December 10, 2018 — Statements and articles about duodenoscopes, medical device reporting and other federal regulations, and a plea agreement finalized with the U.S. Department of Justice. Some quotes from these statements and articles are provided.
Olympus: “Olympus Issues Statement Regarding U.S. Department of Justice Settlement”
U.S. Justice Department: “Olympus Medical Systems Corporation, Former Senior Executive Plead Guilty to Distributing Endoscopes After Failing to File FDA-Required Adverse Event Reports of Serious Infections”
Reuters: “Olympus unit pleads guilty to resolve U.S. duodenoscope probe”
Wall Street Journal: “Olympus Unit Settles Criminal Probe Over Device Linked to ‘Superbug’ Infections”
Allentown Morning Call: “Olympus failed to properly notify the FDA of 3 incidents involving its scopes in Europe. Now, it must pay $85 million.”
Medscape: “Higher Than Expected Contamination Rates Found With Duodenoscopes After Reprocessing, FDA Warns.”
FDA:
- December 10, 2018: Statement from Jeff Shuren, M.D., J.D., Director of the Center for Devices and Radiological Health, on updated safety communication about rates of duodenoscope contamination from preliminary postmarket data.
- “[A]ll three manufacturers are required to conduct two studies; one to sample and culture reprocessed duodenoscopes that are in clinical use to characterize contamination rates and to learn more about issues that contribute to contamination (the sampling studies), and one to assess how effectively the trained hospital staff follow the manufacturer reprocessing instructions (the human factors studies).”
- December 10, 2018: “The FDA Provides Interim Results of Duodenoscope Reprocessing Studies Conducted in Real-World Settings: FDA Safety Communication.”
- The FDA is providing interim results from the ongoing mandated postmarket surveillance studies (“522 study”) to inform patients, hospitals and health care facilities of higher-than-expected contamination rates with duodenoscopes after reprocessing. Facilities and staff that reprocess duodenoscopes are reminded of the importance of manual cleaning prior to disinfection or sterilization and proper servicing of duodenoscopes.
- March 9, 2018: “FDA warns duodenoscope manufacturers about failure to comply with required postmarket surveillance studies to assess contamination risk: FDA News Release.”
- “The U.S. Food and Drug Administration today issued warning letters to all three duodenoscope manufacturers for failing to comply with requirements of federal law under which they were ordered to conduct postmarket surveillance studies to assess the effectiveness of reprocessing the devices.”
- From the warming letters the FDA wrote to the manufacturers: “[F]ailure to comply with a requirement under section 522 of the Act renders a device misbranded under section 502(t)(3) of the Act (21 U.S.C. § 352(t)(3)). … (Certain duodenoscope models from all three manufacturers) are currently misbranded under section 502(t)(3) of the Act.”
- “To date, Olympus has failed to commence data collection, and Pentax and Fujifilm have failed to provide sufficient data, as required for their respective studies to sample and culture reprocessed duodenoscopes that are in clinical use. Olympus and Pentax also have not complied with requirements for their respective human factors studies to assess how well hospital staff are following reprocessing instructions; Fujifilm has been meeting its requirements for its human factors study.”
- October 2015: FDA ordered each U.S. duodenoscope manufacturer (Olympus, Fujifilm and Pentax) to conduct postmarket surveillance studies (“522 study”) to better understand how these devices are reprocessed in real-world settings and their impact on duodenoscope transmitted infections. Postmarket surveillance studies are important tools for collecting useful data about a device that can reveal unforeseen adverse events, the actual rate of anticipated adverse events, or other information necessary to protect public health.
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Also read:
- Section 522 (Post Surveillance Studies) of the Federal Food, Drug, and Cosmetic Act
- Section 522 of the Federal Food, Drug, and Cosmetic Act provides the FDA with the authority to require manufacturers to conduct postmarket surveillance of certain class II or class III devices.
- “Infections Associated with Reprocessed Duodenoscopes“
- “Information for Health Care Facilities: Reprocessing of Reusable Medical Devices“
- Section 522 (Post Surveillance Studies) of the Federal Food, Drug, and Cosmetic Act
Quality, Safety and Reviews: Click here to read about Dr. Muscarella’s quality and safety services designed to help clients reduce the risk of healthcare-associated infections, including superbug outbreaks linked to contaminated duodenoscopes and other types of reusable medical equipment.
Manufacturers’ post-market duodenoscope surveillance data:
- December 10, 2018: Interim results for each duodenoscope manufacturer regarding the respective FDA 522 Postmarket Surveillance Studies: Fujifilm, Pentax, and Olympus.
- FDA (December 10, 2018): “Interim results from these studies indicate higher-than-expected contamination rates after reprocessing, with up to 3% of properly collected samples testing positive for enough low concern organisms to indicate a reprocessing failure and up to 3% of properly collected samples testing positive for high concern organisms. High concern organisms are defined as organisms that are more often associated with disease, such as E. coli, and Pseudomonas aeruginosa. Root cause analyses are currently underway to better understand these culturing results. Some factors that may contribute to device contamination after reprocessing include device damage and errors in reprocessing. These results are preliminary; final results are expected in 2019.”
