The FDA’S plan to track de­vices /

UDI sys­tem aims to help FDA iden­tify prob­lem prod­ucts more quickly

Modern Healthcare - - FRONT PAGE - Jaimy Lee

Hos­pi­tals and health sys­tems will have vary­ing abil­i­ties to use the gov­ern­ment’s new sys­tem of mark­ing med­i­cal de­vices with unique iden­ti­fiers, though the ef­fec­tive­ness of the ef­fort to im­prove safety and ef­fi­ciency re­lies on providers’ vol­un­tary par­tic­i­pa­tion.

The Food and Drug Ad­min­is­tra­tion is­sued a long-awaited pro­posed rule this month on unique de­vice iden­ti­fiers, rec­om­mend­ing a risk-based ap­proach that would re­quire high­risk med­i­cal de­vices to be­gin im­ple­ment­ing UDI stan­dards a year af­ter the fi­nal rule is pub­lished. The im­ple­men­ta­tion pe­riod is expected to take seven years.

While some man­u­fac­tur­ers have es­tab­lished stan­dard iden­ti­fi­ca­tion sys­tems for their prod­ucts, the FDA’s UDI sys­tem will be the first con­sis­tent stan­dards sys­tem for med­i­cal de­vices.

It’s expected to im­prove re­calls and ad­verse-event re­port­ing, as well as re­duce med­i­cal er­rors and es­tab­lish con­sis­tent stan­dards for en­ter­ing in­for­ma­tion about de­vices into elec­tronic health records and clin­i­cal in­for­ma­tion sys­tems. Law­mak­ers passed leg­is­la­tion in 2007 man­dat­ing the de­vel­op­ment of the UDI sys­tem. The re­lease of the pro­posed rule was de­layed for years un­til the user-fee leg­is­la­tion that was passed in June re­quired the FDA to is­sue the pro­posed rule be­fore the end of 2012.

Many hos­pi­tals and or­ga­ni­za­tions rep­re­sent­ing pa­tients and providers have ad­vo­cated for the FDA to move for­ward with the im­ple­men­ta­tion of the UDI sys­tem de­spite the expected costs for im­ple­men­ta­tion and train­ing.

“We built it and now peo­ple have to make changes to their sys­tems and pro­cesses so they can take ad­van­tage of it,” said Jay Crow­ley, se­nior ad­viser for pa­tient safety at the FDA’S Cen­ter for De­vices and Ra­di­o­log­i­cal Health. “We’re hop­ing they will, for a host of rea­sons.”

Im­proved pa­tient safety and busi­ness ef­fi­cien­cies are two rea­sons why some providers are ea­ger to im­ple­ment the UDI sys­tem. One re­port es­ti­mated that UDIS could save the health­care in­dus­try bil­lions of dol­lars.

Mercy Health Sys­tem in St. Louis ex­pects to in­vest in other scan­ning and record-keep­ing tech­nol­ogy to im­ple­ment the UDI sys­tem, said Gene Kirtser, pres­i­dent and CEO of Re­source Op­ti­miza­tion & In­no­va­tion, Mercy’s group pur­chas­ing or­ga­ni­za­tion.

About a year and a half ago, Mercy be­gan putting new scan­ning tech­nol­ogy on its nurs­ing floors. When nurses scan a med­i­cal prod­uct’s bar code, they can record the pa­tient’s use of a prod­uct, send a notice to re­fill the prod­uct, trans­fer the data to an elec­tronic health record and bill the pa­tient.

How­ever, up to 40% of the prod­ucts on Mercy hos­pi­tals’ nurs­ing floors do not have a bar code or use a bar code that doesn’t reg­is­ter with the scan­ning tech­nol­ogy. Man­u­ally en­ter­ing the bar code is time-con­sum­ing, in­ef­fi­cient, frus­trat­ing and un­nec­es­sary, Kirtser said.

“The pa­tient-safety ben­e­fits and busi­ness-ef­fi­ciency ben­e­fits will sig­nif­i­cantly out­weigh any kind of in­cre­men­tal costs that we in­cur,” he added.

There are no es­ti­mates for what providers can ex­pect to pay to im­ple­ment the types of tech­nol­ogy needed to fully use the UDI sys­tem, but the FDA and groups rep­re­sent­ing providers say they be­lieve the ad­van­tages of the sys­tem off­set any costs.

