Medical Records Concerns Increase Nurses Seek More FDA Oversight of Electronic Systems

By Toland, Bill | Pittsburgh Post-Gazette (Pittsburgh, PA), August 3, 2014 | Go to article overview

Medical Records Concerns Increase Nurses Seek More FDA Oversight of Electronic Systems


Toland, Bill, Pittsburgh Post-Gazette (Pittsburgh, PA)


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 - 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 to the promise that was made when the Obama administration won passage its 2009 stimulus bill, which included $25.8 billion for health information technology 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 of 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. …

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