Blog | Mobile Aspects

Hospitals Look To Reprocess N95 Masks Due To Covid-19 Related Shortage

April 2, 2020Sri Mandava Hospital Management Infection Control Operational Efficiency Regulatory Compliance Supply Chain

In the ongoing battle against Covid-19, much of the US healthcare system has suffered from a lack of personal protective equipment (PPE) for its frontline employees. The shortage of this important protective gear has led to hospital workers being put in needless danger of catching the extremely communicable coronavirus.

One company has been working on a special project to allow certain PPE, such as the N95 masks that have been critically needed by employees fighting Covid-19, to be decontaminated after each use to help alleviate the supply shortage. As this article by Conor Hale at FierceBiotech describes:

“Battelle received an emergency go-ahead from the FDA over the weekend to deploy its decontamination system for personal protective equipment (PPE), allowing healthcare workers to clean and reuse scarce N95 respirator masks.

The system is currently operating at Battelle’s Ohio facility—capable of processing up to 80,000 masks per machine, per day, within what looks like a large metal shipping container—and has been working to help stretch supplies for the OhioHealth system based in Columbus.

Using concentrated hydrogen peroxide vapor, the filters are gassed for two and a half hours to destroy bacteria, viruses and other contaminants, including the novel coronavirus SARS-CoV-2. According to the company, the system can clean the same N95 mask up to 20 times without degrading its performance.

The FDA had first OK’d the use of the system on Saturday but initially limited its use to 10,000 masks per day, according to Republican Ohio Gov. Mike DeWine, who called on the agency to unlock the system’s full decontamination capacity. DeWine also said this would have limited Battelle’s plans to deploy machines to the hard-hit New York metro area as well as Washington state and Washington, D.C.

Within hours, and after President Donald Trump also urged the FDA to approve the equipment on Twitter, FDA Commissioner Stephen Hahn tweeted late Sunday evening that the agency had issued an amended authorization.”

Read the full article here: Battelle deploys decontamination system for reusing N95 masks

For hospitals considering a process to decontaminate PPE to allow for multiple uses during the pandemic, they must have a reliable system in place to make sure they get maximum use out of the PPE without exceeding the allowable limits. Mobile Aspects is working with select healthcare systems on a novel tracking system to track PPE including N95 masks to make sure that maximum usage is reached without exceeding published guidelines. Contact us via our website to find out more.

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How Automated Endoscope Drying Cabinets Minimize Bacterial Growth

March 26, 2020Sri Mandava Hospital Management Infection Control Managing Endoscopes Patient Safety Regulatory Compliance

According to a recent study published in the American Journal of Infection Control, storing endoscopes in an automated cabinet with channel drying functionality effectively reduced bacterial growth in the scopes. Because endoscopes are reusable medical instruments, minimizing the amount of bacterial growth in the periods between procedures can dramatically improve patient safety.

The study, performed by researchers at the David B. Geffen School of Medicine at UCLA and Northside Hospital in Atlanta, compared the drying effectiveness of automated cabinets with channel drying capability to standard endoscope storage cabinets. A recent article by Alex Young at Healio detailed the results:

“To test drying times, researchers took reprocessed bronchoscopes, colonoscopes and duodenoscopes and stored them in either an automated drying cabinet or a standard cabinet. They assessed dryness at 30 minutes, 1 hour, 2 hours, 3 hours and 24 hours using cobalt chloride paper.

After 24 hours in the standard cabinet, external surfaces were dry, but the internal channels still contained residual moisture. In the automated drying cabinets, external surfaces were dry at 3 hours and internal channels of the scopes were dry at 1 hour.

“Which makes sense,” [V. Raman Muthusamy, MD] said. “They’re hooked up, and air is getting blown directly through.”

To assess bacterial growth, researchers inoculated scopes after reprocessing with Pseudomonas aeruginosa and compared rates of microbial growth at 0, 3, 12, 24 and 48 hours.

