FDA to Shine Spotlight on PCLC Systems

The FDA is seeking feedback on the design and development of devices that deliver life-saving therapies in critical-care environments.

The issue — physiological closed-loop controlled devices used to deliver anesthesia, vasoactive drugs and fluids and mechanical ventilation — will be the focus of an Oct. 13-14 workshop at the agency’s White Oak campus in Silver Spring, Md.

“Recent advances in medical device technology and control system science have increased the development of PCLC medical devices,” according to an Aug. 17 Federal Register notice announcing the meeting. “This may or may not introduce new risks to patients, but could introduce new medical device hazards that, considered during device design and development, can be mitigated throughout the device life-cycle.”

PCLC devices help clinicians and patients by automatically making adjustments to therapeutic delivery — something that could prove highly beneficial during mass casualty events, for example.

Potential areas of discussion slated for workshop include:

• Benefit-risk considerations;
• Design and development challenges;
• System performance analysis for different controller types;
• Fault detection and fallback modes;
• User interfaces and operational transparency;
• Knowledge gap between clinicians and system engineers;
• Clinician involvement in system design;
• Control system terminology;
• Preclinical evaluation;
• Evidence needed to demonstrate a stable and robust controller;
• Use of computer simulations, including verification, and validation;
• Real-time bench testing;
• Clinical evaluation;
• Clinical validity of sensors;
• Patient populations;
• Environments of use;
• User-related level of expertise; and
• Human factors.

The deadline to submit comments on all aspects of the workshop is Sept. 1.

To learn more, visit www.fdanews.com/082415-PCLC-workshop.pdf. — Elizabeth Hollis