Dr. Christopher Joseph Devine, President, Devine Guidance International
Devine Guidance

Ship the Finished Device to Where?

By Dr. Christopher Joseph Devine
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Dr. Christopher Joseph Devine, President, Devine Guidance International

Compliance to FDA’s requirements for distribution are well-scripted and relatively easy for device manufactures to comprehend. However, it is inevitable that Mr. Murphy will eventually visit a device manufacture, resulting in Dr. D’s favorite six-letter word – RECALL.

It seems like yesterday, Dr. D started writing for the Medical Device Summit. In fact, it has been four years since Rick Biros and the staff of the Summit gave the doctor a forum to preach about the importance of quality and regulatory compliance in the medical device industry. As most of you already know, the doctor loves to write and I hope each of you enjoys reading the fruits of Dr. D’s labor of love.

That being said, the doctor had a mini-epiphany while driving to SFO. Dr. D seldom if ever writes about medical device distribution. Seriously, your organizations can be designing and developing cutting-edge devices in pursuit of providing new technologies and therapies to treat many of life’s maladies. Your organizations can have world-class manufacturing facilities or outsource assembly operations to many of the capable contract manufacturers located around the globe. However, what about order fulfillment and the subsequent distribution of finished medical devices to the healthcare organizations, practitioners, and physicians that need these devices to treat their patients? What are the quality and regulatory requirements for distributing finished medical devices in the United States? The first thing device manufacturers need to take to heart is that medical device manufacturers are not “zarzuela” (look-it-up) companies, so FDA oversight is a given.

Compliance to FDA’s requirements for distribution are well-scripted and relatively easy for device manufactures to comprehend. However, it is inevitable that Mr. Murphy will eventually visit a device manufacturer; and that Murphy’s visit will result in Dr. D’s favorite six-letter word (RECALL). Fail to adequately maintain distribution records, and a device recall becomes a difficult task for any Chief Jailable Officer to oversee. Enjoy!

Warning Letter

The good news for device manufacturers is that violations of §820.160 are rare events, as with today’s ERP/MRP technology basic information associated with the distribution of medical devices is relatively easy to collect and retain. However, there is always going to be that one device manufacturer that fails to comprehend the art of medical device distribution. 

Warning Letter Excerpt – 09 August 2013

“Failure to establish and maintain procedures for control and distribution of finished devices to ensure that only those devices approved for release are distributed and that purchase orders are reviewed to ensure that ambiguities and errors are resolved before devices are released for distribution, as required by 21 CFR 820.160(a). For example, your firm does not maintain a procedure for the distribution of the reprocessed manifolds to include or refer to the location of the name and address of the initial consignee, the identification and quantity of devices shipped, and the date shipped.”

“Your firm’s response to this observation appears to be adequate.  Your firm has provided its established policy to control and distribute the finished manifolds. The policy states that all batches of manifolds will be accompanied by the incoming shipping label as well as a Process Record Log unique to that batch. The Process Record Log documents the name and address of the initial customer, the identification and quantity of the manifolds shipped, as well as the date of the shipment.  Your response will be verified in conjunction with your operations during the next inspection.”

Subpart L — Handling, Storage, Distribution, and Installation

Sec. 820.160 Distribution. 

(a) Each manufacturer shall establish and maintain procedures for control and distribution of finished devices to ensure that only those devices approved for release are distributed and that purchase orders are reviewed to ensure that ambiguities and errors are resolved before devices are released for distribution. Where a device’s fitness for use or quality deteriorates over time, the procedures shall ensure that expired devices or devices deteriorated beyond acceptable fitness for use are not distributed.
(b) Each manufacturer shall maintain distribution records which include or refer to the location of:
         (1) The name and address of the initial consignee;
         (2) The identification and quantity of devices shipped;
         (3) The date shipped; and
         (4) Any control number(s) used.

The Distribution Process

Let the doctor begin this section by stating, device manufacturers do not randomly accept, fill, or ship orders for finished medical devices, at least Dr. D hopes not. Similar to the product realization concept found in ISO 13485:2012, Clause 7.2.2 (Review of requirements related to the product), the FDA expects device manufacturers to actually review purchase orders before committing to order fulfillment and the subsequent distribution of finished medical devices. Remember, this is not a novel concept. Additionally, the FDA has a fundamental expectation that Class III devices have been approved, Class II devices have been cleared, and all classes of devices listed in FURLS, again not rocket science.

Distribution Basics

For starters, devices are expected to survive routine distribution channels and arrive at the user’s facility relatively unscathed. To successfully accomplish this task, the packaging modalities used for medical devices must be capable of actually protecting medical devices as they are shipped across town, across the state, across the country, across the continent, and across the ocean. Yes, Dr. D gets it, so stop with the across already. Seriously, the packaging must be suitable to survive handling by the postal service, UPS, Fed-Ex, etc. To achieve the necessary robustness associated with medical device packaging, the packaging must be validated. Can you say ISO 11607-1 and -2 or ISTA-2A?

Additionally, aging studies must be performed to ensure an adequate device shelf-life has been established. Although accelerated aging (AA) and the application of the Arrhenius model will allow device manufacturers to quickly ascertain some level of shelf-life, real-time (RTA) aging is the requirement. Dr. D recommends commencing the AA and the RTA at the same time so the FDA is not angered. Once the shelf-life life has been defined, please feel free to display it proudly on the product label. Why? It is a basic requirement. Dr. D also recommends reading 21 CFR, Part 801 (Labeling). Remember, in accordance with §820.160, it is an unacceptable practice to distribute product that has expired shelf-life.

Other distribution requirements

Just like everything else associated with FDA and the medical device industry, the expectation is that device manufacturers keep meticulous records to support documented evidence of compliance. However, keeping meticulous distribution records will become extremely valuable should a device recall ever have to be executed. As a minimum, distribution records should include:

  • The name and address of the consignee (purchaser, exporter, importer, buyer, etc.);
  • The name of the device (UPN, UDI, part number, or other relevant identified);
  • The quantity shipped (sold);
  • The actual date the shipment occurred; and
  • The relevant control number (lot/batch number or serial number).

The good news is that with today’s state-of-the art ERP/MRP systems, this information can be collected and stored electronically. This makes obtaining product distribution lists a relatively easy task, should a product recall ever be necessary.

Takeaways

For this week’s guidance, Dr. D will leave the readers with three takeaways. One – Make sure packaging has been properly validated to support product preservation during routine distribution channels. Two – make sure aging studies have been completed and the finished device labeled with the expiration date, as appropriate. Three – Ensure meticulous distribution records are maintained as they will become the CJO’s best friend during a product recall. 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 801: Labeling.  Washington, D.C.: U. S. Government Printing Office.
  2. Code of Federal Regulation. (2013, April). 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. FDA’s enforcement page – warning letters. (2013, November). FDA.gov Website. Retrieved November 17, 2013, from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2013/ucm365433.htm

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Dr. Christopher Joseph Devine, President, Devine Guidance International

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