sutures newsletter

PRODUCED BY AND FOR MEMBERS OF THE DEPARTMENT OF SURGERY December 2013 | Archived Issues

Human Factors in Surgical Care

Work Focuses on Human Behaviors in Complex Systems

By Ken Catchpole, PhD
Director, Surgical Safety and Human Factors

Why do medical errors happen? What helps healthcare providers work to the best of their ability? Human factors — the study of the relationship between humans and the systems they work in, and the practical application of that knowledge — seeks to answer these questions.

» Read more

Faculty Members Receive Grants

Four faculty members in the Department of Surgery — Jennifer Anger, MD, Dolores Di Vizio, MD, PhD, Dan Gazit, PhD, DMD, and Jayoung Kim, PhD — have recently received grants.

» Read more

Luncheon Celebrates Lung Cancer Survivorship

Hundreds of Cedars-Sinai lung cancer patients, family members, physicians, nurses and other healthcare workers celebrated survivorship and learned about the latest advances in lung cancer treatment at the 12th annual lung cancer survivors' luncheon Nov. 15.

» Read more

Cedars-Sinai Patient Undergoes First-of-Its-Kind Stent Graft Procedure

A patient at Cedars-Sinai has become the first in the nation to undergo a less invasive type of stent graft procedure to repair an ascending aorta.

» Read more

Journal's Cover Features Cedars-Sinai Paper

A paper written by several members of the Cedars-Sinai Department of Surgery is featured on the cover of the Dec. 15 issue of the journal Stem Cells and Development.


 

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FDA Warns About Clobazam; Boxed Warnings Summarized

Pharmacy Focus

The U.S. Food and Drug Administration has approved changes to the drug label and medication guide for the anti-seizure drug clobazam (Onfi®) to include a warning regarding the rare but serious risk of skin reactions. Also, a summary of FDA boxed warnings has been issued.

» Read more

Circle of Friends Honorees for November

The Circle of Friends program honored 114 people in November. Circle of Friends allows grateful patients to make a donation in honor of the physicians, nurses, caregivers and others who have made a difference during their time at Cedars-Sinai.

» Read more

Human Factors in Surgical Care

The OR360 project seeks to re-engineer teamwork and technology for 21st-century trauma care.

Work Focuses on Human Behaviors in Complex Systems

By Ken Catchpole, PhD
Director, Surgical Safety and Human Factors

Medical accidents are among the top 10 causes of deaths in the United States, with approximately 10 percent of patients experiencing some form of accidental harm. These accidents cost up to $980 billion per year.

Why do medical errors happen? What helps healthcare providers work to the best of their ability? The causes are complex and multifactorial, yet safety interventions frequently ignore this complexity. Human factors — the study of the relationship between humans and the systems they work in, and the practical application of that knowledge — seeks to answer these questions. Human factors grew out of a combination of management science and applied psychological research, and has become a key component of safety and performance improvement in other high-risk industries. It is vastly underrepresented in healthcare, but it is growing fast.

Healthcare systems create errors through a complex mix of factors. The tasks required, the equipment used, the working environment, the team and pressures from the organization all contribute to failure or success in any complex system. Human beings create safety by holding deficient systems together, and rather than signifying "negligence," adverse events are a symptom of deeper system problems. Putting humans at the center of developments in technology and treatments allows us to address the needs of our providers and patients, improving safety and efficiency, reducing costs and enhancing overall well-being.

The delivery of safe and efficient trauma care requires the precise coordination of multiple hospital teams under considerable time pressure. As part of the Cedars-Sinai OR360 initiative, funded by the Department of Defense, our team observed the entire trauma process for more than 150 patients. We found that flow disruptions occur about every six minutes. These disruptions interrupt or slow the work of trauma teams and cause errors.

Our observations enabled us to identify key aspects of process, workplace modification, teamwork, technology and information management that would benefit from re-engineering, resulting in measured improvements for patients and staff.

Sustaining this optimal human performance remains a challenge, so a secure, cross-platform smart app is now in development to hard-wire these improvements. It will act as a shared information resource, displaying basic patient information to enhance teamwork, situation awareness and decision making to avoid preventable mistakes. Ongoing work based on models of error-free, time-pressured performance in aviation and motor racing is set to improve the reliability and safety of handoffs across the medical center.

In the past, the failure to understand why errors and complications happen has limited improvements, but the lessons are now being learned. As part of its approval process, the U.S. Food and Drug Administration now requires a human factors assessment for every new medical device, leading to safer, easier-to-use devices that minimize the opportunities for errors. Simulation capabilities have grown exponentially, offering the ability improve technical skills, teamwork skills, equipment designs and our understanding of accident causation.

Human factors research is helping to expand our ability to improve performance and safety beyond force of will, awareness, more checks or more rules. The growing understanding of how humans perform in clinical systems will benefit every healthcare practitioner and patient at Cedars-Sinai and worldwide.

