Folks, trust Dr. D when I say, “you just can’t make this stuff up!” Storing gasoline next to orthopedic trays and instrument trays is never a good thing. Who knows, maybe this establishment was playing around with a new sterilization method (gasoline and matches)? With the price of gasoline continuing to spiral downward, it just might be a viable method: Ethylene oxide gas versus gas (just kidding). Back in March, an investigator from the FDA decided to pop into an establishment for a cup of coffee and an inspection. For most establishments that strive to sustain compliance with quality, regulatory and statutory requirements, a visit from the agency is viewed as a minor inconvenience. However, for other establishments that are less inclined to lean toward compliance, a dose of tough love from the agency might be just what the doctor ordered. Dr. D has to believe that there is a fine line between shaking one’s head in disbelief versus attempting to control paroxysms (look-it-up) of anger when such blatant compliance issues are witnessed by FDA investigators. Enjoy!

Warning Letter – September 24, 2015

As implied in the title of this week’s Devine Guidance, gasoline was being stored in the proximity of finished devices. Besides being a Quality System Regulation (QSR) compliance issue, the storage of a flammable liquid in the vicinity of finished goods (regardless of commodity) is a common sense issue, or should the doctor state the obvious and say, lack of common sense issue. Additionally, handling product returns (used or contaminated devices) in the same area as finished medical devices waiting for shipment has got to be viewed as another violation of the common sense clause, a serious “yuck factor,” and clearly a QSR issue.

Warning Letter Excerpt

Observation One: “Failure to establish and maintain procedures for the control of storage areas and stock rooms for products to prevent mix-ups, damage, deterioration, contamination or other adverse effects pending use or distribution and to ensure that no obsolete, rejected, or deteriorated product is used or distributed, as required by 21 CFR 820.150(a). Specifically, your firm did not have a procedure for storage of medical devices when asked by our investigator.

In addition, orthopedic trays awaiting delivery to customers were observed stored immediately in an area also used to inspect orthopedic trays returning to your firm after being utilized in surgery. Also, a container housing gasoline was observed immediately next to orthopedic trays and other instrument trays.”

21 CFR, Part 820.50 – Storage

“a) Each manufacturer shall establish and maintain procedures for the control of storage areas and stock rooms for product to prevent mixups, damage, deterioration, contamination, or other adverse effects pending use or distribution and to ensure that no obsolete, rejected, or deteriorated product is used or distributed. When the quality of product deteriorates over time, it shall be stored in a manner to facilitate proper stock rotation, and its condition shall be assessed as appropriate.

(b) Each manufacturer shall establish and maintain procedures that describe the methods for authorizing receipt from and dispatch to storage areas and stock rooms.”

Compliance for Dummies

Not wanting to state the obvious but obliged to do so, what in the heck is a container of gasoline doing anywhere near finished medical devices? Flammable materials and liquids such as gasoline should be stored in one of those nice brightly-painted yellow storage cabinets. Additionally, these cabinets should not be near the stockroom. Furthermore, Dr. D is an old guy and cannot recollect the last time he actually saw gasoline being stored inside of a building (maybe Enron was the exception—just kidding).

The QSR is very clear on setting the expectations for the stockroom, with a salient focus on protecting products from adverse effects including: (a) mix-ups, (b) damage, (c) deterioration or (d) contamination. The doctor thinks that gasoline stored near finished devices has the potential for causing a serious adverse effect. Can you say combustion? Additionally, having finished devices ready for distribution and returned product that is potentially contaminated in near proximity of each other is an accident waiting to happen. Simply stated, having gasoline and potentially contaminated product in the vicinity of finished devices ready for distribution violates all six of the covenants associated with §820.150(a):

• Preventing mix-ups
• Preventing damage
• Preventing deterioration
• Preventing contamination
• Preventing other adverse effects
• Preventing obsolete, rejected or deteriorated product from entering the distribution channel

Takeaways

For this week’s guidance the doctor will leave the readers with just one takeaway: Use some common sense and the grey-matter between your ears. Gasoline should not be anywhere near finished medical devices, with the exception of the gas tank for the freight company’s truck tasked with product shipments. The same statement holds true for returned medical devices that are contaminated. This product should be moved directly into a quarantine location upon receipt. If common sense doesn’t grab you, maybe the “yuck” factor will. 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.

1. References
2. Code of Federal Regulation. (April 2015). Title 21 Part 820: Quality system regulation. Washington, D.C.: U.S. Government Printing Office.
3. Devine, C. (2011). Devine guidance for complying with the FDA’s quality system   regulation –21 CFR, Part 820. Charleston, SC: Amazon.
4. Devine, C. (2013). Devine guidance for managing key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon.
5. FDA. (September 24, 2015). Inspections, Compliance, Enforcement, and Criminal Investigations, Medsource, Inc. Accessed October 5, 2015. Retrieved from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm464200.htm