FDA gets push for de­vice registries

Modern Healthcare - - NEWS - By Jaimy Lee

The U.S. health­care sys­tem trails other de­vel­oped coun­tries in track­ing the per­for­mance of med­i­cal de­vices through registries. Now, a group of or­ga­ni­za­tions in­clud­ing the Pew Char­i­ta­ble Trusts and the Blue Cross and Blue Shield As­so­ci­a­tion is urg­ing the Food and Drug Ad­min­is­tra­tion to catch up.

The two or­ga­ni­za­tions, along with the Sci­ence In­fra­struc­ture Cen­ter at Weill Cor­nell Med­i­cal Col­lege, is­sued a set of rec­om­men­da­tions last week to im­prove the role of registries. Reg­istry ad­vo­cates say registries make post­mar­ket surveil­lance of new med­i­cal tech­nolo­gies more ro­bust and can help com­pare older, less-ex­pen­sive de­vices to newer more costly prod­ucts.

They cite John­son & John­son’s high-pro­file re­call in 2010 of met­alon-metal hip im­plants as a pri­mary ex­am­ple of the value of registries. Clin­i­cians track­ing out­comes of the im­plants in registries in Aus­tralia and the U.K. were the first to iden­tify the higher fail­ure rates of th­ese types of hip im­plants com­pared with older im­plants that had been on the mar­ket for years. J&J even­tu­ally re­called 93,000 hip im­plants and the company paid bil­lions of dol­lars to set­tle pa­tient law­suits.

“It’s taken us too long to fig­ure out th­ese de­vices have se­ri­ous and un­ex­pected safety prob­lems,” said Dr. Josh Ris­ing, Pew’s di­rec­tor of med­i­cal de­vices. “There’s no rea­son that we shouldn’t be able to iden­tify th­ese prob­lems in the United States.”

Med­i­cal- de­vice man­u­fac­tur­ers have ex­pressed reser­va­tions. In Fe­bru­ary, the Ad­vanced Med­i­cal Tech­nol­ogy As­so­ci­a­tion re­vised its prin­ci­ples for de­vice registries to add ques­tions about ap­pro­pri­ate use, the re­li­a­bil­ity and ef­fi­ciency of the data- col­lec­tion meth­ods and the sta­bil­ity of fund­ing. “Registries can be an im­por­tant tool for gath­er­ing use­ful in­for­ma­tion about the safety and ef­fec­tive­ness of in­ter­ven­tions in­volv­ing med­i­cal de­vices and di­ag­nos­tics, but only if they are de­signed and ex­e­cuted prop­erly,” Ad­vaMed CEO Stephen Ubl said in a writ­ten state­ment at the time.

The gov­ern­ment is mov­ing for­ward with iden­ti­fy­ing best prac­tices around reg­istry de­vel­op­ment. The FDA this year formed two groups to ad­dress is­sues with reg­istry de­vel­op­ment.

The agency doesn’t have the au­thor­ity to re­quire reg­istry de­vel­op­ment, but the CMS can re­quire reg­istry data as part of Medi­care cov­er­age de­ci­sions.

Pew and other groups are lob­by­ing for the Of­fice of the Na­tional Co­or­di­na­tor for Health In­for­ma­tion Tech­nol­ogy to in­cor­po­rate rules that would re­quire unique de­vice iden­ti­fi­ca­tion in­for­ma­tion to be cap­tured by elec­tronic health-record sys­tems as part of the next round of mean­ing­ful-use re­quire­ments.

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