Repo­si­tion­ing re­pro­cess­ing

Hos­pi­tals see big po­ten­tial for sav­ings, but safety re­mains an is­sue for some

Modern Healthcare - - SAFETY - Jaimy Lee

The sup­ply chain staff at Beth Is­rael Dea­coness Med­i­cal Cen­ter in Bos­ton in late 2009 pro­posed a new pro­gram that would re­cy­cle two cat­e­gories of sin­gle-use med­i­cal de­vices by send­ing them to an out­side ven­dor to be dis­abled, ster­il­ized and repack­aged. Such a pro­gram would pro­duce big sav­ings, they promised.

And they were right. The 642-bed aca­demic med­i­cal cen­ter saved roughly $375,000 in 2012 by hav­ing the de­vices re­pro­cessed—some­times at half the cost of orig­i­nal de­vices. It also di­verted 10,000 pounds of med­i­cal waste, which is es­ti­mated to cost about $1 or $2 per pound to dis­card.

Now, the hos­pi­tal re­pro­cesses 15 cat­e­gories of med­i­cal de­vices.

The idea “came up from sup­ply chain as a cost-sav­ings op­por­tu­nity and it kind of evolved from there,” says Adam Robin­son, a clin­i­cal con­tract man­ager at Beth Is­rael Dea­coness.

Re­pro­cess­ing sin­gle-use med­i­cal de­vices is not new. The prac­tice has been around for decades, but the mar­ket has re­ported sig­nif­i­cant growth in re­cent years as more hos­pi­tals have started to im­ple­ment re­pro­cess­ing pro­grams in an ef­fort to save money and re­duce waste.

In ad­di­tion, some of the largest de­vice­mak­ers in the U.S. have gone from crit­ics of re­pro- cess­ing to own­ers of third-party re­pro­cess­ing com­pa­nies.

“Of the dif­fer­ent sus­tain­abil­ity ac­tiv­i­ties that hos­pi­tals are adopt­ing across the coun­try, this seems to be one of the more pop­u­lar ones,” says Su­san Ka­plan, a re­search as­sis­tant pro­fes­sor at the Univer­sity of Illi­nois at Chicago. “The main rea­sons are the cost sav­ings and the ben­e­fits to the en­vi­ron­ment.”

How­ever, there are still lim­i­ta­tions to wide­spread adop­tion of re­pro­cess­ing. Some clin­i­cians con­tinue to ex­press con­cerns about the safety and per­for­mance of re­pro­cessed de­vices, which can put hos­pi­tal ad­min­is­tra­tors and physi­cians at odds over the ad­e­quacy of the re­pro­cess­ing process, and not all hos­pi­tals are mov­ing for­ward with plans to im­ple­ment th­ese pro­grams de­spite the po­ten­tial for cost sav­ings.

“The weight of the other pres­sures im­pact­ing health­care as it be­gins to adopt the Af­ford­able Care Act—(which is) just an enor­mous set of de­mands—might be a bar­rier,” says Gary Co­hen, pres­i­dent of Health Care With­out Harm, a coali­tion of providers and en­vi­ron­men­tal, com­mu­nity and other groups that sup­port sus­tain­abil­ity in the health­care sec­tor. “How­ever, be­cause this is such a sig­nif­i­cant cost-sav­ings mea­sure, you’d think that would be some­thing that would be over­come.”

Hos­pi­tals across the U.S. are re­port­ing that re­pro­cess­ing pro­grams have led to mil­lions of dollars in sav­ings across the sec­tor. The pro­grams of­ten serve as a hos­pi­tal’s flag­ship sus­tain­abil­ity ef­fort. Med­i­cal de­vices rang­ing from en­do­scopes to sur­gi­cal for­ceps can be re­pro­cessed.

About 3,000 of the na­tion’s 5,000 or so hos­pi­tals have im­ple­mented re­pro­cess­ing pro­grams, ac­cord­ing to the As­so­ci­a­tion of Med­i­cal De­vice Re­pro­ces­sors, which rep­re­sents Stryker Sus­tain­abil­ity So­lu­tions and John­son & John­son’s Ster­ilMed. While many aca­demic med­i­cal cen­ters were early adopters of such pro­grams, re­pro­cess­ing pro­po­nents range from hos­pi­tals op­er­ated by for-profit play­ers such as HCA to large not-for-prof­its such as 962-bed Yale-New Haven (Conn.) Hos­pi­tal.

