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The Seattle jurist finds that Olympus Corp. failed to properly disclose evidence that it knew of concerns about cleaning problems with its redesigned medical scopes years before they hit the market and were linked to dozens of deaths. The company maintains the devices were not defective and intends to appeal.
The inspector general at Health and Human Services says defective pacemakers or defibrillators had to be replaced from 2005 through 2014, costing Medicare $1.5 billion.
Agency says a removable cap will lower the risk of antibiotic resistant infections but some experts see it as a modest step in curbing the sort of deadly outbreaks that occurred a few years ago.
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In the first case of its kind in the U.S., the company was ordered to pay damages to the hospital where a patient died of an infection linked to a contaminated scope. But jurors also found the hospital negligent, and it was ordered to pay the patients’ family $1 million.
LivaNova plant in Germany is the likely source behind outbreak that has sickened more than 100 people since 2013.
The Seattle case, the first to reach trial in the U.S., offers possible glimpse into fate of some two dozen lawsuits against manufacturing giant Olympus, accused of failing to address scope contamination linked to numerous deaths. The company faults poor hospital cleaning practices.
Casi todos los estadounidenses con marcapasos -y personas en todo el mundo- caminan portando partes fabricadas en Tijuana, México, en donde se ha creado una industria que podría estar en riesgo si la administración Trump cambia el juego del comercio global.
The medical supply industry makes a particularly revelatory case study of the difficulties of untangling global trade.
A new study, though small, finds extensive damage to commonly used medical scopes that could trap dangerous bacteria. That raises concerns about the potential for more outbreaks.
The FDA and other agencies are loosening restrictions on hearing aid sales and opening the door to less expensive, over-the-counter products.
Lawyers who deposed top company officials in a civil case say they declined to answer questions about their failure to warn American hospitals of infection risks. Industry giant Olympus also is the subject of a criminal probe.
Small manufacturers are betting that disposable medical scopes will slash the risk of infection during procedures. Some doctors are skeptical of the cheaper models.
The federal agency took 14 months to warn the public about the potential for infections. Officials say they acted as fast as they could.
Why an obscure revenue raiser for the Affordable Care Act has found its way into a number of congressional campaign ads.
The agency found several prominent facilities had not followed rules on reporting incidents in which patients were harmed.
The FDA confirms it is looking into more than one problem with the compressor, which is used to power patients’ artificial hearts.
High-intensity focused ultrasound, often not covered by insurance, leads to discussions about which patients benefit in the real world.
The drug’s manufacturer says it has an expiration date of 12 to 18 months but that includes distribution time, so many customers find they have to buy a new device at least once a year.
A closer look shows that industry lobbying was just one factor in EpiPen’s sales explosion.