October 21, 2020

Faulty bronchoscope reprocessing raises risks of infection transmission

By: Judith M. Mathias, MA, RN
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Preventing infection transmission has been a chief concern of healthcare leaders and staff striving to protect their patients and themselves from SARS-CoV-2, the virus that causes COVID-19. The virus poses an insidious threat that includes the possibility of bronchoscopy-associated transmission of COVID-19.

Long before the pandemic, epidemiologist and researcher Cori L. Ofstead, MSPH, had found high bronchoscope contamination rates during routine use in multisite studies conducted by her and her colleagues at Ofstead and Associates, St Paul, Minnesota. The risk of contamination has only been magnified during the pandemic, her research shows.

Although high-level disinfection (HLD) should eliminate these risks when bronchoscopes are well maintained and reprocessed according to manufacturer’s instructions and professional guidelines, practices are frequently substandard, and pathogens are commonly present on patient-ready endoscopes, Ofstead says.


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Gastrointestinal (GI) pathogens found in bronchoscopes and bronchoalveolar lavage (BAL) samples also suggest there may be cross-contamination caused by intermingling bronchoscopes and GI endoscopes during reprocessing.

In addition, recent research reports on COVID-19 patients with diarrhea and abdominal pain—as well as fecal carriage of the virus in severely ill and asymptomatic patients—means great care must be taken to minimize cross-contamination during all endoscope reprocessing, she says.

 

Evidence sparking concern

In January, Ofstead and her team noticed an unusual outbreak of respiratory infections happening in China, where researchers identified a new virus using BAL samples. The samples were obtained by flushing saline solution through a bronchoscope into the lung and suctioning it back out for testing.

As an epidemiologist with a background in vaccine-preventable infections, Ofstead was intrigued. She noticed reports of other pathogens being found in some patients with the virus.

One report described bacteria found in BAL samples from five patients hospitalized with COVID-19. The bacteria included: Stenotrophomonas, Pseudomonas, Escherichia, Salmonella, and Acinetobacter baumannii.

“That caught my attention,” says Ofstead, “because Steno and Pseudomonas are waterborne pathogens often found in contaminated reprocessing rinse water, and E coli, Salmonella, and Acinetobacter are GI flora that shouldn’t be in patient lungs at all.”

The report noted that two of the five patients had coinfections—one had multiorgan failure and died; the other was still seriously ill and hospitalized at the time of publication.

Ofstead says she and her team also saw additional reports of coinfections in COVID-19 patients:

• In Wuhan, China, 5 of 99 patients had other infections with pathogens that included bacteria ( Acinetobacter baumannii, Klebsiella pneumoniae) and fungi ( Aspergillus flavus, Candida glabrata, Candida albicans).

• In Washington State, 4 of 21 patients had coinfections with bacteria ( Pseudomonas) or other viruses (influenza, parainfluenza).

She wondered if the coinfections with GI flora, waterborne pathogens, and fungi were the result of contaminated bronchoscopes. These coinfections are important because they have been linked to increased mortality.

• In a 2020 study of 150 patients in Wuhan, China, researchers found 12 patients with coinfections with other pathogens and 138 without coinfections. Of the 12 with coinfections, 11 died. Only one was alive and well enough to be discharged.

• A 2018 study by Ofstead and colleagues found microbes in 65.7% of reusable bronchoscopes reprocessed in five hospitals in the US. The species found were similar to those found in BAL samples in China, including Stenotrophomonas maltophilia and Sphingomonas phyllosphaerae, which are waterborne pathogens. They also found E coli, which is a GI bacteria, as well as Delftia acidovorans, Rothia mucilaginosa, Staphylococcus, Paenibacillus, and mold.

Ofstead says these findings made her wonder if the reprocessing practices in hospitals managing COVID-19 outbreaks were meeting the standards for infection control.

Critical insight. When waterborne pathogens, fungi, or GI flora are found in samples taken from reusable bronchoscopes, consider the possibility that the bronchoscopes are contaminated.

 

Bronchoscope reprocessing effectiveness

When considering decontamination of surfaces exposed to SARS-CoV-2, Ofstead says to remember that live virus has been detected after 3 hours in aerosolized droplets and after 3 days on stainless steel and plastic surfaces. Fortunately, she says, normal disinfectants used in healthcare facilities should eliminate or neutralize the virus.

