Medical Device Regulation Time to Improve Performance 英文参考文献.docVIP

Perspective MedicalDeviceRegulation:TimetoImprove Performance SanketS.Dhruva1*,RitaF.Redberg2 1University of California, Davis Medical Center, Division of Cardiovascular Medicine, Sacramento, California, United States of America, 2University of California San Francisco,SchoolofMedicine,PhilipR.LeeInstituteofHealthPolicyStudies,SanFrancisco,California,UnitedStatesofAmerica Medicaldeviceshavemadeasignificant contribution to helping patients enjoy longer lives of higher quality. However, numerous weaknesses in their premarket evaluation and post-market surveillance have sometimes left patients worse off from faulty devices. For example, the Sprint Fidelis implantable cardioverter- defibrillatorlead(Medtronic,Minneapolis, Minnesota) was approved by the United States Food and Drug Administration (FDA) in 2004. Three years after its approvalandsubsequentrapiddissemina- tion, this device’s high propensity to fracture was finally recognized; first by independent cardiologists and then the FDAandthemanufacturer,whichvolun- tarily recalled the device. At least several patientdeathshavebeenattributedtothis problem [1,2]. More than 268,000 pa- tients worldwide have been implanted with this device and have had to choose between risky removal of the defective leads or living with uncertainty of death due to a faulty device. The Sprint Fidelis tragedy exemplifies the need for rigorous and transparent post-market surveillance so that problems with approved devices canberapidlydetected. serious dangers to patients. Alternative non peer-reviewed analyses of the same high-riskrecalldataconductedbyindivid- ualsaffiliatedwithdevicecompaniesassert that99.5%ofsubmissionsdidnotleadto recalls. This latter study usedsubmissions as the denominator, instead of approved devices[5]. LinkedResearchArticle This Perspective discusses the fol- lowingnewstudypublishedinPLoS Medicine: Kramer DB, Xu S, Kesselheim AS (2012) How Does Medical Device Regulation Perform in the US and EU?ASystematic