FDA considers regulating safety of electronic health systems

Introduction

Concerned about potential safety risks in health information technology, the U.S. Food and Drug Administration may be moving closer to regulating the systems for the first time.

In the past two years, the agency has received reports of six patient deaths and several dozen injuries linked to malfunctions in the systems, Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, said in testimony prepared for a government hearing on Thursday.

“Because these reports are purely voluntary, they may represent only the tip of the iceberg,” Shuren said.

The FDA has been studying the issue for several years. Its latest concerns are surfacing as the government ramps up an ambitious plan to spend as much as $27 billion in stimulus money helping doctors and hospitals across the country purchase electronic medical records systems that rely on digital software rather than paper medical charts.

Many health policy experts believe that fostering greater use of health information technology, which officials refer to as HIT, will significantly improve the quality of medical care, cut costs and reduce medical errors and waste. The government hopes to have an electronic medical record for every American by 2014.

But digital medical systems are not risk-free. Over the past two years, the FDA’s voluntary notification system logged a total of 260 reports of “malfunctions with the potential for patient harm,” including 44 injuries and the six deaths. Among other things the systems have mixed up patients, put test results in the wrong person’s file and lost vital medical information.

In one example cited in the FDA testimony, an operating room management system frequently “locked up” during surgery. Lost data had to be re-entered manually “in some cases from a nurse’s recollection.” Another system failed to display a patient’s allergies properly because of software errors. In another case, results from lab testing done in a hospital emergency room were returned for the wrong patient. None of the patients, hospitals or clinics are identified in the reports.

“The FDA recognizes the tremendous importance of HIT and its potential to improve patient care. However, in light of the safety issues that have been reported to us, we believe that a framework of federal oversight of HIT needs to assure patient safety,” Shuren said. He said that to date the agency has “largely refrained” from regulating the industry. Through an FDA spokesman, Shuren declined a request for an interview.

The FDA official outlined three possible approaches for tighter scrutiny. The agency could require makers of the devices to register them with the government and to submit reports on safety issues and correct problems that surface. The FDA could track this information “to help improve the design of future products.”

In a second scenario, the agency could require manufacturers to report safety concerns and set minimum guidelines to assure the quality of products on the market. In a third approach, the systems could be subject to the broader regulatory actions that new medical products must face before they ever reach the market.

Though the FDA didn’t specify which approach it favors, Shuren said that at a minimum the agency could “play an important role in preventing or addressing HIT-related safety issues, thereby helping to foster confidence in these devices.”

The manufacturers of the systems generally have opposed regulation by the FDA, arguing in part that imposing strict controls would slow down the government’s campaign to spur widespread adoption of the technology.

Regulation will not necessarily create a “safer” electronic medical record “and might actually limit innovation and responsiveness when it is needed most,” Carl Dvorak, executive vice president of Epic Systems Corporation, a Wisconsin-based company that builds the systems mainly for hospitals and large medical practices, said in his prepared testimony for Thursday’s hearing. The hearing is being held by an advisory group created by the stimulus law.

Yet some inside the industry favor stepped-up scrutiny. One major vendor, Cerner Corporation, which has voluntarily reported safety incidents to the FDA in recent years, signaled its support for a rule that would make those reports mandatory. Cerner has reported potential safety concerns because it is the “right thing to do,” a company official said.

“This transparency is especially important at a time when the federal government—and the American public—are investing heavily in HIT,” wrote Gay M. Johannes, a Cerner vice president and chief quality officer.

Others inside the industry have argued for approaches that don’t involve FDA oversight. James Walker, chief medical information officer at Pennsylvania’s Geisinger Health System, said in prepared testimony for Thursday’s hearing that a “patient safety organization” should be created to collect “automatic, anonymous reporting of potential hazards” in electronic health systems.

Federal officials in late December issued a set of draft guidelines doctors and hospitals must meet to collect stimulus money as reimbursement for investing in digital records systems. Fewer than one in five of the nation’s approximately 600,000 doctors and 5,000 hospitals now use the technology, but officials expect the numbers to grow rapidly as the stimulus money kicks in.

U.S. Sen. Charles E. Grassley, R-Iowa, has asked some of the nation’s largest electronic medical records vendors and most prestigious health care providers about possible safety flaws and other problems with the systems. The hospitals include the Mayo Clinic and some of the country’s pioneers of digital records, such as Kaiser Permanente, a California-based health system with more than eight million members. Grassley has raised questions about a lack of a national system for reporting “product errors or failure and adverse events associated with the use of such products.”

The federal government’s Office of the National Coordinator for health information technology also has recognized the need for better surveillance. In January, the office issued a contract to address “undesirable and potentially harmful unintended consequences” of the systems.

One industry critic said Tuesday that she hoped the FDA would follow through on its concerns. “We need monitoring and reporting systems for problems,” said Sharona Hoffman, a professor at Case Western Reserve University School of Law. “It has to go through the highest level of oversight and regulation. Every American who goes to a doctor will be affected.”

Even those who advocate tighter oversight agree that the technology has the potential to revolutionize health care. The systems could eventually link doctors with hospitals and federal health data banks. Doctors would be able to send and receive medical test results online. Most systems have built-in alerts and alarms to warn doctors of potentially dangerous drug interactions and boast other safety features to assist them in caring for patients.

Though officials in some other countries have tightened oversight of the systems, U.S. manufacturers have managed to stave off formal regulation, telling the FDA in May 2008 that their products should be excluded from review partly as a means to speed up their adoption.

But critics argue that tighter scrutiny is needed to protect the public. “Oversight and quality control may slow things down, but it’s absolutely critical,” said Hoffman, the law professor. “Patients’ lives are at stake.”