The FDA’s Safety Communication Update for Reprocessing Bronchoscopes

Endoscopy Insights

#Tech #Fitness #Medicine #Ambu #Bronchoscopy #Endoscopy #Gastroenterology #Healthcare #Medicaldevices #Patientsafety #Singleuseendoscopy #Urology #And Singleuse Endoscopy #Doctor Who #Physicians

6:43

In 1910, Dorothy Arnold—a wealthy, educated socialite from New York City—left her home for a shopping trip and never returned.

4 years ago 18:03

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The U.S. Food and Drug Administration recently updated a safety communication on reprocessing flexible bronchoscopes. In that update, the FDA recommends, among other things, that healthcare providers consider using single-use bronchoscopes when there is increased risk of spreading infection and when treating COVID-19 patients. To break down this announcement and what it means, we talked to Dr. Hudson Garrett, an infection prevention and control expert who is sought after for strategic insights and advice on infectious disease, epidemiology, patient safety and medical affairs.

22 episodes

The FDA’s Safety Communication Update for Reprocessing Bronchoscopes

Endoscopy Insights

published 4 years ago

MP3•Episode home

22 episodes

#Tech #Fitness #Medicine #Ambu #Bronchoscopy #Endoscopy #Gastroenterology #Healthcare #Medicaldevices #Patientsafety #Singleuseendoscopy #Urology #And Singleuse Endoscopy #Doctor Who #Physicians

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Endoscopy Insights

1
A Day in the Life of an ENT Resident 21:08

3 years ago21:08

21:08

Dr. Wesley Stepp is a resident at the University of North Carolina’s Department of Otolaryngology-Head and Neck Surgery. UNC is a national leader in training the next generation of ear, nose and throat surgeons and Dr. Stepp brings an interesting perspective to this kind of work. Not just because his first exposure to otolaryngology was having sinus surgery in his teens, which proved life changing and set him on his eventual academic and professional course. But also because in his work today as a senior resident, he’s seen firsthand how single-use endoscopy technology has impacted his practice in several ways — from workflow and efficiency to information sharing and medical decision making to patient education. We talked about all this and more with Dr. Stepp, who graduated from the University of North Carolina School of Medicine in 2019 and who will take his practice to the military soon. Dr. Stepp is an Ambu consultant. Show notes: Bio: Dr. Wesley Stepp Dr. Stepp’s PubMed Listing Video: Simplifying FEES Exams with the aScope 4 RhinoLaryngo Slim Endoscopy Insights homepage…

Endoscopy Insights

1
Comparing Single-Use and Reusable Bronchoscopes for Interventional Pulmonology 20:56

3 years ago20:56

20:56

The conventional wisdom in interventional pulmonology has long been that reusable bronchoscopes perform better than their single-use counterparts, but new research counters that thinking. A recent study, part of a poster presentation at the World Congress for Bronchology and Interventional Pulmonology (WCBIP) 2022 in Marseille, France, found that three of four single-use flexible bronchoscopes that were tested performed better in flexion and extension than reusable competitors. The latest single-use flexible bronchoscopes, according to the study’s authors, are a significant advancement over prior generations. One of those authors is Dr. Jonathan Kurman and he’s our guest on the latest episode of Endoscopy Insights . Dr. Kurman is an assistant professor of medicine at the Medical College of Wisconsin and the director of interventional pulmonology for the Froedtert & Medical College of Wisconsin (MCW) health network. He completed an interventional pulmonology fellowship at the University of Chicago and pulmonary & critical care training at the Medical College of Wisconsin. He is board certified in interventional pulmonology, internal medicine, pulmonary medicine and critical care. Disclosure: Ambu provided funding for the study’s evaluation and testing, and Dr. Kurman is an Ambu consultant. Show notes: Poster, “A Comparison of Single-Use Bronchoscopes and Reusable Bronchoscopes for Interventional Pulmonology Applications” Single-Use Endoscopy , “Study: Single-Use Bronchoscopes Show Better Flexion Than Reusables” World Congress for Bronchology and Interventional Pulmonology 2022 Bio: Dr. Jonathan Kurman Endoscopy Insights homepage…

