OR Management Digital Edition - March 2021

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The Independent Source of News ws for Operating Room Managers, Supply Chain Professionals & C-Suite ws Volume 15 • March 2021

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Despite a rocky start, things in the U.S. are starting to look up.

New Device Shrinks Robotics ff Screening Saves Money C. diff SSIs and Hospital Cleaning Brought to you by the publisher of

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†Sterility assurance level of 10-6 accepted by the FDA as laid out in the Association for the Advancement of Medical Instrumentation (AAMI) standards ST67 and TIR 12 for devices contacting normally sterile tissue. ‡The combination of failed tests included visual inspection, optical and scanning electron microscopy, hemoglobin detection, and sterility testing. §Medtronic will not perform complaint investigations on competitive devices. ˨ 2SWLRQDO ULVN VKDULQJ DQG LQGHPQLƬFDWLRQ SURJUDPV LQFOXGH WKH LigaSure™ Technology Performance Pledge and Project Zero collections programs.

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1. &KLYXNXOD 6 5 /DPPHUV 6 :DJQHU - $VVHVVLQJ RUJDQLF material on single-use vessel sealing devices: a comparative study of reprocessed and new LigaSure™ devices. Surg Endosc (2020). https://doi.org/10.1007/s00464-020-07969-8.

4 New Device Takes Robotics in Smaller, Simpler Direction 6 Experts Highlight Emerging Biophysical Approaches to Advanced Wound Care 8 SSIs: What Surgeons Should Know About Their Hospital’s Cleaning Program 10 C. diff Screening May Provide Cost-Saving Benefit for Hospitals Early Antibiotics for Sepsis Don’t Result in Overall Higher Use 12 IV Acetaminophen Does Not Reduce Post-op Hypoxemia in Randomized Trial 14 Inside the COVID-19 Vaccine Rollout 16 Bloodstream Infections Complicate COVID-19 Risks 18 Presurgical Optimization Programs Benefit Patients, Boost Bottom Line 20 Frailty Screening Associated With Reduced Mortality After Elective Surgery The Joint Commission: Update on Surgical Smoke 21 AI Tool Can Predict Post-op Hernia Complications 22 Ultrasound for Diagnosing Appendicitis:

A Potentially Valuable Adjunct 23 Buyer’s Guide EDITORIAL STAFF Paul Bufano Managing Editor pbufano@mcmahonmed.com Kevin Horty Group Publication Editor khorty@mcmahonmed.com

1. Lifelong Financial Planning: A Road Map 2. Robotic-Assisted Hernia Repair: What Exactly Are We Arguing About?

3. COVID-19’s Silver Lining Heard Here First “The annual incidence of SSI in the United States is between 160,000 and 300,000, or 2% to 5% of patients undergoing inpatient surgery, and the attributable health care cost ranges from $3.5 billion to $10 billion annually.”

PAGE 8

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OR Management News • March 2021

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TEC HN O LO GY

New Device Takes Robotics in Smaller, Simpler Direction just a couple of days with no problems or issues,” he said.

The MIRA’s small size does not require a dedicated space or e’ve glimpsed a possible future of robotic surgery, and it’s infrastructure, nor does it need a dedicated setup team, which just slightly larger than a bread box. could give it an advantage over currently available robotic platWeighing less than 2 pounds, the miniaturized in vivo robot- forms. The system is designed to be used anywhere general suric assistant (MIRA) is about the size of a human hand and fits gery is performed—an academic medical center, a community into a patient’s abdomen through a single 2.5- to 3-cm umbilical hospital or an ambulatory surgery center. incision. Assembled together, the robot and a camera extend no “We anticipate the MIRA will open up access to robotic surmore than 24 inches. gery much more broadly. Virtual Incision “When we started our research into is focused on the underserved 80%-plus of robotic surgery, we thought the current the market that needs a smaller and simpler iteration on the market—the very large solution,” Dr. Oleynikov said. and expensive da Vinci system [Intuitive Feedback from robotic and laparoscopSurgical]—was probably not the right way ic surgeons regarding ease of use has been to go about it,” said Dmitry Oleynikov, promising, he said. “The learning curve for MD, the co-founder and chief medical laparoscopic colectomy is around 55 cases. officer of Virtual Incision, a medical device Robotics has reduced that learning curve company that develops miniaturized robotto 15 to 25 for a colectomy. We expect the ic support systems. “The analogy we use is MIRA to further reduce the learning curve comparing the big mainframe computers to five to 10 cases.” from the 1970s and 1980s to what we have The current system has two effectors, a now, in our watches and iPhones.” bipolar grasper, monopolar scissors and a The MIRA features a robotically consurgeon-controlled camera. The robot itself trolled articulating scope that fits through can be reused up to 15 times following sterthe center channel of the robot, and two ilization, and the camera can be used up to interchangeable instruments; it is designed to 50 times. “Our plan would be to recycle create triangulation between the camera and the system after it has completed all of its instruments to provide unobstructed visibil- The miniaturized in vivo robotic cycles,” Dr. Oleynikov said. assistant consists of an articulating ity and reduce the risk for collisions during Although the company has not yet put scope with two miniaturized arms surgery. Once the device is placed through (lower right) and a surgeon console a price on the system—it is too early in the gel port, the surgeon can manipulate it (above and below). development to determine—the cost of a to look at all four quadrants. procedure conducted with the MIRA is “If the device needs to be advanced or expected to be roughly equivalent to a withdrawn, that can be done with the help laparoscopic operation. of the bedside assistant,” said Dr. Oleynikov, Virtual Incision is working with the also the chair of surgery at Monmouth MedFDA for approval of its initial investigaical Center and a clinical professor of surgery tional device exemption trial, on which at Robert Wood Johnson Medical School of Michael A. Jobst, MD, will be one of Rutgers University, in New Brunswick, N.J. the primary investigators. He has been The device is still in an investigational consulting with Virtual Incision on the stage and not available for sale in the United MIRA for a few years and has used it in a States, but Dr. Oleynikov anticipates the dry lab, pig models and a cadaver.

MIRA will be used for general surgery “I think it’s awesome,” said Dr. procedures including colon resection, Jobst, a colon and rectal surgeon at cholecystectomy, sleeve gastrectomy and Surgical Associates, PC, in Lincoln, hernia repair, pending FDA approval.

