Often, what patients catch in the hospital can be worse that what sent them there in the first place.
The recent spread of a "superbug" in two California hospitals is the latest example of what can go wrong – from approving a medical device through the Food and Drug Administration to reporting subsequent issues, notifying the Centers for Disease Control and Prevention of emerging infections, and following up so patients can be quickly protected.
"What [doctors and nurses] are expected to report to the hospital and to the government is expanding," says Dr. Don Goldmann, chief medical and scientific officer at the Institute for Healthcare Improvement.
States vary on what type of reporting they require, and while enforcement has become more stringent in recent months, it has done so only on a few fronts.
Health care-associated infections remain an ongoing problem in hospitals. Nationally, about one in every 25 hospitalized patients gets an infection, and a 2013 report from the Journal of Patient Safety showed that medical errors are the third-leading cause of death in the country. Still, some evidence suggests there has been progress. A report published by the Department of Health and Human Services in December showed the U.S. decreased hospital-acquired conditions decreased by 17 percent in the U.S. from 2010 to 2013.
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In California and elsewhere, a faulty design led to the spread of the antibiotic-resistant bacteria, or "superbug," trapped in duodenoscopes, medical devices used to diagnose and treat cancer and gallstones. Experts have said that even when cleaned between patients for reuse, scopes can harbor deadly bacteria.
The infection is typically seen in people who are exposed to health care settings like hospitals or nursing homes, and carries a 50 percent chance of death if it spreads into the bloodstream.
FDA data show 135 infections were reported from 2013 to 2014, and in 2009 the agency warned of the device's potential dangers. Some members of Congress have questioned why the agency didn't act even faster.
Leslie Wooldridge, press officer at the FDA, told U.S. News in an email that the agency has been actively working with federal partners, manufacturers and other stakeholders to better understand the issues that contribute to the infections and what can be done to mitigate them.
In recent weeks the bacteria spread to seven patients at UCLA Ronald Reagan Medical Center, contributing to two deaths. Cedars-Sinai Medical Center in Los Angeles announced Wednesday that four patients who underwent the procedures were infected, and since 2012, infections linked to the procedure occurred at Advocate Lutheran General Hospital in Illinois, where 44 people were infected, and at the Virginia Mason Medical Center in Seattle, where at least 32 patients became ill and 11 died. The bacteria also infected 18 in North Carolina and was linked to two deaths. Hospitals maintain it isn't clear whether the bacteria played a significant role in any of the deaths.
Every year, device makers, patients and health care providers report several hundred thousand instances of malfunctions, injuries or even deaths suspected to be linked to medical devices. While manufacturers are required to report these issues, the system is voluntary for health care professionals. FDA data show 75 complaints against the device that spread the deadly bacteria, though this total is likely a low estimate given that reporting the issues is not required. However, the agency also had received warnings from the CDC and Sen. Patty Murray, D-Wash., sent a letter in early February to FDA Commissioner Margaret Hamburg urging the agency to address the issue publicly.
FDA review of these types of reports can result in various outcomes, including regulatory guidelines, letters to the manufacturer, or even in no action when it is found that a human error is to blame for device malfunction.
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Though the FDA issued a warning about the duodenoscopes , it is not recommending that health care providers cancel the procedures for patients who need them, and is not taking action against the company. "We consider the public health impact of a recall and whether the risk of recalling the device from user facilities presents a greater health risk than of not recalling the device from use," Wooldridge said in an email to U.S. News. Removing the item would lead to a shortage in the devices. They are used in 500,000 procedures each year and have no substitute.
"We do the [procedures] because they're needed," says Marc-Oliver Wright,board member at the Association for Professionals in Infection Control and head of Infection Control and Quality at NorthShore University HealthSystem in Evanston, Illinois. "We c an't just pull them off the shelf. ... The appropriate response is for infection preventionists to identify where the risks are and to c losely monitor all patients.
"The last thing you want is patients not having them while they need them."
Despite the voluntary reporting nature for devices and for the superbug, medical professionals do have plenty of other required reporting – depending on where they live. Twenty states have rules about specifically reporting on the superbug.
California, where the latest outbreaks have occurred, is not one of them. Rep. Ted Lieu, D-Calif., has said he plans to introduce a law soon that would require hospitals to report cases of the bacteria to the CDC. In a letter he sent Feb. 23, he also called for the House Committee on Oversight and Government Reform to hold a congressional hearing.
Hospitals often do report new infections to their local public health departments. The process of investigation is rarely simple, experts say. "Every time you report something, there’s an investigation, local department of public health could come in," Goldmann says. "You're triggering a whole series of events that takes time."
Chantal Worzala, director of policy at the American Hospital Association, told U.S. News in an email that hospitals are concerned by the lack of focus of current reporting requirements, including the sheer volume of data collected and reported. "It deters staff from actually working on the improvements needed if they are spending an extraordinary amount of time collecting data," she says. "A more focused approach would ensure a better balance of provider resources between sharing data for the public reporting websites and improving care."
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She went on to say, however, that when a new infection emerges, it takes priority. "Hospital leaders and the doctors and nurses who care for the patients know they need to invest time and resources into understanding what has cause this outbreak and how to contain it," she says.
At the federal level, health care providers already must report six different kinds of infection, including MRSA, or methicillin-resistant Staphylococcus aureus. They also must report Clostridium difficile, which can cause diarrhea and be fatal. The government does not report the rates of the superbug at individual hospitals.
Increasingly, however, the federal government is penalizing hospitals for infections. Hospitals since October are receiving lower payments from Medicare for specific injuries or infections. Though the superbug isn't one of them, MRSA and C. diff. are.
"I'm sure [reporting] can be cumbersome to organizations with a lot of competing priorities," says Lisa Waldowski, infection control expert for the Joint Commission, a health care accreditation group. "But how would we know where we are if we don’t have some means to identify and report this?"
For its part, the Joint Commission has a "Sentinel Event Policy" where hospitals can voluntarily report events that have been harmful to patients or resulted in death.
Electronic medical record keeping systems may hold the key to better reporting, though Worzala says it has yet to live up to its promise of reducing the burden of quality reporting under federal programs. The federal government has created incentive programs for hospitals to adopt the systems.
“It’s interesting to consider how health IT and big data analysis allow us to identify issues more efficiently [than in the past],” Dr. John Allen, president of the American Gastroenterological Association, said in an email. “Electronic medical records can help identify common features of adverse events and help us pinpoint the issue and make changes to improve patient safety.”
Goldmann says the FDA is counting on "big data," and hoping some day to have all devices tracked with a chip that would upload data on performance.
"Within a decade this kind of protection is going to be different and close to real time," he says. "Relying on people’s vigilance just isn’t efficient."
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