Huffington Post Investigative Fund
One day in March 2009, hospital workers misread small print on a computer screen, causing them to dispense 10 times the prescribed dose of a drug. Result: The patient has a heart attack.
Another time, a computer fails to alert doctors and nurses when a patient is moved from intensive care to their ward. Left unattended during the night, the patient suffers seizures for hours.
In December 2009, there's a report of a software glitch that delays a patient's medical treatment, causing a disabling injury. "Breakdowns of this magnitude endanger hundreds of patients simultaneously," warns a report on the incident.
Scores of reports on file with the Food and Drug Administration detail consequences to patients when an electronic medical record system fails. Those reports, reviewed by the Huffington Post Investigative Fund, show that a central function of the record systems, known as computerized provider order entry, or CPOE, has been linked to instances in which patients died or suffered serious injuries.
While the data obtained by the Investigative Fund affords only a small glimpse at problems with the system, it could suggest a much larger challenge as the nation's medical establishment swiftly moves from paper medical files to digital ones.
The safety concerns raised by the reports "may represent the tip of the iceberg," said Jeffrey Shuren, who directs the FDA's Center for Devices and Radiological Health. Shuren, who made the remark at a gathering of government officials and safety experts in late February, did not disclose details from the reports, which the Investigative Fund obtained through an FDA database.
The CPOE system is pivotal to the success of government plans for spending billions of dollars in economic stimulus money to entice doctors, clinics and hospitals to switch from paper medical files. Government officials and many safety specialists argue that the system will revolutionize medicine by minimizing errors, cutting costs and protecting patients.
But some of those same experts also worry that the prospect of stimulus funding - an estimated $5 million or more per hospital - encourages hospitals to install systems prematurely, possibly exposing patients to harm associated with software glitches and other system bugs.
The FDA's Manufacturer and User Facility Device Experience (MAUDE) database is the nation's largest repository of adverse events related to medical devices. Using the system, the Huffington Post Investigative Fund identified 237 reports related to health information technology filed with the agency since January 2008.
Altogether, the Investigative Fund identified 237 reports of "adverse events" associated with health information technology reported to the FDA over the past two years. Most problems involved computerized medical ordering software or systems that supply the software with vital information, such as recommended doses of medicine or test results. Most of the adverse events recorded in FDA files were blamed on software malfunctions, user error or the system's lack of user friendliness.
While the reports open a rare window into troubles involving computerized records, much is still not known. Locations, names of institutions and the identities of patients are redacted from FDA data obtained by the Investigative Fund. Many reports don't say what ultimately happened to the patients and could not be independently verified by the Investigative Fund.
There's no way to know how often these problems arise. Most reports to the FDA are submitted voluntarily by health professionals, so the reports provide only a random snapshot of the problem. Meanwhile, the FDA itself is largely in the dark; it lacks a reliable, systematic method of tracking the safety of health information technology.
Justin Starren, a physician who oversees technology at the Marshfield Clinic in Wisconsin, lays out the dilemma starkly: "Computers are strong medicine. Done well, they are wonderful; done poorly they can kill people," he said.
David Blumenthal, who oversees stimulus payouts as the government's national coordinator for health information technology, said that he hasn't seen evidence that "merits a lesser commitment to implementing CPOE."
He said the CPOE devices can greatly help doctors make better decisions in treating patients. Medical experts advising the government have been "virtually unanimous" in concluding that on balance CPOE "improves the safety of care," Blumenthal told the Investigative Fund when asked about its findings.
Even so, he acknowledged concerns, saying, "We are looking at this issue closely."
Since late December, 18 reports received by the FDA involved one manufacturer, Cerner Corp., which sells CPOE devices and other electronic record systems.
One patient died after an "unplanned hospital wide CPOE and electronic record breakdown," which in turn resulted in late or missed doses of medicines, according to one report. "Considering the size of the institution, it is possible that other patients were adversely affected by comparable delays and omissions," stated the report.
Most of the reports filed by physicians alleged malfunctions or poor designs of Cerner's CPOE equipment. One criticized "user unfriendly interfaces" and screens with a small font size and "extraneous and distractive" information that had led pharmacists to overlook changes in medication orders.
Another report described how health care personnel had trouble reading orders on the computer screen - causing a "life threatening acute asthma attack" in a patient given the wrong drug.
