Essay about Case Study
Professor Sharon Kurfuerst
HLTSC 325-1 9 March 2015
Current Event #2
Deadly superbug-related scopes sold without FDA approval
Companies that create, manufacture, repackage and/or import medical devices into the United States must be approved by FDA's Center for Devices and Radiological Health (CDRH). The owner of the device/product could have designed it but then had it manufactured by a contract manufacturer. When FDA review is needed prior to marketing a medical device, FDA will either "clear" the device after reviewing a premarket notification, also known as a 510(k) (named for a section in the Food, Drug, and Cosmetic Act), that has been filed with FDA, or "approve" the device after reviewing a premarket approval …show more content…
Hospital officials believe two medical scopes that still carried the deadly bacteria even after disinfection guidelines were followed were the cause of the superbug outbreak. The medical center has contacted 179 others who had endoscopic procedures between October and January and is offering them home tests to screen for the bacteria. Four other patients at Cedars-Sinai Medical Center in Los Angeles have also been infected with the superbug linked to a contaminated duodenoscope, according to a statement released by the hospital.
The medical scope was used in all four patients, between August and January 2015. Sixty-four other patients who had a duodenoscope procedure with that particular scope are being informed by mail. The procedure is performed by using a long, flexible, viewing instrument (a duodenoscope) about the diameter of a pen. The duodenoscope can be directed and moved around the many bends of the stomach and duodenum. The modern duodenoscope uses a thin fiber-optic bundle to transmit light to the tip of the endoscope, and a thin wire with a chip also at the tip of the endoscope to transmit digital video images to a TV screen. The duodenoscope is inserted through the mouth, through the back of the throat, down the food pipe (esophagus), through the stomach and into the duodenum. ERCP is a diagnostic procedure designed to examine diseases of the liver, bile ducts