Try­ing to im­prove their im­age

But FDA scan­ning hear­ing re­veals reg­u­la­tory void

Modern Healthcare - - The Week In Healthcare - Shawn Rhea

Atwo-day Food and Drug Ad­min­is­tra­tion pub­lic hear­ing to be­gin sort­ing out where providers, man­u­fac­tur­ers and reg­u­la­tors can take steps to im­prove med­i­cal-imag­ing safety high­lighted the need for stan­dards cre­ation in a host of ar­eas.

But the gath­er­ing, held March 30 and 31, also brought to light the FDA’s lim­ited power to man­date such steps.

“If we want to fo­cus on qual­ity as­sur­ance, fo­cus on stan­dard­iza­tion,” Cyn­thia McCol­lough, a pro­fes­sor of ra­di­ol­ogy physics at the Mayo Clinic, Rochester, Minn., said dur­ing day two of the meet­ing.

McCol­lough was among ra­di­ol­ogy pro­fes­sion­als at­tend­ing the meet­ing who said com­mon stan­dards in a va­ri­ety of ar­eas are needed to im­prove pa­tient safety in the med­i­cal imag­ing field. Those ef­forts should in­clude es­tab­lish­ing uni­form equip­ment ter­mi­nol­ogy among man­u­fac­tur­ers, cre­at­ing a com­mon set of ac­cred­i­ta­tion re­quire­ments among the three or­ga­ni­za­tions re­cently au­tho­rized to ac­credit free­stand­ing imag­ing fa­cil­i­ties, and de­vel­op­ing na­tional cer­ti­fi­ca­tion re­quire­ments for med­i­cal-imag­ing tech­nol­o­gists and other equip­ment users.

The FDA meet­ing was part of a ra­di­a­tion­ex­po­sure re­duc­tion ini­tia­tive launched by the agency in Fe­bru­ary. The three-pronged ef­fort seeks to achieve many of the rec­om­men­da­tions made by ra­di­ol­ogy ex­perts dur­ing the meet­ing, in­clud­ing hav­ing man­u­fac­tur­ers in­cor­po­rate dosage safe­guards into their ma­chines, es­tab­lish­ing manda­tory qual­ityas­sur­ance prac­tices to be in­cluded in ac­cred­i­ta­tion re­quire­ments for imag­ing providers, and set­ting up a reg­istry to cap­ture dose in­for­ma­tion on a va­ri­ety of imag­ing stud­ies.

But while the FDA has au­thor­ity to reg­u­late man­u­fac­tur­ers, the agency’s sway over providers and other key play­ers that would need to take ac­tions to im­prove pa­tient safety is less sub­stan­tial, agency of­fi­cials ac­knowl­edged. Charles Finder, as­so­ciate di­rec­tor of pol­icy and clin­i­cal af­fairs for mam­mog­ra­phy qual­ity and ra­di­a­tion pro­grams with the FDA’s Cen­ter for De­vices and Ra­di­o­log­i­cal Health, noted dur­ing the meet­ing, for exam- ple, that the FDA has no au­thor­ity over the three or­ga­ni­za­tions au­tho­rized to ac­credit free-stand­ing imag­ing fa­cil­i­ties.

“One point is that that au­thor­ity has been ap­pointed to the CMS, not the FDA, al­though we are work­ing with them to de­velop ac­cred­ita- tion re­quire­ments,” Finder said.

The lack of any cen­tral au­thor­ity over the med­i­cal-imag­ing in­dus­try makes cre­at­ing uni­form stan­dards, which would be aimed at pre­vent­ing pa­tient over­dose in­ci­dents such as the ones re­cently re­ported with CT per­fu­sion brain scans, a chal­lenge for pa­tient-safety ad­vo­cates.

What’s more, the FDA’s ef­forts to take the lead on ra­di­a­tion safety comes on the heels of sig­nif­i­cant pub­lic scru­tiny over how the agency has pre­vi­ously han­dled ap­proval of risky med­i­cal-imag­ing de­vices.

