On March 8, a diverse group of stakeholders--including medtech manufacturers, hospital personnel, and industry regulators--will meet in Houston to develop an integrated action plan for improving patient safety through an effective--and fair--system for reporting device-related failures. The one-day event is being sponsored by the American College of Clinical Engineering (ACCE) Healthcare Technology Foundation, Texas Children's Hospital, Texas A&M University, and the FDA Medical Device Industry Coalition.
"This colloquium will offer a unique opportunity for participants to hear from key people working in this area and to present their own perspective on what is needed to build a better medical device reporting system that can improve patient safety," says Yadin B. David, president of the ACCE Healthcare Technology Foundation and director of the biomedical engineering department at Texas Children's Hospital (Houston). "By bringing together representatives of medical device manufacturing firms, hospitals administrators, clinicians, legal professionals and risk managers, reporting system vendors, and regulators, a complete understanding of the objectives and barriers to implementation of a blame-free system can be achieved."
In the July/August 2006 issue of MX magazine, David set the wheels of this initiative in motion by calling on leaders across industries and communities to join together to improve device safety. In his commentary, he wrote, "Unquestionably, consumer safety is diminished when there is limited communication among the engineers who design devices, the clinicians who deploy them, the clinical engineers who support them, the regulators who monitor them, and the patients who experience them. Conversely, a coordinated investigation conducted by appropriate experts within an appropriate legal framework will help to supply critical knowledge that could lead to a safer environment in the future. This legal framework must allow free and effective communication without exacerbating manufacturers' risk of litigation or denying wrongfully injured patients appropriate compensation." (The full text of David's commentary is available at www.devicelink.com/mx/archive/06/07/david.html.)
The March 8 colloquium is designed to offer ample opportunities for networking and information exchange among participants. It will open with presentations by representatives of various interests and continue with breakout sessions designed to generate specific recommendations for further action. The program will conclude with the formulation of an integrated action plan that will be published for additional stakeholders' input.
The colloquium will take place at the University of Texas MD Anderson Cancer Center, located in the Texas Medical Center in Houston. For more information or to register, visit www.123signup.com/calendar?Org=acce-htf, or contact William Hyman (979/845-5593; [email protected]) or Yadin David (832/824-1810; [email protected]).
In recent years--due largely to a number of high-profile recalls of complex medical devices--the public has voiced widespread concern regarding the safety of approved medical devices. Therefore, FDA has been moving rapidly to reinvigorate its mechanisms for postmarket monitoring.
In order to examine the new policy environment for medical products and what it will mean for medical device companies, on February 22, MX magazine is hosting a free Webcast, "Handling Adverse Events in a Changing Postmarket World." Sponsored by Oracle Corp. and Deloitte Consulting LLP, the Webcast will explain how advanced complaint-handling and corrective and preventive action systems can help manufacturers meet FDA's emerging requirements for more-stringent postmarket surveillance. To register, visit www.devicelink.com/mx/webcasts/oracle_deloitte_feb22.html.
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