Study finds nearly three-quar­ters of med­i­cal scopes tainted by bac­te­ria

Modern Healthcare - - Quality - By Chad Ter­hune

In an omi­nous sign for pa­tient safety, 71% of re­us­able med­i­cal scopes deemed ready for use on pa­tients tested pos­i­tive for bac­te­ria at three ma­jor U.S. hos­pi­tals, ac­cord­ing to a new study.

The pa­per, pub­lished re­cently in the Amer­i­can Jour­nal of In­fec­tion Con­trol, un­der­scores the in­fec­tion risk posed by com­monly used en­do­scopes. It sig­nals a lack of progress by man­u­fac­tur­ers, hos­pi­tals and reg­u­la­tors in re­duc­ing con­tam­i­na­tion de­spite nu­mer­ous re­ports of su­per­bug out­breaks and pa­tient deaths, ex­perts say.

“These re­sults are pretty scary,” said Janet Haas, pres­i­dent of the As­so­ci­a­tion for Pro­fes­sion­als in In­fec­tion Con­trol and Epi­demi­ol­ogy. “These are very com­pli­cated pieces of equip­ment, and even when hos­pi­tals do ev­ery­thing right we still have risk as­so­ci­ated with these de­vices. None of us have the an­swer right now.”

The study found prob­lems in scopes used for colono­scopies, lung pro­ce­dures, kid­ney stone re­moval and other rou­tine pro­ce­dures. Re­searchers said the find­ings con­firm ear­lier work show­ing that these is­sues aren’t sim­ply con­fined to duo­deno­scopes, gas­troin­testi­nal de­vices tied to at least 35 deaths in the U.S. since 2013, in­clud­ing three at Ron­ald Rea­gan UCLA Med­i­cal Cen­ter. Scope-re­lated in­fec­tions also were re­ported in 2015 at Cedars-Si­nai Med­i­cal Cen­ter in Los Angeles and Hunt­ing­ton Hospi­tal in Pasadena, Calif.

The bac­te­ria this lat­est study found weren’t su­per­bugs, but re­searchers said there were po­ten­tial pathogens that would put pa­tients at high risk of in­fec­tion. The study didn’t track whether the pa­tients be­came sick from pos­si­ble ex­po­sure.

The study’s au­thors said the in­tri­cate de­sign of many en­do­scopes con­tin­ues to hin­der ef­fec­tive clean­ing. Those prob­lems are com­pounded when health­care work­ers skip steps or ig­nore ba­sic pro­to­cols in a rush to get scopes ready for the next pa­tient. The study iden­ti­fied is­sues with colono­scopes, bron­cho­scopes, uretero­scopes and gas­tro­scopes, among oth­ers.

“Sadly, in the 10 years since we’ve been look­ing into the qual­ity of en­do­scope re­pro­cess­ing, we haven’t seen im­prove­ment in the field,” said Cori Of­stead, the study’s lead au­thor and an epi­demi­ol­o­gist in St. Paul, Minn., re­fer­ring to how the de­vices are pre- pared for re­use.

“If any­thing, the sit­u­a­tion is worse be­cause more peo­ple are hav­ing these min­i­mally in­va­sive pro­ce­dures and physi­cians are do­ing more com­pli­cated pro­ce­dures with en­do­scopes that, frankly, are not even clean,” Of­stead said.

The rise of an­tibi­otic-re­sis­tant su­per­bugs such as CRE (car­bapenem-re­sis­tant En­ter­obac­te­ri­aceae), which can be fa­tal in up to half of pa­tients, has made ad­dress­ing these prob­lems more ur­gent. About 2 mil­lion Amer­i­cans are sick­ened by drug-re­sis­tant bac­te­ria each year and 23,000 die, ac­cord­ing to the Cen­ters for Disease Con­trol and Preven­tion.

De­spite the po­ten­tial risks, med­i­cal ex­perts cau­tion pa­tients not to can­cel or post­pone life­sav­ing pro­ce­dures in­volv­ing en­do­scopes since they of­ten spare pa­tients from the com­pli­ca­tions of more in­va­sive surg­eries.

The Food and Drug Ad­min­is­tra­tion and Olym­pus Corp., a lead­ing en­do­scope man­u­fac­turer in the U.S. and world­wide, both said they are re­view­ing the study. Last month, the FDA is­sued warn­ing let­ters to Olym­pus and two other scope mak­ers for fail­ing to con­duct real-world stud­ies on whether health­care fa­cil­i­ties can ef­fec­tively clean and dis­in­fect their duo­deno­scopes. The FDA or­dered the man­u­fac­tur­ers to con­duct those re­views in 2015 af­ter sev­eral scope-re­lated out­breaks in Los Angeles, Seat­tle and Chicago made na­tional head­lines.

