Thursday, 28 July 2016
Wednesday, 27 July 2016
The federal government released its first overall hospital quality rating on Wednesday, slapping average or below average scores on many of the nation's best-known hospitals while awarding top scores to dozens of unheralded ones.
The Centers for Medicare & Medicaid Services rated 3,617 hospitals on a one- to five-star scale, angering the hospital industry, which has been pressing the Obama administration and Congress to block the ratings. Hospitals argue the ratings will make places that treat the toughest cases look bad, but Medicare has held firm, saying that consumers need a simple way to objectively gauge quality. Medicare does factor in the health of patients when comparing hospitals, though not as much as some hospitals would like.
Just 102 hospitals received the top rating of five stars, and few are those considered as the nation's best by private ratings sources such as U.S. News & World Report or viewed as the most elite within the medical profession.
Medicare awarded five stars to relatively obscure hospitals and at least 40 hospitals that specialize in just a few types of surgery, such as knee replacements. There were more five-star hospitals in Lincoln, Neb., and La Jolla, Calif., than in New York City or Boston. Memorial Hermann Hospital System in Houston and Mayo Clinic in Rochester, Minn., were two of the nationally known hospitals getting five stars.
Medicare awarded the lowest rating of one star to 129 hospitals. Five hospitals in Washington, D.C., received just one star, including George Washington University Hospital and MedStar Georgetown University Hospital, both of which teach medical residents. Nine hospitals in Brooklyn, four hospitals in Las Vegas and three hospitals in Miami received only one star.
“Consumers can use this trustworthy program to compare hospitals side by side,” said Debra Ness, president of the National Partnership for Women & Families, a Washington nonprofit. “This is a huge step forward.”
Some premier medical centers received the second highest rating of four stars, including Stanford Health Care in California, Duke University Hospital in Durham, N.C., New York-Presbyterian Hospital and NYU Langone Medical Center in Manhattan, the Cleveland Clinic in Ohio, and Penn Presbyterian Medical Center in Philadelphia. In total, 927 hospitals received four stars.
Medicare gave its below average score of two-star ratings to 707 hospitals. They included the University of Virginia Medical Center in Charlottesville, Beth Israel Medical Center in Manhattan, North Shore University Hospital (now known as Northwell Health) in Manhasset, N.Y., Barnes-Jewish Hospital in St. Louis, Tufts Medical Center in Boston and MedStar Washington Hospital Center in D.C. Geisinger Medical Center in Danville, Pa., which is a favorite example for national health policy experts of a quality hospital, also received two stars.
Nearly half the hospitals - 1,752 - received an average rating of three stars. Another 1,042 hospitals were not rated, either because they did not have enough cases for the government to evaluate accurately, or, as with all Maryland hospitals, Medicare does not collect the necessary data.
Medicare based the star ratings on 64 individual measures that are published on its Hospital Compare website, including death and infection rates and patient reviews. Medicare noted that specialized and “cutting-edge care,” such as the latest techniques to battle cancer, are not reflected in the ratings.
Dr. Elizabeth Mort, chief quality officer at Massachusetts General Hospital in Boston - which Medicare awarded four stars - said Medicare should have factored in attributes of each hospital, such as what kind of services it offered and how the nursing profession assesses the staff quality.
“On a scale of 1 to 5, a 4 or 5 is not a bad score, but I don't put any credence in this,” she said. “Don't clutter it up with measures that have no place being there,” such as infection and readmission measures that she said were not well designed to compare dissimilar hospitals.
Steven Lipstein, the president of BJC HealthCare, which runs Barnes-Jewish Hospital and a 13 others, said that Medicare awarded between two and four stars to the system's hospitals, even though they all “employ the same standards, the same methodology, the same clinical guidelines.” The major difference, he said, was the comparative affluence of the patients each served, with poorer scoring hospitals located in lower income areas.
“The stars tell you more about the socio-demographics of the population being served than the quality of the hospital,” he said in an interview.
