The doctor would like to begin this week’s guidance by wishing a Happy Thanksgiving to the readers and their families that are celebrating this holiday. Just an FYI – drinking and football makes Thanksgiving one of Dr. D’s favorite holidays.

While reading through this week’s FDA warning letters, the doctor was absolutely floored when he stumbled upon an organization that failed to compile Device History Records (DHRs) for nine months. In fact, the doctor is pretty sure a “RECALL” (the doctor’s favorite six-letter word) just might be in the works as there would appear to be no documented evidence that finished medical devices were manufactured in accordance with their Device Master Record (DMR). It appears that our friends at the agency found this establishment’s “execrable” (look-it-up) performance inexcusable and decided the awarding of a warning letter was an appropriate prize. Enjoy.

Warning letter – 28 October 2014

Folks, this week’s offending establishment had just way too much cannon fodder depicted in their warning letter for just one episode of Devine Guidance, so the doctor will revisit this warning letter next week too. Seriously, this firm received a total of eight observations that reflect similar lapses across other requirements delineated within the QSR. In fact, this establishment just might be this year’s poster child for incompetent quality management for their complete failure to establish a quality management system (QMS).

Warning Letter Excerpt

Observation Four: “Failure to establish procedures for Device History Records (DHR), and failure to maintain DHRs for each batch, lot, or unit as required by 21 CFR 820.184. Specifically, no DHRs were maintained for approximately (b)(4) SimulCare II devices manufactured between December 2013 – August 2014.”

Section 820.184 – Device History Record

Each manufacturer shall maintain device history records (DHRs). Each manufacturer shall establish and maintain procedures to ensure that DHRs for each batch, lot, or unit are maintained to demonstrate that the device is manufactured in accordance with the DMR and the requirements of this part. The DHR shall include, or refer to the location of, the following information:

(a) The dates of manufacture;

(b) The quantity manufactured;

(c) The quantity released for distribution;

(d) The acceptance records which demonstrate the device is manufactured in accordance with the DMR;

(e) The primary identification label and labeling used for each production unit; and

(f) Any unique identified (UDI) or universal product code (UPC), and any other device identification(s) and control number(s) used.

Compliance for Dummies

Compiling a DHR for a lot of finished medical devices is far from being rocket science. How darn difficult can it be to:

• Collect the lot number;
• Collect evidence of inspection and testing (a.k.a. acceptance activities);
• Collect the bill of materials and some level of traceability on raw materials, components used (as applicable);
• Collect a copy of the product labeling; and
• Place it all into a folder appropriately called the DHR?

Jokingly, the doc mentioned a potential recall in the introduction to this week’s guidance; however, if no DHR exists, a recall is going to be a challenging task indeed. In fact, if there is no documented evidence (no DHR) did the product really get manufactured? In the eyes of FDA, if an event or activity is not documented in writing, it never happened? Dr. D is full of questions this week because this lapse in judgment is just so astonishing. People, you cannot make this stuff up! The doctor wonders what the Chief Jailable Officer (CJO) was thinking. Hopefully this individual has moved on to another job. Maybe shoveling some snow in Buffalo.

Seriously, the DHR is the documented evidence that finished medical devices that are safe and effective in their intended use are manufactured in accordance with their DMR. The DHR really is nothing more than a compilation of objective evidence of manufacturing compliance (including inspection and test). For those organizations that rely on contract manufacturers, the doctor strongly suggests that you collect the lot traveler from your contract manufacturer. If your establishment’s finished device is sterilized, it is imperative that the sterile load information be linked to the DHR, including the lot release information and the name of the individual releasing the lot of finished devices.

The DHR should contain:

(a) quantities manufactured;

(b) date(s) of manufacture;

(c) quantities shipped;

(d) acceptance activities;

(e) labeling; and

(f) the part number(s).

Additionally, rework activities, non-conformances; and other relevant information, pertinent to the lot manufactured, should be collected as part of the DHR.

Takeaways

For this week’s guidance, the doctor will leave the readers with just one takeaway, DHRs are not optional. The DHR is essentially the documented evidence that a finished medical device was manufactured in accordance with the DMR. Please do not be that CJO that has to sit across from that FDA investigator without the documented evidence of compliance needed to defend your establishment’s QMS, or should Dr. D say, lack of QMS.

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. (2013, 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’s enforcement page. (2014, November). FDA.gov Website. Retrieved November 19, 2014, http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm421235.htm