EVIS EXERA II: TJF-Q180V
Letter from Olympus
Dear Healthcare Professionals, Patients and Family Members –
This letter provides an update on certain developments regarding our duodenoscopes. These devices, like all the products we manufacture, help millions of people lead safer, healthier, and more fulfilling lives. We seek to create the best possible medical equipment for healthcare providers and ensure the safe and effective use of our products.
Duodenoscopes enable doctors to perform important, and often life-saving, diagnoses and treatments that would otherwise require significant abdominal surgery. More than 600,000 endoscopic retrograde cholangiopancreatography (ERCP) procedures are performed safely in the United States each year; with roughly 500,000 performed using an Olympus device. The reported incidence of infection following an ERCP procedure remains extremely low, with a medical device report incidence rate of well less than 0.1% in the United States.
Frequently Asked Questions
Does the TJF-Q180V have 510(k) clearance now? What is the 510(k) #?
The TJF-Q180V has recently received FDA marketing clearance under 510(k) #K143153.
On February 22, 2016, the FDA agreed to grant Olympus permission to remove the statement that only Acecide-C® High Level Disinfectant is validated for reprocessing the TJF-Q180V duodenoscope in the OER-Pro Endoscope Reprocessor. This means that ALDAHOL 1.8 High Level Disinfectant is now approved to reprocess the TJF-Q180V in the OER-Pro. For customers who have chosen to have their OER-Pros converted from ALDAHOL 1.8 to Acecide-C as a result of the corrective action, Olympus will convert the units back to ALDAHOL 1.8 at no charge, in accordance with proper government regulations. Please see the Customer Letter for specific details.
Olympus is preparing for the retrieval and forceps elevator replacement of TJF-Q180V duodenoscopes. Outreach to customers began on February 12, 2016 when our service team began contacting customers with a one week lead time for scope return. We anticipate a complete turnaround time of four business days.
The prioritization for this initial upgrade and subsequent completion of upgrading all current TJF-Q180V duodenoscopes in the U.S. will be based on equipment age and repair history Please note the overall schedule is subject to change pending incoming volumes.
We are requesting that customers respond to Olympus’ service requests in a timely manner.
There are a limited number of units that can be updated each month and delayed or proactively returning units to Olympus will likely result in higher than anticipated return volume and may generate delays in the return time. Customers can use the TJF-Q180V as is until the elevator mechanism is replaced. Please see the Customer Letter for specific details.
On February 1, 2016, the FDA released a website announcing the status of updated high-level disinfection (HLD) or liquid chemical sterilization (LCS) validation testing for reprocessing duodenoscopes in Automated Endoscope Reprocessors (AERs). This website notes that there are five AER manufacturers in the U.S. and, as of February 10, 2016, two of the manufacturers have thus far adequately completed the updated validation testing for one or two of their products. Olympus is working with the FDA to revalidate instructions for reprocessing duodenoscopes in the Olympus OER-Pro. While it has not yet been posted to the AER chart, as of January 15, 2016, the FDA issued 510(k) clearance of the Olympus TJF-Q180V duodenoscope with a new Reprocessing Manual stating this model can be high-level disinfected in the Olympus OER-Pro endoscope reprocessor using Acecide-C as the HLD. For all other Olympus models of duodenoscope, please refer to the most recent Reprocessing Manual for instructions.
The FDA announced today the 510(k) clearance of the TJF-Q180V duodenoscope. Please see our press release and our Customer Letter: Urgent Medical Device Removal and Corrective Action for more information.
The Democratic staff of the Senate Committee on Health, Education, Labor and Pensions released today a report that is an important contribution to understanding the factors underlying reports of patient infections associated with multi-drug resistant organisms such as Carbapenem-resistant Enterobacteriaceae following Endoscopic Retrograde Cholangiopancreatography procedures. For several months, Olympus has cooperated with the Committee staff by providing numerous documents, answering questions and conducting a duodenoscope demonstration and briefing for the staff. We appreciate the staff report noted Olympus’ cooperation and the shared responsibilities of duodenoscope manufacturers, hospitals, manufacturers of automated endoscope reprocessors, and the Food and Drug Administration – each of which contribute to increasing patient safety. Although we do not agree with all of the report’s conclusions, we are closely reviewing the recommendations as part of Olympus’ ongoing efforts and commitment to increase patient safety.