Neb. “Other surgeons point out that In Paraguay two years ago, under strict it doesn’t have a vessel sealer or stapling research protocol, Dr. Oleynikov and capability, but in 2010, the da Vinci system his colleagues performed two colon didn’t have those features, either. At this stage resections with a slightly earlier proin the game, the MIRA is a fantastic concept, totype. “Both patients were successand it’s taking surgical robotics in a different direction.

■ fully discharged from the hospital in I think it will, ultimately, be better.”

By MONICA J. SMITH

W

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OR Management News • March 2021

OCTOBER 21-23 21 23

CLIN IC A L NE WS

Experts Highlight Emerging Biophysical Approaches To Advanced Wound Care Extracorporeal shock wave therapy is an emerging technology that uses sound waves to promote wound healing and decrease pain.

By JENNA BASSETT, PhD

T

he field of wound care is evolving rapidly as novel technologies are steadily being developed.

In a session at the virtual 2020 Symposium on Advanced Wound Care fall meeting, Hollie Mangrum, PT, DPT, CWS, and Renee Cordrey, PT, PhD(c), MSPT, MPH, CWS, reviewed six new and emerging biophysical approaches.

Wounds that heal improperly, incompletely or too slowly may lead to chronic wounds and morbidity that can impose a significant burden on the patient and provider. It comes as no surprise, then, that clinicians and researchers have developed advanced wound care technologies to support safe and optimized healing.

“Physical therapists started using energy modalities, such as electrical stimulation and ultraviolet light, several decades ago,” explained Dr. Cordrey. These technologies support recovery by stimulating a patient’s natural wound-healing processes. Electrical stimulation sends electrical pulses through electrodes attached to the wound site, which increases capillary density and perfusion to support oxygenation. Because cells have an electrical charge, the polarity of the electrode can draw oppositely charged cells, through which electrical stimulation also promotes autolytic debridement and collagen deposition (Nursing 2002;32[12]:17).

“In fact, electrical stimulation earned a strength of evidence of A in the AHCPR [Agency for Health Care Policy and Research] pressure ulcer treatment guidelines in the early 1990s,” Dr. Cordrey said. “Since then, further research has improved our use of the older modalities, but a greater understanding of chronic wound physiology led to the development of new tools to promote wound healing via different pathways.”

Photobiomodulation

Topical oxygen therapy (TOT) is the topical application of pure, humidified oxygen to a wound to hinder the growth of bacteria, enhance growth factor signaling, and promote angiogenesis and collagen synthesis. TOT is delivered via sealed chambers or topical diffusers. Patients using topical oxygen chambers undergo TOT at home for 90-minute intervals several times weekly, whereas topical diffusers are worn continuously under a dressing.

Two randomized controlled trials showed significant improvements with TOT in healing rates among patients with diabetic foot ulcers, including patients with large wounds (J Wound Care 2018;27:S30-S45 and Diabetes Care 2020;43[3]:616-624).

Importantly, the speakers noted precautions to take with TOT to ensure optimal oxygen penetration, for example, removing eschar and avoiding petroleum-based dressings.

Photobiomodulation is a means of altering cell behavior using light to promote healing. The mechanisms of action are complex, but in general, light absorption by tissues causes broad changes in cell signaling, which triggers the release of growth factors and reactive oxygen species and modulates pain response and inflammation. Depending on the wavelength of light used (red vs. blue light), different types of cells will respond. Macrophages, lymphocytes, fibroblasts and epithelial cells all respond in ways that relieve pain and promote more rapid healing.

Clinical studies of the use of red light showed reduced pain and wound improvement. Preclinical studies using blue light found decreased bacteria levels, improved perfusion and altered keratin synthesis (Lasers Med Sci 2018;33[4]:729-735; Int J Low Extrem Wounds 2017;16[1]:29-35; Evid Based Complement Alternat Med 2013;960240; Lasers Med Sci 2017;32[2]:275-282; J Vis Exp 2017;[122]:54997; Injury 2011;42[9]:917-921). Precautions with this treatment include monitoring for inflammatory responses and potential tissue damage.

Cold Atmospheric Plasma

Ultraviolet-C

Topical Oxygen Therapy

Cold atmospheric plasma (CAP) is the application of partially ionized gases to disinfect, promote tissue growth and treat itch 6

around a healing wound. Daily CAP treatment is indicated for chronic wounds, decreasing bacterial load, preparing donor sites for a skin graft, skin conditions such as itch and eczema, scar treatment, and pain relief. Anticancer applications of CAP are also being investigated.

Several studies have reported safe and effective reductions in bacterial load and accelerated wound healing with the use of CAP in different clinical settings (Br J Dermatol 2010;163[1]:78-82; Br J Dermatol 2012;167[2]:404-410; Clin Plasma Med 2013;1[2]:25-30; J Eur Acad Dermatol Venereol 2015;29[1]:148155; Wound Repair Regen 2013;21[6]:800-807). CAP users should be cautious of the generation of reactive oxygen species and potential risks for skin damage.

OR Management News • March 2021

UV-C light is invisible light that is used to stimulate vasodilation, continued on page 9

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PE RSP ECTIVE

SSIs: What Surgeons Should Know About Their Hospital’s Cleaning Program

By DAVID TAYLOR III, MSN, RN, CNOR

M

any patients experience pain postoperatively related to their surgery. Unfortunately, far too many operations result in a surgical site infection (SSI). Doctors and hospitals may say infections following surgeries are a potential risk, but for many, postsurgical infections can be the result of contaminated treating environments and/or negligence. In the United States, approximately 27 million surgical procedures are performed each year, with as many as 5% of those resulting in an SSI.1 Contamination within an OR can be introduced through a variety of sources: surgical instruments and equipment, personnel and the patient, inanimate objects and surfaces, the air, and even insects, potentially causing harm. To provide a safe environment for both the patient and health care worker, an environmental control program should be established for the OR to keep microorganisms to a minimum.

In 2017, the American College of Surgeons and Surgical Infection Society published guidelines noting that SSIs are the most common and costly type of health care‒associated infection (HAI) and accounted for 20% of all HAIs. The annual incidence of SSI in the United States is between 160,000 and 300,000, or 2% to 5% of patients undergoing inpatient surgery, and the attributable health care cost ranges from $3.5 billion to $10 billion annually. On average, an SSI increases a hospital length of stay by 9.7 days.2 The recommendations put forth by the Association for peri-Operative Registered Nurses, and the Association for the Healthcare Environment’s Practice Guidance for Healthcare Environmental Cleaning, are the standards used by most health care facilities in setting up their infection prevention procedures

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OR Management News • March 2021

regarding the OR and other procedural spaces. However, as a consultant, I have provided hundreds of OR assessments across the country, and have often found cleanliness and infection prevention practices to be lacking. Preoperative leaders are not maintaining their ORs to industry standards, and after interviewing surgeons they had no clue of the problems.

