Blog | Mobile Aspects

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.

Physicians Are Spending Too Much Time Documenting In EHRs – And Hospitals Have To Find New Solutions

January 17, 2020Sri Mandava Clinical Documentation Hospital Finance Hospital Management Operational Efficiency The Business of Surgery

A recent New York Times op-ed reinforced the widespread feeling among US physicians that they are spending too much time documenting their work in electronic health record (EHR) software. Recent estimates put physician time spent in their EHR at 50% of their workday, significantly reducing the amount of time they can spend on patient care.

Hospitals and healthcare systems must do what they can to reduce the EHR documentation burden on physicians and other clinical staff. This will not only improve the patient and employee experience but will also increase hospital performance as more time is spent on revenue-generating activities. While hospitals can’t reduce the requirements around documentation, they do have the ability to automate more of the data input to reduce the time spent documenting each patient encounter. As this article at Managed Healthcare Executive discusses:

“As a nurse with years of experience in the profession in hospitals and in the Army, Dana Bensinger has strong opinions about how clinicians should be spending their time. And it’s not in front of the screen for the better part of a day.

“Shortcomings in interoperability, combined with the increased documentation requirements for payment, has turned nurses and doctors into data entry people. In reality, they are supposed to be data consumers,” notes Bensinger, who today leads EHR implementation and optimization projects at IT solutions consultancy CTG.

A primary care doctor should not have to enter the date of a diabetic patient’s last eye exam, Bensinger adds. Likewise a nurse should not be manually entering vital signs. “That data should be automatically pulled into the EHR from a source system and eliminate the need to document it,” says Bensinger.

To reduce documentation burnout, Bensinger says to: “Take stock of who is collecting what data. Then determine if they should even be collecting certain data rather than acquiring it from other sources. When CIOs or CMIOs are asked to add data elements to the EHR, they should first ask ‘where can we get this data?’—not ‘who is going to collect it,’” Bensinger advises.

Bensinger also recommends making it easier for patients to share their data via the patient portal. In just one example, patients on pain medication can answer simple graphic pain scales sent from the portal. Bensinger notes this eliminates the need for nurses to document the pain medication’s effectiveness, while engaging and empowering the patient in the care plan. It also allows the doctor to see if the care plan is working.

He also recommends setting up clinical dashboards that summarize and present meaningful data at a glance. “Clinicians should never have to hunt for data,” Bensinger says.

Tedium out, good data in

EHRs have the potential to facilitate an intuitive flow of information, but too often require prolonged clicking and scrolling instead.

Doug Cusick, CEO at TransformativeMed, believes physicians are spending half their time on EHRs because workflows in the system aren’t configured to how the physician really works. That can be changed, he says, through applications embedded in–or interoperable with–the EHR.

Some specific examples of how these apps are helping include eliminating or auto-completing mundane steps that have been filled elsewhere, or applying algorithms to prompt next steps,” Cusick says. “In another time-saver, providers can dictate an update to a patient’s to-do list and have it automatically write to the EHR.”

Cusick adds: “Ultimately, these apps present information in the EHR in a clinician-intuitive way, specific to the user’s primary interests and presented in their preferred, personalized layout.”

Of course, sometimes no matter how a system is configured, the needed information isn’t there. Julie Mann, chief commercial officer at Holon Solutions, has a recommendation here for healthcare technology leaders.

“Health plans, providers and technology vendors should take a look at ‘data surfacing,’ a technology advance that injects intelligent data into the clinical workflow at the right time,” Mann says. “This is typically at the point of care with the EHR. Data surfacing is one of the single most important steps to take to reduce the amount of time and clicks it takes to find critical patient data in the EHR.”

As for what kinds of data, the technique itself is data-agnostic. But as providers increasingly take on risk, a fuller picture of patient care within a system they already use can considerably improve their opinion of the EHR.

“Many providers now operate within a complex healthcare landscape that straddles both traditional fee-for-service and innovative value-based payment models,” says Heather Trafton, chief operating officer at Arcadia who is also a physician assistant. “As they take on responsibility for the financial care of their patients—in addition to the clinical–they need a comprehensive view of patient care across the care continuum. They also need critical information to be synthesized at the point of care.”