In the standard cabinet, investigators found an average rate of colony forming unit growth of 8.1 × 10⁶ per hour for bronchoscopes, 8.3 × 10⁶ per hour for colonoscopes, and 7 × 10⁷ per hour for duodenoscopes. In the automated drying cabinet, average colony forming unit growth rate was -28.4 per hour (P=.02), -38.5 per hour (P=.01), and -200.2 per hour (P=.02) in each type of scope, respectively.

“There was a pretty profound reduction in the bacterial growth rate when you used automated drying,” Muthusamy said. “The moisture definitely helps with bacterial growth. There will be some growth, but it’s quite low even at a period of several days compared to what you would see with no drying.”

Read the full article here: Automated endoscope drying cabinets reduce bacterial growth

As Dr. Muthusamy revealed through the study, automated endoscope drying cabinets significantly reduce the risk of passing deadly bacteria between patients by reducing dangerous moisture build-up to minimal amounts. One system that can bring these benefits to hospitals is iRIScope from Mobile Aspects, which was introduced in the last several years to guide healthcare providers through the proper, society-recommended HLD protocols every single time a scope is reprocessed. The system includes smart storage cabinets that allow scopes to hang vertically with forced air running through the channels. With iRIScope, sterile technicians will also be guided through the entire HLD process to make sure that any potentially harmful diseases are minimized via proper HLD techniques. Built-in technology will even alert your staff if improperly reprocessed scopes are hung in storage, or if it’s time to re-disinfect a scope based on hospital protocols.

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How One Hospital Reduced Their Scope Reprocessing Times By Over 35 Percent

March 20, 2020Vance Huggins Cost Reduction Hospital Finance Hospital Management Managing Endoscopes Operational Efficiency

Today’s Sterile Processing Department (SPD) managers function as business operators whose primary objective is to adhere to the highest standards of cleaning protocols. Their role is to focus not only on adherence to disinfection standards and requirements, but to operate with high speed and efficiency as well. Specific to endoscopic procedures, a critical requirement for SPD managers is making sure scopes are available when needed. Lack of scope availability can create tension between SPD managers and clinicians, making a well-planned and properly staffed SPD department critical.

Recently, Mobile Aspects worked with a major academic health system on the West Coast of the United States. In 2019, the hospital built out a new Endoscopy suite that included 6 procedure rooms and a scope reprocessing facility spread across different floors of a new outpatient procedure building. As a provider of robust data analytics, Mobile Aspects worked with the customer to evaluate the efficiency of the new area’s scope reprocessing workflow. During a recent quarterly business review, the customer and Mobile Aspects agreed that there were identifiable opportunities to improve the flow of endoscopes within the department.

There are several key factors that determine how quickly scopes are reprocessed inside the endoscope usage lifecycle. Looking closely at the scope reprocessing workflow within the new department, Mobile Aspects and the customer determined that scopes were quickly sent up to SPD to begin reprocessing post-procedure. It typically took only 15 minutes for a scope to reach the SPD department to begin the high-level disinfection process. However, once scopes were loaded into the automated endoscope reprocessor (AER), the time until a scope was unloaded was approximately 160 minutes. With the washing process typically averaging 30 minutes, it meant scopes were sitting in the washer waiting to be returned to clean storage for over 2 hours on average.

The customer identified the source of the issue as insufficient personnel. Though adding a full-time employee was seen as the obvious solution, this was not immediately possible due to budgetary constraints. The SPD managers then decided to allocate temporary resources throughout the day to tackle this issue. When the data analytics were reviewed just 3 months following the updated workflow, the reprocessing time decreased to an average of 105 minutes.

The iRIScope system from Mobile Aspects was designed to ensure hospitals follow a standardized reprocessing cycle for flexible endoscopes while automatically documenting each step along the way. In doing so, iRIScope gathers numerous data points which allow hospitals to continuously monitor their workflows and make improvements to efficiency and patient safety. Contact us today to see how we can help improve and automate your endoscope reprocessing workflows and bring an environment of continuous improvement to your practice.