The hos­pi­tals and health sys­tems that are ad­vanced users of EHRS and other cod­ing sys­tems will likely be early adopters of the UDI sys­tem.

Ac­cord­ing to a com­ment let­ter filed in 2009 by SSM Health Care, the up­front ex­pense would be made up in the time the hospi­tal would save in a re­call that would re­quire iden­ti­fi­ca­tion of prod­ucts.

“The ben­e­fits come about from elec­tronic data cap­ture and the move­ment and ex­change of that in­for­ma­tion and then the vis­i­bil­ity that (in­for­ma­tion) pro­vides,” Crow­ley said. “The real ben­e­fits ac­crue for those hos­pi­tals or health--

care sys­tems that have moved or are mov­ing into hav­ing in­te­grated elec­tronic sys­tems.”

Dur­ing the past sev­eral years, the FDA has worked with nu­mer­ous trade groups and gov­ern­ment agen­cies to en­cour­age provider par­tic­i­pa­tion in the UDI sys­tem. In par­tic­u­lar, the FDA has worked closely with the Of­fice of the Na­tional Co­or­di­na­tor to po­si­tion the UDI sys­tem as tied to mean­ing­ful- use re­quire­ments and cer­tain qual­ity mea­sures, Crow­ley said.

“The elec­tronic health record is a big, big, big piece of this,” he said. “Those health­care sys­tems that have the in­fra­struc­ture in place will be able to much more quickly take ad­van­tage of and ac­crue the ben­e­fits of a stan­dard­ized iden­ti­fi­ca­tion sys­tem.”

How­ever, the FDA does not have the author­ity to re­quire providers to use the sys­tem, which was an is­sue that the Gov­ern­ment Ac­count­abil­ity Of­fice raised in a 2011 re­port about de­vice re­calls.

“FDA’s se­nior ad­viser stated that larger hos­pi­tals might be more ea­ger to adopt the tech­nol­ogy nec­es­sary to track de­vices us­ing the UDI once it is im­ple­mented, but ac­knowl­edged that ben­e­fits for the re­call process are greatly de­pen­dent on hos­pi­tals’ im­ple­men­ta­tion of the UDI, which could take up to 10 years for many hos­pi­tals, es­pe­cially smaller ones,” the GAO wrote.

The de­vice in­dus­try has also ex­pressed con­cern about providers’ role in the UDI sys­tem.

In a state­ment re­spond­ing to the July 3 pro­posed rule, Janet Trunzo, se­nior ex­ec­u­tive vice pres­i­dent of tech­nol­ogy and reg­u­la­tory af­fairs at The Ad­vanced Med­i­cal Tech­nol­ogy As­so­ci­a­tion, said the ben­e­fits of stan­dard iden­ti­fi­ca­tion are de­pen­dent on “de­vice users con­sis­tently and ef­fec­tively uti­liz­ing the UDI sys­tem for re­calls track­ing, ad­verse-event re­port­ing and within elec­tronic health records.”

About half of man­u­fac­tur­ers were us­ing stan­dards iden­ti­fi­ca­tions sys­tems cre­ated by GS1 and HIBCC in 2009, ac­cord­ing to Ad­vaMed. Both sys­tems meet the FDA’s pro­posed re­quire­ments.

Kirtser and Siob­han O’Bara, vice pres­i­dent for health­care for GS1 US, an in­for­ma­tion stan­dards or­ga­ni­za­tion, noted that the hos­pi­tals that don’t ac­quire the tech­nol­ogy needed to draw data from the UDI data­base that FDA has de­vel­oped can also man­u­ally re­trieve the data as nec­es­sary. O’Bara noted, though, that it’s clear the providers that are early adopters of health tech­nol­ogy will also be the early adopters of stan­dards iden­ti­fi­ca­tion sys­tems. “Some of these larger, more well-in­te­grated (de­liv­ery net­works) will be the ones that are the first adopters, and then, hope­fully, it will continue to per­co­late through the en­tire health­care sys­tem,” Crow­ley said.


The FDA is work­ing to get a han­dle on the scope of dan­ger pre­sented by all-metal ar­ti­fi­cial hips, such as this one re­moved from a pa­tient at Mas­sachusetts Gen­eral Hospi­tal in Bos­ton.

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