COLLABORATIVE COMMUNITIES: MEDICAL DEVICE SERVICING INVOLVING HEALTHCARE DELIVERY ORGANIZATIONS (HDOS) AND THE REGULATORY ENVIRONMENT

This presentation will serve to update recent activities associated with the FDA and discussions with manufacturers, third-party servicing organizations, in-house (self-operated) healthcare technology management programs, professional organizations/societies and other stakeholders. Although the FDA found that the evidence presented failed to validate any issue with the safety of medical device servicing and decided not to take regulatory action, manufacturers and other interested parties continue to pressure the marketplace for a potential standardized quality management program for all servicers of medical devices. If you are involved with the servicing of medical devices, purchasing parts, reselling parts or selling other services associated with medical devices, this program will serve to provide new information and data relevant to your business practices.