Dr. Kate Goodrich, who oversees Medicare's quality ratings, said in a statement that it has been using the same type of rating system for other medical facilities, such as nursing homes and dialysis centers, and found them useful to consumers and patients. Those ratings have shown, she said, “that publicly available data drives improvement, better reporting, and more open access to quality information for our Medicare beneficiaries.”
In a statement, Rick Pollack, president of the American Hospital Association, called the new ratings confusing for patients and families. “Health care consumers making critical decisions about their care cannot be expected to rely on a rating system that raises far more questions than answers,” he said. “We are especially troubled that the current ratings scheme unfairly penalizes teaching hospitals and those serving higher numbers of the poor.”
A preliminary analysis Medicare released last week found hospitals that treated large numbers of low-income patients tended to do worse. Medicare does not consider patients' social and financial situations in rating hospitals.
A sizable proportion of the nation's major academic medical centers, which train doctors, scored poorly, according to a Kaiser Health News analysis. Out of 288 hospitals that teach significant numbers of residents, six in 10 received below-average scores, the analysis found. Teaching hospitals comprised one-third of the facilities receiving one-star. A number were in high poverty areas, including two in Newark, N.J., and three in Detroit.
“Hospitals cannot be rated like movies,” Dr. Darrell Kirch, president of the Association of American Medical Colleges, said in a statement. “We are extremely concerned about the potential consequences for patients that could result from portraying an overly simplistic picture of hospital quality with a star rating system that combines many complex factors and ignores the socio-demographic factors that have a real impact on health.”
This story has been updated to add additional comments and KHN analysis of the Medicare ratings.
A U.S. lawmaker is renewing his push for Congress to toughen requirements on medical-device warnings, calling Olympus Corp.'s 2013 decision against issuing a broad alert to U.S. hospitals about scope-related superbug outbreaks “despicable.”
Rep. Ted Lieu, a Democrat from California, said internal Olympus emails about that decision, detailed for the first time in a Los Angeles Times/Kaiser Health News article on Sunday, were “incredibly disturbing” and the company officials involved should face questions at a Congressional hearing. At least 35 patients in American hospitals have died since 2013 after developing infections tied to tainted duodenoscopes.
In company emails from February 2013, a senior executive at Olympus' Tokyo headquarters told its U.S. managers not to issue a broad warning to American hospitals despite reports of scope-related infections in Dutch, French and U.S. hospitals. The executive added that they could respond to questions from a customer.
The company had issued an alert to European customers a month earlier but chose not to do so in the U.S. until last year.
The emails were filed in a Pennsylvania court this month as part of a patient lawsuit and obtained by Kaiser Health News working in collaboration with the Los Angeles Times.
“Olympus' actions in this case were despicable,” Lieu said. “They knowingly failed to warn hospitals and patients of their defective scopes.”
After the company opted against a U.S. alert in early 2013, Virginia Mason Medical Center in Seattle discovered an outbreak involving contaminated gastrointestinal scopes manufactured by Olympus. The hospital said 39 patients eventually became infected and at least 18 of them died. The hospital acknowledged that the patients who died had other underlying illnesses.
Hospital patients in Los Angeles, Charlotte, Denver and other cities were also sickened by antibiotic-resistant bacteria, known as superbugs, after being treated with Olympus duodenoscopes.
“We are very troubled by the now very clear facts that Olympus in Japan knew of the infection problems with their duodenoscopes long before the outbreaks we saw in America, and chose not to warn physicians,” said Dr. Andrew Ross, section chief of gastroenterology at Virginia Mason Medical Center.
“If they had done so, physicians could then determine what is best in how to treat and advise their patients,” Ross said.
Virginia Mason is suing Olympus for fraud and misrepresentation in Washington state court. In court documents, Olympus denies the allegations and contends that the hospital failed to follow the instructions for cleaning the scopes.
Lieu filed a bill in April, known as the Device Act, which would make it mandatory for device makers to share safety alerts more widely, including those issued abroad.
