Hardware Podcasts

129 - Combination Products, Infusion Pumps and Recalls, Responding to Health Disasters with Public Health Service, and FDA Rule-making Process with Captain Alan Stevens

Let's Combinate · 27 Mar 2024 · 32m

What this episode covers

Captain Alan Stevens, Global Head of Complex Devices and Drug Delivery Systems at AbbVie and former FDA official, explains why infusion pumps are highly susceptible to recalls due to reliability, software, and human factors issues in high-use hospital settings. He details the FDA's rule-making and guidance development processes, clarifying that while standards like ISO 11608 are influential, manufacturers must demonstrate safety and performance regardless of compliance. Stevens also discusses the application of reliability engineering to single-use combination products and the importance of systems thinking in public health safety.

Most relevant to

large enterprises

Topics

Mentioned

Companies
AbbVie, FDA, CDRH, Public Health Service
Also
ISO 11608, ISO 13485, Systems Thinking in Safety

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