Now that facilities are returning to performing urology cases, what should staff be aware of regarding COVID-19 and urology in general?
This was the question Lane Jacobs, an expert in global product solutions for Boston Scientific, Marlborough, Massachusetts, asked Cori L. Ofstead, MSPH, president and chief executive officer, Ofstead & Associates, Inc, St Paul, Minnesota, during a September 16 webinar for OR Manager, “OR Infection Prevention in the COVID Era.”
In the webinar, which can still be accessed for free at https://ceu.ormanager.com/webinar/215838, Ofstead discusses the evidence showing that the COVID-19 virus is present not only in the upper and lower respiratory systems but in the gastrointestinal (GI) and urinary tracts, feces, and urine.
She also shows evidence of how pervasive the virus is in the environment around a COVID-19 patient, and how it can remain active on different surfaces from hours to days.
In addition, Ofstead describes research on personal protective equipment (PPE) for personnel during endourology procedures, ureteroscope reprocessing effectiveness, and ways to reduce infection risks associated with endourology.
“Our understanding of the virus and its impact changes every day,” says Ofstead, noting that the pandemic has exceeded her own and many other epidemiologists’ worst case scenarios for several reasons:
• There is no widespread immunity.
• No vaccine is available yet.
• There is no effective cure.
• Direct contact is not needed to become infected.
• There is no good way to know who is carrying the virus.
“The bottom line is that complacency about infection prevention is putting everyone at risk, and things are not likely to get back to normal anytime soon,” she says.
As many facilities are reopening, personnel and patients alike are a bit reluctant to return, says Ofstead, citing two studies. In one study, researchers asked GI endoscopy patients how they felt about returning to the clinic for a scheduled procedure. A total of 44% said they were “very concerned” or “somewhat concerned” about safety.
In a companion study, the same researchers asked the personnel in the clinic how they felt about coming back to work. A total of 66% indicated that they were concerned about their own personal safety.
Because of such concerns, facilities and personnel are coming up with strategies for reopening safely while continuing to see patients and do procedures.
A foundation in many facilities is screening of patients and personnel using a variety of tools:
• questionnaires and symptom histories
• temperature monitoring
• pulse-oximeter monitoring
• nose/throat swab tests.
In addition, personnel maintain physical distance, wear masks, and perform hand hygiene. There is also a move to minimize procedures that could generate aerosols.
It is well documented that COVID-19 is found in the upper and lower respiratory systems and that viral loads in respiratory systems are similar whether patients are symptomatic or not. There is also evidence that the COVID-19 virus is present in the GI system, urinary system, and blood, with similar viral loads for symptomatic and asymptomatic patients (sidebar, “SARS-CoV-2 has been detected in several bodily systems, with similar viral loads for symptomatic and asymptomatic patients”).
“Recent case studies raise the question of whether testing with a nose/throat swab can be counted on to identify patients with COVID-19, or if a urine test would potentially improve our ability to detect cases with prolonged virus carriage,” says Ofstead.
Case 1 is a patient who was symptomatic of COVID-19, but had a negative throat swab. However, the patient’s urine was positive for COVID-19, which turned out to be an earlier indicator that the patient was infected with the virus. The throat swab eventually turned positive also.
Case 2 is a patient who was symptomatic for COVID-19 and had both a positive throat swab and positive urine sample. In this case, the researchers weren’t just looking for the RNA [ribonucleic acid] that shows the virus had been there, they also cultured the patient’s urine. They found that the RNA in the urine culture was able to replicate, which showed that the virus in the urine was actually infectious.
Another profound finding was that the live virus, potentially capable of transmitting infection, remained in the patient’s urine for more than 40 days, even after the throat swabs were negative.
Case 3 involves 73 hospitalized patients with COVID-19. About half (53.4%) of the patients had the virus RNA in their stool, and more than 23% of patients with positive stool samples had negative respiratory samples. These findings suggest the possibility of transmission via a fecal or urinary route in addition to the respiratory route.
