What the Increase in Device Recalls Means for Hospitals

In late March, the U.S. Food and Drug Administration released a report indicating medical device recalls had increased 97 percent over the last decade.

Recalls nearly doubled, jumping from 604 in FY 2003 to 1,190 in FY 2012. What's more, the percentage of recalls categorized as Class I, those that could potentially cause serious harm or death, also increased by four percent during those years.

A global 'recall sprawl'
ExpertRECALL, a recall risk mitigation and management team, released its ExpertRECALL Index earlier this year. Instead of focusing on the number of recalls, the report examined the implications of the recalls. Kevin Pollack, vice president of recalls at ExpertRECALL, says the analysis shows the number of recalls varies quarter to quarter, but the numbers don't necessarily propose an ongoing trend of increasing recalls.

"The main trend we've seen of late, specifically around the FDA, is really the increasing amount of complexity," he says. "We are seeing more nationwide recalls and more global recalls where products are affecting a wider chunk of the country."

The number of recalls affecting at least two countries increased 12 percent, from 23 percent in Q2 2013 to 35 percent in Q4 2013, according to the index. Additionally, the number of recalls affecting the entire country increased from 49 percent in Q2 2013 to 81 percent in Q4 2013, the highest rate in the last seven quarters.

Globalization of healthcare
While the numbers may be worrisome, they aren't indicative of a device industry spiraling downward, says Mr. Pollack. Instead, the increase is reflective of increasing globalization, which allows quicker communication to address issues in the supply chain, which can increase the volume of recalls.

"With the world becoming more connected, information is shared across borders, and agencies are paying more attention to what their counterparts are doing," he says. "Manufacturers think that availability of information is leading to a wider or more quick response to potential issues, which ultimately is a good thing, but it can obviously cause more recalls to happen more quickly."

Additionally, with increased flow across borders, recalled products are affecting a larger population, requiring a larger, more in-depth outreach to mitigate the recall, Mr. Pollack says.

"With manufacturers, that drives a lot of complexity because you have a lot of languages from different countries you have to deal with to manage that recall. You have a surge in interest in calls and notifications that need to go out to notify all the various users," he says.

Hospital ramifications
While manufacturers are dealing with notifying distributors of the recall, hospitals are sent into recovery mode to remove all affected products out of circulation. This process requires time and effort to track the product and can sometimes be an economic burden as hospitals pull resources from elsewhere to address the recall.

"There's a lot of ambiguity and lack of knowledge, and it becomes a resource strain," he says. "If done right and done quickly and efficiently, it won't be a major resource drive on the hospital."

Mr. Pollack says weak communication is often a culprit in this resource drain on hospitals. Whether a hospital's process is more technological or is more manual, having a preplanned process in case of a recall can help remove affected products out of the supply chain more quickly.

"The key is that everybody understands the process and everybody is knowledgeable about how to react and how to think it through," he says. "The key is to get the product off the central floor or off the potential area where it could be used as quickly as possible."

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