Karl Storz Gets FDA Warning Letter Over Endoscopes Due to Cleaning Problems

Federal investigators say that medical device manufacturer Karl Storz has not taken the proper steps to ensure that the cleaning brushes recommended for one of its endoscopes works properly, which could potentially expose patients to blood borne infections and illnesses. 

On December 8, the FDA issued a warning letter (PDF) to Karl Storz’s Endovision unit, outlining the findings of an inspection in October at the company’s Charlton, Massachusetts facility, where the Flex-X2 Flexible Ureteroscope is manufactured. Investigators said processes at the facility linked to production of the Flex-X2 do not conform with current good manufacturing practices.

Most of the problems centered around the cleaning brush for the endoscope, which is a medical device with a light attached to it that is used to look into the body. The devices is usually inserted through a natural orifice, such as the mouth and rectum, during a procedure known as an endoscopy. However, it must be thoroughly cleaned of blood and bodily fluids between uses, or else it could transmit infections and diseases, such as Hepatitis and HIV, from one patient to the next.

FDA inspectors found that the company had no design validation data to demonstrate that the cleaning brush designated for use with the Flex-X2 actually worked. They also found that the company had responded properly to complaints that those cleaning brushes did not actually fit properly into the working channel of the endoscopes.

Additionally, the investigators observed improper cleaning of the devices at the facility itself at a decontamination station.

“On October 17, 2013, our investigator observed your operator did not use the specified brush for cleaning the intubation scope,” noting that the brush did not fit into the device. “The device was subsequently processed through the decontamination station and associated paperwork was stamped ‘Decontaminated.’”

The company has already responded to some of the complaints by the FDA adequately, but not all, the inspectors noted.

Endoscope Cleaning Concerns

An estimated 15 million to 20 million endoscopy procedures are conducted in the U.S. each year.

In June 2013, a study presented at a medical conference found that about 15% of all endoscopes used by hospitals may be improperly cleaned, putting patients at risk. Researchers found cells and other biological material left behind on endoscopes that hospital staff believed had been properly cleaned.

In 2008 and 2009, thousands of veterans were notified that they may have been exposed to contaminated blood during colonoscopy procedures at several Veterans Affairs hospitals, after it was discovered that the staff was not properly cleaning the endoscope equipment.

In November 2012, an Air Force veteran, Robert Metzler, was awarded $1.25 million after suing the VA for contracting hepatitis C from allegedly contaminated endoscopy tools.

The VA endoscopy contamination problems were discovered in December 2008, at the Alvin C. York Medical Center in Murfreesboro, Tennessee. A subsequent review of the procedures at all VA clinics led to the discovery of additional VA health center problems at the Charlie Norwood VA Medical Center in Augusta, Georgia, and the Miami Veterans Affairs Healthcare System in Florida.

The potential exposures, caused by improper cleaning and use of endoscopic equipment, required the VA to notify 11,000 former patients that they should get tested for HIV and hepatitis.