FDA Approves New Cleaning for Duodenoscopes; Infection Transmission Prevention

On March 5, 2016, Olympus Corporation of the Americas (Olympus) issued updated, validated manual reprocessing instructions for the TJF-160F and TJF-160VF duodenoscope models to replace those provided in the original device labeling.


As noted in the FDA's February 2015 Safety Communication, the complex design of duodenoscopes may impede effective reprocessing. Reprocessing is a detailed, multistep process to clean and disinfect or sterilize reusable devices. If not properly reprocessed, residual body fluids and organic debris may remain in microscopic crevices of the device following an attempted cleaning and high level disinfection. If these residual fluids contain microbial contamination, subsequent patients may be exposed to serious infections. The FDA has been working with duodenoscope manufacturers as they modify and validate their reprocessing instructions to further enhance the safety margin of their devices and show with a high degree of assurance that their reprocessing instructions, when followed correctly, effectively clean and disinfect the duodenoscopes.


The FDA reviewed the updated reprocessing instructions and the validation data for Olympus and determined that they meet the Agency's expectations. They recommend that facilities using Olympus' 160 F/VF duodenoscope models train staff on the updated instructions and implement them as soon as possible.


In March 2015, at the Agency's request, Olympus submitted the test protocols and data used to validate the reprocessing instructions for the 160 F/VF duodenoscope models. The Agency reviewed this information and informed Olympus that more robust testing was necessary to demonstrate an adequate safety margin. Between April and June 2015, Olympus modified its reprocessing protocols and, upon acceptance of the updated protocols, Olympus initiated testing to validate the updated reprocessing instructions. In fall 2015, Olympus submitted its cleaning and high-level disinfection reports to the Agency.


The FDA continued to work with Olympus to clarify and ultimately confirm that their cleaning and high-level disinfection instructions met the Agency's expectations. In January 2016, the Agency notified Olympus that the updated reprocessing instructions for the 160F/VF duodenoscope models were adequate.


The updated reprocessing instructions for the 160F/VF duodenoscope models include a more rigorous protocol for pre-cleaning, manual cleaning, and high-level disinfection procedures, specifically additional flushing, brushing and increased flushing volume. They also incorporate the use of an additional reusable brush to manually clean the distal end of the scope, including the elevator recess area. This new brush can be sterilized by autoclave following use, as outlined in the updated reprocessing manual. The agency believes that when followed, these updated, validated reprocessing instructions demonstrate consistent and reliable cleaning and high-level disinfection of Olympus 160 F/VF duodenoscope models.


Olympus sent a letter dated March 14, 2016 to health care facilities and other users of the 160 F/VF duodenoscope models outlining the updated, validated reprocessing instructions. An updated reprocessing manual and one box of MAJ-1534 brushes (3 brushes per box) required for the updated cleaning procedure accompanies Olympus' Customer Notification Letter.


The FDA continues to closely evaluate the association between reprocessed endoscopes and the transmission of infectious agents by working closely with duodenoscope and Automated Endoscope Reprocessor (AER) manufacturers as they validate their reprocessing instructions to a level adequate to clean and disinfect their devices. The FDA is communicating recommendations to health care providers and end users to help mitigate the risk associated with infection transmission and reusable medical devices and is working with the health care community, professional societies, international public health agencies, federal partners and state and local governments to investigate the association between reprocessed reusable medical devices and cases of bacterial infection in health care facilities.


See the FDA Safety Alert


See also Medical Law Perspectives, October 2015 Report: Unclean, Unsterile, Unsafe: Risks of Injury from Unsterilized Medical Equipment


See the Medical Law Perspectives March 11, 2015, Blog: Uncleanable ERCP Duodenoscopes: Manufacturer, Hospital, and Physician Liability?