Under the proposed legislation, companies would have to notify the Food and Drug Administration when they issue safety warnings in other countries related to the design and cleaning of their devices. The legislation also would require manufacturers to notify the FDA when they change the design or cleaning instructions of their devices, regardless of whether those changes warrant new government approval.
Lieu said he will press lawmakers to take up the bill in September when Congress reconvenes.
“This is why Congress needs to act and pass legislation to make sure this doesn't happen again as well as hold a hearing,” Lieu said. “I believe it is now time for the decision-makers at Olympus to be held accountable and for Congress to hear what they have to say.”
Olympus didn't have an immediate comment when reached Tuesday. The company has said previously that patient safety is a top priority and it is “working with the proper authorities and our stakeholders to understand and address the potential root causes” of contamination and infection tied to duodenoscopes.
Federal prosecutors are investigating Olympus and two other smaller scope manufacturers over their role in the superbug outbreaks at U.S. hospitals. In California, UCLA's Ronald Reagan Medical Center, Cedars-Sinai Medical Center and Pasadena's Huntington Hospital all have reported infections linked to Olympus scopes.
At those three hospitals, 28 infections have been reported and 14 of the patients later died. Some of the patients who died were seriously ill and the role of the infection in their deaths is unclear.
Lieu has introduced an additional bill, a companion to legislation that Sen. Patty Murray (D-Wash.) has filed, requiring that the cleaning instructions for medical devices be scientifically validated to ensure they work.
The duodenoscopes are long, flexible devices that are put down a patient's throat during a procedure known as ERCP, or endoscopic retrograde cholangiopancreatography. Nearly 700,000 such procedures are performed annually in the U.S.
Olympus holds an 85 percent share of the U.S. market for these devices and other specialty endoscopes. Pentax and Fujifilm are two other manufacturers.
Overall, as many as 350 patients at 41 medical centers worldwide were infected or exposed to contaminated scopes made by the three manufacturers from January 2010 to October 2015, according to the FDA.
Last summer, Linda Smith learned she was losing significant cartilage in her knees, a consequence of her lifelong love of skiing, running and ultimate frisbee.
Diagnosed with osteoarthritis, she wanted to avoid surgery and was eager to consider alternatives.
So the 56-year-old Morgan Hill, Calif., resident embarked on a search for clinical trials, which test potential treatments on human subjects. She scoured the government-run website, ClinicalTrials.gov, focusing on a form of stem cell therapy - a promising but unproven approach for her condition.
She thought she'd scored with StemGenex, a clinic in La Jolla, and called to inquire. The screener asked a long list of questions, then dropped a bomb: If Smith wanted in, she'd have to pay “associated” costs.
Total charge: $14,000.
“I was outraged,” Smith said. Her anger only grew when the screener suggested she could raise the money, as other callers had, through family and friends in an online GoFundMe campaign, she said.
Smith, a retired hospital administrator, knew enough about clinical studies to understand that the $14,000 price tag was unusual. Most trials are free and some even pay people to participate, in recognition of the possible risks and inconvenience involved.
The ClinicialTrials.gov website, run by the National Institutes of Health (NIH) through its National Library of Medicine, is the most comprehensive such database available to the public in the United States, with listings for more than 210,000 clinical studies both here and abroad. But Smith's experience exposes one of its little-known limitations: It does not require trial sponsors to disclose charges to patients - and does not even independently vet the listings.
“I went back to the website and looked at the study again. It doesn't say that patients are the funding source,” said Smith, who refused the $14,000 proposal. “I was disappointed in the NIH. I thought, 'Why are you letting this occur?'”
StemGenex denies that it charges for participation in its clinical study. It says it only charges for the treatment that is being studied and that participation in the study is separate and voluntary.
Some ethicists and other experts who shared Smith's concern said that's a false distinction. If trial sponsors require participants to pay, they said, the government website ought to let people know.
They argued that ClinicalTrials.gov's failure to disclose charges by trial sponsors misleads consumers and allows the site to become a marketing tool for pay-to-play research.
