DE­FEC­TIVE PROCESS?

Modern Healthcare - - The Week In Healthcare - Source: Na­tional Re­search Cen­ter for Women and Fam­i­lies MOD­ERN HEALTH­CARE GRAPHIC

Most “high-risk” med­i­cal de­vice re­calls have in­volved de­vices ap­proved through the FDA’s less rig­or­ous 510(k) process, ac­cord­ing to a new study of FDA data from 2005-09 180,000 AED Plus de­fib­ril­la­tors, Zoll 6,000 Sta­bilet in­fant warm­ers, Draeger Med­i­cal Sys­tems 400 Triage car­diac pan­els, Biosite 70 TrailBlazer sup­port catheters, EV3 23 Sys­tem II sur­gi­cal nav­i­ga­tion sys­tems, Stryker Corp. 9 Neu­ron 5F Se­lect catheters, Penum­bra

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