The explosive growth in the use of medical devices has been accompanied by an alarming growth in the number of adverse events and recalls related to them, costing private payors, CMS, Accountable Care Organizations, Integrated Delivery Networks, Group Purchasing Organizations, and patients billions of dollars a year for revision surgeries, some of them life-threatening.
The New York Times, 3.20.19, Thousands of Reports of Breast Implant Illness Spur FDA Review
Thousands of women complained of debilitating joint pain and fatigue. The FDA warned on Tuesday that two makers (of breast implants) failed to conduct adequate studies of the devices' effects on women's health.....The agency also issued a statement on Friday that applied to a broad array of medical devices, acknowledging that implanted devices may make some people sick."
A growing body of evidence suggests that a small number of patients may have biological responses to certain types of materials in implantable or insertable devices," the agency said. "Those effects can include inflammatory reactions and tissue changes causing pain and other symptoms that may interfere with their quality of life."
WHAT IF YOU COULD PREDICT THE EFFECTIVENESS OF MEDICAL DEVICES IN PATIENTS WITH MULTIPLE CHRONIC CONDITIONS TAKING MULTIPLE MEDICATIONS BEFORE HARM IS DONE?
The first predictive formulary for medical devices
Challenging the status quo. Enter eHealthAnalytics’ Formulary PREDICT™,
the first commercially available formulary for medical devices, offering healthcare payors and providers with the ability to assess the clinical appropriateness, risk, and cost of medical devices. "The personal and financial cost of an adverse event can be devastating to an affected individual and their family. On a global level, these costs are incalculable. Hospitals and providers, as well as insurers, need tools that will aid in the identification of devices known to be harmful and a company that develops that tech will be positioned to solve this very important problem."