“It's unethical that these companies are saying, 'Sure, come take part in our study and by the way, we're going to charge you for the privilege',” said Alison Bateman-House, a postdoctoral fellow in medical ethics at the New York University School of Medicine. “If you're going to be charging patients for the opportunity to be involved in the study, they should not be allowed to be listed on ClinicalTrials.gov, or at least the cost should be listed on the site.”
She and others worry that many patients seeking to participate in clinical trials might be desperately sick or in pain, and vulnerable to requests for money they don't have. These patients see the website's “.gov” domain and the NIH imprimatur as stamps of approval that mean the research is legitimate, these critics say.
“The average patient and even people in health care … kind of let their guard down when they're in that database. It's like, 'If a trial is listed here, it must be OK',” said Paul Knoepfler, an associate professor at the University of California, Davis, School of Medicine who writes a blog about stem cell research. “Most people don't realize that creeping into that database are some trials whose main goal is to generate profit.”
Leigh Turner, an associate professor at the University of Minnesota Center for Bioethics, said it's not clear if this phenomenon is only occurring with stem cell studies, but the surge in stem cell research - and in clinics offering high-priced, unproven treatments - has intensified the problem.
“It's not just a handful of patients who are encountering these kind of so-called studies on ClinicalTrials.gov and not just a handful of studies,” he said. “It is a bigger problem than that.”
Asked whether costs should be disclosed on ClinicalTrials.gov, Dr. Rebecca Williams, assistant director of the website, said “that's a valid question.”
As a practical matter, she said, “that has been information we don't collect in a systematic way and nor is it available. We have no way to know whether they're for-profit or not, and don't have a policy that would exclude them.”
I was disappointed in the NIH. I thought, 'Why are you letting this occur?'
Williams pointed to the website's disclaimer that the government is not liable for and does not “make any warranties” about information in the database. She also noted that the site suggests questions for consumers to ask, including, “Who will pay for my participation?”
Williams stressed that the website is intended primarily as a “clearinghouse” of listings, and that just because a study is there “does not necessarily mean an endorsement by the federal government.”
It means that the study sponsors have attested that the information they're submitting is complete and that their research complies with “all of the applicable regulations that may apply,” she said.
The website is not legally required to independently verify the information provided by study sponsors. ClinicalTrials.gov relies heavily on the honor system, Williams said.
Study sponsors who wish to list their studies on the website register online and must provide a variety of details, including, in most cases, information about the committees that oversee the welfare and treatment of human subjects.
Thanks to a 2007 law, changes will be made to the website's listings and requirements, possibly by the end of this year. But Williams said it's “unlikely” they will include disclosures of costs to patients.
Generally speaking, the U.S. Food and Drug Administration (FDA) regulates clinical trials of medications and medical devices, and sets guidelines that determine when patients can be charged. But stem cell research, which often uses a patients' own cells for treatment, can fall into a gray area, and what requires FDA approval is sometimes unclear or in dispute.
StemGenex says it does not charge anyone for the osteoporosis study listed in ClinicalTrials.gov.
“StemGenex's study is intended to be an observational study comparing two sets of data - before and after stem cell treatment,” Candace Henderson, the clinic's vice president of operations, said in a prepared statement.
The way she explained it, patients who first pay for the company's stem cell treatment can then “volunteer” to participate in the long-term observational study of how well the treatment works.
“The actual treatment is not part of the study protocol,” Henderson said. She declined to share a copy of the protocol, saying it “is proprietary to StemGenex.”
But the reality is that patients who want to participate in research like this must first shell out thousands for the stem cell treatment, University of Minnesota's Turner said. In effect, he said, they pay to play.
StemGenex says it invests revenue from its clinical trials “in innovation and research to further the development and advancement” of therapies. It has four other studies listed on the NIH website: for Parkinson's disease, multiple sclerosis, rheumatoid arthritis and chronic obstructive pulmonary disease. In those cases, too, participants “are recruited from among patients who are having stem cell treatment,” Henderson said in the company statement.