Endoscopy Insights

1
Navigating Career Paths and Challenges in Flexible Endoscopy 15:10

3 years ago15:10

15:10

Dr. Marybeth Spanarkel describes GI endoscopy as a labor of love. You can hear the passion in her voice when she talks about performing a procedure and the gratification that comes from getting an immediate medical answer to the clinical question that’s being asked. Spanarkel, however, suffered a career-ending neck injury after 28 years in private practice in North Carolina. Without full strength in her right arm, she lost the ability to perform endoscopy procedures and provide those much-needed answers to patients. That musculoskeletal injury brought her career to an end, but it was the catalyst sending her down a new path — keeping other GI endoscopists from suffering a similar fate by educating them on the unique ergonomics challenges they face. She discussed that and more in our first conversation for Endoscopy Insights , which you can listen to here . In this episode, we talk more about her career path, her decision to choose clinical practice over academia, her experiences as a female clinical endoscopist and some of the unique challenges she’s faced and overcome. Show notes: Endoscopy Insights : Dr. Marybeth Spanarkel, Part 1 Q&A: Addressing Ergonomics Challenges in Colonoscopy Survey: Are All Endoscopic-Related Musculoskeletal Injuries Created Equal? American College of Gastroenterology ColoWrap…

Endoscopy Insights

1
Right Pocket, Left Pocket: Achieving Buy-In for Single-Use 23:03

3 years ago23:03

23:03

Healthcare staff shortages, while not new, have spawned a world today where it can take five hours to get an X-ray for a dislocated elbow and another two to get pain medication for the injury. Ambulances sometimes wait eight hours to drop off a patient, and nurses work 12- to 16-hour shifts, without a break. About 400,000 healthcare workers have left jobs since the start of the novel coronavirus pandemic, according to recent estimates from the U.S. Bureau of Labor Statistics. Throughout the pandemic, hospitals have had to implement creative approaches to soften staffing shortages. Medical device companies have also gotten innovative. Single-use endoscopes, for example, can help address staffing shortages. They’re always available. And unlike traditional endoscopes, they don’t require extensive staffing — for preparation, transport, reprocessing, and often direct procedure support. They can be simply used once and discarded. This dovetails with efforts by hospital administrators to alleviate workflow burdens on healthcare professionals. These challenges and more were explored as part of a virtual session sponsored by Ambu during Becker’s Hospital Review’s 12th Annual Meeting. We’re highlighting part of that conversation here in this episode of Endoscopy Insights . Here are the experts you’ll hear from: Karen Conway, vice president, healthcare value, GHX Brian Howard, director, contract services, Vizient Karen Niven, director, performance groups, Premier India D. Randerson, vice president, strategic sourcing and procurement to payment, Henry Ford Health Steering the conversation is Wes Scruggs, Ambu’s vice president of corporate accounts Show notes: Virtual Session: The Financial Case for Single-Use Endoscopy Becker’s Hospital Review : “Strategy: The Financial Case for Single-Use Endoscopy” Single-Use Endoscopy : “’Perfect Storm’ of Healthcare Worker Shortages Creates Need to Alleviate Workflow Burdens” Upcoming Becker’s virtual events Listen: “Calculating the Total Cost of Care ” Listen: “Leading with Value to the Patient ” Single-Use Endoscopy webinars page Endoscopy Insights show page…

Endoscopy Insights

1
Leading with Value to the Patient 12:21

3 years ago12:21

12:21

Medical device suppliers and group purchasing organizations are teaming to bring new healthcare innovations such as single-use endoscopes to hospitals and health systems. By creating specific single-use endoscope categories for their members, these healthcare improvement companies can help accelerate the transition from reusable devices to disposable ones. But capitalizing on an opportunity to expand capacity and avoid costly and unnecessary expenses associated with workflow management and possible patient cross-contamination comes down to more than simply making a purchase. Rather, both sides need to approach these deals as true partnerships, hinging on performance measurements and outcome-based metrics. That was one key takeaway from a conversation that was part of a virtual session sponsored by Ambu as part of Becker’s Hospital Review’s 12th Annual Meeting. Here are the experts you’ll hear from in this episode: Karen Conway, vice president, healthcare value, GHX Brian Howard, director, contract services, Vizient Karen Niven, director, performance groups, Premier India D. Randerson, vice president, strategic sourcing and procurement to payment, Henry Ford Health Steering the conversation is Wes Scruggs, Ambu’s vice president of corporate accounts Show notes: Virtual Session: The Financial Case for Single-Use Endoscopy Becker’s Hospital Review : “Strategy: The Financial Case for Single-Use Endoscopy” Upcoming Becker’s virtual events Listen: Calculating the Total Cost of Care Single-Use Endoscopy webinars page Endoscopy Insights show page…

