Issues with Medical Device Spontaneous Reporting and Improvements through MedSun
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Issues With Medical Device Spontaneous Reporting and Improvements Through MedSun
Melissa Ostuni, MS BostonSclentlFc
Corporation
Unlike userfacilities, manufacturers are directly under thejurisdiction of FDA and rely on device users to report adverse events in a timely manner to help them comp& with their strict regulatory q i m n e n t s . Zkefrn, an cffective postmarket meiflancep r o g m n , is directly dependent on the active pa?ticipationof h d t h care profession&. Howcva, the limitations of the spontancolcs reportingsystem ckdenge the ageng's and manufacturcrs' e f i d to prompt& identifr, quantitate, and understand new risks associated with marketed products. Un-
Key Words MedSun; Spontaneous reporting; Medical device
Correspondence Address Melissa Ostuni, M S . Safety Trial Manager. Boston Scientific Corporation. 100 Boston Scientific Way, Marlborough. M A 01752 (email:
[email protected]).
INTRODUCTION Medical devices have the potential to markedly improve patient care. Nevertheless, they can fail to operate properly or can be misused in ways that may cause serious injuries and deaths. Understanding of the epidemiology and the roles of devices in adverse events (AEs) has lagged behind advances in other areas of safety concern including medications. This may be due to device heterogeneity and complexity; however, an additional challenge lies in the nature of AE reporting in health care in general, and particularly in the case of devices (1)."The reporting of medical device adverse events is the single most important element of postmarket surveillance" (2).
ACTIVE VERSUS PASSIVE SURVEILLANCE FDA has authority for two medical device AE reporting programs. The primary program receives mandatory reports of specific AEs from device manufacturers and user facilities as well as voluntary reports from health care professionals, patients, and consumers. This program is a form of passive surveillance (ie, spontaneous reporting) since it relies on health care professionals to recognize that an event may be device related and to initiate sending a report to the
dmcporting and lack of quality of information make it extremely difficult for FDA and manuf a d u r n to determine the mqgnitude of the problem as wdl as recognizesafety trends. The MedSm pilot p m p m was developed in response to the recognition that FDA needed to arcgment the nporting of device-related adverse eycnfs by he& are facilities. MedSun has been f d l y received by participating user facilities as we4l as king an extremely vduabZe resource in helping to promote patient safetu.
manufacturer and/or FDA. The other method of reporting is via active surveillance, which involves more direct efforts by a sponsoring agency to obtain event information such as through use of patient registries or mandated postmarket studies (3). This article focuses discussion on spontaneous reporting. REPORTING DEVICE-RELATED PROBLEMS When a medical device is suspected to cause or contribute to an adverse outcome, health care professionals, patients, and co
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