On its website, the company explains that it harvests dormant stem cells from a patient's fat through “a mini-liposuction” and isolates the cells from the fat. The cells are then “activated with the patient's growth factors,” and infused back into the patient. The stem cells then “follow inflammatory signals from damaged tissues and have multiple ways of repairing these damaged areas.”
The company, which describes itself as “the premiere leader in the United States for regenerative medicine,” says it offers a “a concierge approach to treatment,” which includes covering the cost of its patients' hotel accommodations and a car service that “will be waiting for you at the airport baggage claim when you arrive.”
The company acknowledges that its procedures - like most stem cell treatments - are not FDA-approved. On its website, however, StemGenex underscores that its studies are “registered through The National Institutes of Health which can be found at http://www.clinicaltrials.gov.”
“By providing patients access to stem cell studies registered through The National Institutes of Health, patients now have the ability to choose treatment for osteoarthritis that focuses on both safety and efficacy,” it says.
Also on its website, the clinic says that having studies registered on ClinicalTrials.gov gives it a “significant advantage compared with treatment centers offering unregistered studies.”
Turner called the messages misleading, because they suggest the NIH has vetted the clinic's osteoarthritis and other studies. “In fact, nobody at the NIH or in our government has necessarily, or even likely, looked at this study,” he said.
He pointed to other stem cell clinics posting on ClinicalTrials.gov that ask patients to pay, including one in Rancho Mirage that is conducting a study on stem cell treatment for conditions such as emphysema, osteoarthritis and erectile dysfunction.
Knoepfler said he used to direct patients to ClinicalTrials.gov, but then, “I started realizing, 'wait a minute … there are listings on that website that are not what I thought would be on ClinicalTrials.gov.'”
He and other critics would like to see ClinicalTrials.gov reevaluate its position on allowing for-profit trials to post on the website.
“It's one of the best sources we have, but there's still room for misleading and incomplete information, and I would imagine in some cases, there are people preying on desperate patients, even on the ClinicalTrials.gov registry,” said Ken Getz, an associate professor at Tufts University School of Medicine, and founder of the Center for Information and Study on Clinical Research Participation.
Tuesday, 26 July 2016
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Sunday, 24 July 2016
Faced with superbug outbreaks in three countries by early 2013, Japanese device giant Olympus Corp. told U.S. executives not to issue a broad warning to American hospitals about potentially deadly infections from tainted medical scopes, internal emails show.
After two dozen infections were reported in French and Dutch hospitals, the company alerted European customers in January 2013 that a scope it manufactured could become contaminated.
A top Olympus executive in the U.S. grew concerned because the company was investigating a similar outbreak at a Pittsburgh hospital.
“Should [we] also be communicating to our users the information that [Olympus Europe] is communicating to their European users?” Laura Storms, vice president of regulatory and clinical affairs in Center Valley, Pa., asked in an email to Tokyo headquarters on Jan. 31, 2013.
No, that's not necessary, said Susumu Nishina, the company's chief manager for market quality administration in Tokyo in a Feb. 6, 2013, reply.
It is “not need[ed] to communicate to all the users actively,” Nishina wrote, because a company assessment of the risk to patients found it to be “acceptable.” However, he added that Storms should respond to questions from a customer.
Outbreaks of infection at hospitals in Los Angeles, Milwaukee, Denver and other cities followed over the next three years. All told, at least 35 people at U.S. hospitals have died since 2013 after suffering infections from contaminated gastrointestinal scopes manufactured by Olympus, according to hospitals and public health officials.
Olympus' actions - and inaction - are being closely examined in lawsuits by American patients and their families who contend that the manufacturer was negligent and might have prevented the outbreaks and deaths had it been more forthcoming. In addition, federal prosecutors are investigating Olympus' handling of the infections - and the emails could become crucial evidence in any future case.
The company's internal emails, filed in a Pennsylvania court this month as part of a patient lawsuit, reveal conflicts inside Olympus over how to respond to a growing threat to patient safety, pitting U.S. executives against their superiors in Japan who had the final say.
Olympus, which controls 85 percent of the U.S. market for gastrointestinal scopes, declined to comment on the emails, citing the pending litigation. It also declined to discuss the ongoing investigation by the U.S. attorney's office in New Jersey.
