Assuring the safety of the patient and the operator of a medical device is the major focus of our group.
When two or more existing components are interfaced to make a medical device, a structured risk management process must be used to identify the salient risks of each component and corresponding protective measures. In many real-world designs, these protective measures add quite a bit of complexity to the system, and some protective measures may introduce new risks that must be mitigated. As a result, safety and risk assessment become major properties of any medical device evaluation.
In our group we focus on understanding how the system safety related components interact with one another, with the user and patient, and with the environment. Our main group efforts are on the basic safety, essential performance and risk management process of the medical devices to assist other offices and centers within the FDA.
Front end of a medical device data acquisition circuit modeled by an FDA engineer to evaluate its Common Mode Rejection ratio.
We achieve our objectives by:
- Analyzing and modeling of medical devices for:
- energy consumption and longevity assessment;
- performance safety (i.e., essential performance);
- basic electrical safety (e.g., component modeling such as batteries, study long-term electrical conductivity characteristics of thin-film or polymeric materials used in implantable medical devices.),
- Safety consults,
- Guidance document development,
- Education and seminars,
- Safety standard and test method development.
Representative list of methods used to achieve our objectives includes:
- Systems engineering methods and modeling methods.
- Fault tree analysis
- Failure modes and effects analysis
- Hazard/risk analysis
Current external funding sources
Michael C. Long
Jeffrey L. Silberberg
Sandy Weininger, Ph.D
Relevant standards & guidance
- IEC 60601-1 (Medical electrical equipment - Part 1: General requirements for basic safety and essential performance) and its collaterals, particulars and normative.
- ISO14791-1 (Implants for surgery — Active implantable medical devices —Part 1: General requirements for safety, marking and for information to be provided by the manufacturer) and its collaterals, particulars and normative.
- UL2054 Household and Commercial Batteries.
- NASA/SP-2007-6105 Rev1 (NASA Systems Engineering Handbook).