From Hospital To Home: Mastering Home Use Medical Device Warnings And Labels

Over the years, we have seen a rapid increase in the demand and utilization of home-use medical devices, giving patients the autonomy to manage their health conditions more conveniently. Yet, the design and implementation of warnings and labels for home-use medical devices can vary significantly from those used in a hospital setting, as there are noticeable differences in user expertise, safety precautions, regulatory requirements, and device complexity.

By exploring critical aspects of product liability and risk mitigation strategies, this presentation aims to educate companies on home-use medical device labels and warnings to protect interests while ensuring consumer safety.

This presentation discusses:

• The rise of home-use medical devices
• The role of warnings and labels in a product liability defense
• Overview of regulatory standards, requirements, and compliance
• Essential components of home-use warnings and labels, including labeling design and placement
• Innovative solutions for the future

Presenter
Lindsey Nelson is a member of Butler Snow’s Pharmaceutical, Medical Device, and Healthcare Practice Group. As a former professional tennis player, she brings a diverse background encompassing sports and law with a unique perspective on medical device safety. Her determined nature, honed through years of athletic training, allows her to navigate complex legal matters and contribute to Butler Snow’s commitment to client success.

Prior to her career in law, she made a name for herself as a tennis player at the University of Southern California (USC). Throughout her collegiate journey, Lindsey was a two-time NCAA finalist, PAC-10 Champion, and named PAC-10 Athlete of the Year. She continued to compete on the professional circuit, playing in prominent venues such as the US Open and the BNP Paribas Open until her career took an unexpected turn when she suffered a career-ending injury. She sought to transfer her passion for tennis to other avenues and pursued a legal career, where she leveraged her work ethic to excel in her studies. Lindsey graduated summa cum laude from Mississippi College School of Law and joined Butler Snow, LLP in 2022.