A newly discovered regulatory report has revealed that contaminated medical scopes may have caused a bacterial outbreak at a California hospital that led to the deaths of at least three people last year.
Officials from the Huntington Hospital in Pasadena said that three of its patients were sickened in August, but they declined to provide any additional details regarding the matter.
An article by the Los Angeles Times on Thursday revealed that officials later informed Olympus Corp., the maker of the medical scopes, about the deaths of the hospital patients. This was based on a federal regulatory report that the news agency had obtained.
The Huntington Hospital said that it was not able to reveal more information about the deaths because of the privacy laws it maintains with their patients.
This is not the only instance where people were sickened because of contaminated Olympus medical scopes.
The company's duodenoscopes have also been linked to bacterial outbreaks that infected hundreds of patients in different hospitals around the United States. Hospital officials said that their staff had followed the instructions on how to clean the medical scopes provided by the manufacturer.
A memo released by U.S. congressman Ted Lieu from California reported that over 41 hospitals in different parts of the world had experienced bacterial outbreaks related to medical scopes from 2010 to 2015.
Lieu said it is likely that these figures fail to represent the magnitude of the situations since not every hospital tests their patients for possible infections caused by antibiotic-resistant "superbugs".
In January, U.S. senator Patty Murray from Washington called for an investigation following another bacterial outbreak involving contaminated medical devices at Seattle's Virginia Mason Medical Center.
The senate report found that as many as 32 patients confined at Virginia Mason were sickened in 2013. At least 11 of these patients later died, though it is still unclear whether these were directly caused by the infections. The Seattle Times said that the number of infection cases later increased to 39.
The patients at Virginia Mason were believed to have been infected by antibiotic-resistant superbugs that were not properly removed from the medical scopes despite having been cleaned according to the maker's directions. Some of the superbugs found included the carbapenem-resistant Enterobacteriaceae bacteria (CRE) and multidrug-resistant E. coli bacteria.
The senate report recommends that several regulatory and legislative changes should be made regarding the use of medical devices. One of these involves having Congress to require electronic health records, device registries and insurance claims to include unique identifiers for such devices.
The Food and Drug Administration (FDA) should also determine whether these medical devices need design modifications. If so, the agency should require device makers to carry out repairs on their products through a recall.
"Patients should be able to trust that the devices they need for treatment are safe and effective," Murray pointed out.
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