FDA Gives Guidance for Scope Cleaning Procedures

March 13, 2015 — The FDA has provided guidance and recommendations for effectively cleaning and sterilizing duodenoscopes.

Just weeks ago, several hospitals in Washington, California, Florida, North Carolina, Connecticut, and Illinois reported deadly outbreaks of antibiotic-resistant infections. The “superbug” infections were traced to medical scopes that were extremely difficult to sterilize.

The recommendations were taken from draft guidance that was drawn up years ago, according to Law360. The FDA issued its first warning about disease-transmission on duodenoscopes back in 2009, after 16 people developed “superbug” infections.

The FDA listed six criteria that must be included in instructions for cleaning reusable scopes. The agency wants manufacturers to take the following steps:

• Label scopes with comprehensive and understandable instructions on how to clean the scope properly.
• Submit testing data on the effectiveness of their cleaning procedures.
• Consider designing the scopes in a way that hospitals can properly clean them.

Dr. William Maisel, director for science and chief scientist at the FDA’s Center for Devices and Radiological Health, said in a press release:

“Patients and health care providers should know that the risk of acquiring an infection from a reprocessed medical device is low. … This guidance is an important step toward further enhancing the safety margin.”

Olympus, the manufacturer of the scope implicated in the UCLA outbreak, has been hit with lawsuits from people who were injured. Officials at the hospital said two patients died, seven patients were infected, and nearly 200 were exposed to carbapenem-resistant Enterobacteriaceae, or CRE.

Duodenoscopes are used in a procedure known as ERCP (endoscopic retrograde cholangiopancreatography) on roughly 500,000 patients in the United States every year.

The FDA is hesitant to recall the scopes because they are used in emergency, life-saving procedures, like cancer biopsies. However, the agency has also warned that a complex “elevator” mechanism in the tip of the scope is extremely difficult to clean.