Reusable bronchoscopes must be cleaned and disinfected or sterilized between uses. After a bronchoscope is used, the basic reprocessing steps recommended in standards include point-of-use precleaning, thorough mechanical or manual cleaning, high-level disinfection or sterilization, drying, and secure storage.

To ensure those steps work, basic quality checks must be performed. These checks are considered the five pillars of quality assurance and are recommended in national standards and guidelines:

• visual inspections

• leak testing

• cleaning verification tests

• minimum effective concentration tests or chemical or biological indicators for sterilized bronchoscopes

• drying verification tests.

The problem, Ofstead says, is that reprocessing quality in the field is very poor (sidebar, “Reprocessing quality issues in study sites,” at right). Audits performed at three sites found:

• Site A did most of the steps properly, but their point-of-care precleaning and visual inspections didn’t meet the standards.

• Sites B and C did almost nothing in accordance with minimum standards and the manufacturer’s instructions for safely reprocessing bronchoscopes.

• Sites A, B, and C were handling patient-ready bronchoscopes with their bare hands.

• Sites B and C had dirty reprocessing and storage areas as well as inadequate dirty-to-clean workflow.

• Site B had intentionally disabled cycles in their automated endoscope reprocessors (AERs) to save time. “They turned off the cleaning cycle because it saved them 20 minutes, and it saved them money because they didn’t have to use any detergent,” says Ofstead.

• Site C skipped leak testing and manual cleaning and relied on their AERs to handle those steps.

Ofstead says in some cases, they saw nurses or technologists skipping a step. In one case, Ofstead took a bronchoscope out of a transport bin in the reprocessing area and found a thick, mucus-like residue all over the bin, and a closer look revealed blood clots amid the mucus.

“This did not bode well for reprocessing effectiveness because substantial blood and soil remained in the scope for a lengthy period of time after the procedure, potentially hardening in the channel and fostering the growth of biofilm,” Ofstead says.

She and her team also found the manual cleaning station in the reprocessing suite of a large urban hospital had multiple infractions, such as dirty sinks, puddles of pink fluid on the floor, discolored irrigation tubing filled with a brown substance, and faucets without foot pedals. This work area was not being cleaned and disinfected sufficiently to prevent COVID-19 transmission, which raises the questions:

• When handling a bronchoscope used on a patient with COVID-19, will the technicians thoroughly clean and disinfect all of the surfaces and equipment before moving on to the next instrument?

• Will the technicians change personal protective equipment (PPE) and wash their hands carefully, or will the virus be spread, leaving the next technician and the next instrument that goes into the sink at risk of picking up the virus?

Ofstead and her colleagues tested brand new bronchoscopes that had never been used or cleaned. The new bronchoscopes had a small amount of protein on them, but there were no microbes.

They sampled the bronchoscopes again after the technician cleaned them in a dirty sink. The protein level went up from 4 to 17, and the cultures detected microbes.

Distal end of a clinically used bronchoscope after manual cleaning and high-level disinfection.

“This is not good,” says Ofstead, “because it shows that the manual cleaning process was depositing soil on the scopes, which reduces the effectiveness of HLD or sterilization.” After manual cleaning and HLD, the distal end of one clinically used bronchoscope had what appeared to be a little pucker and a dent near the tip (photo at right).

Under magnification, the distal end had a brown substance all the way around the rim, and the pucker appeared to be either a missing chunk or adhesive coming up over the edge of the C-cap. “This bronchoscope was clearly dirty and damaged, and disinfection was not going to work,” says Ofstead.

Critical insight. Reprocessing is more effective when every step is done properly every time.

 

Need for universal precautions during COVID-19 outbreaks

Ofstead says she and her colleagues have received many questions from infection prevention experts and reprocessing managers about what to do when reprocessing bronchoscopes used in COVID-19 patients. They also want to know why they can’t just test everyone and segregate those who have the virus from those who don’t have it.

Ofstead says it is important to consider the evidence:

• The SARS-CoV-2 virus has been detected in several areas of the body, including the upper respiratory system, the lower respiratory system, the GI system, and the blood.

