According to trade press and the Food and Drug Administration (FDA), the number of high-risk Class 1 medical device recalls skyrocketed to the highest point ever in 2010, nearly doubling from 23 in 2009 to 51 in 2010, a 122 percent increase.
Class 1 is FDA’s most serious recall category, reserved for situations where the agency believes patients face a reasonable probability of serious injury or death. Years ago, when I was in FDA’s Public Affairs Office, there were only a handful of Class 1 recalls for the entire agency in a year. In contrast, in 2010, Bectin Dickinson and Cardiac Science tied for having the most Class 1 recalls with three each.
Back in the day, the Class 1 recalls that did arise were usually tied to fatalities. Take for instance, the Bjork–Shiley heart valve which became the subject of a famous lawsuit and recall after it was shown to malfunction with dire results. Today, there are many different scenarios in which a Class 1 recall may occur.
What could have caused this astronomical growth in Class 1 recalls? There are differing viewpoints. Having spent more than 17 years at the FDA, and many years since consulting with manufacturers on their interactions with the agency, I see several factors coming into play here.
Complex devices on the rise
One possible rationale posited by FDA recall specialists is the growth in complex devices entering the market. As a whole the sector is growing at a rate of approximately 8-10 percent annually with some segments growing at 15-20 percent. This trend, coupled with the increasing number of companies getting into medical device manufacturing, has resulted in an upsurge in recalls.
Changes in FDA leadership
Another perspective relates to a renewed focus and level of scrutiny by the Agency’s leadership. In late 2009, FDA Commissioner Margaret Hamburg instructed staff to conduct inspections promptly after product recalls occur, responding immediately to any violations that jeopardize public health. Some people think this edict helped to cause the surge in the number of recalls.
Emergence of “The Drugs Model”
Yet one more opinion places responsibility for the increased volume of device recalls on a shifting paradigm within the Center for Devices and Radiological Health (CDRH), the branch of the FDA responsible for approving or clearing all medical devices. One retired staffer shared with me that a 1998 Government Accountability Office report was very critical of how CDRH conducted recalls. In the wake of this report, CDRH has adopted “the Drugs Model” for handling them.
Shortly thereafter, “fresh blood” was brought in to address the criticism. A new recall coordinator for the Devices Center was reassigned from the Center for Drug Evaluation and Research (CDER) and the number of Class 1 recalls grew immediately. In addition, the Devices Center has hired many of CDER’s medical doctors to replace retiring device staffers. These doctors brought a more conservative, risk-averse attitude to CDRH, reflective of their past experience with prescription drugs.
With a more conservative mindset, the FDA has exhibited a tendency to re-classify Class 2 recalls into Class 1. In addition, it has put pressure on manufacturers to conduct a product recall even in cases where the company may not view a recall as necessary.
Knowing all this, what can we do from a communications standpoint to prepare for this increased scrutiny from the FDA? We will re-visit this topic with some key guidelines that may be helpful in our next post. Check back Monday morning or jump in with a comment below if you have any thoughts in the meantime.
Donald C. McLearn is a seasoned communications consultant who has assisted pharmaceutical and medical device clients with strategy and planning, regulatory approvals, advisory committee preparation and issues management for over 30 years.
Tags: Class 1 Recall, FDA, Medical Devices, Medical Recall
[...] Friday we looked at some of the circumstances that have led to the recent influx in FDA recalls. But what this conversation really begs is some [...]