Wednesday, February 15, 2006

Device Companies Would Prefer You Didn't Use the "R" Word

Filed under: Medicine

It looks like the ever-prominent, ever annoying, trend of re-naming words with negative connotations has come our way. According to the St Paul Pioneer Press, many device makers are pushing to dissuade the FDA from using the term "recall."

At a two-day conference this week, regulators and representatives of 50 device makers disagreed on when to use the term. For decades, the FDA has said it's a recall when a manufacturer is asked to repair or replace defective products, like implantable defibrillators, because they are hazardous.

But the industry's 1,300-member Washington, D.C.-based trade group, AdvaMed, said the word is misleading because faulty medical implants don't necessarily have to be removed like defective car parts.

Manufacturers in the $10 billion a year cardiac-device industry prefer to call them "field corrective actions," said Susan Alpert, chief quality and regulatory affairs officer at Fridley-based Medtronic and an AdvaMed activist.

"This is a hot issue for us," Alpert said of the industry. "We want to communicate clearly with our users and our patients on how to manage our products, and the word 'recall' gets in the way."

Even an FDA Class I recall, the most serious kind involving the threat of fatalities, may require only adjustments rather than replacement, said AdvaMed's Alpert, a doctor who once worked as an FDA device regulator.

While FDA officials agreed that the word "recall" may sometimes be confusing, they said it has an unmistakable power and shouldn't be changed without careful deliberation.

"The word 'recall' conveys that there is a potential safety concern," said Kimber Richter, an FDA medical-device compliance officer. "This helps patients understand this is something they really need to pay attention to."

Company representatives at the conference groaned when Michael Verdi, the FDA device-recall coordinator, said there is no point in changing the existing terminology.

"It's what's in the body of the letter where you need to focus," he said. "We're going to waste a lot of time trying to change that word. That word is an attention-getter. It wakes up the public and doctors. It doesn't instruct them to take the product away."

What device companies don't seem to understand is that the public, press, and blogosphere will read the phrase "field corrective actions" and immediately say "recall" in conversations and articles. Only now this comes with the cost of feeling like someone's trying to hide a real problem behind indirect euphemistic language. When will marketing and PR realize that spin and re-naming of commonly used terms only alienates those who they are representing and detracts from their credibility?

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