Medical Devices Research Proposal

MedSun

Patton-Fuller Community Hospital

The need for reporting on adverse events related to medical device usage has never before been more salient. Medical technology has certainly been responsible for improving the quality of care, the quality of life, as well as health outcomes. However, at the same time, medical devices are being developed and released at a much faster rate than ever before. To monitor the progress and the safety of these devices, it requires a centralized monitoring system to evaluate outcomes; especially the adverse outcomes. This can allow the monitoring of devices that have issues associated with them in an efficient and effective manner and would give regulators a better opportunity to stop the usage of devices with questionable track records.

The Medical Product Safety Network (MedSun) is an adverse event reporting program launched in 2002 by the U.S. Food and Drug Administration's Center for Devices and Radiological Health (CDRH); the primary goal for MedSun is to work collaboratively with the clinical community to identify, understand, and solve problems with the use of medical devices (FDA, N.d.). This paper will provide an analysis of why this is an important step in improving the quality of care that hospitals can provide and why the Patton-Fuller Community Hospital should work diligently to register and maintain a clinical reporting system with MedSun as a mediator for the FDA.

Background

The U.S. Food and Drug Administration (FDA) has made it a priority to identify medical device-associated risks as fast as possible through the Medical Product Safety Network (commonly known as MedSun) (Engleman, Rish, Powell, & Flack, 2008).MedSun has expanded nationally to include a variety of hospitals, but outpatient clinics, nursing homes, and home health agencies are also represented and the basic reporting team for each participating site comprises primarily risk managers and clinical patient safety officers.

MedSun participants receive device-related feedback from the FDA relevant to their reported issues and specializes in the exchange of device-related safety information and reports on adverse events with the clinical community provides the FDA Center for Devices and Radiological Health (CDRH) MedSun program with enhanced understanding of medical device-related problems (Engleman, Rish, Powell, & Flack, 2008). However, to expand this reporting mechanism, MedSun is now implementing targeted surveillance efforts that are directed toward "high-risk" areas of the hospitals.

This effort has resulted in the development of subnetworks within MedSun to give attention to the types of products of interest to the FDA and there are four subnetworks than have either been launched for the data collection that began in 2007 (Engleman, Rish, Powell, & Flack, 2008). These have later been expanded and include (FDA, N.d.):

HearNet

HomeNet

KidNet

LabNet

SightNet

The goal has been to build relationships between MedSun/FDA and frontline medical device users so the FDA can work with clinicians to learn about, understand, and solve problems related to the use of medical devices. The FDA is evaluating the impact of developing these reporting relationships on the overall effectiveness of MedSun data collection. The subnetworks also offer the FDA an opportunity to obtain….....