It appears that the story of the duodenoscopes is becoming one of those never ending sagas. A couple of years ago, Dr. D wrote about issues associated with the reprocessing of duodenoscopes, and subsequent patient infections and patient deaths associated with using reprocessed scopes that were not necessarily clean. Please keep in mind: As far as the doctor is concerned, germs are bad things. Once upon a time (note, this story is not make-believe), our dear friends from the agency issued warning letters to all of the key players in the duodenoscopes arena: (a) Pentax of America; (b) Olympus Corporation of America; and (c) Fujifilm Medical Systems, USA. Guess what my dear readers? The FDA has come a calling again with the issuance of three new warning letters. Ouch, ouch, and ouch! Evidently, the FDA issued a post-market surveillance order in accordance with 21 CFR, Part 822 requirements to each of the aforementioned establishments in an effort to better understand the issues associated with contaminated scopes and issues associated with the preprocessing of used scopes. According to the FDA, these establishments failed to meet agency expectations in regards to providing the requested information, in a timely manner, as requested by the 522 Order. According to the FDA: “The 522 Order recommends that your firm conducts the Sampling and Culturing Study in two phases, starting with a pilot phase during which your firm starts data collection and collect culturing samples from clinically used and reprocessed duodenoscopes for continued sample collection in the second phase of the study. The 522 Order states that “FDA expects you [your firm] will commence data collection for Phase 2 within 15 months of the date of the Post-market Surveillance order.” Section 522 of the Act requires a firm to “commence surveillance . . . not later than 15 months after the day on which the Secretary issues an order under this section.” However, your firm has failed to provide sufficient data with commencement of data collection within 15 months after issuance of the 522 Order. The doctor definitely would not want to be the shoes of the Chief Jailable officers (CJO) tasked with having to elucidate (look-it-up) their reasons as to why the commit dates associated with the 522 Order were missed. Enjoy!
Warning Letters (Three) – March 9, 2018
Essentially, each of the three warning letters issued to the offending establishments states the same concerns and violation statements. Although conjecture on the part of Dr. D, the doctor thinks the FDA was very unhappy with the perceived attempts of three scope manufacturers and their execution of the post-market surveillance orders (or lack of). In defense of the duodenoscope manufacturers, something must be going right, as the public outcry over concerns of scope safety and efficacy appear to have waned. Unfortunately, it is imperative to also keep our dear friends from the agency placated, as they are charged with the arduous task of protecting the health of the general population of the United States.
Warning Letter Excerpt
“Failure of a manufacturer to comply with requirements under section 522 of the Act, which includes requirements specified under 21 CFR Part 822, is a prohibited act under section 301(q)(1)(C) of the Act, 21 U.S.C. § 331(q)(1)(C). Further, failure 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)).”
“Your firm has committed a prohibited act under section 301(q)(1)(C) of the Act by failing to comply with requirements under section 522 of the Act.”
The 522 Order
The FDA issued three orders: (a) PS150002; (b) PS150003; and (c) PS 150004 to the establishments awarded with the prized agency warning letter. According to FDA, there were three questions associated with the 522 Order. The expectation was that each of the scope manufacturers was to perform additional studies that addressed the following questions:
“1. Are the user materials that are included in your firm’s duodenoscope labeling and instructions for use sufficient to ensure user adherence to your firm’s reprocessing instructions? (Note: User materials include user manuals, brochures, and quick reference guides from the manufacturer that are provided to the reprocessing staff) (Human Factor Study)
2. After use of your firm’s labeled reprocessing instructions, what percentage of clinically used duodenoscopes remain contaminated with viable microorganisms? (Sampling and Culturing Study)
3. For devices that remain contaminated after use of your firm’s labeled reprocessing instructions, what factors contribute to microbial contamination and what steps are necessary to adequately decontaminate the device? (Sampling and Culturing Study)”
According to FDA, the three warning letter recipient’s failed to meet their promised timelines. As such, the FDA stated that each of their devices was deemed to be misbranded under the act. “Your firm has committed a prohibited act under section 301(q)(1)(C) of the Act by failing to comply with requirements under section 522 of the Act, and your duodenoscope model XXXXX is currently misbranded under section 502(t)(3) of the Act.” If the regulatory gods at FDA are not appeased quickly, bad things are going to happen to these offending establishments. A CJO does not need a crystal ball to see that the agency is about to open that proverbial can of regulatory whoop-ass.
For this week’s guidance, there are no takeaways; however, understanding the power of the agency and all of the regulatory pitfalls that can influence a device establishment when they fail to comply with all of the FDA’s wishes surges to the forefront. These risks must be clearly understood. Now granted, as industry professionals, we tend to focus on Part 820 compliance. However, compliance with all of the Parts encompassed by the Act is important. Remember, “Parts is not Parts.” In closing, thank you again for joining Dr. D, and the doctor hopes you found value (and some humor) in the guidance provided. Until the next installment of DG, cheers from Dr. D., and best wishes for continued professional success.
- Code of Federal Regulation. (April 2017). Title 21 Part 822: Post-market surveillance. Washington, D.C.: U.S. Government Printing Office.
- Devine, C. (2011). Devine guidance for complying with the FDA’s quality system regulation – 21 CFR, Part 820. Charleston, SC: Amazon.
- Devine, C. (2013). Devine guidance for managing key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon.
- FDA. (March 2018). Inspections, Compliance, Enforcement, and Criminal Investigations. Hoya Corp. – Pentax Life Division. Accessed March 11, 2018. Retrieved from https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm600342.htm.
- FDA. (March 2018). Inspections, Compliance, Enforcement, and Criminal Investigations. Olympus Medical Systems. Corp. Accessed March 11, 2018. Retrieved from https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm600330.htm.
- FDA. (March 2018). Inspections, Compliance, Enforcement, and Criminal Investigations. Fujifilm. Accessed March 11, 2018. Retrieved from https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm600340.htm.