Medical Device Postapproval Safety Monitoring

Medical device postapproval safety monitoring: where does the United States stand?

MarketWatch Spending On Postapproval Drug Safety

Withdrawals of high-profile pharmaceuticals have focused attention on postapproval safety surveillance. There have been no systematic assessments of spending on postapproval safety. We surveyed drug manufacturers regarding safety efforts. Mean spending on postapproval safety per company in 2003 was $56 million (0.3 percent of sales). Assuming a constant safety-to-sales ratio, we estimated that ...

Monitoring device safety in interventional cardiology.

OBJECTIVE A variety of postmarketing surveillance strategies to monitor the safety of medical devices have been supported by the U.S. Food and Drug Administration, but there are few systems to automate surveillance. Our objective was to develop a system to perform real-time monitoring of safety data using a variety of process control techniques. DESIGN The Web-based Data Extraction and Longit...

A Medical Device Safety Supervision over Wireless

Interoperability of medical devices is a growing need in modern healthcare systems, not just for convenience, but also to preclude potential human errors during medical procedures. Caregivers, as end users, strongly prefer the use of wireless networks for such interconnections between clinical devices due to its seamless connectivity and ease of use/maintenance. In [KSM10], we introduced a Netw...

Towards Medical Device Maintenance Workflow Monitoring

Concerning the inpatient care the present situation is characterized by intense charges of medical technology into the clinical daily routine and an ever stronger integration of special techniques into the clinical workflow. Medical technology is by now an integral part of health care according to consisting general accepted standards. Purchase and operation thereby represent an important econo...