Cordis Discusses Postmarketing Surveillance Systems
Specialists from a variety of disciplines should evaluate product complaints as part of a solid postmarketing surveillance system, Gaurang Patel, associate medical director for product safety with Cordis, said at a recent industry conference.
Complaint escalation decisions should not be made in a vacuum and different perspectives are needed, Patel said at the Center for Business Intelligence Fifth Annual Product Complaints for BioPharmaceuticals and Medical Devices conference. It is important to have medical, compliance, engineering/design, manufacturing and even legal and marketing personnel assessing product complaints and determining if they warrant further action, Patel said.
The other essential elements of a good surveillance system include a robust electronic data system — preferably with data mining capabilities — and a well-calculated plan for escalating complaints, from continuing trend analyses to initiating product recalls, Patel said.
During internal communications last year, the FDA outlined to Cordis these ideal system attributes, Patel said. The firm, a subsidiary of Johnson & Johnson, was cited by the agency several years ago in a warning letter for failing to fully investigate complaints regarding its Cypher stents. The company recently announced that the issues identified in the warning letter have been resolved.