Currently, there are 14 studies that have documented COVID-19 in the urine. Overall, between 5% and 19% of patients have the virus in their urine with no pain or other urinary tract infection symptoms.
Ofstead says one of the studies that has had the biggest impact on her was conducted by the University of Nebraska on 13 patients from a cruise ship early in the pandemic. These patients had very mild cases of COVID-19 and were not severely ill. They were admitted to the biocontainment unit at the University of Nebraska Medical Center, and they stayed in negative pressure rooms until their tests were negative.
During this time, researchers took samples of the air and surfaces and found environmental contamination regardless of the patients’ symptoms or illness severity. In fact, they found that 80% of the patient room surfaces they sampled were positive for the virus, and the air inside the room and in the hallway outside the door was positive about two-thirds of the time (sidebar, “SARS-CoV-2 gets all over everything, regardless of symptoms”).
Contaminated surfaces included:
• nasal cannula
• pulse oximeters
• bedside tables
• patients’ cell phones
• window ledges.
“This tells us that the virus is getting all over everything in a room where someone with COVID-19 is staying, even when they are only mildly ill or asymptomatic,” says Ofstead.
Another study found that an infectious COVID-19 virus is capable of replicating, and can remain floating in the air for up to 3 hours, on cardboard surfaces for about 24 hours, and on stainless steel and plastic surfaces for 3 days.
These findings demonstrate that the virus also can stay active in the OR on surfaces, and those surfaces must be cleaned and disinfected, she says.
Healthcare personnel working in endoscopy—whether urologic endoscopy, GI endoscopy, or bronchoscopy—should be thinking about where droplets go, says Ofstead.
A couple of studies have shed light on this.
The first study looked at whether microbes got on face shields of endoscopists during GI endoscopy. The study was performed because GI endoscopists did not want to wear face shields, and they wanted to know if it was safe to do procedures without them, she says.
The endoscopists not only wore face shields, but they attached face shields to the wall about 6 feet away from where they were doing the procedure. They also affixed a face shield to the remote patient intake bay wall outside of the procedural area of the room.
After performing GI endoscopy, they found that:
• 45% of samples were positive on the endoscopist’s face shield
• 21% were positive on the face shields on the wall
• 16% were positive on the face shield in the intake bay.
This study, which was done to detect bacteria before the COVID-19 pandemic, found that “microbes are spreading everywhere during these procedures,” she says.
A 2019 urology study found that urologists were exposed to patient secretions or irrigation fluid in 37.5% to 100% of procedures, and their eyes were exposed to blood in 42.8% of procedures.
This means urologists and personnel in urology procedure rooms are getting blood and body fluids splashed on them whether they know it or not, which puts them at risk of exposure to many types of bacteria and viruses, including COVID-19, says Ofstead.
In a study from spring 2020, researchers found that if personnel get the COVID-19 virus on them, they will track it all over the hospital. They found the virus on 50% of shoe soles of ICU personnel, and sometimes on their gowns and gloves.
They also found a 100% rate of COVID-19 virus positivity on floor samples from the inpatient pharmacy where there are personnel but no patients. “That shows us that we are tracking the virus everywhere we go,” says Ofstead.
Looking at implications, she says, one thing to consider is that common screening measures like nose/throat swabs are not always accurate and may not reliably detect infected patients or staff. “We know now, from the studies, that everything is going to get contaminated, whether or not patients or staff are symptomatic. The bottom line is, we’ve got to be taking universal precautions for every patient, every time, period,” says Ofstead.
“Endoscopy is a high-risk proposition, even if we don’t have COVID-19,” says Ofstead. The reason is because the pathway for processing reusable endoscopes has parts of it that are “sketchy.”
Endoscopy room staff tend to see the pathway like this:
• the procedure is completed
• the endoscope leaves the room
• the endoscope goes somewhere
• something happens to the endoscope
• the endoscope comes back shiny and sterile.
