February 16, 2022

Effectiveness of reprocessing ureteroscopes, other endoscopic devices

Each year, there are more studies raising concerns about infections associated with endoscopic procedures and the techniques used to clean and sterilize or high-level disinfect (HLD) endoscopic devices.

Cori L. Ofstead, MSPH

In this article, in partnership with Boston Scientific, epidemiologist Cori L. Ofstead, MSPH, president and CEO of Ofstead & Associates, St Paul, Minnesota, presents a real-world view of ureteroscope reprocessing effectiveness and what has happened since the letter from the Food and Drug Administration (FDA) to healthcare providers in April 2021.

The FDA, in its letter, says it wants to raise awareness among healthcare providers about the risk of infections associated with reprocessed urological endoscopes, including cystoscopes and ureteroscopes. The agency also says it has received and is investigating numerous Medical Device Reports (MDRs) that describe post-procedure patient infections or other possible contamination issues associated with reprocessing.

The FDA emphasizes the importance of following the manufacturer’s labeling and reprocessing instructions for use (IFU) for these devices and their accessory components.


Evidence/contributing factors

Evidence cited by the FDA in its April 2021 letter includes receiving more than 450 MDRs on urological endoscopes since 2017 that resulted in:

• patient infections

• three deaths

• microbial contamination.

Factors the FDA says may have contributed to the adverse events include:

• inadequate endoscope reprocessing

• maintenance issues

• device design

• reprocessing instructions.

“It’s sounding a lot like the situation with duodenoscopes, except, urological endoscopes don’t have the complex elevator mechanisms the scopes used for ERCP [endoscopic retrograde cholangiopancreatography] have,” notes Ofstead.

She and her team researched the FDA’s database because they wanted to know if the problems that led the agency to release the letter were mostly associated with cystoscopes or with ureteroscopes. They found that from October 2020 through March 2021, the FDA was receiving more than 20 reports every month that were related just to ureteroscopes (sidebar, Evidence behind the FDA’s healthcare provider letter).

“This stacks up to a lot of problems with flexible ureteroscopes,” Ofstead says.



Also in its April 2021 letter, the FDA lists a number of recommendations for reprocessing urological endoscopes that organizations could use while it was determining the root causes of the problems.

The recommendations include:

• carefully following reprocessing IFU for precleaning at the point of care, leak testing, cleaning, and sterilization or HLD plus drying

• increasing awareness of reprocessing instructions for reusable accessories

• stopping the use of damaged devices because they can harm patients

• developing schedules for inspection and maintenance

• informing patients of risks associated with reprocessed urological endoscopes

• submitting MDRs for any adverse events experienced with urological endoscopes to MedWatch (https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home).

Ofstead says the recommendation to inform patients of risks associated with reprocessed urological endoscopes was somewhat of a surprise, and that it raised some questions for her:

• “Does your informed consent process currently tell patients they are at risk of infection or injury related to the endoscope?”

• “If it doesn’t, how is it going to impact your patient intake process and procedural efficiency if you start explaining the findings and risks to your patients?”

• “How do you think they are going to respond?”


New standards/guidelines

Lane Jacobs

Lane Jacobs, an expert in global product solutions for Boston Scientific, Marlborough, Massachusetts, notes that the evidence and recommendations from the FDA are “sobering at least,” and asks Ofstead what changes she has observed.

A notable development is the strengthening of guidelines and standards for reprocessing endoscopes, she says.

A new “Multisociety guideline on reprocessing flexible GI [gastrointestinal] endoscopes and accessories” was published last winter, and an update of the Association for the Advancement of Medical Instrumentation (AAMI)/American National Standards Institute (ANSI) standard (ST) 91—“AAMI/ANSI ST 91”—is coming soon.

Even though the Multisociety guideline pertains to GI endoscopes, it spells out practices that healthcare workers need to be aware of when reprocessing all endoscopes, says Ofstead. In addition, AORN has signed onto this guideline.

Key recommendations in the Multisociety guideline focus on three areas:

All personnel

• should receive model-specific training and competency testing—this is no small task, says Ofstead, because most institutions have many different kinds of endoscopes, and they come with different reprocessing instructions

• must comply with infection prevention/control recommendations

• should wear gloves whenever handling endoscopes—there is good compliance with glove-wearing in the OR, she says, but personnel in some outpatient departments are handling fully reprocessed endoscopes with their bare hands. This is no longer permissible in the new guideline.

Reprocessing suite layout, equipment

• there has to be a dedicated reprocessing space with separation of dirty and clean areas—this means endoscopes cannot be cleaned or disinfected in patient care areas, and soaking endoscopes in a basin of disinfectant in patient care rooms or anywhere else is no longer acceptable, Ofstead says. The only time personnel can use manual soaking in disinfectant is when the automated endoscope reprocessor (AER) is broken or when there is an emergency situation

• HLD should be done in an AER.