Trafton adds: “EHRs can be supplemented with time-sensitive and meaningful clinical data that eases the burden of providing more coordinated care, reduces duplication of care and improves patient outcomes. Moreover, this information can be presented to providers within their existing clinical workflows. This increases their ability to offer better preventative care and improve chronic disease management, while substantially reducing administrative burden.”

Read the entire article here: Mutiny on the Horizon for EHRs? Probably Not—But Here are Steps to Ease Clinician Frustration

As more evidence comes to light that EHRs are requiring physicians and nurses to spend too much time documenting their work, hospital administrators must find creative ways to reduce the burden. EHRs are not going away any time soon due to the wealth of data they create and store, so new avenues should be explored to increase documentation efficiency. One way to do this is to eliminate redundant data-entry tasks in EHRs. For example, natural language processing tools can help turn transcription data into notes that need to be only verified instead of typed in from scratch. Additionally, automated data capture systems, such as iRISupply, can provide high quality data by integrating RFID data capture technology directly into your EHR, eliminating the need to have clinicians re-enter supply and implant information into the EHR during hectic procedures.

How One Hospital Transitioned Endoscope Reprocessing To Central Sterile

January 9, 2020Sri Mandava Hospital Management Infection Control Managing Endoscopes Patient Safety

Oregon Health & Science University (OHSU), based in Portland, OR, recently underwent a dramatic change in their endoscopy practice with the opening of the new Center for Health & Healing Building 2 (CHH2). As part of the opening, OHSU moved its endoscopy operations to a new building, with the endoscopy department and central sterile department spread across multiple floors.

The new building layout presented challenges to OHSU’s endoscopy and central sterile staff and led to a worry among endoscopy staff that endoscopes would not be adequately reprocessed in the new setup. As this article in Gastroenterology & Endoscopy News explains the transition:

“To reduce staff anxiety, Ms. [Lisa] Newman and Ms. [Christina] Vargas developed a comprehensive transition plan. The plan included the endoscopy staff training the sterile processing staff and implementation of radiofrequency identification (RFID) technology for tracking scope location and adherence to cleaning protocols. The sterile processing staff worked in endoscopy for a year before the transition. In addition, “after hours” scope processing transitioned to Central Sterile a year before the move.

Go-live training included a training video, development of superusers, and a simulation day in the new space before opening. An RFID tracking system was custom designed to provide real- time alerts to breaches. Protocols were developed to respond to and document actions taken when deviations from standards were identified.

The endoscopy staff was surveyed about anxiety at key points throughout the transition. The authors found that by getting to know and working alongside the sterile processing staff, the endoscopy staff was less anxious and more confident in the competency of the central sterile staff. Surprisingly, the relationship building between endoscopy staff and Central Sterile staff had a greater effect on reducing staff anxiety than implementing technology did, the authors noted. Since the transition, there have been no significant breaches in cleaning protocols.

Beginning the implementation process before relocating allowed staff engagement in continuous performance improvement, Ms. Newman and Ms. Vargas concluded. They said they are continuing to collect data on staff anxiety related to breaches in cleaning protocol, possible scope damage and other deviation from standards.”

Read the entire article here: SGNA Poster Highlights: Focus on Infection Control and Reprocessing

As hospitals continue to roll out new ways to minimize the dangers that poorly disinfected endoscopes pose to patients, they must ensure that they’re doing everything they can to protect themselves and their patients from harm. The study at OHSU points out that a major risk factor of reprocessing endoscopes stems from issues with workflow adherence and documentation. Make sure that your staff is following the proper processes and protocols each and every time an endoscope is reprocessed. Systems such as iRIScope, which OHSU used to document their reprocessing protocols using RFID technology, can display the proper workflow for reprocessing endoscopes and document the process electronically. Any breaches of protocol can be discovered in real-time to protect patients and identify which staff members need additional training on reprocessing workflows and techniques. You owe it to your staff and your patients to offer everyone the peace of mind that flexible endoscopes are being properly reprocessed every single time.