“We hope that it comes back sterile,” she says, “because that is what’s supposed to happen.”
In reality, however, she says, when an endoscope goes to central sterile or an endoscopy unit (ie, goes somewhere) for reprocessing, the manual cleaning (ie, something happens) may not get the residual soil off. This forms a biofilm that protects the microbes on the endoscope. The residual soil and biofilm hinder the effectiveness of high-level disinfection and sterilization (ie, shiny and sterile), and pathogens that might cause problems for the patients are not completely removed.
Reprocessing one endoscope is very complex and takes more than 100 steps, and completing all of the steps is time intensive.
These steps fall into four main areas:
• point-of-use precleaning
• mechanical cleaning
• high-level disinfection or sterilization
• secure, dry storage.
To ensure these four steps are done correctly, there are five quality pillars:
• visual inspection at every step with lighted magnification
• leak test
• cleaning verification
• MEC (minimum effectiveness concentration) test or CI/BI (chemical and biological indicator testing)
• drying verification (sidebar, “Reprocessing one endoscope takes >100 steps)
Ofstead and her colleagues performed two reprocessing cost and time studies and found that it takes more than 90 minutes if all steps are done correctly. One site did it in 41 minutes, but they did it by skipping steps and cutting corners.
The good news is that the COVID-19 virus is an enveloped virus, which means the virus is surrounded by a layer of lipids or fats, says Ofstead. “If you disrupt the lipid surface, you kill the virus.”
Cleaning with detergent and hot water will get rid of the lipid layer and virus, as will alcohol-based hand rubs. All of the typical disinfectants, high-level disinfectants, and sterilants used in hospitals are effective against the COVID-19 virus.
“There is nothing special that is needed, but the reprocessing steps have to be done correctly,” she says. “Facilities may think they can get away with skipping steps, but our samples and microbial cultures have found live bacteria and mold on bronchoscopes, GI endoscopes, and ureteroscopes in facilities where personnel did not follow all of the reprocessing steps.”
In a 2017 ureteroscope study, Ofstead and her team found contamination and damage on sterilized “patient ready” ureteroscopes at two hospitals.
Among their findings:
• bacteria on 13%
• adenosine triphosphate (ATP) on 44%
• hemoglobin on 63%
• protein on 100%
• visible defects on 100%.
“The reason sterilization failed and contamination was present is because the ureteroscopes were still dirty, and they were damaged,” says Ofstead.
The protein found on all of the ureteroscopes is important because it points to how poorly they were cleaned, she says.
For the study, a brand new ureteroscope was unpacked from its box, processed in accordance with the manufacturer’s instructions, and given to Ofstead’s team to test. They found a substantial amount of ATP on it. GI endoscopes with more than 200 RLU of ATP are considered to be dirty, and this processed ureteroscope had 338 RLU. It also had 1µ/mL of hemoglobin on it and 20µ/mL of protein.
In an effort to understand why the ureteroscope was so contaminated, Ofstead and her team tested another new ureteroscope that they unpacked themselves from its shipping container. The ATP was extremely low, at 41 RLU, they could not detect any hemoglobin, and protein was at 2µ/mL, which they believed was because people touched it without wearing gloves during its manufacturing process.
They took this ureteroscope to central sterile personnel, who processed it and gave it back to them. Sampling showed some hemoglobin and an increase in protein from 2 to 24µ/mL. Ofstead says they suspected the problem resulted from processing the ureteroscopes in the same sinks and reprocessors used to process their GI endoscopes.
An audit of these hospitals found that OR personnel were not doing any pre-procedural inspection of the endoscopes or point-of-care pretreatment. They also found that there were delays in delivering dirty endoscopes to central sterile, sometimes as long as overnight, and central sterile had no protocols for delayed reprocessing, such as extra soaking and cleaning.
Ofstead noted that there also is good evidence from others in the field on ureteroscope processing effectiveness.