Gay Johannes, Cerner's vice president and chief quality officer, said in a prepared statement that the company maintains an "internal process" for resolving complaints about its products. "We continue to follow this process that has been in place for many years and investigate all claims Cerner receives or are filed with the FDA." [Click for the full statement.]
She said that Cerner also voluntarily reports incidents to the FDA because the company "believes such disclosures provide much-needed transparency into the successes and challenges of these types of systems." The company did not respond to requests for comment on individual reports.
The FDA also wouldn't discuss the reports or say what action agency officials or manufacturers took in response.
'Systems Do Fail'
Taken as a whole, the FDA reports show that making the complex systems work properly involves far more than simply transferring paper records into a digital format.
Health professionals use CPOE to type in orders for prescription medicines, diagnostic tests and the patient's treatment plan. The information then is shared electronically throughout the hospital. Drawing on computer databanks, the systems can warn doctors of harmful drug interactions and help guide their medical decisions--functions that Obama administration officials promise will significantly improve health care delivery.
Citing this potential, the Obama administration wants to spend as much as $27 billion in economic stimulus funds to help doctors and hospitals adopt the systems and create a digital medical record for every American by 2014. To qualify for the first phase of funding, which starts later this year, hospitals must install the CPOE systems and use them in at least one in every 10 transactions with patients.
But many health information technology experts say past experience at hospitals indicates a need to phase in the systems gradually. Without greater attention to safety, several experts said in interviews, the stimulus plan might backfire, eventually discouraging their use, as risks and costs eclipse advertised benefits.
"Simply pushing CPOE as an unalloyed good has a great potential to negatively influence quality and increase cost," said Starren, of the Marshfield Clinic. Experts generally expect successful installation to take the average hospital several years. Three is "about the fastest CPOE can realistically be implemented effectively," said Starren. "Most places take longer."
Other experts said that many successful CPOE installations have been "home grown" by university hospitals and research institutions and perfected over many years of hard trial and error. Though they strongly believe that the electronic systems will prove far safer than relying on paper files, they worry that federal officials aren't doing enough to keep tabs on hundreds of tech companies aggressively marketing new versions of the complex software.
"These systems have lots of potential to improve safety but if they aren't implemented correctly they might worsen safety," said David Classen, an informatics professor at the University of Utah School of Medicine.
Classen points to his recent research testing CPOE systems at 62 hospitals, which found that the systems caught medication errors only about half the time, including some that would have resulted in serious injuries and possible death. Systems from the same manufacturers performed better at some hospitals than others.
"These systems do fail," he said.
Alerts are 'a joke'
A number of studies have documented that CPOE can significantly reduce medication errors that stem from sloppy physician handwriting on prescriptions. Yet others have found that CPOE can also create new hazards. One of the earliest critical studies was done by Ross Koppel, a University of Pennsylvania professor, who reported in 2005 that the systems can introduce a litany of errors. Koppel also found CPOE systems often flood doctors with warning alerts that are of no consequence, leading many physicians to habitually ignore them - a syndrome so commonplace it even has a name: alert fatigue.
The automated warnings aren't taken seriously. "They are a joke," Koppel told the Investigative Fund. He blames manufacturers for producing systems that rely on what he called "not ready for prime time software."
Others remain optimistic that the systems eventually will live up to their potential. Blumenthal said in an interview that CPOE alert and "decision support" features make doctors better, and he cited his own medical practice in Massachussetts. He said the computerized system helped him decide whether to order X-rays, and what type, based on a patient's symptoms entered into the computer. In some cases, the computer was able to locate results of a previous test, sparing the patient needless exposure to radiation.
"The interaction between me and the computer is emblematic of what's possible to accomplish," Blumenthal said.
Government officials note that phasing in CPOE is vital to achieving broad health reform goals. That view is shared by an influential coalition of consumer groups and labor unions. The coalition, which includes the older Americans' lobby AARP, argues that the systems promote safety and efficiency and will grant patients a greater say in their medical care.
Blumenthal said that CPOE is critical to the success of the electronic health records initiative. "We need to support it and make sure it happens," he said. "How fast and in what form remains to be seen."
Related Story » Amid Digital Surge, a Lack of Policing by FDA
As federal officials encourage the rapid expansion of electronic medical records to help doctors improve care and cut costs, they lack a reliable and systematic method for tracking the safety of these products, agency data and audits show.
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