The company’s commitment to addressing these issues is unchanged. We deeply sympathize with the patients and families who have experienced or have been affected by infections. We have devoted extensive efforts to the duodenoscope issue for many months. We disagree with many of the characterizations in recent news articles including comments regarding specific employees and the Company’s intentions and processes. Our ongoing effort to increase patient safety is our top priority and the duodenoscope issue continues to receive the highest level of attention at Olympus, and we remain committed to understanding and addressing the potential root causes.
On October 5, 2015, the FDA released a Postmarket Surveillance order for Duodenoscopes, announcing it is mandating duodenoscope manufacturers to conduct postmarket surveillance studies in health care facilities. Olympus takes this matter extremely seriously. We complied with the FDA's request and provided the requested information.
Olympus is closely reviewing the FDA warning letter issued on August 12th so that we can respond directly to the FDA in a timely manner. We are committed to addressing the issues identified in the letter; for example, we are currently working to enhance our MDR reporting system. The FDA’s letter notes that Olympus learned in 2012 that 16 patients contracted Pseudomonas aeruginosa after a procedure with an Olympus device, and it suggests that the company submitted an MDR report on the incident only in 2015 (#8010047-2015-00218). To clarify, Olympus submitted an MDR report on the incident on May 25, 2012 (#8010047-2012-00157). In 2015, Olympus submitted additional MDR reports to “unbundle” the 2012 MDR on the 16 patients and to include additional information, including that 22 patients were involved in the event.
On August 4, the FDA released its Supplemental Measures to Enhance Duodenoscope Reprocessing: FDA Safety Communication for healthcare professionals’ consideration. Olympus' R&D team is reviewing the suggested measures and continuing to explore options to further reduce the risk of infection associated with our duodenoscopes.
TJF-Q180V Cleaning and Reprocessing
EVIS EXERA: TJF-160F/VF
Letter from Olympus
Dear Health Care Professional:
Olympus America Inc. (OAI) is writing to inform you that we are issuing validated, new reprocessing instructions for the Olympus TJF-160F/VF duodenoscopes ("TJF-160F/VF"), consisting of revised manual cleaning and high level disinfection procedures.
These new reprocessing procedures should be implemented as soon as possible. The new cleaning procedure requires the use of a new cleaning brush (MAJ-1534), which is enclosed with this letter.
Frequently Asked Questions
Does this corrective action change the design of the TJF-160F/VF?
No. This removal and corrective action is for the TJF-160F/VF Reprocessing Manual only. There is no repair or design change to the endoscope.
Olympus America Inc. is issuing validated, new reprocessing instructions for the Olympus TJF-160F/VF duodenoscopes, including revised manual cleaning and high level disinfection procedures. These new reprocessing procedures should be implemented as soon as possible. The new cleaning procedure requires the use of a new cleaning brush (MAJ-1534) and additional steps including flushing and forceps elevator raising/lowering during reprocessing. More information can be found in our Customer Letter and in the new Reprocessing Manual.
TJF-160F/VF Reference Materials
- March 14, 2016: TJF-160F/VF Customer Letter & Reply Form
TJF-160F/VF Cleaning and Reprocessing
Olympus previously announced corrective actions it is conducting on the Olympus duodenoscope models TJF-Q180V and TJF-160F/VF. One aspect of these corrective actions is updating the duodenoscope reprocessing instructions. The updated TJF-Q180V and TJF-160F/VF Reprocessing Manuals include a new warning requiring users to conduct all duodenoscope precleaning and manual cleaning steps, even when using an Automated Endoscope Reprocessor (AER) that may indicate a user can forego certain steps in precleaning and manual cleaning of the endoscopes.
Consistent with the warnings added to the TJF-Q180V and TJF-160F/VF Reprocessing Manuals, the OER-Pro Operation Manual has been revised to add a new warning to conduct precleaning and manual cleaning as detailed in the duodenoscope's Reprocessing Manual(s). The OER-Pro Operation Manual change also addresses the need for users to conduct precleaning and manual cleaning for the TJF-140F and JF-140F duodenoscope models. Please review the Customer Letter for additional information.
Olympus Technical Assistance Center (TAC)
1-800-848-9024 option 1
For assistance in answering questions on TJF-Q180V cleaning and reprocessing and obtaining additional copies of the TJF-Q180V Reprocessing Manual and supplemental educational materials.
Vice President, Corporate Communications
Olympus Corporation of the Americas