Endoscopy Insights

1
Calculating the Total Cost of Care 17:58

3 years ago17:58

17:58

Transitioning from reusable to single-use endoscopes has obvious infection control benefits and even provides workflow and efficiency advantages — but the financial implications are usually one of the biggest hurdles to implementation. That’s why it’s important to explore all the variables that go into achieving cost savings with single-use devices and assessing that shift within the context of other healthcare paradigm shifts. In this conversation, four experts do exactly that by exploring the elements that go into calculating the total cost of care and better understanding what they call “the math problem” at the root of this analysis. This conversation was part of a virtual session sponsored by Ambu as part of Becker’s Hospital Review’s 12th Annual Meeting. Here are the experts you’ll hear from in this episode: Karen Conway, vice president, healthcare value, GHX Brian Howard, director, contract services, Vizient Karen Niven, director, performance groups, Premier India D. Randerson, vice president, strategic sourcing and procurement to payment, Henry Ford Steering the conversation is Wes Scruggs, Ambu’s vice president of corporate accounts. Show notes: Virtual Session: The Financial Case for Single-Use Endoscopy Becker’s Hospital Review : “Strategy: The Financial Case for Single-Use Endoscopy” Upcoming Becker’s virtual events Single-Use Endoscopy webinars page Endoscopy Insights show page…

Endoscopy Insights

1
How Effective is Flexible Ureteroscope Reprocessing? 9:22

3 years ago9:22

9:22

When the U.S. Food and Drug Administration released a letter to healthcare providers in April 2021 announcing its investigation into numerous medical device reports involving reprocessed urological endoscopes, Dr. Seth Bechis and his colleagues set out to learn more about reprocessing and its effectiveness. They focused on flexible ureteroscopes in their research and found that, while studies assessing the effectiveness of on these specific scopes is limited, their findings line up with recent news about other flexible endoscopes — that a surprising number still harbor protein and other debris even after reprocessing, raising patient safety concerns. Their findings were published in the journal Urology . We caught up with Dr. Bechis at the American Urological Association’s annual convention in New Orleans to talk more about the study. Dr. Bechis is a board-certified urologist and member of the comprehensive Kidney Stone Center at UC San Diego Health. Hes’ also an Ambu consultant. Show notes: Bio: Seth Bechis Urology : “Reprocessing Effectiveness for Flexible Ureteroscopes: A Critical Look at the Evidence” Single-Use Endoscopy : “FDA Investigating Reports of Infections Associated with Reprocessed Urological Endoscopes” The FDA’s Letter to Healthcare Providers: Infections Associated with Reprocessed Urological Endoscopes Single-Use Endoscopy : “Why Problems with Reprocessing Ureteroscopes ‘Haven’t Gone Away’” Endoscopy Insights: Breaking Down the FDA Letter to Healthcare Providers Endoscopy Insights Show Page…

Endoscopy Insights

1
Becoming a Next-Gen Urologist 14:45

3 years ago14:45

14:45

Matthew Katz was at Weill Cornell Medicine when a chance digital encounter ended up steering him into urology. “If you had asked me what a urologist did before medical school I probably wouldn’t have been able to answer the question,” he told me self-deprecatingly when we chatted at the American Urological Association’s annual conference in New Orleans . But a blast email to the entire medical school looking for people interested in robotics research caught Katz’s eye. His background in bioengineering had sparked an interest in doing something medically that was hands on, working with new technology and focusing on minimally invasive procedures. A next-generation urologist was born. Today, Katz brings a unique perspective to starting a urology practice. He’s less than a year out of an endourology fellowship, has an MBA and has co-authored research on telemedicine. He also has interesting insights on the emergence of single-use endoscopes and the role they can play in urology practice going forward. Katz is affiliated with NYU Langone Health and is a clinical assistant professor in the urology department at the NYU Grossman School of Medicine. Show notes: Bio: Matthew Katz Diseases of the Colon & Rectum : “Assessment of Ileostomy Output Using Telemedicine: A Feasibility Trial” Single-Use Endoscopy : “5 Things Urologists Were Talking About at AUA 22” Single-Use Endoscopy : “How Robotics is Shaping the Future of Urology” Endoscopy Insights Show Page…