Storms, Nishina and other company officials named in the emails didn't respond to requests for comment.
In a statement, the company said “patient safety is our top priority. The duodenoscope issue continues to receive the highest level of attention at Olympus, and we remain committed to working with the proper authorities and our stakeholders to understand and address the potential root causes.” The company declined to address why it didn't feel it was necessary to inform U.S. hospitals when it was alerting those in Europe.
At the time of the safety alert in Europe, Olympus was already aware that design flaws could make it difficult to clean its duodenoscope for the next patient. Used in about 700,000 procedures annually in the U.S., the snake-like device is put down a patient's throat to diagnose and treat problems in the digestive tract such as cancers and blockages in the bile duct.
As the Los Angeles Times reported in December, an investigator hired by Olympus and a Netherlands hospital concluded in a June 2012 report that the scope's design could allow blood and tissue to become trapped, spreading bacteria from one patient to another. The independent expert called on Olympus to conduct a worldwide investigation and recall all its scopes if similar problems turned up.
A Senate report released this year said Olympus knew about at least three outbreaks - at hospitals in the Netherlands, France and Pittsburgh - affecting an estimated 46 patients when the European alert went out in early 2013.
Inside Olympus, the debate about how to respond to the emerging outbreaks in the U.S. came to a head on Feb. 6, 2013, the emails show.
Just a few hours after her exchange with the Tokyo official, Storms was confronted by her own U.S. staff.
Donny Shapiro, a director of regulatory affairs for Olympus in San Jose, Calif., sent an email to Storms and seven other employees with “Duodenoscope safety recall??” in the subject line. He cited the problems in Europe and results from the company's microbiology lab showing Olympus scopes had tested positive for bacteria at the University of Pittsburgh Medical Center.
“Why was the alert only issued in Europe?” Shapiro asked his colleagues.
Six minutes later, Storms wrote back: “Donny, [Olympus Japan] has determined that a global communication is not required.”
In these emails, Storms seemed to accept the decision by the corporate office. But in other messages to headquarters that same day, she challenged Japan executives' handling of the investigation into the University of Pittsburgh Medical Center, or UPMC, outbreak. The hospital initially linked one contaminated scope to 18 sickened patients but later downgraded that total to one case.
In a follow-up email to Nishina, Storms questioned the company's determination that the hospital was at fault by failing to clean the scopes properly - known as “insufficient reprocessing.”
“Can you please explain how OMSC [Olympus Japan] reached the conclusion that insufficient reprocessing was the cause for this MDR [medical device injury report]? Since OMSC was not on-site at UPMC and did not investigate this facility, how is OMSC reaching this conclusion?” she asked.
“Specifically what evidence does OMSC have that supports inadequate reprocessing by UPMC? You do not cite any objective findings, testing, etc. for this endoscope model,” Storms wrote.
Nishina replied that the company's cleaning instructions work when followed and “no major observations were noted during the inspection” of the scope in question. In the emails, he discounted lab results showing bacterial growth on Olympus scopes, suggesting that contaminants could have been introduced during testing.
This became the company's standard response in the U.S. after each outbreak over the next two years, according to federal injury reports, company documents and interviews with hospitals. Olympus contended that its scopes did not cause the infections and blamed the hospitals for not cleaning the reusable instruments properly. The company treated each case as an isolated incident, not telling hospitals about outbreaks elsewhere in the U.S.
Pressure on the company increased in January 2014 when physicians representing the American Society for Gastrointestinal Endoscopy asked Olympus to fund testing at hospitals on the effectiveness of scope cleaning against antibiotic-resistant bacteria. Though Olympus months later contributed to the research, the initial response was cautious.
In Tokyo, Shigeki Okuno, who worked in regulatory affairs and quality assurance, expressed concern about getting a “negative result” due to improper testing procedures. Okuno suggested that the company have a hand in the testing by providing the data itself or working closely with the medical society.
