MedSun and the SightNet Subnetwork


The FDA has legislatively mandated, regulatory responsibility for food, drugs, biologicals (e.g. vaccines), radiation health, and medical devices. FDAs Center for Devices and Radiological Health (CRDH) has the primary charge of monitoring both safety and effectiveness for premarket evaluation and postmarket surveillance of medical and radiological devices. Driven mainly by a concern for patient safety, the Medical Product Safety Network (MedSun) is the latest in CDRHs programs for conducting postmarket surveillance of medical devices. MedSun is a voluntary reporting program comprised of 350 representative hospitals and health care facilities across the US. CDRH works closely with a contractor, Social and Scientific Systems, Inc. (SSS), to make this a highly successful program.


The program is dedicated to developing an interactive relationship between FDA/MedSun and the clinical community to improve patient safety through prevention of adverse events (AEs). The objectives are to learn about, understand, solve, and prevent problems associated with the use of medical devices and to provide timely feedback of information to health professionals so they may improve patient safety. The program strives for transparency and in no way attempts to assign blame. Rather, in keeping with modern principles of patient safety, the idea is to promote communication and to develop system fail safes to ensure the primacy of safety. Since its inception in 2002, more than 7600 hundred reports have been submitted to the FDA through the MedSun program.


MedSun has received reports involving ophthalmic devices, although they do not make up a large percentage of the total number of reports received. In 2006, the FDA and the clinical community were made aware of an increase in cases of Toxic Anterior Segment Syndrome and fusarium keratitis associated with contact lens care solutions. In 2007 FDA and CDC have cooperatively addressed the increase in the number of reported cases of acanthamoeba keratitis associated with another contact lens care product manufacturer. These are prime examples of the impact of cooperative reporting among device users, FDA, industry and state health departments.


In order to improve such interactions even further, FDAs premarket Division of Opthalmic and Ear, Nose, and Throat Devices along with the postmarket Patient Safety and Surveillance Staff have launched a subproject network within MedSun called SightNet. SightNet is designed to utilize the collaborative communication model that was instrumental in managing TASS, fusarium, and acanthamoeba keratitis outbreaks as well as to implement other methodologies for prevention of additional public health threats. In addition, SightNet aims to focus on adverse events observed with ophthalmic medical devices used in providing all levels of eye care. Of particular interest for this project are contact lenses and care products, ophthalmic lasers, intraocular lens implants, and ophthalmic viscoelastics, just to name a few. Information regarding the performance of these devices is collected and shared with the ophthalmic community comprised of ophthalmologists, optometrists, hospitals, and eye clinics. Information is shared via round table discussions among participants, FDA, and professional organizations on topics of interest through audio and web conferences; the SightNet Newsletter with highlighted reports of interest, actions regarding recalls, safety tips and articles; and MedSun educational programs (video, slide presentation(s), audio conferences)


Pediatricians, cardiologists and other physician groups have come to learn about and participate in the MedSun activities through subnetworks such as HeartNet and KidNet. They recognize the opportunities for improving patient safety through the prevention of AEs associated with the use of medical devices. Eye care providers are encouraged to share any medical device problems related to SightNet via the MedSun reporting system.