Endoscopy Insights

1
Mentoring and Empowering Women in Endoscopy, Part 2 16:10

3 years ago16:10

16:10

Empowering women in endoscopy is something Dr. Arthi Sanjeevi is clearly passionate about. It shows in her work mentoring young gastroenterologists and in the way she tackles gender-related challenges in the field. In this conversation, Dr. Sanjeevi discusses what’s missing when it comes to empowering women in gastroenterology, and what still needs to be done to bring more female physicians into the practice, especially advanced therapeutic endoscopy. Sanjeevi is based in Tampa, Florida, with AdventHealth Medical Group and is double board certified in gastroenterology and internal medicine. She specializes in conditions of the pancreas and gallbladder, digestive cancers, esophageal motility and swallowing disorders, and advanced endoscopy, including therapeutic endoscopic retrograde pancreatography and deep enteroscopy. Be sure to check out the first part of our conversation with Dr. Sanjeevi where we discuss the importance of mentoring and her work with the nonprofit Women in Endoscopy , which was launched in 2016 to provide classes and seminars about professional growth and leadership and foster networking among its members. Show notes: Bio: Dr. Arthi Sanjeevi Women in Endoscopy Study: Barriers and bias standing in the way of female trainees wanting to learn advanced endoscopy Single-Use Endoscopy: Breaking Down Barriers in Gastroenterology Q&A: Women in Endoscopy During COVID-19 Lockdowns and Beyond Endoscopy Insights homepage and podcast archive…

Endoscopy Insights

1
Mentoring and Empowering Women in Endoscopy 15:04

3 years ago15:04

15:04

Dr. Arthi Sanjeevi remembers a fellowship during her residency, when a mentor played a key role in helping guide her career path. Seeing her passion for therapeutic endoscopy — and her ability to perform the complex procedures — he gave Sanjeevi the push she needed. Dr. Sanjeevi does the same today for the residents she mentors. This is particularly important for female gastroenterologists, because studies show that even as female medical graduates outnumber males in every country except Japan and Switzerland, female gastroenterologist numbers remain stagnant. The nonprofit Women in Endoscopy was launched in 2016 to provide classes and seminars about professional growth and leadership and foster networking among its members. Sanjeevi uses her personal experience to steer young clinicians to good mentorship opportunities and their own promising professional paths. “If you can identify with a person who can empathize with your unique life path it makes it so much easier for that person to guide you,” she says in the first part of a two-part conversation. Sanjeevi is based in Tampa, Florida, with AdventHealth Medical Group and is double board certified in gastroenterology and internal medicine. She specializes in conditions of the pancreas and gallbladder, digestive cancers, esophageal motility and swallowing disorders, and advanced endoscopy, including therapeutic endoscopic retrograde pancreatography and deep enteroscopy. Look for the second part of our conversation with Dr. Sanjeevi in a couple of weeks. Show notes: Bio: Dr. Arthi Sanjeevi Women in Endoscopy Study: Barriers and bias standing in the way of female trainees wanting to learn advanced endoscopy Single-Use Endoscopy: Breaking Down Barriers in Gastroenterology Q&A: Women in Endoscopy During COVID-19 Lockdowns and Beyond Endoscopy Insights homepage and podcast archive…