Stryker Sus­tain­abil­ity and Ster­ilMed say they are re­port­ing year-over-year growth based on the num­ber of hos­pi­tals that are start­ing new pro­grams as well as on the hos­pi­tals that are ex­pand­ing the num­ber of de­vice cat­e­gories to re­pro­cess.

Both com­pa­nies de­clined to dis­close rev­enue fig­ures. Stryker and Ster­ilMed, which was ac­quired by J&J in 2011 for an undis­closed amount, make up about 95% of the es­ti­mated $373 mil­lion mar­ket for third-party re­pro­cess­ing. Stryker paid $525 mil­lion in

cash in 2010 to ac­quire Phoenix-based As­cent Health­care So­lu­tions and re­named it Stryker Sus­tain­abil­ity So­lu­tions.

Mike Gustafson, world­wide pres­i­dent of Ster­ilMed, says the com­pany helps “hos­pi­tals build ro­bust re­pro­cess­ing pro­grams so that they can achieve their eco­nomic and en­vi­ron­men­tal goals.”

“Both hos­pi­tals and in­de­pen­dent de­liv­ery net­works, as well as clin­i­cians, (un­der­stand) the need to in­crease ac­cess to care and im­prove af­ford­abil­ity and they’re look­ing for so­lu­tions,” he adds.

Both com­pa­nies say the prac­tice of re­pro­cess­ing is safe, and noted that the Food and Drug Ad­min­is­tra­tion reg­u­lates the re­pro­cess­ing of sin­gle-use de­vices and has strength­ened its ex­ist­ing over­sight since 2000. All re­pro­cessed de­vices must re­ceive 510(k) clear­ance from the FDA, which also in­spects re­pro­cess­ing com­pa­nies and mon­i­tors re­ports of ad­verse events. The 510(k) path­way does not re­quire clin­i­cal test­ing.

In­creas­ing scru­tiny

Dur­ing the past decade, the prac­tice of re­pro­cess­ing has faced in­creased scru­tiny at both the state and fed­eral lev­els, but a pair of Govern­ment Ac­count­abil­ity Of­fice re­ports found lit­tle ev­i­dence of harm, with a 2008 re­port con­clud­ing that cur­rently avail­able in­for­ma­tion did not in­di­cate re­pro­cessed de­vices were less safe than orig­i­nal de­vices.

The FDA has said that the risks of get­ting a health­care-ac­quired in­fec­tion from in­ad­e­quately re­pro­cessed med­i­cal de­vices, which may re­tain blood or tis­sue, are “rel­a­tively low … al­though the po­ten­tial for out­breaks of in­fec­tions as­so­ci­ated with their use re­mains an im­por­tant pub­lic health con­cern.”

“A lot of the furor and the con­tro­versy be­gan to go away af­ter the FDA be­gan reg­u­lat­ing the prac­tice,” says Chris Lavanchy, en­gi­neer­ing di­rec­tor at the ECRI In­sti­tute, a not-for-profit or­ga­ni­za­tion that re­searches pa­tient-safety and tech­nol­ogy is­sues. “Ev­ery­thing we’ve looked into has sug­gested that there’s re­ally not an is­sue” with safety.

How­ever, a com­mit­tee opin­ion re­leased last year by the Amer­i­can Col­lege of Ob­ste­tri­cians and Gyne­col­o­gists called for stud­ies that eval­u­ate the safety, qual­ity and cost-ef­fec­tive­ness of re­pro­cessed sin­gle-use de­vices used in gyne­co­logic pro­ce­dures. “Physi­cians should be in­formed whether the in­stru­ments used in surgery are orig­i­nal or re­pro­cessed, and ad­verse events should be re­ported to im­prove the safety in­for­ma­tion about re­pro­cessed sin­gle-use de­vices,” the opin­ion states.

The opin­ion also ques­tioned whether pa­tients should be in­formed that a re­pro­cessed de­vice will be used dur­ing a surgery.

Much of the com­mit­tee’s con­cern stemmed from physi­cians who say they weren’t aware that hos­pi­tals were pro­vid­ing re­pro­cessed de­vices to doc­tors, says Dr. Denise Elser, a gyne­co­logic sur­geon in Chicago.

