The FDA backs off its re­call of a med­i­cal de­vice linked to su­per­bug out­breaks

De­vices linked to su­per­bug out­breaks are still on the mar­ket “I’ve never seen a re­call get changed like that”

Bloomberg Businessweek (Asia) - - NEWS - John Tozzi

In Novem­ber 2015 the U.S. Food and Drug Ad­min­is­tra­tion in­structed the maker of a med­i­cal scope clean­ing de­vice tied to a deadly su­per­bug out­break to take the ma­chines off the mar­ket “as soon as pos­si­ble.” Af­ter man­u­fac­turer Cus­tom Ul­tra­son­ics of­fered to cor­rect flaws, the FDA re­peated it­self in a Fe­bru­ary let­ter, writ­ing in bold text: “FDA or­ders Cus­tom Ul­tra­son­ics to im­me­di­ately re­call all Sys­tem 83 Plus de­vices by re­mov­ing them from use.” It cited doubts about whether the 2,800 Sys­tem 83 Plus ma­chines in use at hos­pi­tals across the U.S. could prop­erly clean duo­deno­scopes, which are used to look in­side the small in­tes­tine and are par­tic­u­larly hard to dis­in­fect.

At the end of April, Cus­tom Ul­tra­son­ics wrote cus­tomers say­ing that, in fact, they could keep us­ing their Sys­tem 83 Plus ma­chines to clean en­do­scopes, as long as they weren’t used on duo­deno­scopes. The FDA says it’s pulled back its re­call or­der and is work­ing with the Ivy­land, Pa., com­pany to en­sure its equip­ment is “val­i­dated in a timely man­ner,” says agency spokes­woman Deb­o­rah Kotz. (Un­der FDA rules, a de­vice is con­sid­ered “val­i­dated” once a man­u­fac­turer has proved it works as ad­ver­tised.) The change in rec­om­men­da­tion was “based on in­for­ma­tion pro­vided by the com­pany,” Kotz says. “We have noth­ing more to share on this at this time.”

Robert Blan­chard, direc­tor of prod­uct management and sales for Cus­tom Ul­tra­son­ics, de­clined to com­ment on the FDA let­ters or its change in po­si­tion. Ed­ward Tei­tel, a Hous­ton doc­tor and at­tor­ney who ad­vises Cus­tom Ul­tra­son­ics, says the ac­tual duo­deno­scopes, not the ma­chines used to clean them, are the root cause of dif­fi­cul­ties in dis­in­fect­ing them.

Tei­tel adds that the FDA has re­versed it­self on re­calls in the past “as more in­for­ma­tion be­comes avail­able.” But med­i­cal pro­fes­sion­als say the sharp tone of the FDA’s ini­tial let­ters makes its si­lence about its de­ci­sion to back down on Cus­tom Ul­tra­son­ics puz­zling. “In the 20 years that I’ve been in the busi­ness, I’ve never seen a re­call get changed like that,” says Mark Duro, direc­tor of ster­ile pro­cess­ing operations at New Eng­land Bap­tist Hospi­tal in Bos­ton, which doesn’t use Cus­tom Ul­tra­son­ics equip­ment.

Us­ing Cus­tom Ul­tra­son­ics ma­chines to clean duo­deno­scopes was one of sev­eral fac­tors that “likely con­trib­uted” to the spread of drug-re­sis­tant bac­te­rial in­fec­tions, ac­cord­ing to a

re­port is­sued in Jan­uary by Se­nate Democrats. As many as 350 pa­tients may have been af­fected at dozens of hos­pi­tals since 2010, ac­cord­ing to doc­u­ments re­leased in April by the House Com­mit­tee on Over­sight and Government Reform. Dozens of in­fected pa­tients later died.

Some out­breaks oc­curred at hos­pi­tals that don’t use Cus­tom Ul­tra­son­ics equip­ment, and other brands of clean­ing ma­chines have had trou­ble dis­in­fect­ing duo­deno­scopes. An ex­pert panel con­vened by the FDA in 2015 con­cluded that duo­deno­scopes aren’t re­li­ably safe. One model man­u­fac­tured by Olym­pus was re­called in Jan­uary. The FDA has rec­om­mended ad­di­tional pro­to­cols in­clud­ing re­peat wash­ing, test­ing for con­tam­i­na­tion, or us­ing eth­yl­ene ox­ide gas to ster­il­ize the scopes. Cus­tom Ul­tra­son­ics ma­chines clean in­stru­ments with water, dis­in­fec­tant, and sound waves. A study pre­sented at a med­i­cal con­fer­ence on May 22 sug­gests Cus­tom Ul­tra­son­ics de­vices are more ef­fec­tive at clean­ing en­do­scopes than their com­peti­tors’.

The FDA’s scru­tiny of Cus­tom Ul­tra­son­ics pre­cedes the re­cent out­breaks. In­spec­tions as long ago as 1991 found “sig­nif­i­cant vi­o­la­tions” of fed­eral rules meant to en­sure qual­ity man­u­fac­tur­ing and timely re­port­ing of harm to pa­tients, ac­cord­ing to a civil com­plaint filed in 2006 by fed­eral prose­cu­tors in Philadel­phia. In 2007, Cus­tom Ul­tra­son­ics set­tled the government case; the com­pany, which de­nied in court fil­ings that its prod­ucts had caused or con­trib­uted to pa­tient in­jury, didn’t ad­mit any wrong­do­ing.

It’s not clear how many hos­pi­tals still use Cus­tom Ul­tra­son­ics de­vices. Nine out of 16 U.S. hos­pi­tals that had su­per­bug cases linked to duo­deno­scopes were iden­ti­fied in the Se­nate staff re­port as us­ing Cus­tom Ul­tra­son­ics ma­chines. Only one, Hart­ford Hospi­tal in Con­necti­cut, con­firmed it had re­placed the ma­chines af­ter the re­call.

UCLA Med­i­cal Cen­ter in Los An­ge­les and Mas­sachusetts General Hospi­tal in Bos­ton both say they’re switch­ing to other ven­dors. Oth­ers de­clined to spec­ify what equip­ment they’re us­ing; one, Thomas Jefferson Univer­sity Hospi­tal in Philadel­phia, said the Se­nate re­port was in­cor­rect and it had never used Cus­tom Ul­tra­son­ics.

Lawrence Mus­carella, a for­mer direc­tor for in­fec­tion con­trol for Cus­tom Ul­tra­son­ics who left in 2013, says the FDA’s change of course “ap­pears to be send­ing the wrong mes­sage.” Pa­tients should be told if their hospi­tal is us­ing equip­ment that has raised safety con­cerns, he adds: “It’s OK for hos­pi­tals to do that, pro­vided the pa­tient is told of this, so the pa­tient is aware of the care that they’re get­ting.”

The bot­tom line Hos­pi­tals have got­ten con­flict­ing sig­nals from U.S. reg­u­la­tors about ma­chines used to dis­in­fect med­i­cal scopes.

Cus­tom Ul­tra­son­ics’ Sys­tem 83 Plus au­to­mated en­do­scope re­pro­ces­sor

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