Endoscopy Insights

1
The State of Bladder Cancer Awareness and Research 12:03

3 years ago12:03

12:03

May was Bladder Cancer Awareness Month, so we wanted to share a conversation with Dr. Yair Lotan on the state of bladder cancer awareness and research, his work with the Bladder Cancer Advocacy Network, and some of the advancements in bladder cancer research that most excite him. Dr. Lotan is a urology professor and chief of urologic oncology at University of Texas Southwestern Medical Center in Dallas, Texas. He’s known nationally for his research on urine markers and molecular markers, which will help determine patients at higher risk for recurrent cancer. Bladder cancer is the sixth most common cancer diagnosed annually in the U.S., according to the National Library of Medicine . This is the second part of a two-part conversation we conducted with Dr. Lotan. In the first, we discussed a micro-cost analysis published in Urology that broke down per-procedural costs for cystoscopy and explored how single-use cystoscopes might provide a cost-effective option for providers. Dr. Lotan is an Ambu consultant. Show notes: Bio: Dr. Yair Lotan Bladder Cancer Advocacy Network Why Cystoscopy is Still Vital for Bladder Cancer Diagnosis May is Bladder Cancer Awareness Month 5 Things Urologists Were Talking About at AUA 2022 The Economics of Cystoscopy: A Microcost Analysis…

Endoscopy Insights

1
Study Probes FDA Adverse Event Data Tied to Flexible Endoscopes 28:34

3 years ago28:34

28:34

A comprehensive review and analysis of adverse event reports involving flexible endoscopes filed with the U.S. Food and Drug Administration shows a marked increase for six types of scopes from 2014 through 2021. The analysis was undertaken by Dr. Larry Muscarella, president of LFM Healthcare Solutions and an independent safety expert who advises hospitals, manufacturers and the public about medical device safety and the causes of infections in healthcare facilities. Muscarella combed through the FDA’s so-called MAUDE database — the acronym stands for “Manufacturer and User Facility Device Experience” — and identified reports describing endoscope contamination. In this conversation, we discuss why this kind of analysis is significant and what the findings reveal about the safe and effective cleaning of endoscopes. Dr. Muscarella is an Ambu consultant. Show notes: Contamination of Flexible Endoscopes and Associated Infections: A Comprehensive Review and Analysis of FDA Adverse Event Reports Bio: Dr. Larry Muscarella Medtech Insight - Study: FDA Data Shows Endoscope-Related Adverse Events Continue to Rise FDA Pushes Switch to ‘Innovative’ Duodenoscope Designs to Enhance Patient Safety Urological Endoscope Manufacturer Issues ‘Urgent’ Recall…

Endoscopy Insights

1
How Single-Use Cystoscopes Solved Continuation of Care Challenges from Major Floods 15:14

3 years ago15:14

15:14

A storm dumped three to five inches of rain in the Detroit metro area one day in June 2021, and a major flood forced a Michigan urology clinic to close. Urologists with Henry Ford Health System were forced to quickly pivot and take all their patients coming in for clinic appointments and procedures and push them to a downtown Detroit campus. Single-use cystoscopy technology enabled them to do just that. Dr. Craig Rogers explains how in the latest episode of Endoscopy Insights. What happened is a testament to the power of new technology at a time when healthcare systems find themselves challenged on several fronts — clinical, financial, supply chain and logistics, even staffing. Show notes: Case Study: How This Urologist Kept Caring for Patients After His Clinic Flooded Bio: Dr. Craig Rogers Henry Ford Health System U.S. News: States With the Biggest Hospital Staffing Shortages Subscribe to Endoscopy Insights…

Endoscopy Insights

1
The Economics of Cystoscopy 15:21

3 years ago15:21

15:21

A micro-cost analysis published in Urology broke down per-procedural costs for cystoscopy and explored how single-use cystoscopes might provide a cost-effective option for providers. One of the authors of that study, Dr. Yair Lotan, is our guest on the newest episode of Endoscopy Insights and he walks us through his findings. Factors such as capital equipment costs, labor, and supply costs, as well as the number of procedures performed each year, impact the price of cystoscopy. Dr. Lotan is a urology professor and chief of urologic oncology at University of Texas Southwestern Medical Center in Dallas, Texas.…

Endoscopy Insights

1
Let’s Talk About Efficiency in Flexible Endoscopy 12:32

3 years ago12:32

12:32

Improving workflows to better meet your patients where they are — whether they find themselves in an ICU bed or at a satellite clinic — is something all patients and providers can be happy about. As we learn from two clinicians in this episode, when they have equipment that is portable, easily deployed, and does not require sterilization between uses, they can cut down on procedural delays.…