Cleaning measures are needed before, during and after surgical procedures (in between procedures), and at the end of each day. Such cleaning must be considered an environmental essential, and infection prevention considerations should include the following: Air handling or ventilation systems of the surgical suite should be designed to minimize contaminants. Air entering the room through the HVAC system should originate from the ceiling and exit through the return near or at the floor. Air exchanges should be a minimum of 15 per hour with at least four of those air exchanges originating from a fresh air source, and be HEPA filtered. Many hospitals have increased their air exchange rates to as high as 25 per hour with 100% of those being fresh air.

Proper attire (scrubs) should be freshly laundered and donned at the hospital to reduce the number of contaminants carried in from outside of the OR. Because scrubs are considered a form of personal protective equipment, they should be taken off prior to health care workers leaving for the day.

Traffic during the operation should be confined to the members assigned to that procedure. The microbial levels in the air are directly proportional to the number of people moving about and talking within the OR. Minimizing the number of people in the room, or how many times members of the team enter or exit throughout the procedure can help reduce infection rates.

Bloodborne pathogens have the potential to be infectious, as well as other body fluids including saliva; cerebrospinal, synovial, pleural, pericardial, peritoneal and amniotic fluids; semen; and vaginal secretions. Caution should be taken when handling specimens, organs (other than intact skin), and cell or tissue cultures.

Employing New Technologies New technologies are designed to help keep ORs cleaner and can include products with ultraviolet light and advances in heating, ventilation and HVAC systems, such as needlepoint bipolar air ionization (NPBI) technology. What are the pros and cons of using these technologies?

According to the Environmental Protection Agency, indoor air can be two to five times more polluted than outside air.3 A newer technology, NPBI produces a high concentration of positive and negative ions, which allows similarly charged particles to combine (get larger), making it easier for them to be filtered more effectively. Basically, as the ions travel within the airstream, they attach to pathogens, particles and gas molecules, breaking them down and rendering them ineffective.

Ultraviolet light technology has been thoroughly vetted and has a proven track record since the 1940s. The technology works by using UV-C band wavelength to degrade organic material and inactivating microorganisms and pathogens. Use of the UV-C band energy to inactivate microorganisms is often referred to as UV germicidal irradiation. Many companies are now offering this technology for use in hospitals and other industries. In the wake of the COVID19 pandemic, UV technology has been used more extensively, but unfortunately there are limitations for its use. Because UV radiation exposure is hazardous to humans, it is typically used in one of four configurations: in unoccupied room disinfection, upper room disinfection, air handler unit surface disinfection and air handler surface airstream disinfection.4 Whether or not an infection rises to the level of medical malpractice will depend on the circumstances surrounding how and when the infection occurred. Medical malpractice cases can be difficult to prove; nevertheless, surgeons should be aware of preventive measures and call on their hospital leadership to do everything in their power to ensure patients remain safe and free of infection.

■

References 1. Hospital infection control: surgical site infections. http://bit.ly/3qYmYbX 2. Ban KA, Minei JP, Laronga C, et al. American College of Surgeons/Surgical Infection Society surgical site infection guidelines‒2016 update. Surg Infect (Larchmt). 2017;18(4):379-382.

3. Indoor air quality: what are the trends in indoor air quality and their effects on human health? http://bit.ly/2O1UNKX 4. UVGI vs. BPI: which air-cleaning technology is best for your building? http://bit.ly/3bHUfBZ

—David Taylor III, MSN, RN, CNOR, is the principal of Resolute Advisory Group LLC, a health care consulting firm in San Antonio.

He can be reached at DavidTaylor@ResoluteAdvisoryGroup.com.

He is a board member of OR Management News.

Biophysical continued from page 6

histamine and growth factor release, and wound contraction. At therapeutic doses, UV-C causes DNA damage that destroys pathogens without causing irreparable damage to human cells. UV-C is effective against antibioticresistant organisms, and UV-C resistance has not been reported. There are no standard protocols for the use of UV-C, but it can be applied in short, up to 120-second treatments. Notably, UV-C is contraindicated in patients with a history of skin cancer.

“I really think ultraviolet-C, which is covered under Medicare, is underused. It is a simple, safe and inexpensive means to treat superficial infections and critical colonization, even with organisms resistant to our antibiotics,” Dr. Cordrey said.

Extracorporeal Shock Wave Therapy Extracorporeal shock wave therapy (ESWT) is an emerging technology that uses sound waves to promote wound healing and decrease pain by stimulating inflammation, growth factor release, and production of collagen and nitric oxide synthase; disrupting biofilms; and promoting angiogenesis, fibroblast proliferation, cell migration and keratinocyte activity. Meta-analyses show improved healing of diabetic foot ulcers with ESWT compared with standard-of-care treatment (Wound Repair Regen 2017;25[4]:697-706; Can J Diabetes 2020;44[2]:196204.e193). Studies are ongoing to understand the role of ESWT in other etiologies, and there remain unanswered questions about its use, for example, around malignancies, near the head and in pediatric patients.

Vibration Therapy Vibration therapy is a low-intensity treatment that may help prevent muscle breakdown and necrosis. Studies in patients with healthy feet suggest that vibration increases perfusion and decreases hyperemia (Wound Manag Prev 2020;66[8]:7-14). Although the responses were less pronounced in patients with diabetes, these small changes may still be clinically relevant (Front Bioeng Biotechnol 2019;7:310). More research is needed to understand the future roles of this therapy.

Each of the emerging technologies discussed in this session offers promising new opportunities for wound healing support. Further development and adoption of new strategies will optimize healing and help patients recover from injury and surgery more quickly and comfortably.

“I have no idea about what is next in wound care technology. That’s why it’s so interesting,” Dr. Cordrey said.

“It’s a rapidly evolving field of practice, and as we learn more about how chronic wounds function, we find new ways to target them.”

