What happens when a manufacturer decides or is compelled to change the material it uses to produce a medical device? What regulatory hurdles must it clear before it can bring the modified product to market? Kevin Posey, quality and regulatory consultant for Indianapolis-based Maetrics, will probe these questions at MD&M West on Tuesday, February 10, 1:00–1:40 p.m., in a presentation titled “Updating Your Risk Management Protocol When Using a New Material.”
|Photo by ddpavumba, courtesy of FreeDigitalPhotos.net.|
Risk management, according to Posey, is a required lifecycle process. “It starts as soon as you begin with the concept of a new medical device and does not end until the device is completely removed from the market. When considering introducing a new material, ask yourself if it affects the safety, performance, or efficacy of the approved device.”
For medical devices, ISO 14971 stipulates that whenever an already existing product undergoes any type of change, it must be evaluated as a postmarket surveillance item, regardless of whether the source of the change was an external complaint or the result of an internal design modification. While FDA does not require explicitly that manufacturers follow ISO 14971, this standard is generally accepted in the medical device industry.
The challenge arises when manufacturers must decide which material changes must be evaluated, Posey explains. An already existing device could require new regulatory approval if the new material constitutes a substantial design change. But what if a like-like exchange takes place in which the new material differs from the old material only in its detailed chemistry, while the material’s characteristics and performance remain essentially unchanged?
“A good example of this situation is the plasticizers that have been included in the Restriction of Hazardous Substances (RoHS) regulations in the last few years. And with the planned addition of four materials to the RoHS directive—a brominated flame retardant and three plasticizers, including DEHP—the risk management challenges facing the medical device industry could increase. However, because these materials generally belong to the same class as the other materials already specified in the directive, this addition doesn’t represent a major sea change, Posey comments.
Many manufacturers—especially those that produce such high-volume disposable devices as syringes—may focus more on compliance as the business model to maximize profits. But what if a syringe manufacturer must change a material to eliminate the use of a plasticizer such as DEHP? Will it use a new plasticizer or choose a material that does not incorporate a plasticizer? “Although such disposable devices as syringes have minimal contact with the body, the company must still determine whether its decision will affect the plastic’s performance,” Posey says. “And it must still be prepared to defend its decision before a regulatory agency.”
There is no one method that will work for every company, Posey notes. It depends on the device. “For a fairly low-risk device—say, a Class I medical device such as a tongue depressor—if we were to use a different species of wood, our compliance burden would be low because this device has short-term contact with the body’s mucous membranes. However, because it has contact with mucous membranes, a manufacturer would have to perform biocompatibility testing.”
From a business perspective, medial device companies strive to satisfy the minimum compliance requirements, but they also have a social responsibility, Posey insists. “What’s the right thing to do beyond the compliance requirements? For FDA, this means determining what’s safe and effective, while for the EU and generally the rest of the world, this also means determining whether a device meets its essential requirements.” Thus, there’s a gray area between FDA’s concept of minimum compliance for safety and efficacy and the EU’s perspective of ensuring and documenting that a material change will not impact the device’s essential requirements.
“Within the context of their mission and vision, medical device companies define their compliance requirements while developing strategies to determine how far they want to go to be socially responsible,” Posey explains. “This creates business as well as regulatory challenges.” —Bob Michaels
Bob Michaels is senior technical editor at UBM Canon