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ECRI List of Top Patient Safety Concerns Includes Sterile Processing

March 12, 2020Sri Mandava Hospital Management Infection Control Managing Endoscopes Patient Safety Regulatory Compliance

The ECRI Institute, based in Philadelphia, has just released its annual list of patient safety concerns for 2020. This year’s list includes an entry at number 5 for device cleaning, disinfection and sterilization, echoing prior year concerns about sub-standard disinfection practices for flexible endoscopes and other reusable medical equipment.

ECRI’s list is the result of extensive data accumulated from member hospitals, as well as input from interdisciplinary patient safety experts. The list is voted on by patient safety experts from inside and outside of ECRI, and the list is meant to identify new risks, existing concerns that are changing because of new technology or care delivery models, and persistent issues that need focused attention or pose new opportunities for intervention.

It’s no surprise that sterilization practices came in as number 5 on the list, as reports of safety breaches due to poorly sterilized or disinfected medical equipment continue to occur all around the country. The Executive Brief published by ECRI Institute explains why device disinfection continues to be such a concern:

“In spite of several barriers, sterile processing departments (SPDs) are responsible for cleaning, decontamination, inspection, assembly, packaging, storage, and distribution of instruments, equipment, and supplies—tasks that rely on strict adherence to processes that leave no room for error. Some of these barriers include productivity pressures; lack of access to current manufacturer instructions for use and processing technologies; lack of necessary supplies; communication breakdowns between SPD staff and the departments they support; and a lack of universal training and certification requirements.

Incidents involving improperly reprocessed instruments can potentially result in devastating effects on patients, damage to organizational and provider reputations, citations and fines from regulatory bodies, prompt review by accrediting agencies, and lawsuits. However, “patient safety starts in the sterile processing department,” says Gail Horvath, MSN, RN, CNOR, CRCST, senior patient safety analyst and consultant, ECRI, and “everyone has a role.”

To help mitigate the risk of errors and their consequences, ECRI recommends facilities establish effective workflows that involve SPD and clinical staff input, incorporate quality checks throughout the sterilization process, improve interprofessional relationships, and provide continuing education opportunities for staff. Establishing relationships with instrument manufacturers and accessing resources from organizations such as the Association for the Advancement of Medical Instrumentation [AAMI], the American Society for Health Care Engineering [ASHE], and the Association of periOperative Registered Nurses [AORN] can help fine-tune SPD policies and procedures to ensure timely and safe turnaround times, reduce preventable errors and associated costs, and ensure patient safety and satisfaction.”

The article also noted that “Sterile processing failures can lead to surgical site infections, which have a 3% mortality rate and an associated annual cost of $3.3 billion.”

Read the entire Executive Brief here: Top 10 Patient Safety Concerns 2020

As the spotlight on reusable medical equipment such as endoscopes and surgical instruments continues to shine, hospitals and ambulatory surgical centers must continue to be vigilant in enforcing the highest standards for sterilization and high-level disinfection. We must make sure that team members are performing the steps of the sterilization or reprocessing cycle consistently and are documenting their findings along the way. If your department wants to automate the workflow and documentation process of the endoscope reprocessing cycle, consider a software system like iRIScope. Systems like these ensure that your staff are performing consistent, repeatable and documented steps during reprocessing. They also minimize manual efforts to document the process by incorporating advanced data collection technologies like RFID directly in to the workflow.

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Government Continues Scrutiny Of Hospital Accrediting Bodies

March 5, 2020Sri Mandava Hospital Finance Hospital Management Joint Commission The Business of Surgery

The government continues to question the neutrality of The Joint Commission (TJC) and other healthcare accreditation firms that also have consulting arms. In a recent speech Seema Verma, the head of the Centers for Medicare & Medicaid Services (CMS), said her organization is continuing to evaluate options to increase oversight of accrediting firms.