■ OR Management News • March 2021

9

INF ECTIO N CO NTRO L

C. diff Screening May Provide Cost-Saving Benefit for Hospitals

By ETHAN COVEY

M

ore standardized screening of patients for Clostridioides difficile infection (CDI), instead of testing for infection only when indicated, may be a costeffective or cost-saving strategy for hospitals, according to a new study presented at the 2020 virtual IDWeek.

“Hospital-acquired CDI is a common and costly problem,” said Mohamed H. Yassin, MD, PhD, an associate professor of medicine at the University of Pittsburgh. “However, many of these cases are not traced to any hospital acquisition,” Dr. Yassin said. “Identification of C. difficile carriers by surveillance could help in two major ways,” he continued. “The first is to avoid the hospital-associated definition. Second, this information could affect the rate of antibiotic utilization by ordering physicians.”

Dr. Yassin and his colleagues used computer software to conduct a cost–benefit analysis of the financial impact of C. difficile screening versus traditional testing practices (poster 779).

They used Medicare and CDC data on community-associated and hospital-acquired CDI and costs of C. difficile testing.

The probability of infection was estimated based on recently published literature and unpublished clinical reporting.

The investigators analyzed how knowledge of C. difficile carrier status could affect antibiotic prescribing, and potential cost savings to hospitals if CDI were prevented by screening.

The team found that if antibiotic use was unchanged by C. difficile status, surveillance increased per-patient costs by $39. However, if knowledge of C. difficile status decreased the risk for CDI by 10% or 20%, which in turn decreased antibiotic prescribing, the cost savings were $15,519 and $3,822, respectively, per case of CDI avoided.

Hospital costs also were decreased due to surveillance. Estimated savings were $336 per patient if patients found to be colonized on admission were not considered to have hospital-associated CDI. “This analysis is important because it used clinical data to estimate the actual saving by using this approach,” Dr. Yassin said.

“There are major benefits for health care facilities and patients from C. difficile surveillance based on this model.”

Dr. Yassin and his colleagues hope to build upon this report with a larger study to confirm these results.

■

Early Antibiotics for Sepsis Don’t Result in Overall Higher Use

By ETHAN COVEY

D

ecreasing the time it takes to deliver antibiotic therapy to patients with sepsis does not necessarily correspond to an overuse or misuse of antibiotics, according to data presented at the SCCM’s 50th Critical Care Congress (abstract 38).

“A variety of programs have incentivized rapid antibiotic treatment for severe sepsis, but at the same time, there has been growing concern that earlier antibiotic timing for sepsis may result in increased antibiotic treatment for more patients overall, including those without infection,” said Sarah M. Seelye, PhD, a data scientist with the VA Center for Clinical Management Research, in Ann Arbor, Mich.

To date, however, there has been little evidence to support this claim.

Dr. Seelye and her colleagues investigated whether hospital-level acceleration

10

OR Management News • March 2021

in antibiotic timing for sepsis is associated with increased antibiotic use among all patients hospitalized with potential infection.

They identified 1,101,239 hospitalizations for potential sepsis infection, which took place in 132 Veterans Health Administration hospitals during 2013-2018.

More than half (55.2%) of these patients received antibiotics within 48 hours of emergency department (ED) admission, and 10.7% met the criteria for sepsis.

During the study period, a marked acceleration in time to antibiotics was seen, with the median time to antibiotics among sepsis hospitalizations declining from 5.8 hours in 2013 to 4.8 hours in 2018. This acceleration was seen in 84% of the surveyed hospitals, she said.

However, no association was found between changes in the timing of antibiotic delivery and total antibiotic use among

patients with potential infection. In 2013, approximately 57% of patients with potential infection were treated with antibiotics within the first 48 hours following ED arrival. By 2018, the percentage had declined to 55%.

“Despite this acceleration in antibiotic timing for sepsis, we found no evidence that changes in time to antibiotics for sepsis were associated with rising antibiotic use among all hospitalizations for potential sepsis,” Dr. Seelye said.

■

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CLIN IC A L NE WS

IV Acetaminophen Does Not Reduce Post-op Hypoxemia in Randomized Trial

By CHRISTINA FRANGOU

I

n patients who underwent abdominal surgery, IV acetaminophen did not reduce the duration of postoperative hypoxemia compared with placebo in a randomized, double-blind trial.

In the trial, IV acetaminophen did not significantly reduce postoperative pain, and it reduced opioid consumption by 14%, or 4 mg per day, an amount that was neither statistically significant nor clinically important.

“The study findings do not support the use of intravenous acetaminophen for this purpose,” concluded the authors from Cleveland Clinic, led by Alparslan Turan, MD, a professor of anesthesiology and the vice chair of outcomes research at the anesthesiology institute of Cleveland Clinic, in Cleveland.

“This study has changed our clinical practice,” Dr. Turan said. Cleveland Clinic has eliminated IV acetaminophen from its formulary, he said.

The study was published in JAMA (2020;324[4]:350-358).

Introduced in the United States in 2011, IV acetaminophen does not promote bleeding or delay bone healing and, although expensive, is used to complement or reduce the use of opioids as postoperative analgesics. However, its efficacy as an analgesic is unclear. Small studies have shown mixed results.

The FACTOR clinical trial is the largest randomized trial to examine the use of IV acetaminophen in patients undergoing abdominal surgery.

Between February 2015 and October 2018, 580 patients at two Cleveland Clinic institutions were randomized to receive IV acetaminophen at 1 g, or normal saline placebo starting at the beginning of surgery and repeated every six hours until 48 hours postoperatively or hospital discharge.

There was no significant reduction in the study’s primary outcome of median duration of hypoxemia (hemoglobin oxygen saturation of <90%) per hour: 0.7 minutes among patients in the acetaminophen group and 1.1 minutes among patients in the placebo group (P=0.29). Analysis

12

OR Management News • March 2021

revealed no significant difference in secondary outcomes, including nausea and vomiting, sedation, fatigue, active time and respiratory function.

Patients had a mean age of 49 years and 48% were women. All of them had an ASA physical status class of I to III, were scheduled for elective open or laparoscopic abdominal or pelvic surgery, and were expected to be hospitalized for at least two nights. They were randomized in a 1:1 ratio, and stratified based on long-term opioid use and trial site.

There was no significant reduction in median duration of hypoxemia (hemoglobin oxygen saturation of <90%) per hour: 0.7 minutes among patients in the acetaminophen group and 1.1 minutes among patients in the placebo group.

