Regulatory Focus™ > News Articles > Report: Repeat Recalls by Device Companies at 30-Month High

Report: Repeat Recalls by Device Companies at 30-Month High

Posted 14 February 2013 | By Alexander Gaffney, RAC

A new report out today from the recall company SteriCycle focusing on recalls overseen or ordered by the US Food and Drug Administration (FDA) shows that recalls of pharmaceutical and medical device products fell slightly in the fourth quarter of 2012 relative to Q3, but the number of recalled units fell dramatically.

Those recalls generally fall into one of two categories: voluntary recalls, which comprise the vast majority of all recall activity, and mandatory recalls, which are considerably rarer and typically indicate a serious failure.

Medical Device Recalls

It should come as no surprise to anyone who tracks FDA's weekly enforcement reports that medical devices get recalled often. A cursory glance at any of those lists reveals dozens, sometimes hundreds of devices.

Stericycle's data puts a number to that observation: 314 medical device-related recalls in the fourth quarter of 2012 alone. While high, that's actually down 23% from the previous quarter, when FDA tracked 407 recalls. It is still higher than the other three previous quarters (Q4 2011, Q1 2012 and Q2 2012), which saw between 100 million and 270 million device recalls.

As in all previous quarters, nearly all medical device recalls (286/314) were Class II recalls, or those that exhibit problems with the potential to moderately affect patients. Just 16 recalls were Class I (high risk of patient harm) recalls, and 12 were for the lowest-risk Class III recalls.

Altogether, the medical device recalls "affected more than 10 million units, compared with about 26.5 million units recalled in the previous quarter. The number of recalled medical device units reached the lowest level seen in at least six quarters, with no recalls affecting more than 5 million units," wrote SteriCycle. "In addition, the average number of units affected per recall during the fourth quarter dropped by more than 60 percent, reaching the lowest average in at least 10 quarters."

Another interesting observation in the report: While just 16 Class I recalls occurred (5%), they affected a disproportionately high number of units-27% of all units, in fact. This could be attributed to the seriousness of the problem necessitating a 'recall first, determine quality later attitude,' but the report doesn't specify what factors might be behind that trend.

Pharmaceutical Recalls

Pharmaceutical recalls were notably more muted in the fourth quarter relative to Q3, which saw a massive spike in Class II recalls.

Still, the sector saw 81 drug and pharmaceutical product recalls affecting 11.7 million units. Stericycle's data shows that while the overall number was down-likely due to the effects of a single drug recall in the previous quarter-the overall average of units affected per recall actually increased by 50,000 on average relative to the third quarter of 2012.

As with medical devices, most recalls were Class II recalls (63%), while a lesser number were Class III (24.6%) and Class I recalls (13.4%). Just four recalls affected over-the-counter-products, though one affected a massive number of units (1.5 million).

Unlike medical devices, where Class I recalls affected a disproportionate number of products, Class II recalls actually exhibited a slightly higher number of recalls in the pharmaceutical sector (63% of products, 76% of units).

Misery Loves Company

Another recurring trend found in the report: companies involved in multiple product recalls. Not necessarily surprising given that many recalls are associated with manufacturing issues rather than design issues, which are less likely to affect multiple products. But the scope of the problem is considerable. Forty percent of all medical device companies and 45% of all pharmaceutical companies were involved in more than one recall in the fourth quarter.

"This is the highest percentage of repeat violations by [pharmaceutical] companies in at least the last ten quarters," the report noted. No similar analysis was available to put the medical device numbers into context.

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