Galligan Reid PC
practice areasview our practice areas

New medical scope, same infection concerns

In January 2016, Olympus Corp. decided to voluntarily recall one of its medical products. The TJF-Q180V duodenoscope is a commonly used scope used in a number of procedures. In 2015, the Olympus scope was linked to an outbreak of drug-resistant bacteria, which led to the death of multiple patients. Olympus committed to redesigning the scope to address the risk of infection posed by the product. The company also released new guidelines concerning the proper cleaning of the devices by hospitals and medical staff.

Another outbreak

The redesign and cleaning protocol may not have resolved the problem. The new scope has been connected to another outbreak this past December. The device in question received the new mechanism, designed to eliminate the threat of infection, in October. The latest outbreak includes five patients infected by a drug-resistant bacteria that can lead to pneumonia, meningitis and other infections. 

A parade of errors

Olympus was aware of the flaw in the original scope in 2012. An investigation revealed that the company concealed evidence of the infection risk. Senate hearings found the Olympus, as well as other manufacturers of similar scopes did not live up to their duties to be transparent with the FDA.

The FDA, itself, was targeted for investigation regarding its actions concerning these scopes. The scopes were sold, and went into use, in 2010, despite the fact that the FDA had not approved them. This condition persisted for four years before the FDA caught on. The prior actions of Olympus and the FDA do not inspire confidence that this latest danger to patients will be addressed quickly or satisfactorily.

Source: LA Times, "Olympus' redesigned scope is linked to infection outbreak," by Melody Petersen, 22 March 2017 

No Comments

Leave a comment
Comment Information
short formemail us for a response

Learn How We Can Help

Bold labels are required.

Contact Information
disclaimer.

The use of the Internet or this form for communication with the firm or any individual member of the firm does not establish an attorney-client relationship. Confidential or time-sensitive information should not be sent through this form.

close

Privacy Policy