Dur­ing the first day of the meet­ing, a for­mer FDA sci­en­tist said his job was elim­i­nated af­ter he raised con­cerns about the risks of ra­di­a­tion ex­po­sure from high-grade med­i­cal scan­ning, ac­cord­ing to the As­so­ci­ated Press. Ju­lian Ni­cholas said that he and other FDA staffers “were pres­sured to change their sci­en­tific opin­ion” af­ter they op­posed the ap­proval of a CT scan­ner for rou­tine colon can­cer screen­ing, the AP story said. Ni­cholas said he ob­jected to ex­pos­ing oth­er­wise healthy pa­tients to the can­cer risks of ra­di­a­tion. Af­ter FDA of­fi­cials pushed ahead with plans to clear the de­vice, Ni­cholas, now a physi­cian at the Scripps Clinic in San Diego, said he and eight other staffers raised their con­cerns with the divi­sion’s top di­rec­tor last Septem­ber.

FDA of­fi­cials said, how­ever, the re­cent meet­ing was an en­cour­ag­ing sign that the en­tire med­i­cal imag­ing in­dus­try is will­ing to take action to pre­vent over­dos­ing and im­prove imag­ing qual­ity. “What the meet­ing points out is that all par­ties in­volved rec­og­nize stan­dard­iza­tion as an im­por­tant is­sue and have ex­pressed their will­ing­ness to work to­wards a so­lu­tion,” said Al­berto Gutierrez, di­rec­tor of the FDA’s in vitro di­ag­nos­tic de­vice eval­u­a­tion and safety of­fice, in an e-mail.

While man­u­fac­tur­ers, imag­ing providers and reg­u­la­tors all ex­pressed sup­port of pa­tient-safety stan­dards, ne­go­ti­at­ing those stan­dards will be a del­i­cate bal­anc­ing act be­tween or­ga­ni­za­tional in­ter­ests and re­spon­si­bil­ity to the greater good, ac­knowl­edged med­i­cal-imag­ing pro­fes­sion­als. For ex­am­ple, man­u­fac­tur­ers have said they will be­gin build­ing ra­di­a­tion dose-check fea­tures into their CT ma­chines and that they will con­sider stan­dard­iz­ing equip­ment ter­mi­nol­ogy used dur­ing their user-train­ing ses­sions. But they ex­pressed con­cern over calls for in­dus­try to share pro­pri­etary codes that would al­low tech­nol­o­gists and ra­di­ol­o­gists to track and de­ci­pher the pro­cess­ing his­tory of an im­age. “What I want is for the im­age to come with a his­tory of things that have been done to it, so I can tell if what I’m see­ing is some­thing that is dis­ease, or some­thing that is the re­sult of a fil­ter” that’s been ap­plied to the im­age, said Jenifer Siegel­man, sec­tion chief of CT scan at 184-bed William W. Backus Hospi­tal, Nor­wich, Conn. “Th­ese are ma­jor cor­po­ra­tions that do a great job in col­lect­ing data, so we’re looking for them to pro­vide us that same type of in­for­ma­tion.”

Bet­tye Wil­son, a ra­di­ol­ogy tech­nol­o­gist and trus­tee of the Amer­i­can Reg­istry of Ra­di­o­logic Tech­nol­o­gists, said, how­ever, that while much of the meet­ing fo­cused on what man­u­fac­tur­ers could do to im­prove med­i­cal imag­ing safety, providers and pro­fes­sional as­so­ci­a­tions also need to sup­port more strin­gent stan­dards around what level of train­ing should be re­quired for imag­ing-equip­ment users. She called for the cre­ation of a na­tional train­ing re­quire­ment for ra­di­ol­ogy tech­ni­cians.

“My take is you can train any­one on a piece of equip­ment, but if they don’t have the proper ed­u­ca­tional back­ground, that’s where the prob­lems oc­cur. I don’t be­lieve it’s the job of ven­dors to train op­er­a­tors. It’s their job to train qual­i­fied op­er­a­tors on how to use their spe­cific ma­chines.”

Siegel­man, above, wants im­ages to come with a his­tory. Wil­son, left, seeks na­tional train­ing re­quire­ments.

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