Who's Afraid of the Big Bad BPA?Who's Afraid of the Big Bad BPA?

There have been plenty of public health concerns raised in recent years about bisphenol A (BPA)--a common building block for the polycarbonate plastic and epoxy resins that serve as workhorse materials for disposable medical devices.

But such concerns should not weigh heavily on device designers, says Len Czuba, president of design firm Czuba Enterprises (Lombard, IL).

Yes, there have been issues raised over potential BPA links to cancer and reproductive problems, especially because it has a chemical structure similar to estrogen. The FDA has been supporting the replacement of BPA-based plastics in baby formula packaging, bottles, and sippy cups--and is still studying its use in medical devices.

Still, the amount of BPA a patient might receive over a disposable polycarbonate IV line component, for example, is much smaller than what someone might be exposed to after washing a polycarbonate beverage container in hot, soapy water, according to Czuba.

"The amount that's broken down or comes out is extremely minute. ... It's hard to get the bisphenol out of it," Czuba says.

A study out last year from Ethicon (Cincinnati, OH) even found that medical-grade polycarbonate has a substantially lower BPA threat than consumer-grade polycarbonates. According to the study, a device with 10 grams of medical-grade polycarbonate will result in a daily BPA exposure of less than 0.040 (?g/kg. This is less 1250 fewer (?g than a level that would pose a risk to patients through chronic exposure.

So what should medical device designers actually be concerned about when it comes to using polymers? The most alarming issue for Czuba involves U.S. health providers seeking to save money by having supposedly single-use medical components sterilized and reprocessed so that they can be reused. 

"Don't call it a single-use devices then. By definition, an SUD should only be used once," Czuba says.

Czuba advises anyone getting a medical procedure to ask their health provider whether they're being exposed to a reprocessed medical device. "If anyone uses reprocessed devices, patients should be made aware of it," Czuba says. "There have been cases where the tip of a balloon catheter has broken off. They have had to go in and open up the patient and fished out the lost piece."

In contrast, the BPA issue does not seem much of an issue at all to Czuba.

"It's one of these deals where you spend so much time and effort trying to raise the boogyman out there, and it's really not that much of a problem," Czuba says.

Czuba notes that polycarbonate is not used for implantable devices anyway, but rather is used for housings, connectors, flow manifolds for IV and blood solutions, and the hubs for needles and catheters. The material is an affordable, disposable polymer able to withstand the three major sterilization techniques: radiation, ethylene, and steam.

"The leaching will only happen if the solutions are in contact with the polycarbonate during the heat exposure, when hydrolysis can happen. Typically, the steam sterilization is done on solution containers like IV bags ... I don't know of any containers made out of polycarbonate that are steam sterilized," Czuba says.

It also is often thrown away after one use. That means extremely limited exposure to BPA. "All of these allegations--they're generalizing that these things happen in certain conditions," Czuba says.

Even when it comes to the risk of exposure through food and drink containers, the FDA does not seem overly alarmed:

Chris Newmarker is senior editor of MPMN and Qmed. Follow him on Twitter at @newmarker and Google+.