Endoscopy Insights

1
Ergonomics Challenges in GI Endoscopy 21:51

3 years ago21:51

21:51

Dr. Marybeth Spanarkel loved the “immediate gratification” in performing a colonoscopy or upper GI endoscopy and getting an immediate answer to a medical question. Unfortunately, she had to step away from the field after 28 years in private practice in Durham, North Carolina, after a career-ending neck injury that caused sudden paralysis in her right arm. That musculoskeletal injury brought her career to an end, but it was the catalyst sending her down a new path — keeping other GI endoscopists from suffering a similar fate by educating them on the unique ergonomics challenges they face. In this episode of Endoscopy Insights , we delve into ergonomics issues and training and also discuss her work on the development of an abdominal compression device used to prevent ergonomics injuries. Show notes: Q&A: Addressing Ergonomics Challenges in Colonoscopy Survey: Are All Endoscopic-Related Musculoskeletal Injuries Created Equal? American College of Gastroenterology ColoWrap…

Endoscopy Insights

1
Study: Single-Use Bronchoscope Can Reduce Readmission Rates, Infection Risk 15:07

4 years ago15:07

15:07

Hospitals that perform bronchoscopies can reduce readmission rates by over half, and potentially lower costs, by adopting single-use flexible bronchoscopes. That’s according to a new abstract that was submitted and presented at the recently completed CHEST 2021 annual meeting. The study examined the health outcomes of more than 14,000 patients who underwent a bronchoscopy procedure and found that sterile, single-use bronchoscopes reduced the re-admissions rate 53 percent, from 7.7 percent to 3.6 percent, compared with reusable bronchoscopes. Dr. Hudson Garrett joined Endoscopy Insights to discuss the findings. In our conversation, he talks about why readmission rates are such an important performance metric for hospitals, the key clinical findings he identified in looking at this data, and the larger quality-of-care and patient safety conversations taking place in healthcare. Garrett is an Ambu consultant.…

Endoscopy Insights

1
The Evolution of Single-Use Urologic Endoscopy 17:36

4 years ago17:36

17:36

A recent study conducted at Duke University Hospital and published in the Journal of Endourology found that a new single-use cystoscope demonstrated superior flexion and comparable optics to the reusable scopes already being used in a hospital urology department. Dr. Michael Lipkin, a urologist in Durham, North Carolina, and one of the study’s authors, joined Endoscopy Insights to discuss the findings. In our conversation, he talks about the key technological capabilities of the cystoscopes that he and his fellow researchers set out to assess, and other factors that impact the calculus of single-use vs. reusable. Lipkin also touches on a physician feedback survey that was done as part of the research and what his fellow urologists had to say, and other issues such as cost, infection prevention, and environmental factors.…

Endoscopy Insights

1
Best Practices in Endoscope Reprocessing 19:51

4 years ago19:51

19:51

The U.S. Food and Drug Administration revealed in a letter to healthcare providers that it’s investigating numerous medical device reports describing patient infections and other possible contamination issues potentially associated with reprocessed urological endoscopes. Dr. Larry Muscarella delves into more detail on reprocessing best practices and some of the challenges therein. He also shares his key takeaways from the FDA letter — for clinicians, regulators and healthcare consumers alike.…

Endoscopy Insights

1
FDA Investigating Reports of Infections Associated with Reprocessed Urological Endoscopes 13:37

4 years ago13:37

13:37

The U.S. Food and Drug Administration is investigating “numerous” medical device reports (MDRs) describing patient infections and other possible contamination issues possibly associated with reprocessed urological endoscopes. Dr. Larry Muscarella , an independent safety expert who advises hospitals, manufacturers and the public about medical device safety and infection prevention, talks about the letter to healthcare providers from the FDA. He also breaks down what it means, what surprised him about this latest course of action surrounding endoscopes and reprocessing, and what to watch for next.…

Endoscopy Insights

1
The FDA’s Safety Communication Update for Reprocessing Bronchoscopes 18:03

4 years ago18:03

18:03

Endoscopy Insights

1
Infection Control Risks and Endoscopy 20:52

4 years ago20:52