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.”
After Olympus Corp. paid to fly three doctors from a prominent California hospital to Japan for a weeklong vacation, one of the physicians thanked the company for providing them with “so much extra entertainment that we did not expect.”
The superbug that raged through Bill Warner’s body after a routine medical scope procedure in early 2013 was so dangerous that his family was warned about entering his room at a time when he needed them most.
Scores of hospital patients treated with medical scopes were infected with potentially deadly bacteria because of repeated failures by manufacturers, regulators and hospitals to report outbreaks, according to a U.S.
Recent events involving scope-related outbreaks of antibiotic-resistant superbug infections 2010 August: Japanese device maker Olympus Corp. introduces its TJF-Q180V duodenoscope. 2012 April 23: An Olympus employee dismantles a duodenoscope suspected of infecting 22 patients at a Netherlands hospital.
A U.S. lawmaker is calling on the Securities and Exchange Commission to investigate Olympus Corp. in response to a Times article that detailed how the company kept selling its scopes despite warnings from a 2012 superbug outbreak in the Netherlands.
Amid an ongoing investigation into superbug outbreaks nationwide, U.S. regulators have ordered a Pennsylvania company to recall its scope-cleaning machines used at UCLA and more than 1,000 other hospitals and clinics.
In response to deadly superbug outbreaks, the Food and Drug Administration recommended extra steps that hospitals can take to clean medical scopes while work continues on redesigning the troublesome devices.
More than a year before a medical scope infected patients with a superbug at UCLA and Cedars-Sinai medical centers, a similar outbreak in the Netherlands prompted Dutch regulators to ask the manufacturer to prove the device was safe.
Nearly two years before superbug outbreaks hit UCLA and Cedars-Sinai medical centers, the maker of the scopes involved was already warning hospitals in Europe about the risk of such patient infections.
Under fire for selling a medical scope linked to superbug outbreaks, Olympus Corp. is pushing back against its critics and says the design of its product isn’t necessarily the sole cause for infections.
Patients across the nation continue to face considerable risk from medical scopes linked to deadly bacterial outbreaks due to basic design flaws and a lack of easy fixes, a federal panel was warned Thursday.
The cardiac surgeon had unknowingly spread a staph infection from the rash on his hand to the hearts of at least five patients by the time Los Angeles County health investigators learned of the outbreak.
The Food and Drug Administration, under fire for its slow response to superbug outbreaks from tainted medical scopes, said it will now require proof from manufacturers that new devices can be cleaned reliably.
In the latest superbug outbreak, Cedars-Sinai Medical Center discovered that four patients were infected with deadly bacteria from a contaminated medical scope, and 67 other people may have been exposed.
As more infections come to light from tainted scopes, several members of Congress are demanding answers from the Food and Drug Administration about what it knew about the risk beforehand and for how long.
The Food and Drug Administration, already under fire for its response to superbug outbreaks at U.S. hospitals, has tried and failed twice to get medical scope manufacturers to prove their controversial devices can be cleaned of deadly bacteria.
A senior Food and Drug Administration official voiced reservations about the new method UCLA’s Ronald Reagan Medical Center is using to clean medical scopes linked to an outbreak of antibiotic-resistant bacteria.
In the first lawsuit stemming from the superbug outbreak at UCLA, an 18-year-old patient accused a major healthcare device maker of negligence for selling a medical scope prone to spreading deadly bacteria.
Hospitals nationally are scrambling to figure out how to keep using a controversial medical device that benefits patients while avoiding another deadly bacterial outbreak like the one at UCLA Medical Center.
Nearly 180 patients at UCLA’s Ronald Reagan Medical Center may have been exposed to potentially deadly bacteria from contaminated medical scopes, and two deaths have already been linked to the outbreak.
UCLA hospital officials said they began investigating the possibility of a deadly bacterial outbreak in mid-December, but one patient’s account suggests they missed a chance to discover the problem much earlier.
The manufacturer of the medical scopes at the center of a deadly bacterial outbreak at UCLA Medical Center is under investigation by federal officials for possible violations of laws that ban improper payments to doctors and other customers.