• Testing can have false negative results. Evidence from the field shows that 93% of BAL samples contain the virus, whereas only 63% of nasal swabs and 32% of throat swabs contain the virus. “That means there may be a lot of false negative results, if we rely only on swabs of the nose and throat to determine who is infected,” she says.

• Of feces samples tested, 29% harbored the virus. “We’ve got to be careful about the fecal-oral route of transmission, too, not just droplets from coughing and sneezing,” she says.

Ofstead says it is also important to note that lack of symptoms doesn’t mean a person isn’t infected.

• Data from 44,415 confirmed cases in China found that 81% had mild illness with no pneumonia or only mild pneumonia, 14% had severe illness, and 5% were critically ill.

• Data on asymptomatic patients in Washington State found that during an outbreak in a nursing home, 76 residents were tested, and 23 were positive for COVID-19. At the time they were tested, 13 had no symptoms at all, which is 56% asymptomatic. One week later, 10 of those patients had developed symptoms.

• Another example is the Diamond Princess cruise ship, where 331 of 712 passengers and crew who were infected with COVID-19 were asymptomatic at the time of testing, which is 46.5% asymptomatic.

Critical insight. Healthcare workers cannot be sure whether a patient is infected with COVID-19. Therefore, they must follow infection control standards and take universal precautions with all patients and reusable instruments.

 

Strategies for reducing risk

Numerous high-risk activities are present for personnel in the work environment when using reusable bronchoscopes.

• Point-of-use precleaning requires personnel to wipe down the bronchoscope, flush the channel with a large volume of cleaning solution, and dispose of the contaminated fluid and wipes. The personnel who perform these tasks also will have to carefully remove their PPE to prevent exposure.

• Transporting dirty bronchoscopes will contaminate the transport bins or containers and may expose carts or personnel to contaminated bins.

• When dirty bronchoscopes reach the decontamination area in the reprocessing suite, they will come into contact with counters and sinks, leak testers, and irrigation systems. The technician may not change gloves between activities, which could also contaminate computers and AER control panels.

In most institutions, the decontamination areas are not thoroughly cleaned and disinfected between instruments, and with evidence that the COVID-19 virus can remain on stainless steel and plastic for up to 3 days, the decontamination area is at high risk for contamination, she says.

Ways to mitigate risks associated with bronchoscopy include performing fewer procedures and using disposable bronchoscopes, which can reduce exposure of patients and personnel and allow implementation of more stringent quality control.

“Using disposable bronchoscopes also can improve your confidence in laboratory results,” says Ofstead. “Reusable bronchoscopes are likely to harbor bacteria and fungi, which means you can’t be confident that the lab results are telling you what’s in the patient’s lungs versus what’s in the scope. This could impact your treatment decisions.”

Other benefits associated with using sterile, single-use bronchoscopes include:

Personal protective equipment used for reprocessing an endoscope.

• Reducing reprocessing risks because there’s no point-of-use precleaning, no transport issues, no reprocessing unit contamination, and no technician exposure.

• Saving time and resources by reducing PPE use, which is an issue because of COVID-19. The PPE for reprocessing an endoscope is substantial (photo at right).

• Reducing reprocessing supply costs and the need for after-hours staffing for reprocessing.

• Decreasing the risk of damaging reusable bronchoscopes during emergent procedures and the risk of biofilm buildup because of delayed or inadequate reprocessing.

Concerns also have been raised about the use of single-use disposable bronchoscopes, notably:

• Advanced bronchoscopy may require reusable bronchoscopes with particular features that single-use bronchoscopes don’t have.

Garbage from one bronchoscope reprocessing cycle.

• There is an environmental impact from discarding single-use bronchoscopes. However, Ofstead says reprocessing a reusable bronchoscope generates more garbage than does a single-use bronchoscope (photo, at right).

• Disposable bronchoscopes increase costs. A study by Ofstead and associates performed in 2019 found that cost is not a real barrier. Single-use bronchoscopes cost $220 to $315 per procedure, and reusable bronchoscopes cost $281 to $803 per procedure when they took into consideration the costs of acquisition, maintenance, and reprocessing.