The study had several limitations. Enrollment was limited to two hospitals belonging to Cleveland Clinic; about 15% of patients in each group used current analgesics; and 10 patients had missing data due to unexpected technical problems. Only abdominal procedures were included because they typically require considerable opioid use.

Intravenous acetaminophen may be more effective for less painful procedures, the authors noted.

The study results should persuade clinicians to curtail their use of IV acetaminophen for surgical patients, said Elizabeth Wick, MD, a professor of surgery at the University of California, San Francisco School of Medicine. She added that evidence supports the use of nonopioid analgesia, particularly nonsteroidal anti-inflammatory drugs, for abdominal surgery patients as long as they do not have a contraindication.

“We need to hold ourselves accountable to practice evidencebased perioperative care, and if the data isn’t there to use IV acetaminophen, we shouldn’t ■ use it,” Dr. Wick said.

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FE ATUR E

Inside the COVID-19 Vaccine Rollout

Despite a rocky start, the COVID-19 vaccine rollout in the United States is looking up.

By VICTORIA STERN

14

OR Management News • March 2021

FEAT URE

In early February, Anthony S. Fauci, MD, the director of the National Institute of Allergy and Infectious Diseases, told the NBC show “Meet the Press” that although demand for the vaccine “clearly outstrips supply” right now, “things are going to get better, as we get from February into March, into April, because the number of vaccine doses that will be available will increase substantially.”

The numbers are already bearing out Dr. Fauci’s prediction. By Jan. 31, just over 25 million Americans had received a total of 31 million total doses. Fifteen days later, that number had jumped to 38 million Americans receiving more than 53 million doses, and the number of fully vaccinated Americans more than doubled from 5.6 million to 14 million, according to the CDC’s COVID data tracker (http://bit.ly/2O7WqXa).

Despite these improvements, the United States still has a long way to go. As of March. 4, only about 8.1% of Americans have received two vaccine doses. Furthermore, with new, more contagious viral variants circulating in the country (http://bit. ly/37PxeMl), accelerating the pace has taken on new urgency.

The race to beat back the virus is on. The key question comes down to whether the United States can resolve the shortfalls of the vaccine campaign to vaccinate as many people as possible before the more infectious variants take hold.

A Bumpy Beginning Slow. Erratic. Troubled.

Those adjectives encapsulate critiques of the vaccine rollout since mid-December, after the FDA granted emergency use authorization of the Pfizer/BioNTech and Moderna vaccines.

Hampered largely by limited supply and a disjointed distribution plan, only 3 million doses reached Americans by the end of 2020, even though states received 14 million.

“Each stage of the vaccine rollout has been fraught with inefficiencies, which has delayed getting shots into people’s arms,” said Nicolette Louissaint, PhD, the executive director and president of Healthcare Ready, a disasters support organization.

The lack of a national strategy early on is partly to blame, Dr. Louissaint said. Without a national plan, decisions about vaccine distribution occurred at multiple hubs, often resulting in a lag between doses delivered to the federal government and states and administered by facilities.

“We haven’t seen institutions holding back vaccine or leaving doses unused,” Dr. Louissaint said. “What we have seen is facilities wanting to know when to expect new shipments of first and second doses.”

Eric Werttemberger, PharmD, the manager of the COVID19 vaccination rollout at Providence Regional Medical Center, in Everett, Wash., understands the challenges of an uncertain vaccine supply. Providence had been planning the hospital’s rollout since the Pfizer and Moderna vaccines were authorized last September.

Keeping in lockstep with the Advisory Committee on Immunization Practices’ guidelines (http://bit.ly/2O1jLdo), the 600-bed hospital began inviting the tier 1A group of high-risk caregivers in the hospital and first responders for their initial dose. When Providence received its first shipment of the Pfizer vaccine on

President Joe Biden visited Kalamazoo, Mich., to tour a Pfizer manufacturing plant Feb. 19, 2021. Source: Wikimedia Commons

Dec. 17, the hospital was ready to go.

Over the next six weeks, Providence received five total shipments: two earmarked for first doses, two for second doses and one transferred to another site. After the initial shipment of 2,925 doses, Providence received 5,000 more doses, which covered the first shots for 60% of the hospital’s 4,547 employees and booster shots for 40%.

However, the supply delivered each week varied, making it difficult to plan ahead.

“There is no shipment schedule, so you only know at the end of the week if you will get vaccine the following week,” said Dr. Werttemberger, the director of pharmacy and digestive health services at Providence. “Not knowing what our future allocation will be makes the process much more challenging.”

Health care institutions across the country have faced a similar stumbling block. New York City established 15 mass vaccination sites, but “the sites had to close in late January because we ran out of first doses,” Lewis W. Marshall, MD, JD, FACHE, the chairman of the board of directors of the Regional Emergency Medical Services Council of New York City, told OR Management News.

The vaccine shortage caused 23,000 first-dose appointment cancellations in the city.

Another major hurdle is that states are operating on different time lines, “depending on how large their priority groups are, their capacity to vaccinate, and vaccine supply,” according to a report from the Kaiser Family Foundation (http://bit.ly/2Mz6Y1q).

In California, teachers became eligible for shots toward the end of February, while New York teachers had been receiving them since Jan. 11. In Minnesota, eligibility for older adults has varied by provider due to supply limitations. As of Feb. 4, Allina Health and CentraCare included people over 65 while Mayo Clinic had continued on the following page

OR Management News • March 2021

15

INF ECTIO N CO NTRO L

Bloodstream Infections Complicate COVID-19 Risks

By ETHAN COVEY

S

econdary bloodstream infections (sBSIs) may pose a significant risk to patients with severe COVID-19, according to a Rutgers University study.

The study is the first to assess the microbiology, risk factors and outcomes among hospitalized patients with sBSIs and severe COVID-19 (Clin Infect Dis [Epub Nov 20, 2020]. doi. org/10.1093/cid/ciaa1748).

“In our clinical experience, we noticed anecdotal trends of secondary bloodstream infections in severely ill patients with COVID-19, which led us to conduct this study,” said Navaneeth Narayanan, PharmD, a clinical associate professor in the Department of Pharmacy Practice and Administration at Rutgers University Ernest Mario School of Pharmacy, in Piscataway, N.J. “COVID-19 is a novel disease, so our understanding of its complications and how to predict and manage these complications is limited; therefore, we need more rigorous data evaluating this.”

