Post-mar­ket scru­tiny sought

Modern Healthcare - - LATE NEWS - Jaimy Lee

Reg­u­la­tory ac­tion to re­quire man­u­fac­tur­ers of metal-on-metal hip im­plants to prove their de­vices are safe and ef­fec­tive has trig­gered new calls for an im­proved post-mar­ket sur­veil­lance sys­tem for all med­i­cal de­vices.

The Food and Drug Ad­min­is­tra­tion pro­posed last week that the mak­ers of metal-on­metal hip im­plants sub­mit clin­i­cal trial data show­ing their de­vices are safe and ef­fec­tive. The move would, in essence, change the reg­u­la­tory sta­tus of the con­tro­ver­sial im­plant, which has led to early re­place­ment op­er­a­tions in numer­ous pa­tients, from a fol­low-on de­vice to a new one re­quir­ing more rig­or­ous clin­i­cal test­ing. The man­u­fac­tur­ers will have 90 days af­ter the fi­nal or­der is is­sued to make the sub­mis­sions.

Cur­rent reg­u­la­tions al­low de­vices, in­clud­ing hip im­plants, to be cleared un­der the agency’s ex­pe­dited 510(k) process rather than the more rig­or­ous pre-mar­ket ap­proval path­way. The 510(k) process is re­served for de­vices deemed “sub­stan­tially equiv­a­lent” to an­other prod­uct on the mar­ket.

“It’s a really im­por­tant move by FDA to give more weight to ap­proval of metal-on- metal hip im­plants,” said Lisa McGif­fert, di­rec­tor of Con­sumers Union’s Safe Pa­tient Project. “We hope this is a sig­nal that the FDA might be start­ing to look at the (other de­vices) that ap­peared to have been grand­fa­thered in to the 510(k) process.”

Metal-on-metal hip im­plants have higher fail­ure rates than other hip im­plants. Metal re­leased by th­ese im­plants can dam­age a pa­tient’s bone or soft tis­sue, which can lead to loos­en­ing of im­plants, de­vice fail­ures, re­vi­sion surg­eries and el­e­vated metal ion lev­els.

John­son & John­son’s DePuy Orthopaedics busi­ness re­called 93,000 metal-on-metal hip im­plants in 2010 and was hit with thou­sands of law­suits in the wake of the re­call. Zim­mer and Smith & Nephew also re­called metal-on­metal im­plants or re­lated com­po­nents.

The FDA re­ceived author­ity last year in the in­dus­try user-fee agree­ment leg­is­la­tion to re­clas­sify de­vices by or­der rather than by reg­u­la­tion.

“That is ab­so­lutely and ex­actly what we’re hop­ing for,” said Diana Zuck­er­man, pres­i­dent of the Na­tional Re­search Cen­ter for Women & Fam­i­lies. “This ex­pe­ri­ence, with metal-on­metal hips, should have taught all of us … that we need clin­i­cal tri­als for all hips.”

In ad­di­tion to sup­port­ing the new re­quire­ments for pre-mar­ket clin­i­cal trial data, physi­cian or­ga­ni­za­tions and pa­tient groups have called for a stronger post-mar­ket sur­veil­lance sys­tem that would in­clude a na­tional reg­istry to track im­plantable med­i­cal de­vices. Reg­istries in Aus­tralia and the United King- dom were the first to iden­tify prob­lems as­so­ci­ated with metal-on-metal hips.

“We don’t have a post-mar­ket sur­veil­lance sys­tem,” said Dr. Kevin Bozic, vice chair­man of the or­tho­pe­dic surgery de­part­ment at the Univer­sity of Cal­i­for­nia at San Fran­cisco. “There is no reg­istry, of hip or knee, on the scale that would pick up th­ese kinds of prob­lems.”

The Amer­i­can Joint Re­place­ment Reg­istry is one of a few reg­istries that have been devel­oped in the U.S. The Amer­i­can Academy of Orthopaedic Sur­geons, which formed the AJRR in 2009, said it has en­rolled 118 hos­pi­tals and gath­ered data on 32,000 pro­ce­dures since its pi­lot pro­gram went into ef­fect in March 2011.

“It’s bet­ter to have the data be­fore­hand,” Zuck­er­man said, “but the reg­istries are go­ing to pro­vide the kind of long-term data you need.”

Newspapers in English

Newspapers from USA

© PressReader. All rights reserved.