CMS has spent over a year taking a closer look at some accreditation firms like the TJC that are being paid to accredit hospitals once every 3 years. These accrediting organizations are simultaneously paid through their consulting arms by those same hospitals to help them pass the accreditation process. The matter of passing an accreditation is an important one, as it determines a hospital’s eligibility to be reimbursed by Medicare and Medicaid, a huge contributor to their bottom-line. As this article by John Commins at HealthLeaders Media notes:

“Verma said that CMS in recent years has found inconsistencies in the way accrediting organizations inspect providers.

“Some even use standards that differ from our own, which is simply not acceptable,” she said.

CMS in December 2018 put out a request for information from accrediting organizations that Verma says was designed to “ascertain the scope of the issue.”

On Tuesday, Verma did not name specific accrediting organizations in her critique, but she called “a spate of serious deficiencies” that included patient harm and deaths at hospitals that had been deemed Medicare compliant “deeply concerning.”

“Receiving CMS’s authorization to inspect and deem healthcare providers compliant with Medicare’s quality standards is nothing short of assuming a sacred public trust responsibility,” she said. “But an increasing amount of evidence indicates that accrediting organizations are not living up to that high bar.”

“Our concerns are not only heightened by the growing trend of accrediting organizations providing fee-based consulting services to the same organizations they accredit; a glaring conflict of interest,” Verma said, adding that CMS does not allow “these kinds of relationships” in other areas, such as Quality Improvement Organizations in Medicare or external reviews in Medicaid.

The Joint Commission, the nation’s largest hospital accrediting organization, has denied any conflict of interest, citing a “long-standing firewall” it has created between its accrediting division and its consulting division, Joint Commission Resources, Inc.”

Read the entire article here: Verma Raps Accrediting Organizations’ ‘Glaring Conflict of Interest’

One possible result of this probe may be that hospital inspection reports will be made public in order to give additional information to consumers regarding their choice of healthcare providers. Is your hospital ready for your inspection reports to be made public? To prepare, hospitals have to make sure that they are following all of their detailed processes all of the time. Any breakdown in your processes would be made public via an inspection report, putting your hospital’s reputation and finances at risk. Consider automation tools that help track the processes that The Joint Commission and other accreditation agencies focus on during their inspections. Systems such as iRIScope and iRISecure have been developed to ensure that processes and protocols are being followed since your managers can’t watch over every step of the way.

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A First Of Its Kind Solution For Tracking, Storing and Charging Vocera Badge Batteries

February 21, 2020Sri Mandava Cost Reduction Hospital Finance Hospital IT Operational Efficiency The Business of Surgery

Many hospitals have implemented the Vocera platform to improve communications and connectivity among staff. The Badges and Smartbadges used with the Vocera platform allow clinical staff, who are typically busy rounding on patient floors and not tethered to a desk, to stay connected to their colleagues and discuss important items via calls or messages.

One pain point of users of the Vocera system has been the battery life and the need to monitor the batteries that need to be charged or swapped out daily. Because of the small footprint and lightweight nature of the batteries, many staff members often misplace or lose the batteries. This leads to some hospitals ordering hundreds or even thousands of extra batteries per year just to keep up with demand.

One major academic hospital in the Northeast uses Vocera in their busy operating rooms and orders hundreds of badge batteries per year to replace lost ones. This cost, and the constant frustration of employees in search of new batteries, has led them to implement a battery charging and tracking station that uses RFID technology.

This system, developed by Mobile Aspects, allows hospitals to effectively track the chain of custody of Vocera badge batteries while providing a convenient charging station for employees. The system uses RFID-enabled cabinets that automatically detect when batteries are loaded or removed from the cabinets. Employees can only access the batteries after logging in to the cabinet using their badge, so all batteries they remove are associated with them. This allows hospitals to monitor which employees are misplacing the most batteries for accountability purposes. The cabinets are also outfitted with battery chargers so the batteries can recharge while being stored.