Be­cause hos­pi­tals don’t gen­er­ally track whether a re­pro­cessed de­vice was used in a pro­ce­dure, it is dif­fi­cult to un­der­stand whether those de­vices lead to more com- pli­ca­tions or in­juries. “We have no real data on that,” she says. “What we’re ask­ing for is to help us un­der­stand this is safe be­cause right now we haven’t been given that in­for­ma­tion.”

An­other fac­tor may con­trib­ute to lin­ger­ing con­cerns among clin­i­cians. Sev­eral sources say that John­son & John­son and

Stryker were ma­jor crit­ics of re­pro­cess­ing be­fore mak­ing their in­vest­ments in the sec­tor. And, in some cases, hos­pi­tals might be hes­i­tant to pro­mote their use of re­pro­cessed de­vices to pa­tients who are un­in­formed about the re­pro­cess­ing process.

“Some hos­pi­tals have ex­pressed that there’s a pub­lic­ity is­sue from when re­pro­cess­ing was still the Wild West,” ECRI’s Lavanchy says. The prac­tice is “much more preva­lent to­day.”

A 2012 study funded by the Com­mon­wealth Fund looked at dif­fer­ent hos­pi­tal sus­tain­abil­ity pro­grams that in­clude re­pro­cess­ing pro­grams, as well as en­ergy use re­duc­tion, waste re­duc­tion and more ef­fi­cient pur­chas­ing of op­er­at­in­groom sup­plies. The study rec­om­mended that all hos­pi­tals adopt th­ese types of sus­tain­abil­ity pro­grams.

“Given the re­turn on in­vest­ment, the au­thors rec­om­mend that all hos­pi­tals adopt such pro­grams and, in cases where cap­i­tal in­vest­ments could be fi­nan­cially bur­den­some, that pub­lic funds be used to pro­vide loans or grants, par­tic­u­larly to safety-net hos­pi­tals,” the au­thors wrote.

The Health­ier Hos­pi­tals Ini­tia­tive, an al­liance of hos­pi­tals and health sys­tems that are seek­ing to boost sus­tain­abil­ity in the health­care sec­tor, re­leased a re­port in April

“Some hos­pi­tals have ex­pressed that there’s a pub­lic­ity is­sue from when re­pro­cess­ing was still the Wild West. (The prac­tice is) much more preva­lent to­day.” —Chris Lavanchy ECRI In­sti­tute

that found 185 hos­pi­tals saved $32 mil­lion last year by re­pro­cess­ing sin­gle-use med­i­cal de­vices. HHI is aligned with Health Care With­out Harm.

Ac­cord­ing to pub­lished re­ports, Tenet Health­care Corp. re­ported sav­ing $9.4 mil­lion and di­vert­ing more than 1.5 mil­lion pounds of med­i­cal waste from land­fills last year, while the Fran­cis­can Health Sys­tem, based in Ta­coma, Wash., and af­fil­i­ated with Catholic Health Ini­tia­tives, ex­pects to gener- ate about $2 mil­lion in sav­ings this year.

“Re­pro­cess­ing of sin­gle-use de­vices is re­ally be­com­ing a very com­mon stan­dard of prac­tice,” says Diane Karagory, a se­nior di­rec­tor at Huron Health­care, which is part of the Huron Con­sult­ing Group.

She es­ti­mates that a re­pro­cessed de­vice can cost be­tween 30% and 50% less than the orig­i­nal de­vice. Data from Prac­tice Green­health, a not­for-profit fo­cused on im­prov­ing en­vi­ron­men­tal prac­tices in health­care, show that a new ul­tra­sound catheter costs about $2,900, while a re­pro­cessed one is $1,400. New la­paro­scopic in­stru­ments may cost $1,240 when pur­chased from the orig­i­nal equip­ment man­u­fac­turer, but a re­pro­cessed one might cost only $250.

“There is a whole di­men­sion about ed­u­cat­ing clin­i­cians,” says Co­hen of Health Care With­out Harm. “I think it’s true with a lot of th­ese sus­tain­abil­ity mea­sures that the big­gest is­sue is cul­ture change.”

Ster­ilMed’s re­pro­cess­ing fa­cil­ity in Maple Grove, Minn., uses an ul­tra­sonic process to clean sin­gle-use med­i­cal de­vices.

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