The researchers focused on 375 patients diagnosed with severe COVID-19 from March through May 2020 who were admitted to three different New Jersey hospitals. Among this group, 128 cases of sBSIs were diagnosed, 91.4% of which were bacterial and 5.5% were fungal.

Patients with sBSIs were more likely to have altered mental status, a lower percentage of oxygen saturation, septic shock and to be admitted to the ICU compared with those without sBSIs. “These presenting symptoms could reflect either superimposed effect of the sBSI with severe COVID-19 or just a marker of critical illness due to COVID-19 itself,” said Pinki J. Bhatt, MD, an assistant professor in the Division of Infectious Diseases at Rutgers Robert Wood Johnson Medical School in New Brunswick, N.J. “I think this proves that further larger and prospective studies are needed to better assess how common sBSI are in patients diagnosed with severe COVID-19.”

The team also found that approximately 80% of patients received antimicrobials at some point while they were hospitalized, and, notably, many received antimicrobials despite having negative blood cultures.

“At the time, there was limited information regarding the natural course of the disease, and, thus, it likely prompted the clinician to give antimicrobials,” Dr. Bhatt said. “But we feel this supports the fact that antimicrobial stewardship is very important at this time to prevent adverse drug reactions, drug resistance and other infections, such as Clostridioides difficile.”

While the researchers noted that further study is needed to better understand the interrelationship of sBSIs and COVID19, they agree the results shed light on a previously unclear ■ aspect of the disease.

16

OR Management News • March 2021

Vaccine Rollout continued from the previous page

only expanded to include those over 80 years old.

“We may have a directive to vaccinate people 65 and older, but don’t have enough vaccine to get a fraction of that group,” Melanie D. Swift, MD, MPH, the medical director of the Mayo Clinic Physician Health Center and an assistant professor of medicine, explained in a Jan. 20 webinar.

A Brighter Road Ahead?

The race to beat back the virus is on. The key question comes down to whether the U.S. can resolve the shortfalls of the vaccine campaign to vaccinate as many people as possible before the more infectious variants take hold.

What will it take for the United States to overcome these initial obstacles and forge a path ahead?

According to Dr. Louissaint, “our priority should be developing a national vaccine strategy that takes a lot of the burden off states and can help smooth out the delays.”

A national strategy is taking shape. In late January, President Joe Biden outlined a five-part national campaign focused on increasing vaccinations and securing doses for all Americans (http://bit.ly/3kzg1fm). On Feb. 11, Biden announced that the federal government had purchased enough vaccine to inoculate all Americans and is “now working to get those vaccines into the arms of millions of people.”

The United States has made progress, ramping up from an average of 900,000 doses per day to about 2 million doses daily as of March. 4.

Still, experts say that goal needs to be closer to 3.3 million doses per day by April to enable most Americans to get at least one shot by June. Moderna and Pfizer have agreed to increase production to meet that pace, and FDA authorization of a single-shot vaccine from Johnson & Johnson, plus a possible fourth option from Novavax, should help the country tackle the vaccine shortage.

“It’s been quite a wild ride so far, but I think things are improving,” said Desi Kotis, PharmD, the chief pharmacy executive at the University of California, San Francisco Health. “In the next couple of weeks, we will have more relief and more doses coming to states.”

Once the vaccine supply becomes consistent, the main challenge will center on the logistics of administering those doses.

Dr. Kotis thinks the United States is up to the challenge. “The rollout can be a fine-oiled machine. We have the structure, people, safety and work protocols in place, and it’s now a matter of scaling all this up,” she said. Despite the bumpy start, “I am seeing a ■ bright light ahead and it’s not a train coming back at me.”

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C LIN IC A L NE WS

Presurgical Optimization Programs Benefit Patients, Boost Bottom Line

By CHRISTINA FRANGOU

P

reoperative optimization programs (POPs) can improve patients’ readiness for surgery, reduce day-of-surgery cancellations, and produce financial benefits for surgical practices, new research suggests.

In a study from the University of Michigan, high-risk patients who attended a low-cost preoperative optimization clinic in the months before their elective abdominal hernia repair were successfully optimized for surgery and experienced a low rate of unintended health consequences in the lead-up to their operation.

The program also had financial benefits for the clinic, with more patients able to undergo surgery and an increase in herniarelated relative value units (RVUs) for the institution.

In 2018, the University of Michigan launched an optimization program for patients undergoing elective hernia repair.

Patients who requested an elective hernia repair and had a body mass index over 40 kg/m2, were smokers, or were older than 75 years of age were directed to the once-weekly, half-day clinic led by an advanced practice provider. In appointments, the provider counseled patients about smoking cessation and nutrition, made referrals to bariatric surgery or weight programs, did weight loss check-ins, and coordinated with other health care providers to improve patients’ comorbidities. Patients could become eligible for surgery if they successfully mitigated controllable risk factors.

Of 176 patients referred to the clinic, 52% were for weight, 34% for tobacco use and 14% for age. Median follow-up was 183 days (range, 39-378 days).

Overall, 10% of referred patients were successfully optimized for surgery. Tobacco cessation was achieved in 12% of active smokers, and 9% of people with obesity elected to pursue bariatric surgery.

The rate of hernia incarceration requiring emergent surgery was 3%.

In its first year, the program increased the rate of referred patients who underwent surgery, leading to a 19% increase in surgical yield, compared with the number of new hernia patients who were immediately eligible for surgery in 2018. Surgeons saw 10% more patients in the surgical clinic, and there was a 27% increase in hernia-attributed RVUs without altering surgeon workflow.

“These results showed a low rate of adverse health events during the time period of surgical delay, suggesting we can safely delay surgery in order to mitigate risk factors for high-risk surgical patients,” said Lia D. Delaney, BS, a medical student and researcher at the University of Michigan Medical School, in Ann Arbor, who presented the findings. “There is no detriment to the institution because we are increasing patient capacity and financial gain.”

Financial concerns, along with fears of emergent presentation, are often cited as barriers to optimization, she said. However, the

18

OR Management News • March 2021

University of Michigan model is low-cost, scalable and sustainable for other practices.

“Implementation of a similar model only requires a workflow adjustment for the institution, based on triaging patients who request elective surgery,” she said.

In a study from Stamford Hospital in Connecticut, patients who participated in a POP before their elective surgery were less likely to have their operation canceled on the day of their procedure.

