Outbreak Involving Potentially Fatal Bacteria Raises Concerns About Contaminated Medical Scopes


April 06, 2015

Our personal injury attorneys in Atlanta report that a deadly 2013 outbreak of CRE an antibiotic-resistant bacteria has raised concerns about disinfection of high-tech appliances like medical scopes. According to a recent USA Today article, contaminated duodenscopes that were disinfected by automatic endoscope reprocessor (AER) units may have spread the CRE infection, which has a disturbing fatality rate of forty percent or higher. The outbreak has affected a minimum of eight hospitals across the U.S. and has been linked to 135 incidents involving infection by the potentially deadly bacteria.

The FDA has recently issued a safety alert confirming that duodenoscopes have caused hospital acquired infections in patients even when medical personnel meticulously comply with the manufacturing instructions. The federal agency alert also indicated that the design features of many duodenoscope devices may not allow for effective cleaning of all areas. The agency's safety warning has raised questions about the validity of the safety clearance provided by the agency for the scopes as well as the AERs used to disinfect the medical devices.

Andrew Ross, head of gastroenterology at Virginia Mason Hospital in Seattle told USA Today, "You either need a new design for the scope, which is known for being difficult to clean, or you need a better way to clean the instrument." The hospital was the site of 30 CRE-related bacteria infections suspected to have been caused by duodenscopes that were not adequately disinfected.

The spread of the CRE bacteria through contaminated scopes may be linked to inadequate handling procedures by medical personnel, faulty design of the duodenscopes or ineffective sterilization by AERs. With regard to the duodenscopes, the FDA has focused on design features of the scopes as a potential problem. The agency is investigating whether the devices' crevices entrap bacteria that subsequently is spread to other patients. These scope devices are flexible tubes equipped with an "elevator" at the tip, which controls tiny tools used to cut away tissues or other obstruction and to insert stents. These small crevices can be extremely difficult to sterilize.

When technicians do not use custom brushes to ensure the devices are clear of biological material, this can cause bacteria to be spread. The process of decontaminating the scopes is more effective when all bacterial material has been removed through proper scrubbing by technicians prior to sterilization in the AER devices. When the appropriate pre-cleaning procedures indicated in the instructions are not performed properly, this can compromise the effectiveness of the AER during the sterilization process.

A number of issues involving AERS also might play a role in the spread of the CRE bacteria. AERs are specialized dishwasher-like units that pump disinfectant in and around the device. However, the devices do not always come with specific guidelines for the types of brushes and pre-cleaning tools that are customized to the particular model of duodenscopes. Further, new models of duodenscopes might be incompatible with AERs that were designed, tested and approved for prior models of the scopes.

If you have suffered a hospital acquired infection because of improper infection control practices or defects in medical devices, you might be entitled to compensation for your injuries.

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Sources:

http://www.usatoday.com/story/news/2015/03/18/duodenoscope-reprocessors-infection-concerns/24930569/


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