Changes nec­es­sary to make de­vice registries work

Modern Healthcare - - COMMENT -

Re­gard­ing “Groups press FDA to en­cour­age med­i­cal-de­vice registries” (Mod­ern­Health­, Sept. 3), de­vice registries are chal­lenged by their in­abil­ity to track pa­tients over time. Un­like drugs, de­vices aren’t gen­er­ally “re­newed/re­filled,” so track­ing them with on­go­ing claims is not pos­si­ble. Also, the re­la­tion­ship be­tween the im­plant­ing sur­geon and the pa­tient is of­ten tran­sient. Un­til a de­vice’s Unique De­vice Iden­ti­fi­ca­tion num­ber is a re­quired field in the elec­tronic health record and pro­vided on be­half of the pa­tient for lon­gi­tu­di­nal fol­lowup, in­sti­tu­tional-based registries will have limited abil­i­ties to track de­vices and es­sen­tially no abil­ity to no­tify all de­vice re­cip­i­ents in the event of a re­call/prob­lem.

Dr. Ed­ward Fotsch Sausal­ito, Calif.

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