FDA, Obama Digital Medical Records Team At Odds Over Safety Oversight
By Fred Schulte and Emma Schwartz
Huffington Post Investigative Fund
Computers at a major Midwest hospital chain went awry on June 29, posting some doctors' orders to the wrong medical charts in a few cases and possibly putting patients in harm's way.
The digital records system "would switch to another patient record without the user directing it to do so," said Stephen Shivinsky, vice-president for corporate communications at Trinity Health System. Trinity operates 46 hospitals, most in Michigan, Iowa and Ohio.
Less than two weeks later, an unrelated glitch caused Trinity to shut down its $400 million system for four hours at 10 hospitals in the network because electronic pharmacy orders weren't being delivered to nurses for dispensing to patients, he said.
"As soon as it was brought to our attention, we moved to fix the problem," Shivinsky said of Trinity's system, one of the hospital industry's largest digital medical record repositories with more than seven million patient files. He said nobody was injured in either event, the Cerner Corp. system now works properly, and the hospital chain determined that "technician error" led to the system shutdown and that the mixing up of patients was the result of a "Cerner coding issue" involving software that occurred after an upgrade.
TIMELINE: Safety Overshadowed? Two Decades of Warnings and Inaction
For more than two decades the technology industry has resisted attempts to strengthen government safety oversight of electronic health record systems. View an interactive timeline.
Even absent any harm to patients, such incidents underscore possible risks faced by even large health organizations that have eagerly embraced new medical software to track patient records and treatment. As the Obama administration ramps up plans to create a digital medical file for every American by 2014 - at an anticipated tab to taxpayers of up to $27 billion - technology's boosters tend to tout its potential benefits to patients and ability to slow runaway medical costs.
Yet despite the high political and financial stakes, the administration has established no national mandatory monitoring procedure for the new devices and software. That no process exists to report and track errors, pinpoint their causes and prevent them from recurring is largely the result of two decades of resistance by the technology industry, a review of government records and interviews by the Huffington Post Investigative Fund shows. The industry argues that even with flaws, digital systems are an improvement over current paper records.
"There's an assumption that just because you have an electronic system, it's going to be safer, so people let down their guards," said Vimla Patel, who directs research on the topic at the University of Texas Health Science Center in Houston.
Monitoring could help others learn from problems faced by early users of the technology, which is being sold nationally, or how they were remedied. Shivinsky said he wasn't sure if federal officials had been notified of the difficulties at Trinity -- or would be. No rule requires it.
Almost a month after the first event at Trinity, David Blumenthal, the government's top medical health information technology official, didn't know about it. "First I've heard about it," Blumenthal said when told by a reporter July 20, as he left a Capitol Hill hearing.
Since then, Blumenthal has declined to discuss the incident or its implications.
Kelli Christman, a spokesman for Cerner, the manufacturer of the software used at Trinity, did not respond to repeated emails and phone calls over the past week seeking comment.
Detailed government regulations announced July 13, three days before the four-hour shutdown at Trinity, spell out how doctors and hospitals can collect stimulus money to help defray the costs of buying digital systems. But safety and quality standards - which Food and Drug Administration officials had suggested earlier this year could be in the offing - weren't included.
The safety debate has long pitted the FDA, with the duty to make sure medical devices are safe and effective, against the Office of National Coordinator, whose central task is to promote the technology's swift adoption. Under Blumenthal, a Harvard physician, the office has campaigned tirelessly since last April to sell the medical community and the public on the wisdom of spending billions of tax dollars for digital records.
Many industry groups contend that FDA regulation would "stifle innovation" and stall the national drive to wire up American medicine. That view resonates among the dozens of health information technology experts serving as consultants to Blumenthal's office and on advisory groups. Blumenthal also has been skeptical of the need for regulation and argued that even if some miscues occur, digital systems are far less prone to error than paper ones.
"We know that every study and every professional consensus process has concluded that electronic health systems strongly and materially improve patient safety. And we believe that in spreading electronic health records we are going to avoid many types of errors that currently plague the healthcare system," Blumenthal said when unveiling new regulations in Washington on July 13.
In public remarks that day, Blumenthal said he "expects" an eventual certification process for the digital systems to "collect information about the problems that occur with the implementation of electronic health records, if any." He did not say when that would happen. In a later interview, Blumenthal said "safety concerns are not being ignored," but wouldn't comment further.
Blumenthal declined to answer questions from the Investigative Fund about the status of negotiations with the FDA over these and other safety issues.
In answering a question at a House Energy and Commerce Committee hearing on July 27, Blumenthal said that he was not aware of any plans by FDA to "do anything further than what they've already done."
An FDA spokesman on Aug. 3 referred all questions on its regulatory strategy on digital records to Blumenthal's office, which declined to answer specific questions. A spokesman for Blumenthal described enhancing safety as a "continual process," noting that Blumenthal's team is "working with a number of organizations throughout the health care industry" to make systems safer. As for the Food and Drug Administration, which is moving towards even tighter regulation of other medical technology such as X-ray machines and drug pumps, "FDA is one agency that we are working with," the spokesman added.
'Glossing over' Problems?
Critics argue that both industry and government should work more closely to improve both safety and the efficiency of digital systems. Some doctors and hospitals have shunned electronic records because they remain clunky and unwieldy for many medical professionals to use--despite years on the market--and that these deficiencies can pose risks.
"The industry is glossing over these problems," said Robert B. Elson, a Cleveland consultant and former medical director for a digital records manufacturer. "It's mind-boggling how little innovation there has been over the last ten to fifteen years."