The hospital deployed the first-of-its-kind system with the hopes of reducing or eliminating its $60,000 annual spend on replacement batteries. Employees will also benefit from having a convenient, central location to charge their batteries and swap them out when needed. For more information visit www.mobileaspects.com

How One Hospital Optimized Their Staffing Levels Using Scope Tracking Software

February 13, 2020Sri Mandava Hospital Finance Hospital Management Managing Endoscopes Operational Efficiency

Many hospitals find it difficult to optimize staffing levels for their operations. This can be due to any number of variables that become even more extreme as the size of a hospital increases – an influx of patients can throw off carefully planned schedules; certain cases extend way past their estimated closing times; and missing staff or equipment can delay case starts. With so many variables, hospitals must constantly measure and improve their efficiency in order to maximize revenues.

Sterile Processing and Endoscopy departments have a particular challenge in ensuring flexible endoscopes are used and then reprocessed in an efficient manner. With certain endoscopes being requested for use multiple times a day, and with high-level disinfection cycles taking two or more hours to complete, staff in many hospitals face a serious challenge in preparing endoscopes for their next case. Many hospitals resort to costly tactics in order to ensure they have scopes available when they need them, such as buying extra scopes or overstaffing during certain times of the day.

Instead, one large academic medical center used data from their iRIScope endoscope tracking software to optimize their operations and improve scope reprocessing times. When they first started using the software to measure their reprocessing cycle times, they found that it took over 3 hours to reprocess the average endoscope and have it ready for its next use. By looking closer at the data in iRIScope, they were able to identify bottlenecks in reprocessing and assess where they could make the biggest improvements.

One of the hospital’s key findings was that during certain busy parts of the day when the most scopes were coming in for reprocessing, they were understaffed compared to other parts of the day when less endoscopes were coming in for reprocessing. They used that data to shift a few staff members’ schedules to make sure they were properly staffed for the busiest times. Based on these staffing changes and a couple other adjustments made after looking at the data, they reduced their average endoscope reprocessing time from just over 3 hours to just under 2 hours.

Scope tracking systems such as iRIScope from Mobile Aspects have been introduced in the last several years to automate the documentation of the entire endoscope usage lifecycle. These systems automatically record all of the usage and reprocessing activity associated with each flexible endoscope to create an all-electronic audit trail. As discussed above, this audit trail provides numerous benefits to your Endoscopy practice in the areas of operational efficiency. For busy Endoscopy departments and Operating Rooms that can go through dozens of endoscopes per day, having a software system that can keep an eye on scope efficiency and safety can be a huge benefit to department administrators.

Olympus Receives FDA Clearance For Duodenoscope With Disposable Component

February 6, 2020Sri Mandava Hospital Management Infection Control Managing Endoscopes Patient Safety Regulatory Compliance

Olympus has joined the list of duodenoscope manufacturers receiving the green light to market a duodenoscope with disposable components by the United States Food and Drug Administration (FDA). Following closely on the heels of Pentax and Fujifilm’s models with disposable components, and Boston Scientific’s fully disposable duodenoscope, Olympus is now cleared to sell a duodenoscope with a disposable distal endcap.

The FDA has been pushing manufacturers of duodenoscopes to introduce models with disposable components or fully disposable models. This is due to the difficult nature of effectively reprocessing duodenoscopes, which have shown high levels of contamination in many studies even after high level disinfection was completed. The FDA recently issued a recommendation for hospitals to consider transitioning to duodenoscopes with disposable components or fully disposable duodenoscopes as soon as possible. As this press release from Olympus explains:

“The TJF-Q190V duodenoscope responds to the FDA’s call for duodenoscopes with disposable components that improve access to the elevator mechanism for ease of reprocessing.

