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.
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.