Post-Treatment Surveillance
In recent years there have been numerous reports of failed medical devices, drugs, and treatment protocols. In many cases, failures go unnoticed for months or even years following treatment. This is an extremely complex issue; in some cases the risks and negative effects are so devastating that the product must be removed immediately from the market, and in other cases the product can continue to be marketed but only under increased surveillance.
As companies apply for new approvals, many are finding that new rules from government regulators such as the FDA are requiring continuous monitoring following market introduction. Companies are also conducting prudent follow-up surveillance programs because the potential liability associated with failures is extremely high.
Hospitals operate at the intersection between the companies supplying these products and their patients being treated with them. Hospitals have an ethical obligation as well as a financial incentive to ensure that the treatments they recommend to their patients are sound. However, companies don't have access to pertinent patient data due to hospitals' patient confidentiality policies.
Companies marketing medical products need access to this information to ensure that their products are safe over the long-term.