A 2019 study done in Europe tested surfaces and channels of 20 patient-ready, high-level disinfected ureteroscopes that were brand new at the beginning of the study. The researchers collected 389 samples. After high-level disinfection of the ureteroscopes:
• 40.6% had more than 10 CFU (colony forming units) of microbial growth
• 12.1% had more than 30 CFU of microbial growth
• 2.3% contained more than 30 CFU of uropathogens.
“Their process with brand new ureteroscopes resulted in almost half of the scopes having other patients’ germs on them,” says Ofstead.
A total of 25 patients developed urinary track infections (UTIs) during the study, which was 6.4% of their patients, and all had received prophylactic anti-biotics.
A study from King’s College Hospital in London reported on a multidrug-resistant Pseudomonas outbreak that resulted from a dirty ureteroscope. Of 40 patients who had procedures with the ureteroscope, 13 of them became infected with multidrug-resistant Pseudomonas aeruginosa, an attack rate of 32%. “A third of the patients who had a procedure with that scope picked up a superbug,” says Ofstead. “That’s terrible, particularly because they were giving every single patient prophylactic gentamicin,” she says.
An audit of the ureteroscopes found exterior cuts that were visible, and the channels were damaged. They also found that the OR staff were not doing any bedside precleaning, and there were delays in completing the reprocessing, which they blamed on insufficient staffing.
“The bottom line for these studies is that it doesn’t make a difference if prophylactic antimicrobials are given or not,” says Ofstead. “It doesn’t reduce the infection rate, and it opens the door for superbug development.”
“Studies are just starting to come out about infections from endoscopes in patients with COVID-19, and they are troubling,” says Ofstead.
A study from China of COVID-19 patients who had undergone bronchoscopy to get BAL (bronchoalveolar lavage) samples found waterborne pathogens and Escherichia coli.
“Using dirty endoscopes is messing up the lab tests because we end up testing what’s inside the scope instead of what’s in the patient’s urine or lungs,” Ofstead says.
Using dirty endoscopes also can cause inflammation or transmit infection, and COVID-19 patients are already very vulnerable to inflammation and infections.
“The complacency about infection prevention and antibiotic usage is going to get us in trouble,” says Ofstead. “It’s going to contribute to superbug formation, and it’s going to put both patients and personnel at risk.”
To improve this, the guidelines for reprocessing need to be strengthened. “There need to be more urology-specific guidelines, and more urology-specific research is urgently needed,” she says. Ofstead urged urologists and urology nurses to participate in the AAMI/ANSI (Association for the Advancement of Medical Instrumentation/American National Standards Institute) standards development process.
It is also important for personnel to interrupt the chain of transmission of COVID-19 by:
• wearing full PPE at work
• hand washing, face washing, and ideally taking a shower before leaving work
• cleaning and disinfecting shoes
• changing clothes before going home
• wearing masks if physical distance can’t be maintained
• using single-use, disposable endoscopes and accessories when it’s possible and practical.
Single-use ureteroscopes may be a good option for many institutions, says Ofstead. They are delivered sterile in their own packaging, and they may be cost effective. Cost studies done for bronchoscopes by Ofstead and her team have shown that it costs between $280 and $800 to use a reusable bronchoscope, each time it is used. The cost of purchasing a single-use bronchoscope ranges from $220 to $315.
Sterile single-use endoscopes not only protect patients from exposure to soil and microbes, but they also protect staff. A single-use endoscope stops the whole potential chain of transmission, she says.
“In the end,’’ says Ofstead, “it is important when using reusable endoscopes to make sure you are following manufacturer instructions, AAMI standards, and AORN guidelines for reprocessing. It is also important to protect yourself and patients by using proper PPE and cleaning and disinfecting the environment.”
Ofstead urges meticulous attention to the reprocessing steps and the quality pillars for “every endoscope, every time,” which, she says, is essential for reducing risk when reusable endoscopes are used. ✥
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