Duodenoscope Safety Continues To Move Forward With First Disposable Model

January 3, 2020Sri Mandava Hospital Management Infection Control Managing Endoscopes Patient Safety

The United States Food and Drug Administration (FDA) has cleared the first fully disposable duodenoscope on the market. The industry believes that a move to disposable parts, and now 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 granted clearance to Boston Scientific’s EXALT Model D disposable duodenoscope in December 2019. The disposable model has been designed to function similarly to other duodenoscopes on the market. As this article by Conor Hale at FierceBiotech explains:

“The availability of a fully disposable duodenoscope represents another major step forward for improving the safety of these devices, which are used in more than 500,000 procedures in the U.S. each year,” said the FDA’s device center director, Jeff Shuren, in an agency statement. “Unlike duodenoscopes that are used on multiple patients, a fully disposable duodenoscope doesn’t need to be reprocessed, eliminating the risk of potential infection due to ineffective reprocessing.”

Boston Scientific says the lightweight device mimics the controls of reusable duodenoscopes to be more familiar to physicians. The company plans to roll out the EXALT Model D, which previously received a breakthrough-device designation from the FDA, in a limited commercial release during the first quarter of 2020.

The FDA recently cleared Pentax Medical’s Video ED34-i10T2, its first duodenoscope with a fully disposable head piece—which typically houses intricate moving parts and tight crevices where biomatter and bacteria can survive disinfection processes. The device’s predecessor, the ED34-i10T, was the first OK’d by the agency to have a disposable plastic end-cap covering.

In October, the FDA greenlighted a disposable, sterile cover for duodenoscopes developed by GI Scientific. The ScopeSeal device fully encloses the front end and acts as a barrier for its inner working areas, preventing them from becoming soiled with biomatter during biopsy collection or when draining fluids.

“Improving the safety of duodenoscopes is a top priority for the FDA since such devices remain critical to life-saving care for many patients, and the FDA continues to encourage innovative ways to improve the safety and effectiveness of these devices,” Shuren said.

New data from FDA safety surveillance studies earlier this year tracking contamination rates from reprocessed duodenoscopes found up to 5.4% of samples taken from the reusable devices tested positive for “high concern” organisms—including Escherichia coli and Staphylococcus infections.

But in terms of overall infection rates, the FDA said it has seen dramatic declines, though patient deaths and disease outbreaks have been reported.”

Read the entire article here: FDA clears Boston Scientific’s disposable duodenoscope, the world’s first

While the transition from rigid end caps, to disposable end caps to now fully disposable duodenoscopes takes place, hospitals must make sure that their staff is following the proper protocols each and every time a duodenoscope is disinfected. Fully disposable duodenoscopes may make financial sense to some facilities, but most will be expected to continue to high-level disinfect their reusable duodenoscopes after each use. Systems such as iRIScope can display the proper workflow for reprocessing duodenoscopes and document the process 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 everyone the peace of mind that duodenoscopes and all other flexible endoscopes are being properly reprocessed every single time.

Joint Commission Increases Scrutiny Of Endoscope Reprocessing Procedures

December 30, 2019Sri Mandava Hospital Management Infection Control Joint Commission Managing Endoscopes Patient Safety

With endoscope cleaning procedures continuing to be a focus for hospitals emphasizing patient safety, the Joint Commission has also increased its scrutiny of reprocessing protocols at its member hospitals. In order to minimize the chances of using poorly reprocessed endoscopes, hospitals should concentrate on understanding endoscope instructions for use and knowing the evidence-based guidelines put out by the associations concerned with the best ways to high-level disinfect endoscopes. As this article at Gastroenterology and Endoscopy News explains:

“The key phrase in reprocessing is “follow the manufacturer’s IFU,” Ms. [Nancy S. Schlossberg, RN, CER] added.

To prevent human errors, she recommended that all technicians be certified and follow proper hand hygiene and personal protective equipment protocols. Nurse managers should document competency and training protocols at regular intervals, starting with orientation, and at least annually or after release of institutional policies and procedures and/or professional society recommendations. Lack of quality control measures can lead to infection and endoscope damage, she added.

For evidence-based guidelines, there are a number of options, including those from SGNA, AORN, the FDA, the CDC and the American National Standards Institute/AAMI, among others. Staff should be well versed in the guidelines and updated when new alerts are issued.

Retaining staff can become an issue. “Insufficient staff and resources to support the volume and workflow can disrupt reprocessing, lead to delays in reprocessing scopes, and pose potential infection risks to patients,” she noted.