In March 2014, an infection-control expert at the University of North Carolina's School of Medicine raised more red flags in an email to Olympus, according to the correspondence filed in court.
William Rutala, a UNC professor of infectious diseases, notified the company that 40 percent of scopes tested at his academic medical center were contaminated, even after following the company's cleaning protocol.
“This is a critical issue for U.S. hospitals to resolve/understand to ensure patient safety and I need your input,” Rutala wrote to Mary Ann Drosnock, head of infection control at Olympus in the U.S. at the time. “Despite substantial time and effort we have been unable to discover the exact cause of these positive cultures and implement a strategy to prevent contamination.”
Drosnock shared the information with officials at Olympus under the subject line “Urgent: Confidential.”
Rutala declined to comment for this story on the test results at North Carolina or the company's response.
The U.S. Food and Drug Administration began looking into reports of scope-related infections in September 2013. By May 2014, the government investigation was intensifying and the agency requested information from Olympus on a “potential safety concern involving infections,” according to FDA records and the company emails.
Storms forwarded the notice to the Tokyo headquarters and labeled it “urgent.”
“I am respectfully requesting that [Olympus Japan] assign their best English writers to work on this letter draft,” she wrote in her email. “Please give this FDA letter urgent priority. This letter is a clear indication of the FDA's concern.”
As Olympus carried out its decision not to warn American hospitals, the number of patient infections linked to dirty scopes continued to climb. Overall, as many as 350 patients at 41 medical facilities worldwide were infected or exposed to contaminated scopes made by Olympus or two other companies from January 2010 to October 2015, according to the FDA.
Eventually, in February 2015 - more than two years after Olympus first warned European hospitals - the FDA issued a safety alert saying that patients had become infected even when the manufacturer's cleaning instructions were followed correctly.
At the same time, Olympus notified customers that it was aware of 95 infection complaints in the U.S. about its newest duodenoscope model, and the scope required “careful attention to cleaning.”
The FDA alert came one day after an outbreak was reported at the Ronald Reagan UCLA Medical Center. Three patients died and five more were sickened after being treated with Olympus scopes there, according to UCLA. The university said one of the patients who died also had cancer.
Olympus didn't announce a U.S. recall of its duodenoscopes until January 2016 - two days after a congressional report criticized the company for failing to notify patients, doctors and hospitals sooner about a serious safety hazard.
The Olympus devices remain on the market and in use while the company recalls them for repairs. The recall is expected to be completed nationwide next month.
Some doctors and researchers say the problems will persist unless Olympus completely redesigns the duodenoscope to keep bacteria from becoming trapped in tiny crevices at the tip.
In the meantime, U.S. hospitals are trying a variety of new cleaning and surveillance methods to prevent more infections.
And patients are continuing to wage their legal fight against Olympus. The internal emails were filed in the pending Philadelphia County Court case of Daniel Nietzold, a patient in Gastonia, N.C.
Nietzold, who sued Olympus in February for negligence, said he was exposed to a contaminated scope during multiple procedures at Carolinas Medical Center in Charlotte between January 2013 and July 2015. The hospital declined to comment.
The company is fighting Nietzold in court, saying Nietzold had “failed to allege particular facts.” This month, the Philadelphia judge dismissed the Japanese headquarters as a defendant on jurisdictional grounds but allowed the case to proceed against the company's U.S. unit.
Pete Kaufman, a Los Angeles attorney representing Nietzold and nearly 20 other patients in scope-related lawsuits around the country, said the internal documents show that Olympus knew patients were in jeopardy but chose not to act.
Charles McIntyre of Waxhaw, N.C., another Kaufman client, said he suffered a superbug infection after being treated with an Olympus scope in February 2015 at the Charlotte hospital. The 61-year-old auto mechanic, who sued the device maker earlier this year in Philadelphia, said he's still struggling to regain his strength after spending much of last year in the hospital fighting the infection.
“Olympus had plenty of time to tell everybody in the U.S. that they had an issue with the scope,” McIntyre said. “I feel betrayed.”
