Karl Storz Endoscope Recall Issued Over Inadequate Sterilization Process

Healthcare professionals are being warned not to follow instructions for high-level disinfection methods, due to the risk of exposing patients to infectious materials and bloodborne diseases.

Problems with the reprocessing, or sterilization, instructions for some Karl Storz urological endoscopes has led to a recall and a warning from federal regulators to health care providers about the risk of serious and potentially life-threatening infections.

On April 4, the FDA sent a letter to health care providers to make sure they are aware of a Karl Storz urological endoscope recall (PDF), indicating that they should discontinue all high-level disinfection methods and liquid chemical sterilization for the medical devices, which are used to view and access the urinary tract.

Karl Storz first announced the recall in an urgent medical device recall notice sent to its customers on April 1. The manufacturer sent out the notice after determining that the current reprocessing instructions for these devices, when followed, failed to achieve the appropriate level of sterilization.

Reprocessing is the medical term for cleaning and sterilizing medical devices intended to be used on multiple patients. Following use, these types of devices need to be immaculately sterilized to prevent the spread of disease and infection from one patient to the next.

The recall includes about 30 different models of flexible urological endoscopes, including certain cystoscopes, ureteroscopes, cystourethroscopes and ureterorenoscopes. All of the affected devices are single channel endoscopes with an attached T-Leur. A complete list of affected devices is available in the recall notice.

Karl Storz is not asking for the devices to be returned, but instead is calling on healthcare providers to discontinue all high-level disinfection methods and sterilize the devices after each use, utilizing other sterilization methods detailed in each devices instructions. The devices should only be returned to the manufacturer if the customer does not have access to an appropriate sterilization method. The company indicates it anticipates releasing updated instructions for the affected endoscopes by April 18, 2022.

Customers with questions can call 1-888-352-9616 or can contact the company by email at karlstorz7041@sedgwick.com.

The FDA first warned of potential sterilization problems with the devices almost exactly one year ago, and requested Karl Storz validate its reprocessing instructions, which is how the failure of the high-level disinfection methods was discovered. However, the FDA has been battling against inadequate cleaning instructions for various types of endoscopes, particularly duodenoscopes, over the last several years.

Duodenoscopes are used during endoscopic retrograde cholangiopancreatography (ERCP) procedures, but difficulties cleaning device manufactured by several different companies have resulted in reports of serious hospital infection outbreaks, typically involving aggressive, antibiotic-resistant “superbugs”, which have caused a number of severe injuries and deaths.

While the recalled Karl Storz endoscopes are not duodenoscopes, they have similar design features which can make sterilization difficult.

Questions about the safety of endoscopes first emerged after a  duodenoscope infection outbreak at UCLA’s Ronald Reagan Medical Center in February 2015, involving carbapenem-resistant enterobacteriaceae (CRE) infections that resulted in at least seven infections and two deaths. At least 200 other patients had to undergo testing after being placed at risk by duodenoscopes manufactured by Olympus Corp.

The infections were linked to problems with the “reprocessing” instructions provided by the manufacturer, which are used to clean the devices for use by another patient. FDA reviewers determined that the instructions sent out at the time were inadequate, and that even if the recommended steps were followed to clean ERCP endoscopes, flaws in the design may allow them to become easily contaminated.

In November 2019, the FDA approved a duodenoscope design with a disposable elevator tip; the most problematic and hard to clean part of the duodenoscope. A month later the agency approved the first disposable, single-use duodenoscope. The FDA has pushed for widespread use of the disposable devices.

In addition to switching over to disposable components, the FDA is reminding hospitals to also ensure staff “meticulously” follow reprocessing instructions, and institute a quality control program which includes sampling and microbiological culturing. The agency also recommends hospitals consider supplemental reprocessing measures such as liquid chemical sterilant systems, monitor reprocessing procedures to make sure they are being done correctly, and develop schedules for routine inspections and maintenance according to the duodenoscope manufacturers’ instructions.