Researchers conducted a retrospective data review of all elective surgical procedures with planned same-day inpatient admission at Stamford Hospital between October 2018 and January 2020.

Of 5,352 patents scheduled for surgery over this period, 2,934 attended the hospital’s POP. Among patients who attended the POP, only 0.55% of cases were canceled on the day of surgery—far lower than the 12.4% reported in the group who were not POP participants.

There were 300 patients of 2,418 in the non-POP group who had same-day cancellations. All were due to incomplete workups.

In comparison, 16 of 2,934 patients in the POP group experienced same-day cancellations. Acute changes in status or noncompliance with preoperative instructions were the most significant drivers of cancellations in the POP group.

“Formalized perioperative optimization programs can significantly decrease day-of-surgery cancellation rates, can also decrease hospital costs, and, above all, provide a streamlined perioperative experience for our patients,” said presenting author Nicolle Burgwardt, MD, a surgical resident at Stamford Hospital.

Participation in the POP clinic increased over time as surgeons became more supportive of the program, she said. Nearly 70% of surgical patients are now seen at the clinic, up from 39% in 2018.

■

CLIN IC A L NE WS

Frailty Screening Associated With Reduced Mortality After Elective Surgery

By CHRISTINA FRANGOU

O

ne-year mortality after elective surgery decreased significantly across nine surgical service lines after staff began screening patients for frailty using a validated tool, researchers reported.

In July 2016, surgeons at the University of Pennsylvania implemented the Risk Analysis Index (RAI), a 14-item instrument used to measure surgical frailty, as part of the standard assessment for all new patients and preoperative visits. Within six months, clinics achieved 84% compliance with recommended screening.

A year and a half into the program, staff added the RAI as an Epic Best Practice Advisory (BPA) that required providers to act on RAI scores greater than or equal to 42.

Investigators examined one-year mortality among 28,876 patients who presented for elective surgery between 2013 and 2019 and were available for analysis.

One-year mortality rates remained

stable at 9.9% in the months leading up to the RAI implementation. After the assessment tool was added in the summer of 2016, absolute one-year mortality fell by 0.2% per month. This negative trend increased to 0.87% after the BPA intervention, resulting in a one-year mortality rate of 8.7% once the RAI was fully integrated into the system.

Presenting author Patrick R. Varley, MD, an assistant professor in surgical oncology at the School of Medicine and Public Health at the University of Wisconsin–Madison, said it’s unclear why the initiative affected mortality rates so significantly. It could be that providers selected patients more carefully for surgery and diverted high-risk patients to nonoperative therapies, or providers might have engaged in more prehabilitation measures to improve patient fitness for surgery, he said.

“But because people knew there was a focus on frailty and frailty screening, they

engaged in practices which improved outcomes for patients,” Dr. Varley said. “This makes it difficult to pinpoint one element of the initiative that had the most effect.”

In this study, 48% of patients underwent surgery prior to the RAI, 32% after RAI implementation but before the BPA, and 18% after the RAI was integrated into the BPA. ■

The Joint Commission: Update on Surgical Smoke

By ORM STAFF

A

n increasing amount of research confirms that surgical smoke can contain toxic gases and vapors such as benzene, hydrogen cyanide, formaldehyde and bioaerosols, as well as live cellular material and viruses (http://bit.ly/3qfQCc8).

“While exposure of surgical smoke to patients is short term and relatively low risk, surgeons, perioperative nurses and other operating room staff are exposed to surgical smoke daily,” Ana

20

OR Management News • March 2021

Pujols McKee, MD, the executive vice president, chief medical officer, and chief diversity and inclusion officer at the Joint Commission, said in a press release. “At high concentrations, surgical smoke may cause ocular and upper respiratory tract irritation and potentially create visual problems for the surgeon. This is why it is so important for hospitals and ambulatory surgery centers to be aware of the risks of surgical smoke and how they can best mitigate those risks.”

The literature reveals that nanoparticles comprise 80% of surgical smoke and are the real danger in inhaled smoke (Biointerphases 2007;2[4]:MR17-MR71). These particles are less than 100 nanometers in size (i.e., 0.1 micron), and when inhaled, enter a person’s blood and lymphatic circulatory systems and travel to distant organs (Circulation 2002;105[4]:411-414).

In an effort to keep health care workers up-to-date, the Joint Commission recently published a new advisory, “Alleviating the dangers of surgical smoke,” which reviews current regulations, recommendations and standards from several governmental and professional organizations. To view the guidelines, and several safety actions, go to http://bit.ly/3oGSPgd. ■

T ECHNOLOGY

AI Tool Can Predict Post-op Hernia Complications

By KAREN BLUM

A

n artificial intelligence algorithm could be used to help surgeons determine which hernia patients have complex cases and are best suited for care at larger referral centers, according to new research.

When presented with pixels from hernia patients’ preoperative CT images, an AI tool developed by investigators at Carolinas Medical Center, in Charlotte, N.C., learned to predict which patients would require component separation or transfer to the ICU because of pulmonary insufficiency, or develop a surgical site infection (SSI), with 64% to 83% accuracy. The work was presented during the Americas Hernia Society virtual annual meeting and received the society’s 2020 Best Paper Award.

“Early studies of AI show promising results aiding surgeons in successful identification of malignancy, ocular and skin pathology, and cerebral bleeding. However, the role of AI in general surgical procedures is unknown,” said lead author and general surgeon Sharbel Elhage, MD. “Determining which hernia patients will require complex surgical techniques or specialized postopera‘These tools, once tive care remains difficult and is refined, can allow often a subjective decision-making process. The aim of our study for objective analysis was to develop a machine-learnof hernia patients ing algorithm that could predict complexity and complications in preoperatively, hernia patients based on preoperreplacing much of the ative CT imaging alone.”

Dr. Elhage’s team pulled incurrent subjectivity.’ house data of hernia patients —Sharbel Elhage, MD undergoing open abdominal wall reconstruction who had CT scans containing the entire hernia defect. Their outcomes of interest were component separation, defined as transversus abdominis release or external oblique release; pulmonary failure, defined as transfer to the ICU for respiratory complications or intubation; and wound complications, specifically SSIs. The investigators analyzed images using TeraRecon’s Aquarius iNtuition software and created their tool using the programming language Python and open source Tensorflow and OpenCV

frameworks. They standardized all CT images to 150✕150 pixels, which was analyzed by an eight-layer convolutional neural network to determine the key image characteristics. Next, they batched the images into training and validation sets.