- Regarding some relatively high, and unusual, bacterial culturing results, a footnote to some of the data states that some of the samples were collected using non-sterile methods, and the FDA therefore “does not believe these data reflect real-world contamination rates.”
CDC:
- February 26, 2018: FDA, Centers for Disease Control and Prevention (CDC), and American Society for Microbiology (ASM), together with other endoscope culturing experts, released voluntary standardized protocols for duodenoscope surveillance sampling and culturing. See: “Duodenoscope Surveillance Sampling and Culturing: Reducing the Risks of Infection.”
- These protocols are an update to the Interim Duodenoscope Surveillance Protocol released by CDC in March 2015, and address the concerns regarding validation of duodenoscope culturing protocols raised in ASM’s April 2015 Policy Statement on Culturing of Duodenoscopes.
- For health care facilities that choose to implement duodenoscope surveillance sampling and culturing, these protocols can be used to help monitor the quality of a facility’s endoscope reprocessing procedures. Adequate monitoring may reduce the risk of infection.
Some related articles (by Lawrence F Muscarella, PhD):
- “Risk of transmission of carbapenem-resistant Enterobacteriaceae and related “superbugs” during gastrointestinal endoscopy”
- “A Duodenoscope Has Been Linked to ‘Probable Transmission’ of a Colistin-Resistant Superbug“
- “A Bronchoscope is Linked Again in the U.S. to an Outbreak of the Feared ‘CRE’ Superbug“
Also read:
- “New Guidance to Prevent Other Types of Flexible Endoscopes From Transmitting Superbugs“
- “Delayed Reprocessing of Endoscopes“
- “Reprocessing Flexible and Rigid Laryngoscopes“
- “Endoscopes Are Not Immune to Resistant Klebsiella pneumoniae Contamination“
Quotes:
- U.S. Justice Department:
- “Under the FDCA, devices for which required MDRs and supplemental MDRs have not been filed are deemed misbranded, and it is a crime to ship such devices in interstate commerce.”
- “But when a device manufacturer becomes aware of risks that could lead to illness, injury, or death, there is a statutory obligation to report that information to the FDA in a timely manner. By failing to do so, (patients’ health is put at risk.” (Assistant Attorney General Jody Hunt for the Department of Justice’s Civil Division.)
- “(Important FDA reports regarding adverse events were not filed.) … It is especially troubling that they remained quiet when they received additional information from an independent expert questioning the safety of Olympus’ device. Patient safety must always be a paramount concern for medical device companies, and these defendants simply failed to treat that concern with the gravity it deserves. Today’s resolution is a reminder that this office will act whenever patient safety is put at risk by a quest for profits.” (Attorney for the United States Rachael Honig, District of New Jersey.)
- FDA:
- “Medical device adverse event reporting requirements are designed to protect Americans by providing FDA with a tool to detect potential safety issues. When device manufacturers fail to report adverse events, unsuspecting patients are placed at risk.” (FDA Commissioner Scott Gottlieb, M.D.)
- “Interim results from the sampling studies indicate higher-than-expected contamination rates after reprocessing,” with some samples testing positive for “high concern” organisms” (e.g., bacteria that may be associated with disease, such as E. coli). (Jeff Shuren, M.D., J.D., Director of the Center for Devices and Radiological Health)
- “However, it has become clear that following the manufacturer’s reprocessing and maintenance instructions, while critical, is not sufficient to avoid all infections associated with the use of duodenoscopes.” (Jeff Shuren, M.D., J.D., Director of the Center for Devices and Radiological Health)
- “The FDA’s Office of Criminal Investigations recently worked with the U.S. Department of Justice to bring criminal action against Olympus for failing to adequately file adverse event reports involving infections that occurred in Europe in 2012 and 2013 that were associated with their TJF-Q180V duodenoscope. After pleading guilty to three counts of distributing misbranding devices in interstate commerce, the company was fined $80,000,000 and ordered to forfeit $5,000,000.” (Jeff Shuren, M.D., J.D., Director of the Center for Devices and Radiological Health)
- Olympus: “The investigation did not identify any direct harm to patients as a result of the disclosure failures, and Olympus acknowledged that it failed to comply with the federal reporting requirements. The settlement does not impact the availability of Olympus products and services worldwide.”
- Wall Street Journal:
- “There were at least three incidents in Europe in 2012 involving infections connected to the use of (the duodenoscope), according to the Justice Department. Under U.S. law, device manufacturers that sell their product in the U.S. are required to report such incidents to the FDA if they are known.”
- “A device for which such reports haven’t been filed is deemed under U.S. law as ‘misbranded,’ and it is a crime to ship misbranded devices. The company shipped hundreds of misbranded duodenoscopes in the U.S. between August 2012 and October 2014, generating about $33 million in total gross profit, prosecutors said.”
- “A U.S. investigation didn’t identify any direct harm to patients as a result of the disclosure failures, (the manufacturer) said when acknowledging that it failed to comply with the reporting requirements.”
- “(The manufacturer) admitted it had failed to file the reports, known as medical device reports, regarding those incidents.”
(New information, statements and news reports will be added as warranted.)