Effort to track medical safety issues faces long road ahead

Introduction

Despite mounting concern over safety risks posed by digital medical records systems, government officials are years away from starting to track hazards stemming from use of the devices.

A federal advisory panel wants to create the first national database of medical software malfunctions and problems as a part of the Obama administration’s drive to spend billions of dollars in economic stimulus money helping doctors and hospitals adopt the technology.

But the proposed system wouldn’t be up and running before 2013 — even though a growing chorus of technology experts is warning that rapidly converting paper records into digital formats can unleash new types of medical errors.

“I don’t see why we would need such a long start-up time for an adverse event reporting process,” said Sharona Hoffman, a professor at Case Western Reserve University School of Law and industry critic. “There are real dangers to patient safety, and adverse event reporting should begin as soon as possible.”

Some doctors, however, said that analyzing patient injuries and medical errors linked to technology — as well as hashing out details such as whether to make any safety reports public — is a complex undertaking that’s likely to take several years or more to perfect.

“I think it will take a while to do this right,” said Robert M. Wachter, a professor in the Department of Medicine at the University of California San Francisco, and a prominent patient safety advocate.

“The problem here is that there are potentially dangerous systems and we have no mechanism to figure out what they are or to force them to improve,” Wachter said.

Although risks from digitizing medicine have been documented in academic journals for years, they have received relatively little attention from federal officials. The Obama administration plans to spend as much as $27 billion in coming years to help doctors and hospitals buy the data systems or software in the hope that every American will have a digital health record by 2014.

Most health policy experts believe that wiring up the nation’s medical infrastructure holds great promise to improve health care quality and lower costs. Even advocates for tighter oversight of the tech industry generally agree that computerized record systems can be superior to paper charts in helping doctors diagnose disease.

Yet many authorities also worry that the systems are not as safe as possible. Last month, Food and Drug Administration official Jeffrey Shuren told a government advisory panel that six patients died and 44 sustained injuries over the past two years possibly linked to the technology. He cited a hospital lab system that returned test results for the wrong patient and a software error that failed to record a patient’s allergies as examples.

Shuren said these cases reflect “several serious safety issues” and called them the “tip of the iceberg.” He called for tighter scrutiny of the industry, as did several other experts who testified at the hearing. Others say that the threat to patients is minimal because most mistakes are caught before anyone gets hurt.

The proposed database could help designers work out software bugs before they cause harm and fix other hazards. Some errors result from software glitches, while others can be caused by human error, such as entering the wrong data or missing a system warning.

The draft proposal would require doctors and hospitals to report problems as a condition of receiving stimulus money, starting in 2013. The panel, which is expected to finalize the plan next month, also wants to require that manufacturers alert customers when software glitches are discovered and require all users of the systems to undergo safety training.

The system could complement a patchwork of existing data centers — some government and others private — that try to keep tabs on all kinds of medical errors. These systems don’t connect to one another, use different terminology for reporting problems and rarely share information with the public — except in heavily redacted form.

The FDA, for instance, tracks problems through voluntary reports, filed primarily by hospitals and other health care providers and manufacturers. But FDA records show that the agency only asked a network of hospitals to report these sorts of mishaps starting last month. The system provides only limited public access and redacts all identifying information.

Private sources typically restrict release of their findings, too. Quantros, a healthcare software company, in 2008 received 27,969 reports in which computer technology contributed to an error. Of those, 278 resulted in some level of patient harm, according to the company.

Another group that collects technology-related errors, the non-profit Institute for Safe Medication Practices, posts some technology related error alerts on its Web site. One describes how a patient received the wrong medicine after a computerized prescription ordering system mixed up patients. In another example, a pharmacist reported potential safety concerns to a manufacturer only to find out that it already was aware of the problem but had failed to alert its other customers.

Whether the contents of the proposed databank will be public is not yet clear. However, most medical experts who have testified at hearings on the topic favor allowing doctors and hospitals to report incidents anonymously — and keeping the data under wraps. They argue that doctors will resist reporting out of fear of potential lawsuits that could arise from reports made public.

Steven Findlay, a Consumers Union analyst who serves on the standards advisory panel, disagrees. “If it’s paid for by federal dollars, it ought to be public,” he said. “We are not generally in favor of data about errors and mistakes that are not identified.”

Several physicians who specialize in health information technology said that creating the database may help overcome a belief among some in their ranks that government is pushing digital medical systems too aggressively as part of the stimulus plan.

Under the stimulus bill, doctors can receive up to $44,000 in extra Medicare payments if they adopt a digital medical record system and make “meaningful use” out of it. Hospitals are eligible for millions of dollars in payments. Those who fail to adopt face penalties starting in 2016, a situation government officials hope will lead thousands of medical providers to go paperless.

But many early adopters, who often have spent a decade or more and tens of millions of dollars working out kinks, say that even additional oversight can’t stave off every potential hazard. And they are becoming increasingly vocal about the downside of rushing into buying the highly complex technology.

“There is a great fear among many people that we are asking organizations to go too far too fast,” said Justin Starren, who directs health technology at the Marshfield Clinic in Wisconsin. “It’s a foregone conclusion that with this many installations that some people will make some mistakes.”

Starren said it’s “completely unclear” to him “how many and bad” those mistakes will be. “There are many nervous people out there,” he said.

Marc Probst, the advisory panel co-chair, said Intermountain Healthcare, the non-profit system of hospitals and clinics in Utah, where he directs computerized medical systems, hasn’t experienced many software bugs. But he said: “It’s amazing what an end user can do to a system to make it not work.”

Probst said he agrees that federal officials need to be mindful of the potential for unforeseen medical errors to accompany the installation of new technology. “If we do this too quickly without the right infrastructure in place we could introduce a lot of patient safety issues,” he said.