If an establishment really wants to endear themselves to the agency, just fail to report a recall. For additional terms of endearment, fail to report a recall a second time. If the establishment wants to really tempt fate, fail or refuse to provide information requested by an investigator when he or she appears in the lobby for a cup of coffee and an inspection. In the case of this week’s Devine Guidance (DG), I hope the offending establishment’s Chief Jailable Officer (CJO) was smart enough to give the FDA decaf, when they magically appeared for an inspection last summer. In fact, the FDA spent almost two months at this offending establishment (June 3–July 27), and Dr. D is going to climb out on a limb and emphatically state that it was probably not for the Walleye fishing in Wisconsin. As many of the doctor’s faithful readers already know, Dr. D always preaches a message of compliance. The best advice the doctor can offer to CJOs is to always be cordial and responsive when the FDA arrives for an inspection. Failing or refusing to fulfill FDA requests for information is always going to end badly. Couple the failure to provide information with a marmoreal(look-it-up) demeanor and the doctor guarantees the CJO will have a tremendously miserable time during an FDA inspection. Enjoy!
Warning Letter – September 30, 2015
The recipient of this warning letter received a six-observation warning letter. Most of the observations were fairly benign and with a robust response, a warning letter could have been averted. However, failing to correctly classify and report a recall (Dr. D’s favorite nasty six-letter word), and a warning letter will be lurking on the offending establishment’s horizon. When in doubt, it is always considered best practice to contact the local office and inform them of a pending correction or removal (nice way of saying recall). In fact, Dr. D always recommends obtaining the agency’s concurrence on the classification before launching a recall effort.
Warning Letter Excerpt
“Our inspection also revealed that your Merge Hemo 9.10, 9.20.0, 9.20.1, 9.20.2, 9.30, 9.40.0, 9.40.1, 9.40.2 with Massimo PHASEIN End Tidal CO2 (EtCO2) module is misbranded under section 502(t)(2) of the Act, 21 U.S.C. § 352(t)(2), in that your firm failed or refused to furnish material or information respecting the device, as required under section 519 of the Act, 21 U.S.C. § 360(i), and 21 CFR Part 806 – Medical Devices: Reports of Corrections and Removals. Significant violations include, but are not limited to, the following:”
Observation Six – Failure to submit a written report of a correction or removal of a device initiated to reduce a risk to health posed by the device, or to remedy a violation of the Act caused by the device, which may present a risk to health, as required by 21 CFR 806.10. Specifically, two recall notices (1/21/15 and 4/16/15) were sent to the firm’s Install Base having Merge Hemo devices equipped with Phasein EtCO2 modules to explain that the Client PC could “Freeze Up” or record multiple short recordings of Invasive BP readings if the user unplugs the Phasein EtCO2 module and re-plugged into the patient data module. The failure mode adversely affects the collection of the Invasive BP measurements required to calculate the Fractional Flow Reserve (FFR) feature as was reported in no less than eight instances with a patient on the table, leading to delay in treatment while “re-booting” the system (causes temporary loss of all patient vital signs monitoring and recording) or when no treatment was performed at all when the clinician chose to stop treatment due to the inability to obtain accurate and reliable Invasive BP readings.”
“Your firm failed to notify the FDA of the medical device correction or removal, and did not provide the information required by 21 CFR 806.10. Your firm’s actions have been reviewed by FDA and determined to meet the definition of a Class II Recall, which also meets the risk to health threshold for a 21 CFR Part 806 report, as specified in 21 CFR 806.10. Therefore, your firm’s actions should have been reported to the FDA.”
“We have reviewed your response dated August 12, 2015. We acknowledge your commitment to updating your medical device incident reporting and field corrective action procedure. However, your response is inadequate in that you have not provided an updated procedure, specifically how you plan to address determination of a risk to health and the need to report a correction or removal to the Agency. Additionally, you have not provided a timeframe and/or the results of your retrospective review to determine whether additional corrections and removals require reporting to the Agency.”
21 CFR, Part 806.10 – Reports of Corrections & Removal
(a) Each device manufacturer or importer shall submit a written report to FDA of any correction or removal of a device initiated by such manufacturer or importer if the correction or removal was initiated:
(1) To reduce a risk to health posed by the device; or
(2) To remedy a violation of the act caused by the device which may present a risk to health unless the information has already been provided as set forth in paragraph (f) of this section or the corrective or removal action is exempt from the reporting requirements under §806.1(b).
Please note, Dr. D only included the first part of 806.10 due to its length.
