For this week’s Devine Guidance
, Dr. D is going to briefly explore the need for device manufacturers to collect, assemble, and retain a Device History Record (DHR) that accurately reflects the complete lot history for finished medical devices. Remember, the DHR is not a nice-to-have or a record to be taken lightly. In fact, the FDA feels so strongly about the importance and composition of the DHR, the Quality System Regulation (21 CFR, Part 820) contains a section dedicated to the almighty DHR (§820.184).
If a device manufacturer fails to recognize the importance of the DHR, try managing your organization’s complaint management system, performing a complaint investigation, filing an MDR, or even attempting to manage a RECALL (Dr. D’s favorite six-letter word), if accurate lot/batch information is not collected and maintained. In an effort to reduce the doctor’s “sesquipedalian” (look-it-up) prose, Dr. D will simply state; “Not having a DHR is a bad thing.” Enjoy!
Device history record
So what is the real value of the DHR? For starters, the DHR is the receptacle of documented evidence that each manufactured device, batch, or lot of devices has been manufactured in accordance with the Device Master Record (DMR). Without documented evidence, it will be an impossible task, for the Chief Jailable Officer (CJO) to sit across from an investigator from the agency, and defend the practice of not having adequate DHRs. So the doctor is perfectly clear on his position pertaining the importance of the DHR; “No DHR will equate to a Form 483 observation, no questions asked.” As a minimum, the DHR shall include:
- The actual date(s) a device, batch, or lot was manufactured;
- The actual quantity of devices manufactured;
- The actual quantity of devices accepted and entered into distribution;
- All of the records, inspection results, test results, evidence of sterilization, and other quality and manufacturing records that support devices being manufactured in accordance with the DMR;
- A copy of the actual product label (pouch and carton) and the Directions for Use (DFU); and
- Any additional identification, serial, or control numbers employed.
Remember, a good rule of thumb is to ensure all documentation relating to the actual manufacturing of a finished medical device be retained in the DHR. Why? Time for a Dr. D broken-record moment: “The DHR is the documented evidence needed, by device manufacturers, to support compliance to the QSR.” Why? Because documented evidence is always a device manufacturer’s best defense during an FDA inspection. Why? Device manufacturers do not like responding to Form 483 observations. Why? Dr. D says so.
In closing, the doctor hopes you have found some value in this week’s guidance. Cheers from Dr. D. and best wishes for continued professional success.
- Code of Federal Regulation. (2012, April). Title 21 Part 820: Quality system regulation. 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.