Friday, 22 July 2016
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Thursday, 21 July 2016
Wednesday, 20 July 2016
Dr. Thomas Gallagher has been through many tough conversations with patients. He remembers once standing in front of a patient and the patient's family, preparing to tell them about a mistake that had occurred.
“This is a topic I think about all the time and it was still very nerve-racking and embarrassing,” said Gallagher, an internist and a professor at the University of Washington's medical school specializing in quality and patient safety issues. The patient had been sent to another clinic an hour away to get an MRI, but because of a miscommunication, the MRI was done in the wrong area of the body and would have to be repeated.
“The patient was disgusted,” Gallagher recalled about the event that occurred before he came to Washington. “His family was furious … that after all the patient had gone through to get this test … we still couldn't even figure out something this basic.”
Medical mistakes often happen. National guidelines call for doctors to provide full disclosure about adverse events, and studies have shown that those discussions benefit patients. But new research finds that the act of disclosure, combined with stress from the procedure gone wrong, can be an anxious experience for some doctors - and more training is needed to help them engage in these difficult conversations.
The study, published in JAMA Surgery Wednesday, examines what surgeons tell patients and what effect those discussion can have on the doctor.
“For a long time in the field, people thought that the primary reason that physicians have trouble reporting adverse events is that they were worried about being sued, but there are other barriers that are more important,” said Gallagher, one of the authors of the study. “This paper helps highlight how embarrassing and upsetting these events are for clinicians … (and) makes it difficult for the physician to admit to the patient, 'Here is exactly what happened.'”
The researchers used surveys of surgeons who reported adverse events at three Veterans Affairs medical centers. They found that about 90 percent of the surveys showed that doctors said they had disclosed the event to patients or their families within 24 hours, expressed concern for the patient's welfare, explained why the event happened, expressed regret and discussed with patients steps to treat subsequent problems.
But only about half showed the doctors discussed whether the event was preventable and a third reported they talked about how it could be avoided in the future. Just over half apologized to the patient.
The study also reported that those surgeons who find an event very or extremely serious and who had difficulty discussing that event are more likely to suffer anxiety over the experience. That was also true of surgeons who feared negative reaction from patients, an impact on their reputations, bad publicity or a malpractice suit.
“These surgeons who have volunteered to participate probably feel very comfortable talking to patients compared to those who didn't participate, and even among these surgeons there was a lot of anxiety,” said A. Rani Elwy, an associate professor at Boston University and an investigator and researcher at the VA Boston Healthcare System who was the lead author of the study. “I can only imagine it is much more accentuated among the bigger population.”
Initial questionnaires were administered to 67 surgeons between January 2011 and December 2013. Of those doctors, 35 contacted the researchers during the study period to report adverse events and filled out 62 individual surveys on those events. Surgeons could complete up to three surveys for the study.
Elwy said that the VA surgeons who participated in the study had not been taught how to deal with patients in these situations and the study called for more training to create a “culture of professionalism” that will help surgeons better handle patients' needs and allow for “self-care following disclosures [that] may also increase surgeons' well-being.”
“Lots of clinicians don't feel comfortable about these conversations, and doctors say they don't know what to say, they don't know how to say it,” Gallagher said. “I've had no training on having these conversations in medical school or residency.”
That's also a concern of Dr. Marjorie Stiegler, an associate professor of anesthesiology at University of North Carolina at Chapel Hill who was not associated with the study.
“Every physician, perhaps every clinician, at some point will have some kind of adverse event,” she said, adding, “It's never easy to break bad news to a family member of a loved one.”
She wrote an article in JAMA in 2015 arguing for more awareness of physicians' well-being when faced with clinical adverse events. She noted a study that found physicians were twice as likely to commit suicide than the general population and a survey documenting post-traumatic stress disorder symptoms among anesthesiologists involved in surgical deaths.
Gallagher said that in the case of the botched MRI he apologized to the patient and tried to help the family figure out the next steps.
“At the end of the conversation, while they were unhappy, they felt like they were getting care at an organization that would tell them if there was a problem,” he said.