The rapid evolution of healthcare technology threatens to outpace the ability to manage risk effectively, according to several experts who are on the frontlines of ensuring medical devices are used safety and effectively. 

“We feel pressure to be early adopters of the latest technology, but we don’t always fully consider the risk-to-benefit ratio,” said Stephen Grimes, chief technology officer at ABM Healthcare Support Services in Holliston, MA. “We need to make sure we’ve sufficiently vetted these technologies.” 

Grimes was one of seven experts who participated in a roundtable discussion on risk management organized by AAMI for the spring 2015 edition of Horizons, dedicated to the subject of risk management. Many of the participants agreed that a multidisciplinary systems approach is needed to manage risk. “More disciplines, such as clinical, nonclinical, and administrative, need to collaborate and communicate to create long-term solutions within this complex environment,” said Salim Kai, clinical safety specialist at the Office of Clinical Safety at the University of Michigan Health System in Ann Arbor, MI. 

Another component for effectively managing risk is open dialogue. “Whenever we have concerns with a piece of equipment, we contact the manufacturer and expect feedback from them,” said Jacque Mitchell, risk manager at Sentara Norfolk General Hospital in Norfolk, VA. “This was not the case 20 years ago,” she added. 

“That mechanism will incentivize manufacturers to get very good at analyzing risk data and using that analysis to proactively anticipate potential risk events, design out risk more effectively, or at least to make better next-gen products,” Mitchell said. 

Kai said that even more transparency between regulators, facilities, and manufacturers is needed to ensure the safety of devices prior to their going on the market. 

During the roundtable, Susan Nicholson, MD, vice president of safety operations and compliance, medical devices at Johnson & Johnson, said the unique device identification (UDI) system introduced by the U.S. Food and Drug Administration is a major game changer in terms of managing risk. The UDI rule, which is being phased in over several years, requires most medical devices to have a unique numeric or alphanumeric code that makes it easy to identify and track these products within the healthcare supply chain. 

AAMI members and subscribers can access the full transcript of the discussion by visiting http://bit.ly/1EuaVYi. 

Source: AAMI News