The innovative features designed to improve cleaning and reprocessing, which are based on findings of human factors studies, include:

Use of a sterile, clear, single-use distal endcap cover that is removed and discarded post-procedure. This design prevents the possibility of reuse.
Improved visualization of and access to the distal end for manual cleaning and disinfection.
A first-of-its-kind, proprietary distal-end flushing adaptor for cleaning the elevator mechanism.
A sealed elevator wire channel port that does not require separate cleaning.
A new water-resistant scope connector that minimizes the risk of fluid ingress.

Olympus will perform periodic inspection and maintenance of every TJF-Q190V based on frequency of reprocessing, to better ensure that normal wear and tear does not compromise the functionality of the duodenoscope or the ability to properly reprocess the duodenoscope.

Finally, the TJF-Q190V duodenoscope addresses the clinical needs of physicians. Recent statements from medical societies regarding duodenoscope reprocessing and infection control clearly reinforce the need to be able to offer the potentially lifesaving ERCP (endoscopic retrograde cholangiopancreatography) procedure to treat seriously ill patients, rather than more invasive options, such as surgery. The performance of the duodenoscope is critical to reaching difficult-to-access digestive system anatomy. The advanced features of the TJF-Q190V include an expanded field of view, reliable guidewire locking, and more precise handling.”

Read the entire communication here: Olympus Announces FDA Clearance of the TJF-Q190V Duodenoscope

Whether your facility prefers Olympus, Pentax, Fujifilm or other duodenoscopes, the transition from rigid end caps, to disposable end caps and elevators to now fully disposable duodenoscopes is underway. To ensure patient safety, hospitals must design a standard protocol that ensures maximum disinfection of duodenoscopes after each use. Hospitals must also implement systems and processes that allow them to check that staff are following their protocols and documenting their steps for regulatory purposes, such as Joint Commission surveys. Systems such as iRIScope can display the proper workflow for reprocessing duodenoscopes and other endoscopes and document the individual steps automatically. Any breaches of protocol can be alerted in real-time to protect patients and identify which staff members need additional training on reprocessing techniques. You owe it to your staff and your patients to offer the peace of mind that duodenoscopes and all other flexible endoscopes are being properly reprocessed every single time.

How One Hospital Avoided A Patient Safety Disaster Using Scope Tracking Software

January 31, 2020Sri Mandava Hospital Management Infection Control Joint Commission Managing Endoscopes Operating Rooms Patient Safety Regulatory Compliance

Flexible endoscopes present a unique challenge for hospitals to track and manage – these expensive medical instruments must be quickly re-processed after usage in order to provide the required instrumentation for the next procedure, yet they must undergo rigorous, time-consuming reprocessing after every use to ensure the highest levels of patient safety.

Due to different employees having opposing priorities, hospitals and surgery centers often have inconsistent processes around endoscope management. Many sites have no accountability for their endoscopes at all, not even a basic “sign-in/sign-out” log book. Others have a manual or even nonexistent system for documenting the steps of the reprocessing cycle in between uses. These poor documentation practices lead to headaches for managers who are in charge of making sure that scopes are readily available and disinfected at all times.

At Mobile Aspects, we have built our iRIScope endoscope tracking software and smart cabinets to help capture all of the documentation around endoscope reprocessing. We have built RFID technology into our solution to make all data available electronically in real-time with minimal human interaction. Along with the significant regulatory benefit of having electronic documentation for groups such as The Joint Commission, the system offers additional benefits such as patient safety alerts and operational efficiency data.

How One Hospital Avoided Disaster

Because iRIScope captures reprocessing and usage data electronically, it is able to analyze the data in real-time to help avert patient safety issues. One of our customers recently had a patient safety alert triggered by iRIScope software that helped them avoid using a potentially contaminated scope on a patient.

