Custom Ultrasonics, Inc. (CUI) manufactured Automated Endoscope Reprocessors (AERs), a Class II medical device, until the FDA essentially told them to stop manufacturing in 2012 (under the terms of a consent decree issued in 2007).  CUI’s troubles began in June 2005, when this establishment ran afoul of FDA due to significant compliance issues noted in their Ivyland, PA facility, during a friendly visit from FDA for a cup of coffee and an inspection. Dr. D guesses that the eight observations noted in the 2005 warning letter thoroughly ticked off the agency. When CUI failed to remedy the warning letter observations quickly, the FDA elevated their game and enlisted the help of the U.S. Attorney’s Office and the federal courts. With one wave of the agency’s magic wand, a consent decree was born: United States v. Custom Ultrasonics, Inc., Civil Action No. 06-5267 (E.D. Pa.). The doctor wonders if the Chief Jailable Officer (CJO) was able to maintain some level of equanimity (look-it-up) in the face of disappointment and failure after his or her establishment was dragged into court. Enjoy!

FDA Press Release – November 16, 2015

If you would like to enjoy reading the entire press release, Dr. D has provided a link at the end of this week’s Devine Guidance (DG). However, it is the doc’s humble opinion that the first paragraph really says it all.

“The U.S. Food and Drug Administration today ordered Custom Ultrasonics to recall all of its automated endoscope reprocessors (AERs) from health care facilities due to the firm’s continued violations of federal law and a consent decree entered with the company in 2007. The identified violations could result in an increased risk of infection transmission. The FDA ordered this recall under the terms of the consent decree. The agency also issued a safety communication today recommending that health care facilities currently using Custom Ultrasonics AERs transition away from their use to alternative methods to reprocess flexible endoscopes as soon as possible.”

Compliance for Dummies

Folks: This week’s DG is a classic example of how the FDA actually increases the regulatory pain on establishments that fail to play by the agency’s rules. Remember my dear readers. the FDA owns the proverbial medical device sandbox in the United States, so those establishments wishing to play in the sand must do so by the agency’s rules. It does not get any simpler than that, their sandbox – their rules! However, continuing to have compliance issues after a consent decree, that is inexcusable. This issue rings especially true when the finished medical device mentioned in the press release is linked to the cleaning of endoscopes. Remember people, the FDA is really increasing the level of regulatory pain on scope manufacturers and reprocessors, so it is only fair that manufacturers of reprocessing equipment share in the pain.

Additionally, considering the time and expense associated with navigating through a successful conclusion to a consent decree, the doctor was surprised to see that the FDA considers this consent decree still ongoing after eight years. What in the heck is going on? As many of you already know, as part of the consent decree process, the establishment named in the consent decree essentially must contract with a third-party quality/regulatory organization that is tasked with helping the offending establishment navigate a path back toward compliance. Considering the most recent agency inspection of CUI resulted in the agency determining that a continued state of non-compliance existed at this establishment, Dr. D has to question what in the heck happened at CUI. There has to be an underlying reason associated with this establishment’s failure to achieve compliance. Was it the support level and relationship with the third-party service provider? Was it insufficient vigilance and oversight from regulators? Typically, establishments that have successfully emerged from a consent decree do so with a stronger quality and regulatory infrastructure in place. Did CUI simply revert back to its bad habits, which resulted in the 2005 warning letter, or were the compliance issues never adequately resolved?

Furthermore, there is never a good excuse for failing to comply with the Federal Food, Drug and Cosmetic Act. For establishments that fail to comply with federal regulations such as 21 CFR, Part 820 (the QSR), the regulatory pathway and consequences for failing to comply are well-documented. During an inspection one or more Form 483 observations may be identified. If an establishment agrees to fix these transgressions quickly and provides the agency with a well-written corrective action plan, then further regulatory action from FDA is not likely to occur. However, fail to respond to the Form 483 observation(s) or provide a poorly-thought-out and poorly-worded response, then a warning letter will be in the establishment’s future (no crystal ball required). Fail to respond to the warning letter or provide a poorly thought out and poorly worded response, then a consent decree will be in the offending establishment’s future, and one does not have to be clairvoyant to predict the future of the offending establishment.

Under the consent decree, the price of poker becomes unbelievably expensive. Third-party service providers, tasked with assisting in the cleanup of the quality/regulatory mess, are not cheap. In fact, depending on the size of the organization and the compliance issues requiring mitigation, the cost could easily run into the millions of dollars, ouch!  Dr. D is sure that the chief financial officer will tire quickly of signing checks made out to the third-party service provider. Additionally, our friends from the agency will remain firmly implanted in the offending device establishment’s knickers. For all intents and purposes, the offending establishment will remain in a severely crippled state, until the FDA believes that all of the compliance issues have been resolved. Can you say repeat inspection?

Takeaways

For this week’s guidance, the doctor will leave the readers with just one takeaway. There is never a good reason for a device establishment to become victim to a consent decree. Please don’t be that establishment. It is Dr. D’s humble opinion that it is much easier to remain in a state of compliance than to take compliance shortcuts that become expensive projects to resolve when a warning letter is issued. If your establishment is on the receiving end of a Form 483 observation, fix the darned issue ASAP! In fact, make sure the FDA understands that management is fully-committed to compliance. For you CJOs out there, do not be afraid to fall on that proverbial sword, if it prevents the awarding of a warning letter to your establishment. In closing, thank you again for joining Dr. D, and I hope you find value in the guidance provided. Until the next installment of DG, cheers from Dr. D. and best wishes for continued professional success.

References

1. Code of Federal Regulation. (2015, April). Title 21 Part 820: Quality system regulation. Washington, D.C.: U.S. Government Printing Office.
2. Devine, C. (2011). Devine guidance for complying with the FDA’s quality system   regulation – 21 CFR, Part 820. Charleston, SC: Amazon.
3. Devine, C. (2013). Devine guidance for managing key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon.
4. FDA. FDA Orders Recall under Consent Decree for all Custom Ultrasonics Automated Endoscope Reprocessors. (November 2015). Accessed November 17, 2015. Retrieved from http://www.fda.gov/Safety/Recalls/ucm472940.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery
5. FDA.  (June 2005). Inspections, Compliance, Enforcement, and Criminal Investigations. Custom Ultrasonics, Inc. Accessed November 17, 2015. Retrieved from http://www.fda.gov/iceci/enforcementactions/warningletters/2005/ucm075455.htmx