Olym­pus spokesman Mark Miller said the Tokyo-based com­pany in­tends to “meet the mile­stones set forth by the FDA. … Pa­tient safety has al­ways been and re­mains our high­est pri­or­ity.”

The lat­est study ex­am­ined 45 en­do­scopes, with all but two man­u­fac­tured

The study found prob­lems in scopes used for colono­scopies, lung pro­ce­dures, kid­ney stone re­moval and other rou­tine pro­ce­dures.

by Olym­pus. The other two were Karl Storz prod­ucts.

Last year, re­searchers vis­ited three hos­pi­tals, which weren’t named, and per­formed visual ex­am­i­na­tions and tests to de­tect fluid and con­tam­i­na­tion on re­us­able en­do­scopes marked ready for use on pa­tients. One hospi­tal met cur­rent guide­lines for clean­ing and dis­in­fect­ing scopes, while the other two com­mit­ted nu­mer­ous breaches in pro­to­cols.

Nev­er­the­less, 62% of the dis­in­fected scopes at the top-per­form­ing hospi­tal tested pos­i­tive for bac­te­ria, in­clud­ing po­ten­tial pathogens. It was worse at the other two—85% and 92%, re­spec­tively.

The study painted a trou­bling pic­ture at the two lower-per­form­ing hos­pi­tals, which were well aware re­searchers were watch­ing.

Among the safety is­sues: Hospi­tal tech­ni­cians wore the same gloves for han­dling soiled scopes fresh af­ter a pro­ce­dure and later, when they were dis­in­fected and em­ploy­ees wiped down scopes with reused tow­els. Stor­age cab­i­nets for scopes were vis­i­bly dirty and drip­ping-wet scopes were hung up to dry, which is a known risk be­cause bac­te­ria thrive on the mois­ture left in­side. The two hos­pi­tals also turned off a clean­ing cy­cle on a com­monly used “wash­ing ma­chine,” known as an au­to­mated en­do­scope re­pro­ces­sor, to save time.

Of­stead and her co-au­thors rec­om­mended mov­ing faster to­ward ster­il­iza­tion of all med­i­cal scopes us­ing gas or chem­i­cals. That would be a step above the cur­rent re­quire­ments for high-level dis­in­fec­tion, which in­volves man­ual scrub­bing and au­to­mated wash­ing. A shift to ster­il­iza­tion would likely re­quire sig­nif­i­cant changes in equip­ment de­sign and ma­jor in­vest­ments by hos­pi­tals and clin­ics.

In their cur­rent form, many en­do­scopes aren’t built to with­stand re­peated ster­il­iza­tion. Some also have long, nar­row chan­nels where blood, tis­sue and other de­bris can get trapped.

In some cases, dis­pos­able, sin­gle-use scopes are an op­tion, and new prod­ucts are start­ing to gain ac­cep­tance. In other in­stances, cer­tain parts of a scope might be dis­pos­able or re­mov­able to aid clean­ing.

The Joint Com­mis­sion, the na­tion’s largest health­care ac­cred­it­ing body, is­sued a safety alert last year about dis­in­fec­tion and ster­il­iza­tion of med­i­cal de­vices in re­sponse to a grow­ing rate of non­com­pli­ance. In 2016, the ac­cred­i­tor cited 60% of its hos­pi­tals for non­com­pli­ance and 74% of all “im­me­di­ate threat to life” ci­ta­tions from sur­vey­ors re­lated to im­prop­erly ster­il­ized or dis­in­fected equip­ment.

Michelle Alfa, a pro­fes­sor in the Univer­sity of Man­i­toba’s med­i­cal mi­cro­bi­ol­ogy depart­ment, said ac­cred­i­tors may need to con­duct more fre­quent in­spec­tions, and en­doscopy labs should be shut down “if they don’t get their act to­gether. These re­sults are to­tally un­ac­cept­able.”

This story orig­i­nally ap­peared in Kaiser Health News, a not-for-profit health news­room whose sto­ries ap­pear in news out­lets na­tion­wide. It is an ed­i­to­ri­ally in­de­pen­dent part of the Kaiser Fam­ily Foun­da­tion.


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