During a typical, busy day in the Endoscopy department, a sterile processing department (SPD) tech was in the middle of taking care of an endoscope-related issue and temporarily placed an unwashed scope in the clean elevator, intending to gather it in a minute. Around that same time, another employee placed a set of clean scopes in the same elevator and all scopes, including the scope that was not reprocessed, were stocked into an iRIScope endoscope storage cabinet. As designed, the iRIScope cabinet locked down and sent an automated email alert to department administrators. Because iRIScope correctly identified an unclean scope stored in a cabinet with properly disinfected scopes, the department was able to act immediately. Within minutes, all 8 scopes were removed from the locked down cabinet and sent to SPD for reprocessing again. This removed any chance that the unclean scope would be used on a patient.

Why Scope Tracking Software Changes The Game For Endoscopy and ORs

Systems such as iRIScope from Mobile Aspects have been introduced in the last several years to automate the documentation of the entire endoscope usage lifecycle. These systems automatically record all of the usage and reprocessing activity associated with each flexible endoscope to create an all-electronic audit trail. As discussed above, this audit trail provides numerous benefits to your Endoscopy practice in the areas of regulatory compliance, patient safety and operational efficiency. For busy Endoscopy departments and Operating Rooms that can go through dozens of endoscopes per day, having a software system that can keep an eye on scope safety and efficiency can be a huge benefit to department administrators.

No more log books, no more printed tickets from your endoscope reprocessor and no more paper tags – just electronic documentation that makes your department more effective and more efficient. When Joint Commission comes knocking, blow them away with your ability to trace all of your endoscope-related transactions instantaneously in an electronic format. When a physician asks for that new scope, verify with data how necessary that new scope really is. And when steps in the reprocessing cycle are missed, make sure patient safety stays priority #1 by having the system alert administrators about possible cross-contamination issues.

FDA Issues Recommendation For Use Of Duodenoscopes With Disposable Components

January 24, 2020Sri Mandava Hospital Management Infection Control Managing Endoscopes Patient Safety Regulatory Compliance

Shortly following the recent United States Food and Drug Administration (FDA) clearance of the first duodenoscopes with disposable components, the bureau is now recommending that facilities move to the new models where available. The FDA firmly believes that a move to disposable parts, and in some cases fully disposable scopes, will help reduce infection risks. Poorly disinfected duodenoscopes have been linked to numerous cases of superbug outbreaks over the past several years.

The FDA has granted clearance to several disposable duodenoscopes and duodenoscopes with disposable components in the past several months. The manufacturers of these innovative models include Pentax Medical, Boston Scientific, Olympus and Fujifilm. As this safety communication from the FDA explains:

“Duodenoscopes play a vital role in the assessment and treatment of diseases and conditions of the pancreas and bile ducts, and are used in more than 500,000 endoscopic retrograde cholangiopancreatography (ERCP) procedures each year in the U.S. These devices have complex designs that include reusable hard-to-clean components. Failure to correctly reprocess a duodenoscope could result in tissue or fluid from one patient remaining in a duodenoscope when it is used on a subsequent patient. In rare cases, this can lead to patient-to-patient disease transmission.

The FDA takes the risk of patient infection very seriously and continues to take steps to help improve the effectiveness of duodenoscope reprocessing. Today, we are sharing the following recommendation and updates:

We are now recommending that hospitals and endoscopy facilities transition away from fixed endcap duodenoscopes to those with newer design features that facilitate or eliminate the need for reprocessing. Please note, we recognize that a full transition away from conventional duodenoscopes to the newer, innovative models will take time.

We continue to work with manufacturers to increase the supply of disposable cap duodenoscopes and the development of other new and innovative device designs that will further minimize or eliminate the risk of patient infection.

We continue to address challenges with current reprocessing methods and support expanding the types of validated methods available to reprocess duodenoscopes.

Patients: Important Recommendations

Be aware that the risk of infection from inadequate reprocessing is relatively low.

