Expert Recall

By Willie Bryant

I recently discussed on this blog concerns that the medical device industry has about FDA’s new “corrective fix” pilot program. This pilot program may require some manufacturers to recall older devices when FDA’s Center for Devices and Radiological Health (CDRH) approves improvements to the device. According to FDA News, CDRH recently acknowledged at the Food and Drug Law Institute annual conference that the “corrective fix” pilot is part of CDRH’s “Signal Escalation,” a post-market transformation program launched by CDRH in 2008.

But it’s not yet clear to me how the “corrective fix” program fits into “signal escalation.” The goal of the CDRH is to fully implement a business process for signal escalation by December 31, 2010.  Until then, it may not be clear how the two will fit together.

In fact, it still remains to be seen how CDRH can justify “corrective fix” actions given that the FDA currently has no authority to require device recalls except under Section 518. Under this regulation, the product in question is to be recalled if the following criteria apply:

1. The device, intended for human use and introduced into interstate commerce for commercial distribution, presents an unreasonable risk of substantial harm to the public health; and
2. Notification is necessary to eliminate the unreasonable risk of such harm; and
3. No other practicable means is available to eliminate such risk.

In the latest version of its Investigation Operations Manual, FDA provides guidance to investigators conducting recall inspections which may relate to “corrective fix” situations.  If the older device has been on the market for more than a year and the new model has been improved by a design change that eliminated a problem, then the FDA investigator is charged with determining such things as:

1. Was the design feature which caused the problem included in the design of the device that was the subject of a premarket submission?
2. If the design feature which caused the problem is part of the original design, did the manufacturer recall all products manufactured since the device was introduced to the market? If not, why not?
3. If the problem was introduced via a design change, did the manufacturer follow established design change or change control procedures? If yes, are the procedures adequate? Was the nature of the problem such that it should have been anticipated, and the design verification/validation study fashioned to detect the problem?
4. Has the manufacturer recalled all products distributed since the design change was introduced? If not, why not?

The answers to these questions will likely determine the necessity and scope of a recall.

Regardless of how little we may understand about what a “corrective fix” actually means and how it will be implemented, medical device manufacturers have to be prepared to take action to remove older products from the market. Be sure you have a recall plan in place which clearly details the responsibilities of all management and involved personnel in a recall.  How do you handle consignee notification and verification that the requested action has been accomplished?  Can you trust your distributors to undertake the sub-recall to final consignees in a manner that best represents your company and the device in question? Would it be in your company’s best interest to have a third party personally contact or visit the consignees to handle necessary action?  How will you handle communication with consumer consignees?  Is your Customer Relations staff capable of answering and triaging hundreds or thousands of calls in a short time? 

These are questions that you should keep in mind whenever you update or modify a medical device you manufacture. And this is yet another reason why you need to be prepared with a recall plan to help you and your team execute the recall process quickly and effectively.

Stericycle ExpertRECALL™ is the industry leader in recall logistics and regulatory compliance for consumer product, pharmaceutical, medical device, juvenile product, and food and beverage recalls. ExpertRECALL’s professionals are experts in recall management who can help you streamline the entire product recall process.