AAMI News June 2015

FDA, Industry Eye Shared View of Risk Management

Seeking to ensure that safety issues with medical products on the market are addressed promptly and effectively, the U.S. Food and Drug Administration (FDA) is trying to bridge differences between regulators and industry on the subject of postmarket risk management.

Risks and Rewards“Risk is everywhere,” said Jean Cooper, a senior staff fellow within the FDA’s Center for Devices and Radiological Health’s (CDRH) Office of In Vitro Diagnostics and Radiological Health. Speaking at a public workshop hosted by the agency in April, she added that risk is viewed in different ways. That sentiment was echoed by Tony Carr, vice president of global quality systems at Boston Scientific, a leading developer of medical devices. “Risk management—the term itself can mean a lot of different things to different people,” he said. Carr added that risk management terminology can be confusing to the C-suite.

A large focus of the workshop was on the need to develop a common terminology when considering recalls, warning letters, and other enforcement actions.

Device manufacturers are not the only ones trying to navigate the murky waters of risk. It’s an issue for healthcare facilities, too, and one speaker emphasized the collective nature of risk management. “Everyone in a hospital who uses technology is a risk manager,” said Jeff Natterman, the risk manager and associate senior counsel at Johns Hopkins HealthCare in Baltimore, MD. He added that there must be a system-wide appreciation for risk.

Patients, who are at the heart of effective risk management, also had a chance to address the workshop. Karen Smith, a patient and representative from the Parkinson’s Disease Foundation, said that patients must often act as their own risk managers.

She described some of the struggles she has faced. Diagnosed with Parkinson’s at age 42, Smith was surprised to learn that the gold standard treatment was the same as it was when her grandmother developed the disease in her early 40s. However, she later learned of a newer treatment option, deep brain stimulation, which utilizes a lead implanted into the brain and a neurostimulator placed below the clavicle.

When her healthcare provider asked whether she wanted treatment on one or both sides of her brain, she didn’t know how to answer. She opted for treatment on one side, and only learned a year later that she needed treatment on both. This episode only confirmed that healthcare is complex, she said, “leaving patients in a vulnerable position.”

Smith urged manufacturers to provide more education to patients and their families. Patients have been forced to become experts about their devices, and they may not know about all of the risks.

“Risk management can only be enhanced by patient involvement,” she said.

In an effort to advance the conversation about risk management, AAMI convened an informal working group of industry representatives and CDRH staff to develop a white paper that articulated “a shared view of risk.” AAMI is currently reviewing feedback it received on the draft paper, and the final version is expected to be released this summer.