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When Medical Devices Are Recalled: The Risks and the Responsibilities

Overview: Medical device recalls have always been a significant tracking and reporting issue for Supply Chain Management and Risk Departments. With technology and the use of new software packages, hospitals are able to receive, track, and report medical device (and product) recalls, but the process remains problematic for both supply chain and healthcare risk managers alike for multiple reasons. For example, the use of medical device implants has created new issues for those who need to track and report medical device recalls and for those who need to mitigate the risks associated with medical device implants. The hospital is responsible for documenting the products, lot numbers, and serial numbers of devices implanted in the O.R. and must be able to pull reports should any of these devices become part of a recall. Medical device implants also represent issues for supply chain, healthcare risk managers, and financial managers if or when the original implant has to be removed. Removed originals or explants are associated with reimbursement rules that cover which require a credit or refund to be issued to the insured/responsible party.

Explants are, unfortunately, only one of any number of recall issues for both supply chain and healthcare risk professionals. So how do risk managers and supply chain managers adequately track, report, and manage the financial, patient safety, and organizational risks associated with medical device recalls? What exactly are your responsibilities and how can the risks be managed adequately? These are the types of questions addressed in this important educational session co-presented by the American Society for Healthcare Risk Management (ASHRM) and the Association for Healthcare Resource & Materials Management (AHRMM) of the American Hospital Association.

Speakers: Gary Wagner, Vice President, Supply Chain, Methodist Hospital System – Houston
David Mair, Managing Partner, Soter Healthcare
Leilani Kicklighter, RN, ARM, MBA, CHSP, CPHRM, LHRM, Healthcare Consultant, The Kicklighter Group, LLC

Cost: $69 per recording link – AHRMM Members; $99 per recording link – AHRMM Non-members

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This webinar took place on October 26, 2011.

Biographies:
Gary Wagner is currently the Vice President of Supply Chain Management at The Methodist Hospital System in Houston, Texas, where he has responsibility for all supply chain activities for this multi-hospital system with over $400 million dollars in annual purchases. The Methodist Hospital System has 1,561 operating beds and over 13,000 employees. Gary has over 35 years of experience within the healthcare supply chain industry; holding corporate executive positions within multi-hospital systems over the last 20 years. Before joining Methodist, he was the Assistant Vice President, Materials Management with Inova Health System. At Inova he was directly responsible for developing and implementing an integrated Supply Chain strategy. Prior to being with Inova, he was Assistant Vice President of Materials Management with Bon Secour Health Care System. During his tenure his accomplishments included an OR consolidation and implementing a strategic supply chain management process for the Richmond Division.  At Bon Secour he also had responsibility for Support Services and OR Operations. Gary is a member of the Board of Directors of the Strategic Marketplace Initiative; an organization whose purpose is to reengineer and advance the healthcare supply chain.  He is also a Board Member of Hire Heroes USA; an organization whose purpose is to serve as a bridge to fulfilling careers of our returning veterans, specializing in career placement of those wounded or with any level of disability. Gary holds a Bachelor of Science degree from The University of Stubenville, Ohio.

David Mair is an international speaker, author and expert on issues facing risk management and its professionals. He has testified before Congress, the Occupational Safety and Health Administration, and consulted with Congress, the Treasury Department and the White House, along with state legislatures and insurance departments. His comments have appeared in the New York Times, Washington Post, Business Insurance, Forbes, CFO Magazine, the Christian Science Monitor, and on National Public Radio, and he has spoken to audiences in more than over two dozen countries.

Currently, Mair is Managing Partner of Soter Healthcare, an international destination healthcare firm he co-founded in 2010. David has more than 25 years of experience in risk management, beginning at the United States Olympic Committee, where he managed risks for athletes and organizations around the world. Following his departure from the USOC in July 2002, Mair was President of Risk Excellence, a strategic risk and leadership consultancy with an emphasis on governmental and nonprofit entities. Prior to launching Soter Healthcare, he was Chief Risk Officer and Director of Client Relations for MEDEX Global Group and later Chief Operating Officer for China Connection Global Healthcare. 

David Mair is a Former President of the Risk and Insurance Management Society (RIMS), and served eight years on the RIMS Executive Council, a former president and board member of the Nonprofit Risk Management Center. He also served on the Board of Directors of the International Federation of Risk and Insurance Management Associations (IFRIMA). He holds a Bachelor of Arts degree from Oklahoma Baptist University and a Master of Science degree from the University of Oklahoma.

Leilani Kicklighter has extensive healthcare experience in the areas of risk management, quality, and infection prevention.  She began her career as a Registered Nurse.  She has been active in risk management organizations, having served as President of the ASHRM and the FL and the Greater Houston chapters.  She holds the DFASHRM, the ARM, the CHSP, the CPRHM and is a licensed healthcare risk manger.  She is one exam away from earning the CPCU.  Her career has encompassed risk management in multi-state, multi-facility integrated systems, academic and community medical centers, a large long term care organization, the first demonstration Medicare Managed Care Organization and as a consultant for a global insurance broker allowing her opportunities to consult in the field in other countries and all over the US. Currently she is an entrepreneur as a healthcare consultant in the areas of risk management, error prevention, infection prevention, workers’ compensation and stress management.