Medical Device Daily Washington Editor

WASHINGTON — Product safety may sound like an absolute where medical devices are concerned, but one discussion at Wednesday's session of the annual meeting held jointly by FDA and the Food and Drug Law Institute (FDLI; Washington) made clear that the definition of safety is somewhat dependent on context after all.

Patricia Shrader, senior VP for corporate regulatory and external affairs for BD (Becton Dickinson; Franklin Lakes, New Jersey), said she had little new to say about safety, "so I may have tended more toward the philosophical" in crafting her presentation. She said that the definition of the word "safety" suggested absolute safety, although the definition in regulatory terms is "a little different" in that it does not entail absolute safety.

In a regulatory context, Shrader said, "safety, like beauty, is in the eye of the beholder," noting that absolute safety will always be commercially unavailable, assuming it is possible. After several decades in the business, she said, "I have yet to hear a manufacturer say 'I don't care about the safety of my devices.'" All the same, things can slip, she noted.

Shrader said the company at one time offered a heat therapy patch, which the first test users said "wasn't very warm, it could be warmer." So the company redesigned the product, and hence, "we weren't surprised when we got a trickle of complaints of reddening skin."

That trickle increased, though, and in the company's investigation into the complaints, "we found a reasonable amount of misuse of the product," such as keeping it on for too long and covering it with clothing. BD noticed that a similar product was withdrawn from the market after "reports of more serious burns."

"We concluded that there were other products on the market that could achieve the same purpose," Shrader said, and the benefit of the heat patch was not utterly crucial to any patients. BD thought about putting more warnings on the label, but "we concluded – there was an economic consideration as well – we didn't make that much money on the product anyway," and the firm dumped the patch. So while safety was not a huge consideration, it nonetheless trumped the product's importance to both patient and manufacturer, a death knell for any product.

In a previous episode dealing with a needle-and-syringe combination equipped with tip caps, BD was prompted by customers – in this case hospitals – who said doctors and nurses liked having a cap over the needle so that filled syringes could be safely shipped to patient rooms. "The syringes were sterile and in order to have an appropriate sterilization process, we had to have slits in the caps" to ensure that the needles came out sterile, Shrader commented.

Unfortunately, these syringes found their way into the hands of patients outside of hospitals and doctors offices, and parents evidently let their kids use them for beverage squirt guns. The kids and their parents did not notice the needles were still affixed because the cap was the same color as the barrel, and some children jabbed themselves with the needles while shooting milk and soda pop into their mouths.

"We issued a letter to all our customers and let FDA know" about the situation, Shrader said, and while the problem ebbed, "it happened again." This situation was different from the heat patch because the capped needle was a huge convenience for hospital personnel, and eliminating the tip cap meant not being able to hang the syringe to dry after manufacturing.

BD tried changing the color of the tip cap from white to blue "so that at least it would be obvious to users," and added warnings, but eventually yanked the product. Despite expectations that the firm would lose market share, BD didn't suffer much from the move. "I don't know that we've lost a lot of market share as a result," Shrader said.

Shrader acknowledged that the safety dilemma hits other firms in much more profound ways than BD. "We don't get a lot of tough cases at BD," she admitted, stating that in the case of high-risk implantables, a ready substitute is not always waiting on the sidelines, so a market withdrawal is not always an option.

Still, firms have to communicate with FDA and the public. "You don't want to unduly alarm people, but you do want to adequately inform them," she said.

When it comes time to talk to FDA about a safety issue, "we're always apprehensive when we do it," because the agency might overreact and/or slow things down, "and both things have happened" to BD, Shrader said. On the other hand, BD has been successful in dealing with FDA with regard to risk communications to the public, so it can be done without crippling a company.

Other safety issues have popped up on the firm's radar screen, however. Shrader said BD "got caught up in the whole heparin issue" via the company's lock-flush preparations for intravenous drip assemblies, and said the company "had no idea our supplier was sourcing heparin from China."

The firm that sold the heparin to BD had applied the then-current USP standard to test the product, and Shrader reminded the audience that "it was only through the development of new test methods that FDA" diagnosed the problem. "Sometimes you need to go deeper than the surface" to establish a root cause, she warned.

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