Description

Growing trends involving drug-resistant microbes and hospital-acquired infections that can result in complications, morbidity, and death are concerning healthcare providers. Infection prevention is critical for manufacturers and users of medical devices, as these products can harbor drug-resistant microbes and transmit device-related infections even after the devices have been disinfected. FDA has responded to increased infection rates with guidance and numerous recommendations for industry as the agency intensifies its scrutiny of product design and use. 

Our panel of experts will address: 

• Causes of medical device infections 
• Design strategies for infection prevention for single-use and reusable devices 
• Intellectual property (IP) and product liability matters 
• Environmental concerns 
• FDA regulatory implications such as design verification and validation (V&V) 

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