More Deaths Due to Medical Errors Found in New Review

By Jennifer Larson, contributor

October 1, 2013 - How many deaths in hospitals could be prevented each year? The number may be higher than you think.

For more than a decade, the accepted number of preventable deaths occurring in U.S. hospitals was a figure put forth by the Institute of Medicine (IOM) in its landmark 1999 “To Err is Human” report: as many as 98,000 each year.

Now, a new study published in the September issue of the Journal of Patient Safety suggests that the number may be higher--much higher. Authored by toxicologist John T. James, PhD, the study proposes that “a lower limit of 210,000 deaths per year was associated with preventable harm in hospitals.” But even that number is conservative, James said.

“I would say that up to 440,000 lose their lives every year prematurely,” he said. “Their lives are significantly shortened because of an error in a hospital that is a preventable error.”

Time for updated data

The IOM “To Err is Human” report, now 14 years old, used some data that was already 15 years old; one of the two estimates of deaths due to medical errors came from data that was collected from discharge records in 1984 as part of the Harvard Medical Practice Study. Many things have changed in the three decades since that time, including medical technology and other factors that have contributed to an increasingly complex health care system.

“I thought it was time for a new estimate,” said James.

James analyzed data from four newer studies to develop an evidence-based estimate of “lethal PAEs,” or preventable adverse events. The four studies all used two-tier approaches to screen medical records and determine if an adverse event had occurred, and they all used the Institute for Healthcare Improvement’s Global Trigger Tool for Measuring Adverse Events as the primary screening method, with some variations in additional tools.

Patricia McGaffigan: IOM To Err is Human report has old data.
Patricia McGaffigan, RN, MS, chief operating officer and senior vice president at the National Patient Safety Foundation, said that the IOM "To Err is Human" report has become dated.

Patricia McGaffigan, RN, MS, chief operating officer and senior vice president of the National Patient Safety Foundation, agreed that the IOM report’s numbers had become dated and were based on the evidence that was available at the time.

“I think the more systematic way that we’re approaching the incidence of preventable adverse events is a positive step in the right direction,” she said.

James also noted that there are still limits to the four studies that must be considered. For one, there are limits to the Global Trigger Tool (GTT). It still misses errors of omission and diagnostic errors. The GTT also cannot pick up on information that is not entered into the medical record, which shows the importance of keeping medical records as accurate as possible.

Also, none of the four studies could be used alone to “provide a defensible estimate for hospitals across the United States.” The combination was necessary to provide that evidence-based estimate.

Responses to the new estimate

Several prominent experts have expressed their support for James’ research and new estimates, including Lucian Leape, MD, a leading expert on patient safety who served on the IOM committee that produce the 1999 report. He told ProPublica that even the IOM committee knew that their estimate was low--and that medicine’s complexity has evolved since then, leading to the likelihood of even more mistakes.

However, the American Hospital Association (AHA) has some reservations about the study’s new estimates and questions the methodology used to attain them, said Akin Demehin, AHA’s senior associate director for policy. So the AHA will continue to refer to the IOM data.

Regardless of the numbers used, the AHA remains committed to identifying the causes of preventable adverse events and the implementation of process to reduce or eliminate them, Demehin said.

“We absolutely agree that one preventable adverse event is one too many,” he said.

McGaffigan said she hopes that people will not get distracted by debating about the specific numbers of deaths due to medical errors. While the National Patient Safety Foundation believed that the IOM report’s numbers were probably lower than what was occurring, the fact is that any number of deaths is too large.

“The issue for us is the reality that deaths due to preventable adverse events is a major problem, whether it’s 100,000 or 400,000 or a million people,” she said. “Our goal is to get it to zero.”

An ‘outcry for overdue changes’

“One must hope that the present, evidence-based estimate of 400,000+ deaths per year will foster an outcry for overdue changes and increased vigilance in medical care to address the problem of harm to patients who come to a hospital seeking only to be healed,” James wrote in the study’s conclusion.

"I want people to take it seriously without being alarmed. It is what it is,” he said. “But I want the people with power to be a little alarmed."

McGaffigan said that leaders demonstrate their commitment to patient safety so that everyone else can follow their example.

“The burden for addressing this problem really has to fall upon the leaders in our health care society,” she said. “It’s not optional.”

James acknowledged that the health care system is very stressed today--and so are the people who work within it. But having lost his own 19-year-old son as the result of medical error in 2002, James hopes that his estimates will make people seriously consider the problem and the changes that must be made to address it.

“We can do better,” he said.

Related articles and resources:
Physicians, Patients and Errors: Exercising the Right Amount of Disclosure
High Rate of Medical Mistakes: Patient Perception or Reality?
Preventing Never Events: Evidence-based Nurse Staffing - white paper (PDF)

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