Dozens of other health information technology insiders, from academics to front-line users who believe digital medical records can promote better and cheaper health care, told the Investigative Fund in interviews that they nonetheless fear safety issues will mount as doctors and hospitals move quickly to install the systems and collect stimulus checks.
"People just assume that computers will make things safer," said Nancy Leveson, a safety engineering expert at Massachusetts Institute of Technology. "While they can be designed to eliminate certain kinds of hazards, they increase others and sometimes they introduce new types of hazards."
Some experts are calling for closer government monitoring of the systems to protect the public. "We need to have some scrutiny at the front end and have an approval process to make sure they are safe before they're deployed," said Sharona Hoffman, a law professor at Case Western Reserve University, who has written about the issue in academic journals.
Through the years, the industry has been largely left to police itself. The FDA has wrestled with how to oversee medical software since the mid-1980s. The agency has published several such proposals and held discussions with industry leaders, but not taken any final action on a regulation.
In 2004, digital record keeping got a boost when President George Bush signed an executive order to create a digital medical file for every American within a decade, a goal officials said at the time they could reach "without substantial regulation."
"The time wasn't right at that time to move forward or the support wasn't there (for safety regulations)," said Robert Kolodner, who ran the national coordinator's office during some of the Bush years.
Edward H. Shortliffe, president of the American Medical Informatics Association and a longtime industry figure, agreed that safety issues weren't a "primary concern" as tech companies began to expand their offerings.
Earlier this year, the trade group convened an expert panel to study the issues for the first time, but its findings have yet to be made public. Shortliffe said he didn't think the organization would take a stand on government regulation of the industry, but said: "We recognize that there are significant challenges that the field as a whole is facing."
Concern Within the FDA
The FDA's interest in the issue picked up after Congress decided in February 2009 to spend billions of dollars making digital medical records a cornerstone of the health care reform campaign.
The FDA's top brass heard those concerns last fall, records show. In a 45-minute meeting on Sept. 22, 2009 at FDA headquarters in White Oak, Md., staff briefed Commissioner Margaret Hamburg on regulatory strategy, including "possible risk implications." That day, Hamburg "stated that FDA needs to be involved in the White House initiative," according to minutes of the meeting obtained by the Investigative Fund.
In backing her staff, Hamburg, a physician, risked a collision with a top White House goal to roll out the electronic health records plan and begin paying hospitals to adopt them starting as early as this fall.
The clash of priorities became public in late February when FDA official Jeffrey Shuren tied 6 deaths and more than 200 injuries to health information technology and said these were likely the "tip of the iceberg." The data review, based on mostly voluntary reports to the FDA, suggested "significant clinical implications and public safety issues surrounding health information technology," according to an agency report.
Shuren laid out three possible options for regulations, none of which have happened. They range from mandatory reporting of "adverse events" to a full blown regulatory structure that would require all digital records system to be approved by the agency prior to marketing.
ONC director Blumenthal, the point man for the administration, has called the FDA's injury findings "anecdotal and fragmentary." He told the Investigative Fund that he believed nothing in the report indicated a need for regulation. Yet others see anecdotes as a starting point for a more methodical look at problems that arise.
Both FDA and the ONC are branches of the Department of Health and Human Services. HHS Secretary Kathleen Sebelius is a key player in the administration's health reform agenda.
The same day that Blumenthal, Sebelius and other federal health officials unveiled their digital records plan in Washington, an obscure government agency held a conference less than 20 miles away in suburban Maryland to discuss the state of quality controls.
Ben-Tzion Karsh, an engineering professor at the University of Wisconsin in Madison who attended the National Institute of Standards and Technology conference said he heard a "broad consensus" among experts that electronic medical records need to function better and safer. "The truth is that we do not at this time know what would make an EHR (electronic health record) safe," he said.
Others said that despite the rosy view taken by many political figures in Washington, many systems on the market today aren't designed in ways that prevent and limit new errors--and that nobody is holding the industry accountable.
Sometimes poor designs lead to inconvenience and frustration. It can take numerous clicks for a doctor to order a prescription that seems more easily accomplished with pad and pen. Some systems issue so many alerts that doctors ignore them or turn off built-in alarms. Experts say not enough is done to test for so-called "usability," even when such issues can impair safety.
Systems that are not "user friendly" can generate errors, said Patel, the University of Texas researcher in the field, who with her team has a $15 million grant to study the topic for the federal government.
Others experts are asking how well the systems do at preventing potentially disastrous mistakes, such as sending doctors' orders to wrong patient's treatment file. Nothing in the current law, experts say, requires manufacturers to focus on these issues, though other sectors such as aviation have done so for years.
Officials at Trinity Health said the malfunctions in both events were rare occurrences, and that overall their "major investment" in the Cerner system has paid big dividends by improved the quality of medical care.
Trinity Health has noted improved care for patients from its use of electronic records.
More than 1,200 doctors and staff use the system at any given time and more than 600,000 medical treatment orders are processed daily through the networks. Spokesman Shivinsky said that when the system slowed down July 16, technicians shut it down for about four hours. During that period, he said, doctors and nurses were able to rely on backup systems.
"We are not aware of any patient safety or quality of care issues caused by this event," he said. Still, he said: "There's a lot of potential for improvement in all of our systems."
While doctors were concerned about the problems, Shivinsky said that most are happy with the system and would "never go back to paper." Meanwhile technicians are still trying to figure out the root cause. "We'll get to the bottom of it and fix it," he said.
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HuffPost Investigative Fund First Posted: 08/04/10 09:25 AM ET Updated: 05/25/11 06:15 PM ET