Postmarket medical device safety: moving beyond voluntary reporting

Improving patient safety: moving beyond the "hype" of medical errors.

Effects and Satisfaction of Medical Device Safety Information Reporting System Using Electronic Medical Record

OBJECTIVES This paper describes an evaluation study on the effectiveness of developing an in-hospital medical device safety information reporting system for managing safety information, including adverse incident data related to medical devices, following the enactment of the Medical Device Act in Korea. METHODS Medical device safety information reports were analyzed for 190 cases that took p...

Voluntary Medical Incident Reporting Tool to Improve Physician Reporting of Medical Errors in an Emergency Department

INTRODUCTION Medical errors are frequently under-reported, yet their appropriate analysis, coupled with remediation, is essential for continuous quality improvement. The emergency department (ED) is recognized as a complex and chaotic environment prone to errors. In this paper, we describe the design and implementation of a web-based ED-specific incident reporting system using an iterative proc...

Privacy and Regulatory Innovation: Moving Beyond Voluntary Codes

According to its many critics, privacy selfregulation is a failure. It suffers from an overall lack of transparency, weak or incomplete realization of the Fair Information Practice Principles, inadequate incentives to ensure wide-scale industry participation, and ineffective compliance and enforcement mechanisms. Rather than attacking or defending self-regulation, this Article explores co-regul...

FDA Regulation of Medical Devices and Medical Device Reporting

There are three main stakeholders in medical device regulation: people in industry, regulators and practitioners. A medical device report is filed after a device-related adverse event occurs. Studies show that while most medical device reports begin with practitioner observations, people in industry file 97% of reports and practitioners file 3% of reports. The objectives of this article are to ...