pre-installation vetting, or post-market surveillance, for “safety, usability and efficacy,” he said.
And regulators should keep a watchful eye on human usability.
“Ninety percent of [complaints] have got something to do with faulty user-device interaction,” said Robert A. North, chief scientist at Human Centered Strategies, a Colorado company that studies and seeks to reduce risk and error in medical device design. “It’s not that something that is breaking or freezing. ... it’s nothing to do with the electronic circuit board. It’s the human circuit board.”
While Mr. Marella is aware of the design shortcomings of electronic health records, he’s still a believer that the systems can, and are, improving patient and population health.
He points to the example of a Pennsylvania hospital that noticed some its patients were overdosing on narcotic painkillers while in the hospital, and had to be given reversal agents to mitigate the overdose symptoms. When clinicians dug into the electronic records, they saw that the overdoses were happening primarily among people being given painkillers for the first time.
“So they decided that the default dose was actually too high” for first-time opioid recipients, and adjusted the first-time dosage going forward, Mr. Marella said. Identifying a hospital-wide problem, and addressing it quickly, probably couldn’t have happened without electronic health records.
“We really have to do a lot more work in what we call human factors,” so that the systems are intuitive, he said. “We’re quite a long ways from there.”