Scope maker ‘waited years’ to re­port prob­lems


U.S. reg­u­la­tors have un­cov­ered new vi­o­la­tions by the man­u­fac­turer of med­i­cal scopes re­cently linked to out­breaks of deadly “su­per­bug” bac­te­ria at U.S. hos­pi­tals.

Olym­pus Corp. failed to alert reg­u­la­tors to a clus­ter of 16 in­fec­tions in pa­tients who un­der­went pro­ce­dures with the com­pany’s scope in 2012, ac­cord­ing to a warn­ing let­ter posted online Mon­day by the U.S. Food and Drug Ad­min­is­tra­tion. Olym­pus did not re­port the prob­lems to the FDA un­til 2015, when the com­pany was al­ready un­der scru­tiny for a more re­cent se­ries of out­breaks.

Med­i­cal de­vice man­u­fac­tur­ers are re­quired to re­port se­ri­ous de­vice prob­lems to the FDA within 30 days of learn­ing about them. The in­fec­tions re­ported to the com­pany in­volved a bac­te­rial strain called pseu­domonas, which can cause pneu­mo­nia, se­vere sick­ness and death in hos­pi­tal pa­tients.

Ad­di­tion­ally, FDA in­spec­tors found that the com­pany has no stan­dard pro­ce­dure for promptly re­port­ing se­ri­ous prob­lems with its de­vices, a re­quire­ment for med­i­cal de­vice com­pa­nies. The FDA in­spected four com­pany sites in Ja­pan and the U.S. be­tween March and April this year.

A spokesman for the Tokyo man­u­fac­turer said in a state­ment: “We are re­view­ing the FDA’s warn­ing let­ter so that we can pro­vide the re­quired re­sponse in a timely man­ner.”

Med­i­cal scopes from Olym­pus were linked to in­fec­tions of an­tibi­otic-re­sis­tant bac­te­ria at two sep­a­rate Los An­ge­les hos­pi­tals ear­lier this year. Hos­pi­tal staff at CedarsSi­nai and UCLA med­i­cal cen­ters said the in­fec­tions oc­curred de­spite fol­low­ing Olym­pus’ in­struc­tions for clean­ing the de­vices, known as duo­den­do­scopes.

Olym­pus is the mar­ket leader for duo­deno­scopes in the U.S., ac­count­ing for about 85 per­cent of sales, ac­cord­ing to the FDA.

The spe­cial­ized scopes con­sist of a flex­i­ble fiber-op­tic tube that is in­serted down the throat into the stom­ach and small in­tes­tine to di­ag­nose and treat con­di­tions in the pan­creas and bile ducts. The tip of the scope in­cludes move­able in­stru­ments de­signed to re­move tu­mors, gall­stones and other block­ages. But this com­plex de­sign also makes the in­stru­ments ex­tremely dif­fi­cult to clean. Bod­ily flu­ids and other de­bris can stay in the de­vice’s joints and crevices even af­ter clean­ing and dis­in­fec­tion.

Since 2013, there have been eight out­breaks of an­tibi­otic-re­sis­tant bac­te­ria linked to the de­vices at U.S. hos­pi­tals, ac­cord­ing to gov­ern­ment fig­ures.

The FDA also posted warn­ing letters Mon­day to two other scope man­u­fac­tur­ers — Hoya Cor­po­ra­tion and Fu­ji­film Cor­po­ra­tion — cit­ing prob­lems with the test­ing, de­sign, re­port­ing and qual­ity con­trol of their de­vices. All of the letters are dated Aug. 12. The com­pa­nies are given 15 busi­ness days to re­spond with their plans to fix the prob­lems.

Fu­ji­film said in a state­ment that it “takes the is­sue very se­ri­ously and is work­ing closely with FDA.” Hoya Corp. did not im­me­di­ately re­spond to a re­quest for com­ment Mon­day.

The FDA pre­vi­ously dis­closed that Olym­pus did not seek fed­eral clear­ance for the latest ver­sion of its duo­deno­scope, which it be­gan selling in 2010.

De­spite these prob­lems, the FDA pre­vi­ously ruled it would keep the de­vices on the mar­ket be­cause they fill an im­por­tant need in a halfmil­lion pro­ce­dures per­formed each year.

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