Reprocessing practices

• initiate manual cleaning within 60 minutes after a procedure or follow IFU for delayed reprocessing—this involves extended soaking and extra cleaning steps

• use model-specific cleaning devices (brushes)—personnel cannot use one brush for every endoscope or every channel

• perform visual inspection with lighted magnification—this applies to every endoscope, every time

• sterilize all devices classified as Critical according to Spaulding—Ofstead notes that urological endoscopes, in particular ureteroscopes, should be classified as Critical because they are coming into contact with the kidney, which is sterile tissue. As such, they should be sterilized, not just disinfected

• completely dry endoscopes using 10 minutes or more of pressure-regulated forced-air between uses—this should be done before they go into the sterilizer or before they go into storage, whether or not they are going to be used again that day, she says.

“There are some new things in this updated guideline,” notes Ofstead, “and it’s stronger than we have seen before in the field.”


FDA reports since April letter

With the FDA letter raising awareness of issues and the new Multisociety guideline in place, Jacobs asks, have things gotten better in the field?

Ofstead answers that from her perspective, things have not improved.

Her team reviewed new reports of adverse events related just to ureteroscopes released by the FDA since April. There were 20 to 25 reports a month until August and October, when they increased to more than 35 reports, and that uptick continued through the fall (sidebar, FDA reports released since the April 1 letter).

“This indicates that either the problems haven’t gone away or that more people are filing reports since they heard about the risks,” she says.

Between April and October, the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database had 177 new MDRs, and 105 were for reusable flexible ureteroscopes, including:

• five patient injuries or exposures

• 11 reprocessing breaches

• 18 ureteroscopes with residual contamination in spite of reprocessing

• 72 damaged ureteroscopes.

The FDA also reported six new MDRs on semi-rigid or rigid reusable ureteroscopes, including:

• two reports of infections (one reporthad multiple patients becoming infected)

• four damaged ureteroscopes (one with a patient exposure).

The MDRs were associated with various brands and models.


New FDA Safety Communication for reprocessing bronchoscopes

On June 25, 2021, the FDA posted a new Safety Communication on “Flexible bronchoscopes and updated recommendations for reprocessing” that was similar to the April letter for urological endoscopes.

Between July 2015 and January 2021, the FDA received 867 new MDRs, and there were seven deaths related to infections or device contamination associated with reusable flexible bronchoscopes.

In the Safety Communication, the FDA recommends the following:

• consider sterilization rather than HLD—Ofstead notes that OR managers and OR personnel need to know that the FDA is now calling for sterilization rather than HLD for bronchoscopes

• follow manufacturer IFU

• perform routine inspections and maintenance

• do not use damaged devices

• discuss risks with patients

• consider single-use bronchoscopes in high-risk situations.

Ofstead adds that she is not sure how the FDA defines high-risk situations, but in her view, it is high risk anytime an endoscope is inserted into a sterile area like a lung or a kidney.


New evidence from the field on endoscope reprocessing

There is new evidence from the field showing the problems associated with reprocessing safety and effectiveness for reusable endoscopes, says Ofstead.

Breaches have been documented by several federal agencies, including the FDA, Centers for Medicare and Medicaid Services (CMS), and the Office of Inspector General (OIG) for the Veterans Administration healthcare system.

Among the breaches noted were:

• no precleaning of endoscopes after procedures

• no flushing of endoscope channels with detergent and water as recommended in the IFU

• lack of instrument maintenance and inspection

• improper storage of fully reprocessed endoscopes

• inadequate infection control, insufficient training, and lack of adherence to the dirty-to-clean workflow

• no reference manuals available

• no hand sanitizer or hand-wash stations available for reprocessing personnel

• personal protective equipment (PPE) breaches and PPE that wasn’t convenient to personnel.

There is also new evidence showing the benefits of single-use flexible ureteroscopes, including that they:

• eliminate risk of cross-contamination

• are clinically equivalent to reusable ureteroscopes in procedural outcomes and complication rates

• reduce repair costs for reusable ureteroscopes when used occasionally

• have comparable environmental impact.


Reducing risks

To reduce the risks to patients and personnel, the use of sterile single-use ureteroscopes should be considered in some circumstances, particularly for overnights and weekends when delayed reprocessing might be an issue, says Ofstead.

Facilities also should be moving to sterilization rather than HLD, and personnel should be noticing and repairing damage to ureteroscopes before they harm patients.

Organizations also have to provide personnel with reprocessing training and competency testing for every single model of endoscope, she says, and ensure that “proper steps are done for every endoscope, every time, no exceptions.” ORM

—Judith M. Mathias, MA, BS, RN, is the clinical editor of OR Manager. Previously, she was clinical editor of the AORN Journal and a cardiac surgical nurse at Rose Medical Center, Denver, and Massachusetts General Hospital, Boston.



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