Do not cancel or delay any planned procedure without first discussing the benefits and risks with your health care provider.

Hospitals and Endoscopy Facilities: Important Recommendations

Consider using duodenoscopes that have disposable components, if available at your facility; this design may lower but not eliminate risks of infection.

Ensure staff are meticulously following reprocessing instructions.

Institute a quality control program that includes sampling and microbiological culturing, and other monitoring methods.

Consider reprocessing with supplemental measures such as sterilization or use of a liquid chemical sterilant processing system consistent with the device’s labeling.

Monitor your reprocessing procedures. Examples of monitoring are sampling and culturing using the Duodenoscope Surveillance Sampling & Culturing: Reducing the Risks of Infection developed by the FDA-Centers for Disease Control and Prevention-American Society of Microbiology Working Group on Duodenoscope Culturing.

Develop schedules for routine inspection and periodic maintenance in accordance with the duodenoscope manufacturer’s instructions.

…

Transition to Duodenoscopes with Innovative Designs that Can be Reprocessed More Effectively

Device design is a key factor that contributes to reprocessing challenges. The FDA believes the best solution to reducing the risk of disease transmission by duodenoscopes is through innovative device designs that make reprocessing easier, more effective, or unnecessary. For example, duodenoscopes that incorporate disposable components can facilitate cleaning, reduce contamination and reduce disease transmission following reprocessing. Disposable designs may reduce between-patient duodenoscope contamination by half as compared to reusable, or fixed endcaps.

To date, the FDA has cleared five duodenoscopes with disposable components that facilitate reprocessing:

Boston Scientific Corporation, EXALT Model D Single-Use Duodenoscope (fully disposable duodenoscope cleared under K193202)

Fujifilm Corporation, Duodenoscope model ED-580XT (disposable endcap duodenoscope cleared under K181745)

Olympus Medical Systems, Evis Exera III Duodenovideoscope Olympus TJF-Q190V (disposable endcap duodenoscope cleared under K193182)

Pentax Medical, Duodenoscope model ED34-i10T (disposable endcap duodenoscope cleared under K163614 and K181522)

Pentax Medical, Duodenoscope model ED34-i10T2 (disposable elevator duodenoscope cleared under K192245)

Because of our concerns of high contamination rates associated with conventional, fixed endcap duodenoscopes, we have asked each duodenoscope manufacturer to transition away from fixed endcap duodenoscopes to those with more modern design features that facilitate or eliminate the need for reprocessing. Hospitals and endoscopy facilities should transition to innovative duodenoscope designs that include disposable components such as disposable endcaps, or to fully disposable duodenoscopes when they become available.

We recognize that an immediate transition away from conventional duodenoscopes to the newer, innovative models will take time due to cost and market availability. We encourage health care facilities purchasing new duodenoscopes to begin developing a transition plan and work to replace their conventional duodenoscopes with newer models.

ERCP procedures performed with duodenoscopes are often life-saving and the benefits continue to outweigh the risks for appropriately selected patients. The continued availability of duodenoscopes to perform these procedures remains a critical public health need.”

Read the entire communication here: The FDA is Recommending Transition to Duodenoscopes with Innovative Designs to Enhance Safety: FDA Safety Communication

While the transition from rigid end caps, to disposable end caps and elevators to now fully disposable duodenoscopes takes place, hospitals must design a standard protocol that ensures maximum disinfection of duodenoscopes after each use. Hospitals must also implement systems and processes that allow them to check that staff are following their protocols and documenting their steps for regulatory purposes, such as Joint Commission surveys. Systems such as iRIScope can display the proper workflow for reprocessing duodenoscopes and other endoscopes and document the individual steps automatically. Any breaches of protocol can be alerted in real-time to protect patients and identify which staff members need additional training on reprocessing techniques. You owe it to your staff and your patients to offer the peace of mind that duodenoscopes and all other flexible endoscopes are being properly reprocessed every single time.

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