Compliance for Dummies
For starters, you just might want to consider beginning with the scripting of a well-written procedure defining your organization’s approach for managing corrections and removals (don’t forget about advisory notices, too). The procedure should incorporate all of the little nuances associated with the FDA-mandated requirements delineated within Part 806. Make sure you focus on the customer notification process, the product recovery process, good-faith effort process, effectiveness checks, the reporting process to FDA, and the certified destruction process. Dr. D sees many organizations merging multiple post-market activities for various regulatory environments into one procedure. The doctor would like to dissuade the readers from doing this, as each regulatory environment has its own little nuances.
If your establishment lacks an ERP/MRP system, then the doctor strongly suggests investing in an ERP/MRP system that will adequately support medical device traceability, including product shipments. Why? Because when Mr. Murphy comes knocking, it will just be a matter of time before Murphy raise his ugly little head and screams “RECALL!”
Executing a successful recall will be driven by knowing where all of the suspect medical devices reside: (a) with a healthcare organization, (b) on a consignment shelf, (c) sitting on a shelf in a distribution center, (d) in transit, or (e) in the infamous trunk stock location (a.k.a., in the back of a sales rep’s car or in the rep’s garage).
The FDA has identified three categories of recalls, each premised on risk to public health and safety. The recall class will drive the level of attention to detail and FDA involvement with the recall process.
These guidelines categorize all recalls into one of three classes, according to the level of hazard and risk involved:
- “Class I – a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
- Class II – a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
- Class III – a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.”
The classification of a particular recall will define the boundaries for executing the recovery process. For the most part, product recalls are voluntary; however, the FDA giveth and the FDA taketh away. If a medical device poses an imminent threat to public health and safety, the agency can order a Class I recall. Even for a device-manufacturer sponsored recall, FDA notification is required. Through the concept of “First Alert”, the FDA becomes aware of a product issue and the clock starts ticking.
Executing the Recall
Right after that first call is made to FDA, for the initial consultation, the device manufacturer begins the arduous task of identifying where the medical devices requiring to be recalled are located within the United States. Written notification will be required (please note, FDA notification is not required for Class III recalls). Ensure evidence of notification is collected (e.g., use FedEx, UPS or USPS to ship the recall packets and collect evidence of receipt). Just in case you are wondering, evidence of receipt equates to a signature acknowledging receipt of the recall package. In the eyes Dr. D and the FDA, the magic number is three, which equates to three attempts to collect product being recalled. Collecting the suspect devices will require significant vigilance and a recall manager with the persistence and tenacity of a pit bill—ruff, ruff! As product is returned and collected, it is imperative that the product be placed into a quarantine location. Please note, meticulous records associated with the recall shall be maintained. Once the device manufacturer is in a position to accurately determine that no more devices are going to be returned (hopefully an effectiveness rate of greater than 90.0%), then FDA can be contacted, and plans for the certified destruction of the devices can be executed or work instructions for product rework can be reviewed and approved. Regardless, recalled product shall not be moved until FDA concurrence is obtained (minus Class III recalls, of course).
Once upon a time, in a distant land called California, Dr. D watched in amazement as a forklift was driven back and forth over a couple of hundred catheters in an effort to destroy them. Was it effective, heck yes; however, it was also quite messy. The doctor recommends contacting a firm specializing in the certified destruction of medical devices. Make sure the certificate of destruction is included in the recall documentation. FYI, do not forget to invite the FDA to the destruction party. They may choose to attend.
Dr. D strongly recommends pursuing the same rigor when executing a Class II or Class III device recall. Remember, the FDA will want to look at all of the documentation associated with a recall as part of one of their friendly visits (a.k.a., facility inspection). The agency is always interested in the effectiveness of a device manufacturer’s recall efforts, regardless of the classification.
For this week’s guidance, Dr. D will leave the readers with three takeaways. One: Please do not be that establishment that fails to notify FDA of a pending recall. Two: It is best practice to contact FDA and obtain their agreement in regard to the recall classification selected. Three: Remember to keep impeccable records of all recall activities. The FDA will want to review them during a friendly visit for a cup of coffee and an inspection. 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.
- Code of Federal Regulation. (April 2015). Title 21 Part 806: Medical devices; Reports of corrections and removals. 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. (September 30, 2015). Inspections, Compliance, Enforcement, and Criminal Investigations. Merge Healthcare, Inc. Accessed February 23, 2016. Retrieved from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm466204.htm
I learn something new every time I read your column! Thank you for being so thorough in your research.
Robyn, thank you so much for reading. I try to inform and entertain at the same time.
Be Well, Dr. D