FDA Warns Superbug-Prone Devices Makers

Posted: Aug 18 2015, 9:14am CDT | by , in News | Misc

 
FDA Warns Superbug-Prone Devices Makers
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  • FDA warns duodenoscope manufacturers against sanitization problems

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FDA warned three companies about unsatisfactory duodenoscope that have caused the propagation of disease.

Duedenoscope is a medical scope that has been used in multiple procedures every year. Doctors consider them a key tool in detecting and treating medical problems early and in a minimally invasive way. Regulators and industry officials alike have argued that the benefits of duodenoscopes far outweigh the risks.

The risks implying that the patients undergoing procedures involving duodenoscope have been contracting diseases. FDA has recently discovered that the scope is associated with outbreaks of a deadly “superbug” virus. In recent years to outbreaks of tough-to-fight bacterial infections involving carbapenem-resistant Enterobacteriaceae, or CRE.

Since 2012, other outbreaks have occurred at Advocate Lutheran General Hospital near Chicago, where 44 people were infected. Virginia Mason Medical Center in Seattle recorded at least 32 patients becoming ill and 11 deaths.

The outbreak of disease was recently recorded in Ronald Reagan UCLA Medical Center in Los Angeles. The hospital claims that at least two people died. Officials said scores of other patients potentially were exposed to the dangerous bacteria.

At Cedars-Sinai Medical Center, as well as in Los Angeles, officials this year claim that four patients had been infected by a superbug after undergoing a duodenoscope procedure, according to Reuters.

A Connecticut hospital said it had contacted nearly 300 patients who might have been exposed to a dangerous type of drug-resistant E. coli after undergoing duodenoscope procedures. FDA had to notify the hospitals and doctors that duodenoscope was involved in the spread of the bug.

Furthermore, FDA also notified the three production companies of the scope. Including Olympus, Pentax and Fujifilm. The companies were notified in very strong words about the role of the scope in spread of disease.

They were also warned about failing to notify their customers about the proper sanitation of the scope between use. More so, the companies failed to validate the proper sanitization of the product. The companies had also failed to tell FDA that their products has caused patients’ death.

The companies insured FDA even before they got the warnings that they were working very hard to make the scope safe for use. The companies said that the patient care was the number one priority for all healthcare concerned people.

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