Overall, the team assessed images from 233 patients. Hernias had an average defect width of 9.4 cm. Patients had a component separation rate of 46.2%, a pulmonary failure rate of 7.3%, and an SSI rate of 22.5%.

The investigators first assessed the AI tool’s ability to predict component separation, Dr. Elhage said. After reviewing CT images 8,000 times while being provided correct information, the algorithm reached 100% accuracy in assessing images in the training set. Next, presented with CT scan images from a validation set of patients, the computer tool accurately predicted whether those patients would require a component separation technique with an accuracy of 74% (P<0.001). Assessing postoperative complications, the tool also reliably predicted patients who would develop pulmonary failure 83% of the time (P<0.001).

The AI program also predicted which patients would develop an SSI postoperatively at a rate of 64%, but this did not reach statistical significance (P=0.081).

The work demonstrates that “AI can successfully be used to predict complexity and complications in hernia patients solely based on preoperative CT imaging,” Dr. Elhage said. “This is a groundbreaking proof of concept for the entire surgical field, showing that valuable intra- and postoperative information can be garnered by AI analysis. These tools, once refined, can allow for objective analysis of hernia patients preoperatively, replacing much of the current subjectivity involved in the evaluation and risk stratification of hernia patients, and allowing for the creation of a data-driven, tiered hernia referral system that should improve care for hernia patients around the world.”

Preliminary testing has shown the program has been more successful than a panel of expert hernia surgeons in predicting which patients will require component separation, Dr. Elhage added.

The team is continuing work to optimize the algorithms, through methods such as adding additional patient images, assessing what the algorithm is weighting as most important, and adding database variables such as tobacco use, diabetes status and body mass index, with the goal of testing the tool in multicenter prospective ■ trials, he said.

OR Management News • March 2021

21

CLIN IC A L NE WS

Ultrasound for Diagnosing Appendicitis: A Potentially Valuable Adjunct

By CHASE DOYLE

D

espite more than 280,000 appendectomies being performed in the United States every year, appendicitis remains a diagnostic challenge. Up to 40% of cases do not present in the classic manner, and the negative appendectomy rate has stayed the same for decades.

During the American College of Surgeons Clinical Congress 2020, Norma T. Walks, MD, a general surgeon at Yuma Regional Medical Center, in Arizona, discussed the benefits of using ultrasound to diagnose appendicitis and compared it with the current gold standard CT. “Although it has its limitations, ultrasound can be a valuable tool for evaluating appendicitis,” Dr. Walks said. “The specificity of ultrasound approaches that of CT scan without the concurrent risks, and it can be a valuable adjunct for indeterminate cases.”

Problems With the Gold Standard As Dr. Walks reported, the use of CT imaging for diagnosing appendicitis has been increasing steadily since the 1990s.

Although fast and accurate, with a sensitivity and specificity of approximately 95% in both adults and children, CT scans present some problems.

“CT scans are expensive; you have to deal with IV or oral contrast; and rural access can be particularly challenging,” Dr. Walks explained.

A 2008 study of the imaging capabilities of various emergency departments in the United States found that although CT scanners were available in most (96%), 5% of rural hospitals had on-call CT technicians and 1% had no after-hours access. Rural hospitals also tended to have lower-resolution CT scanners of less than four slices, Dr. Walks said.

Another problem is that CT scans are associated with radiation exposure. A 2013 study from the National Institutes of Health found that CT scans of the abdomen and pelvis cause one cancer for every 300 to 390 scans in girls and 670 to 760 scans in boys, respectively.

Advantages of Ultrasound Imaging In contrast, ultrasound has the benefit of being fast and low cost with no radiation risks. In addition, no contrast is needed, Dr. Walks said, and it provides immediate point-of-care imaging.

Although ultrasound is easily repeatable, it’s considered operator dependent and technician skill can affect its utility.

The patient’s anatomy can also be a barrier. “When the appendix is in the retrocecal position, it can change the field of view,” Dr. Walks noted. “Obesity, previous surgeries and perforation can also influence the effectiveness of ultrasound.”

The sensitivity and specificity of ultrasound are inferior to CT scans. A meta-analysis comparing CT scans and ultrasounds in children and adults found that ultrasound had a 22

OR Management News • March 2021

sensitivity and speci-ficity of 88% and 94%,, respectively (Radiology 2018;288[3]:717-727).

Although CT scans had a higher sensitivity at 94%, the specificity of 95% did not differ by much, Dr. Walks said. as In addition, ultrasound has been used to reduce the negative appendectomy rate. Guidelines for appendicitis introduced in the Netherlands in 2010, that made ultrasound imaging mandatory for suspected appendicitis in children, helped to decrease the rate of negative appendectomy to 2.7% without increasing the frequency of CT scans.

‘Ultrasound is cheap, fast, safe and relatively easy to learn. Basically, if you see something on ultrasound, it means something.’

—Norma T. Walks, MD

Learning the Technique For competence in ultrasound, there’s a shallow learning curve, according to Dr. Walks, who noted that studies have shown rapid improvement in performance with minimal experience. In one study, for example, third-year surgery residents being trained in ultrasound on children improved their accuracy from 85% at the start of a three-day course to 93% by the end.

As Dr. Walks explained, ultrasound technicians use a technique called graded compression and look for the following primary signs: blind tubular structure, diameter greater than 6 mm and a “target sign” as with CT imaging. Secondary signs include free fluid, compression, fat changes and a phlegmon.

“Ultrasound is cheap, fast, safe and relatively easy to learn,” Dr. Walks concluded. “Basically, if you see something on ultrasound, it means something.”

The moderator of the session, Daniel L. Dent, MD, the director of the general surgery residency program and a professor of surgery at the University of Texas Health Science Center at San Antonio School of Medicine, acknowledged “trust issues” concerning ultrasound, given the “fuzziness of the pictures.”

Dr. Dent said: “I’ve been spoiled by having good CT imaging. How much practice should it take to develop trust in my own ability to interpret ultrasound, and where is it typically performed?”

“Personally, I would just practice wherever I have access, whether it’s in the pre-op area or the operating room, but it’s really not that complicated,” Dr. Walks said. “You don’t have to be that sophisticated in your ultrasound skills to see an appendicitis. If you see a tubular structure in the right lower quadrant, there’s probably something wrong with the patient’s appendix.”

■

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