Joint Commission Tightening Reins

In the first half of 2018, the Joint Commission cited 72% of hospitals and 60% of ambulatory surgery centers for noncompliance. Reasons given included not adhering to manufacturers’ IFU, not following evidence-based guidelines, lack of validation of competency, lack of competent oversight by area manager, and lack of involvement of infection prevention staff. In September 2018, the Joint Commission revised the scoring in seven areas related to HLD and sterilization. The common theme, according to Ms. Schlossberg, was “establishing processes that support manufacturers’ IFU instructions.”

For microbial surveillance of duodenoscopes, the FDA and CDC recommend traditional culturing. Although SGNA does not recommend routine culturing, many institutions have adopted this practice to enhance patient safety, Ms. Schlossberg noted. If a scope tests positive, SGNA recommends that the scope undergo repeat HLD followed by liquid chemical sterilization, if needed.

Ms. Schlossberg noted that cleaning verification tests including adenosine triphosphate and protein, carbohydrate, and hemoglobin do not equal surveillance. “Cleaning tests measure levels of organic debris remaining on the device following manual cleaning. Microbiological sampling and culturing detect bacterial contamination remaining on a scope following high-level disinfection. Surveillance sampling and culturing can send an early alert of potential problems with reprocessing quality,” she said.”

Read the entire article here: Tips for Avoiding Poor Compliance Grades

Hospitals must ensure that they’re doing everything they can to protect themselves and their patients from harm. The article points out that hospitals must focus on ensuring their staff is following established evidence-based guidelines and avoiding human error. Make sure that your staff is following the proper processes and protocols each and every time an endoscope is reprocessed. Systems such as iRIScope can display the proper workflow for reprocessing endoscopes and document the process electronically. Any breaches of protocol can be discovered 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 everyone the peace of mind that flexible endoscopes are being properly reprocessed every single time.

Study Reveals Up To One-Third Of Endoscopes Carry Bacteria

December 19, 2019Sri Mandava Hospital Management Infection Control Managing Endoscopes Patient Safety

A recent study conducted by biotech company OneLife showed that between 10% and 30% of endoscopes in use at Belgian hospitals are contaminated by bacteria. This is the result even though the endoscopes in question were tested after going through the high-level disinfection process.

Due to the complex nature of endoscopes, they are high-level disinfected or sterilized in order to prepare the instruments for the next procedure. While these processes are designed to remove any dangerous bacteria from the scopes, in practice this isn’t always the case. As this article by Alan Hope at The Brussels Times states:

“Precisely because of the danger of cross-contamination in the multiple uses of an endoscope, the devices are routinely disinfected by the hospital. But OneLife found that even carefully disinfecting the device according to approved procedure was no guarantee of removing bacteria completely.

According to estimates, about 5% of patients contract an infection as a result of a stay in hospital, and research has shown that endoscopes are a common vector for cross-contamination. “More outbreaks are linked to contaminated endoscopes than to any other medical device, the study concludes.

The reason is, OneLife argues, that endoscopes are disinfected but not sterilised, and the established procedure does not remove biofilms – collections of cells which grow on surfaces and also to each other, making their removal more difficult without radical measures to ensure removal. To make matters worse, the endoscope is a complex construction consisting of a camera and a flexible tube to direct the camera to its target, and as such offers up a multitude of hiding places for biofilms.

Without cleaning to remove the biofilms, disinfecting has no purpose, OneLife says. “It is impossible to disinfect an inadequately cleaned instrument. Any disinfection process is doomed to fail if cleaning is inadequate.”

Read the entire article here: Up to one in three endoscopes in hospitals contaminated by bacteria

Evidence continues to accumulate about the dangers that poorly disinfected endoscopes pose to patients. Hospitals must ensure that they’re doing everything they can to protect themselves and their patients from harm. The article points out that a major risk factor of using endoscopes stems from issues with cleaning and disinfecting scopes. Make sure that your staff is following the proper processes and protocols each and every time an endoscope is reprocessed. Systems such as iRIScope can display the proper workflow for reprocessing endoscopes and document the process electronically. Any breaches of protocol can be discovered 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 everyone the peace of mind that flexible endoscopes are being properly reprocessed every single time.

The Blog