Ofstead recommends several actions to take that can reduce contamination risks when reprocessing reusable bronchoscopes:

• Centralize reprocessing to one highly competent department. In most cases, that’s a central supply and sterile processing department.

• Sterilize reusable bronchoscopes whenever possible.

• Segregate bronchoscope from GI endoscope reprocessing to avoid cross-contamination with GI microorganisms.

• Enforce strict adherence to the strongest standards and guidelines, which include: following the five pillars of quality assurance; cleaning and disinfecting counters, sinks, and equipment in the reprocessing suite after every use; using correct procedures for donning and doffing personal protective equipment; and performing hand hygiene using proper techniques.

• Audit reprocessing practices to evaluate adherence to guidelines and ensure patient and personnel safety.

 

Bottom line

Patients who are critically ill with COVID-19 or other conditions may need bronchoscopy, and contaminated bronchoscopes could efficiently spread infections, says Ofstead. “Current practices in the field are simply not sufficient to ensure patient or personnel safety.”

Ofstead calls on all OR managers to take action to reduce the risk for themselves, their patients, and their communities. ✥

 

Editor’s Note: Because of the urgency of the COVID-19 pandemic, Ofstead & Associates are offering free webinars and resources on their website as well as other webinars with CE credits. https://ofstead.elevate.commpartners.com/all-webinars.

 

References

Arentz M, Yim E, Klaff L, et al. Characteristics and outcomes of 21 critically ill patients with COVID-19 in Washington State. JAMA. 2020;323(16):1612-1614.

 

Chen N, Zhou M, Dong X, et al. Epidemiological and clinical characteristics of 99 cases of 2019 novel coronavirus pneumonia in Wuhan, China: A descriptive study. Lancet. 2020:395;507-513.

 

ECRI Institute. Disinfectant concentrations and contact times for EPA’s list of products effective against novel coronavirus SARS-CoV-2, the cause of COVID-19. Health Devices. March 10, 2020 (updated May 13, 2020).

 

Kimball A, Hatfield K M, Arons M, et al. Asymptomatic and presymptomatic SARS-CoV-2 infections in residents of a long-term care skilled nursing facility—King County, Washington, March 2020. MMWR. 2020;69(13):377-381.

 

Moriarty L, Plucinski M, Marston B, et al. Public health responses to COVID-19 outbreaks on cruise ships—worldwide, February-March 2020. MMWR. 2020;69(12):347-352.

 

Ofstead C L. Minimizing the risk of exposure, injury, and infection during bronchoscopy. Ofstead & Associates Webinar. https://ofstead.elevate.commpartners.com/all-webinars.

 

Ofstead C L. COVID-19 and bronchoscopy: Evidence from the field. Ofstead & Associates Webinar. https://ofstead.elevate.commpartners.com/all-webinars.

 

Ofstead C L, Hopkins K M, Binnicker M J, et al. Potential impact of contaminated bronchoscopes on novel coronavirus disease (COVID-19) patients (Letter to the Editor). Infect Control Hosp Epidemiol. 2020;41:862-878.

 

Ofstead C L, Hopkins K M, Eiland J E, et al. Managing bronchoscope quality and cost: Results of a real-world study. PROCESS. 2019; March/April:63-71.

 

Ofstead C L, Quick M R, Wetzler H P, et al. Effectiveness of reprocessing for flexible bronchoscopes and endobronchial ultrasound bronchoscopes. Chest. 2018;154:1024-1034.

 

Ren L, Wang Y, Wu Z, et al. Identification of a novel coronavirus causing severe pneumonia in human: A descriptive study. Chinese Medical Journal. 2020;133:1015-1024.

 

Ruan Q, Yang K, Wang W, et al. Clinical predictors of mortality due to COVID-19 based on an analysis of data of 150 patients from Wuhan, China. Intensive Care Medicine. 2020;46:846-848.

 

Wu Z, McGoogan J M. Characteristics of and important lessons from the coronavirus disease 2019 (COVID-10) outbreak in China: Summary of a report of 72,314 cases from the Chinese Center for Disease Control and Prevention. JAMA. 2020:323(13):1239-1242.

 

Zhu N, Zhang D, Wang W, et al. Brief report: A novel coronavirus from patients with pneumonia in China, 2019. NEJM. 2020;382:727-733.

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