Customer Duodenoscope Guidance
Customer Duodenoscope Guidance
Letter from Olympus
Dear Valued Customer:
As you are aware, the FDA recently published a Safety Communication and Press Release recommending the transition from fixed endcap to disposable endcap duodenoscopes and announced results of the 522 order for postmarket surveillance studies. We are writing to you because we value our relationship with you and understand the importance of the decisions you will make in the future as you consider FDA guidance.
Can customers still safely use their duodenoscopes?
Olympus duodenoscopes can still be used safely following the instructions for use. Olympus duodenoscopes continue to be FDA-cleared devices and are an important and effective option.
Can customers sterilize duodenoscopes?
Olympus provides instructions for sterilization using ethylene oxide (EtO), though it is important to note that sterilization alone does not preclude pre-cleaning and manual cleaning steps, vital steps in the cleaning and sterilization process.
What is Olympus doing to support customers?
- Improving our IFUs
- Making additional reprocessing resources available to technicians, a Visual Reprocessing Guide for the TJF-Q180V, which provides detailed illustrations of reprocessing steps
- Enhancing customer training and instituting technician retraining
- Evaluating design changes to enhance reprocessing efficacy
- Providing additional on-site support
What customer resources are available?
Technical Assistance Center (TAC)
1-800-848-9024, option 1
You can contact our Technical Assistance Center (TAC) at 1-800-848-9024, option 1. The TAC department can assist in answering questions on TJF-Q180V cleaning and reprocessing and obtaining additional copies of the TJF-Q180V Reprocessing Manual and supplemental educational materials.
Endoscopy Support Specialists (ESS)
Request a site visit by calling our TAC department at 1-800-848-9024, option 1
Olympus has dedicated field personnel, called Endoscopy Support Specialists, who visit customer sites to access and observe customer reprocessing methods and to provide reprocessing training and education. If you would like an ESS to visit your facility to review and train on TJF-Q180V cleaning and reprocessing instructions, please request a site visit by calling our TAC department at 1-800-848-9024, option 1.
OlympusConnect.com is our customer portal that houses the full library of training support, including: Reprocessing Videos, Visual Reprocessing Guides, Instruction Manuals, Reprocessing Manuals, In-service Guides, and more. Registration is free and sites may have multiple log-ins.
Are contamination and infection rates the same?
Contamination does not equal infection. Rates of patient infection associated with duodenoscopes have always been relatively low and have more recently declined due to enhanced efforts to improve patient safety. Dr. Jeffrey Shuren of the U.S. Food and Drug Administration (FDA) notes in a statement dated April 12, 2019, that efforts to improve the safety of duodenoscopes have led to a “dramatic decline in reports of patient infections,” and “an individual patient’s risk of acquiring infection from an inadequately reprocessed medical device remains relatively low given the large number of such devices in use.” https://www.fda.gov/news-events/press-announcements/statement-jeff-shuren-md-director-center-devices-and-radiological-health-continued-efforts-assess
In accordance with FDA recommendations, Olympus will be modifying the labeling on our duodenoscopes to indicate the current infection rate.
EVIS EXERA II: TJF-Q180V
Letter from Olympus
Dear Healthcare Professionals, Patients and Family Members –
Olympus takes its role in protecting patient safety very seriously, and we are continuously seeking to improve the next-generation of our products, provide guidance on their safe use and increase the ease and efficacy of endoscope reprocessing. As we enter a new calendar year, we would like to provide a few updates regarding our duodenoscopes.
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.
Frequently Asked Questions
Does the TJF-Q180V have 510(k) clearance now? What is the 510(k) #?
The TJF-Q180V is FDA cleared under 510(k) #K143153.
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, 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.
Director, Public Relations
Olympus Corporation of the Americas
FDA Duodenoscope Surveillance Sampling and Culturing Protocol
In February 2018, the U.S. Food and Drug Administration (FDA), Centers for Disease Control and Prevention (CDC) and American Society for Microbiology (ASM) Working Group on Duodenoscope Culturing published a Duodenoscope Surveillance Sampling and Culturing Protocol as a quality control measure of the adequacy of duodenoscope reprocessing. Olympus was a participant in the Working Group and the development of this Protocol. This Protocol provides recommendations for healthcare facilities that choose to implement duodenoscope microbiological surveillance sampling and culturing. Olympus intends to facilitate awareness of this Protocol by hosting educational webinars and has published a link to the Protocol on our website. As always, patient safety remains our top priority. We are committed to developing solutions for healthcare professionals that help improve clinical outcomes and enhance quality of life for patients.
The Protocol can be found here.
Customer questions should be directed to the Technical Assistance Center (TAC) at 1-800-848- 9024, option 1.