AAMI News October 2018
News in Brief
FDA Issues Draft Guidance on Considering Uncertainty in Device Submissions
The Food and Drug Administration (FDA) has issued draft guidance intended to update how it approaches acceptable levels of uncertainty when determining the benefits and risks of medical devices during certain premarket submissions.
According to the draft guidance, Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions, the FDA will consider several factors when determining the appropriate levels of uncertainty in its benefit-risk determinations, depending on the circumstances.
It also includes several examples, the amount of postmarket data collection available, and the context. The FDA said it seeks to “acknowledge and appropriately address uncertainty in benefit-risk determinations supporting certain FDA premarket decisions. This includes considering the applicable patient population’s willingness to accept more uncertainty in a device’s benefits and risks, particularly when there are no acceptable alternatives available.”
In addition, new ways of generating evidence, such as in a clinical setting, make it “important to continuously refine our understanding of how medical devices are used and perform, and corresponding patient outcomes, within the broader healthcare system, which can inform FDA’s regulatory decision making regarding medical devices,” the agency wrote.
Comments on the draft guidance can be submitted via www.regulations.gov until Dec. 5.
AAMI Welcomes New Board Member
Michael Appel, MD, a quality and safety expert in healthcare, joined the AAMI Board of Directors in September.
Appel, a board-certified anesthesiologist, is the chief patient safety officer at Northeast Georgia Health System in Gainesville, GA. He also is an attending anesthesiologist at Northeast Georgia Medical Center, a 557-bed tertiary care hospital, and a faculty member at the Institute for Medical Leadership in Pacific Palisades, CA, where he provides leadership development and executive coaching for physicians and healthcare executives.
Appel also is the founder and president of North American Safety Education Group, LLC, a healthcare safety and management consulting firm. He is chairman of the International Electrotechnical Commission Technical Committee 62, Standards: electrical equipment in medical practice.
Earlier in his career, Appel was a commercial airline pilot for Delta Airlines. Appel earned his undergraduate degree in psychology and chemistry from the University of Pennsylvania, where he graduated magna cum laude and was inducted into Phi Beta Kappa. He earned his medical degree from Columbia University and completed his residency at Columbia-Presbyterian Medical Center.
Light is emitted by nanoparticles injected into the mammary fat pads of live mice.
Light-Emitting Nanoparticles Provide Window into Living Cells
Researchers at the U.S. Department of Energy’s Lawrence Berkeley National Laboratory and the University of California, San Francisco, have developed a medical imaging technology that “lights up” inside of living tissues using energy from a safe, ultra-low-power laser. The technology is being developed with the hope of improving the targeted treatment of cancerous cells.
The tiny metallic particles, called alloyed upconverting nanoparticles, are designed to emit energy that has been absorbed from a laser beam and then emit visible light that is detectable by standard imaging equipment. The trick is producing enough light using a laser that will not damage the cells. In what Berkeley Lab described as a“breakthrough,” researchers were able to boost the nanoparticles’ efficiency in emitting light absorbed from the laser.
“With a laser even weaker than a standard green laser pointer, we can image deep into tissue,” said Bruce Cohen, a member of Berkeley Lab’s Molecular Foundry, in a statement. “The challenge is: How do we image living systems at high sensitivity without damaging them? This combination of low-energy light and low-laser powers is what everyone in the field has been working toward for a while.”
The research team is looking to develop a system so that nanoparticles can attach to specific components of cells, which would help in the targeting of single cancer cells.
A study demonstrating the nanoparticles in mice tissue was published online in the open-access journal Nature Communications.
Submit Your Questions to The Joint Commission
Do you have a question about a standard or practice from The Joint Commission? Now’s your chance to get it answered by Kenneth Monroe, director of engineering at TJC, and his team! AAMI is launching a new column in its journal, BI&T (Biomedical Instrumentation & Technology), called “Ask The Joint Commission.”
The format will be similar to BI&T’s long-running and popular “Ask George” department, which featured answers from Monroe’s predecessor at TJC, George Mills.
“We at AAMI would like to thank Ken for making himself available to answer questions. At a time when healthcare technology is changing fast, it’s important for the HTM community to have access to accrediting agencies such as The Joint Commission,” said Danielle McGeary, vice president of healthcare technology management at AAMI. “AAMI is pleased to help make that access possible by launching this new feature in BI&T. Don’t be shy in submitting your questions!”
Monroe agreed to the ongoing column after an informative and enjoyable presentation in tandem with Mills at the AAMI 2018 Conference & Expo. He has also agreed to speak at the AAMI Exchange, the name for the reimagined AAMI Annual Conference & Expo. The Exchange will be held June 7–10 in Cleveland, OH.
Participating in “Ask The Joint Commission” is easy. Just submit your question and your name to www.aami.org/AskTJC. Your submission may be featured in BI&T and on AAMI Connect, an online discussion forum.