Introduction
Concern over safety risks posed by health information technology has led the Food and Drug Administration to step up scrutiny of the products, including digital medical records systems on which the government plans to spend billions of dollars in coming years.
The FDA last month asked a network of 350 hospitals it set up across the country to report data on potential hazards from a range of computer-assisted medical devices, according to an agency document obtained by the Huffington Post Investigative Fund.
The FDA action comes as federal officials forge ahead with plans to use as much as $27 billion in economic stimulus money to replace paper patient records with digital ones. The Obama administration wants to create a digital health file for every American by 2014, saying the conversion will save money and improve the quality of health care.
Reports that hospitals send to the FDA are to be posted on an agency Web site. The FDA maintains it has the authority to regulate the technology, but has not taken steps to do so, leaving the industry largely to police itself. Reporting of problems is voluntary and most manufacturers have not done so.
During a hearing in Washington on Feb. 25, FDA official Jeffrey Shuren noted that “several serious safety concerns have come to light.” He said the agency had logged reports of six deaths in the past two years, which “may represent the tip of the iceberg.”
In the letter sent to hospitals last month, Marilyn Flack, of the FDA’s Center for Devices and Radiological Health, said use of digital medical equipment “continues to grow and affect patient care and safety.” The FDA “is exploring problems….that may affect patient safety,” she wrote.
The agency plans to collect reports using its Medical Product Surveillance Network, called MedSun. It is asking hospitals to note a wide range of problems involving electronic health records and other computerized systems for hospital laboratories, pharmacies and anesthesia and radiology devices, including hand-held ones.
In an interview, Flack said that the agency “has been talking about these issues for over a year,” but the letter was the first time the hospitals had been sent an alert. “Sometimes we need to remind them about certain things they should be looking for,” she said.
Flack’s letter made special mention of potential glitches in systems that help doctors prescribe medications. She also cited an example of a software package used in a hospital emergency room in which lab tests “ordered for one patient returned the results for another.”
In another case, a hospital in the MedSun network reported an operating room software product that often “locked up” during surgery, without alerting anyone that “data entry had ceased.”
According to the FDA letter: “At the end of the surgical procedure, surgical procedure notes were incomplete—compromising the accuracy of the data as nurses had to manually re-enter from memory many of the surgical notes.”
In a third case cited by Flack, a radiology workstation became “extremely slow, delaying procedures and causing X-ray techs to subject patients to repeat X-rays.” The cause was determined to be a software glitch that happened when too many characters were entered in.
Graham Yuill, director of clinical engineering at the East Alabama Medical Center, which participates in the MedSun program, said he believed it was the first time the FDA had specifically asked about problems with health information technology.
“In the past I probably would not have gotten involved with that or reported that,” he said.
Arthur Bartosch, director of Biomedical Engineering Services at Westchester Medical Center in New York, agreed. He said he planned to circulate the FDA’s alert to the hospital’s chief medical information officer and they would “probably” create a task force to figure out how to document any problems.
Given all the federal money flowing into health information technology, Bartosch said, he wasn’t surprised to see the FDA taking an interest. “I think you’re looking at the early checks and balances of what is going to be there in health care,” he said.
In the past, the FDA has relied mainly on another data system to track medical software system failures. But that system only receives sporadic reports from a few technology companies and users on a voluntary basis.
That other system in the past two years has captured 260 reports of malfunctions with the potential for patient harm, including 44 reported injuries and the six deaths the FDA cited at the recent safety hearing. Adding the MedSun system could substantially boost the number of reports.
“The more data we get – I view that as a valuable thing,” said Paul Egerman, co-chair of a government panel looking at the safety of health information technology.
“The fundamental problem we have here is we’re dealing with an industry that really isn’t used to a transparent reporting of problems,” he said.
Egerman, whose advisory panel expects to make its findings public in April, said government officials have a long way to go in fully understanding the potential hazards of adopting the new technology.
“Are there much more serious problems that we would know about if we had the data?,” he said. “These are all reasonable questions to ask.”
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