Following is the list of the recommendation made to Guidant (Indianapolis) concerning strengthening its product surveillance and reporting.
1. Establish an external committee of experts to serve as advisors to Guidant regarding evaluation of product performance and health risk assessment, potential acti-ons to be taken in regard to device failures and malfunctions, and guidance on when and how to communicate with physicians and patients.
2. Designate or hire an in-house physician whose primary responsibility is patient safety and who will participate in product performance analysis, health hazard analysis, internal communications and external communication policies and procedures.
3. Strengthen management links between the company and its Cardiac Rhythm Management (CRM) business unit, with specific attention to postmarket product performance, patient safety issues and communication policies.
4. Enforce the general policy of the CRM business on the primacy of patient safety by better integrating patient safety concerns into the factual and statistical analysis of product performance and performance failures.
5. Ensure that the CRM business, and the company generally, implement and enforce policies of transparency of information regarding product performance and health hazard risk both to physicians and the general public as new information is emerging.
6. Develop processes for confronting the challenge of achieving more effective surveillance of marketed devices, in conjunction with others in the industry, the Heart Rhythm Society (Washington) and the FDA.
7. In addition to the analysis of product performance and safety event trends, develop processes to identify and act on even a single event when it is associated with risk of death or serious injury, has a suspected or defined basis for the malfunction or failure, and is likely to be systematic and to occur in other patients.
8. When a life-threatening defect has been identified and mitigated in a specific product line, Guidant and its CRM business should expedite review for immediate consideration of ceasing shipments of unmitigated de-vices, and retrieving those in possession of the sales force or in hospital inventories.