Faculty Members Receive Grants

Four faculty members in the Department of Surgery have recently received grants.:

  • Dolores Di Vizio, MD, PhD, received a grant from the Avon Foundation for Women titled "Large Oncosomes in Tumor Tissues and in the Circulation of Patients With Aggressive Breast Cancer" in the amount of $300,000.
  • Dan Gazit, PhD, DMD, received a California Institute for Regenerative Medicine (CIRM) Early Translational IV research grant titled "Gene Targeting to Endogenous Stem Cells for Segmental Bone Fracture Healing" in the amount of $5.2 million over three years.
  • Jayoung Kim, PhD, received the University of California, Davis, West Coast Metabolomics Center pilot grant titled "Urinary Metabolites in IC/PBS Diagnosis."
  • Jayoung Kim, PhD, and Jennifer Anger, MD, are co-principal investigators of a project that received a National Institutes of Diabetes and Digestive and Kidney Diseases grant titled "Urinary Metabolites in IC/PBS Diagnosis" in the amount of $416,000.

Luncheon Celebrates Lung Cancer Survivorship

Thoracic surgeon Heather Merry, MD, speaks at the luncheon.

Hundreds of Cedars-Sinai lung cancer patients, family members, physicians, nurses and other healthcare workers celebrated survivorship and learned about the latest advances in lung cancer treatment at the 12th annual lung cancer survivors' luncheon Nov. 15.

At Cedars-Sinai, more than 90 percent of lung cancer surgery is done using minimally invasive techniques, Robert McKenna Jr., MD, told the crowd at the event.

Jo-Ann Lautman was one of several patients who spoke at the luncheon.

About 200 people attended the Thoracic Surgery Program's event in Harvey Morse Auditorium. The main speaker was Robert McKenna Jr., MD, medical director of Thoracic Surgery, and co-medical director and surgical director of the Cedars-Sinai Women's Guild Lung Institute.

McKenna said physicians are now able to screen effectively for very small tumors, and he pointed out that minimally invasive surgical techniques allow for much quicker recovery. Cedars-Sinai surgeons were the first to perform these techniques, he said, and more than 90 percent of lung cancer surgery at the medical center is done using minimally invasive techniques.

Cedars-Sinai is constantly exporting new techniques and treatments for lung cancer, McKenna said. "We are very committed to changing the world when it comes to lung cancer, and we are teaching our techniques every day to surgeons from the U.S. and around the world," he said.

In addition to McKenna, speakers included Harmik J. Soukiasian, MD, associate director of Thoracic Surgery and associate program director of the Thoracic Surgery Residency Program, and thoracic surgeon Heather Merry, MD. Patients also gave testimonials.

The Thoracic Surgery Program is part of the Cedars-Sinai Women’s Guild Lung Institute in the Samuel Oschin Comprehensive Cancer Institute.

Cedars-Sinai Patient Undergoes First-of-Its-Kind Stent Graft Procedure

A patient at Cedars-Sinai has become the first in the nation to undergo a less invasive type of stent graft procedure to repair an ascending aorta.

Ali Khoynezhad, MD, PhD

Thoracic endovascular aortic repair (TEVAR) has become the standard of care for the majority of patients with descending aortic or distal aortic arch pathologies, including aneurysms, dissections, aortic ulcers, intramural hematomas and traumatic aortic injuries. All of these pathologies are now approved indications for this less invasive procedure, according to U.S. Food and Drug Administration.

Open repair, on the other hand, remains the standard of care for all diseases of the ascending aorta, such as type A aortic dissection and aortic aneurysms.

Recently, a patient of Ali Khoynezhad, MD, PhD, director of Thoracic Aortic Surgery at Cedars-Sinai, underwent successful stent graft repair of an ascending aortic pathology. This patient is the first in the U.S. to undergo an approved stent graft procedure as part of the FDA's investigational device exemption.

Without this less invasive procedure, the patient would have needed an extensive operation involving sternotomy and open-heart surgery with a heart-lung machine to replace the ascending aorta. Instead, he had the stent graft placed though the femoral arteries and was discharged two days later.

Patients with the following conditions may be candidates for the less-invasive TEVAR as part of this FDA pathway: aortic aneurysms, type A aortic dissections, ascending aortic ulcers, and intramural hematomas and pseudoaneurysms of the ascending aorta.

If you would like to know if your patients are candidates for this less invasive procedure, contact Khoynezhad at 310-423-4345 or ali.khoynezhad@cshs.org.

Journal's Cover Features Cedars-Sinai Paper

A paper written by several members of the Cedars-Sinai Department of Surgery is featured on the cover of the Dec. 15 issue of the journal Stem Cells and Development.

The paper's title is "Bone Morphogenetic Protein-2/-4 Upregulation Promoted by Endothelial Cells in Co-culture Enhances Mouse Embryoid Body Differentiation." Its authors are Dodanim Talavera, MD, PhD, Ankur Gupta, MD, Silvia Kurtovic, MD, Kira L. Chaiboonma, Vaithilingaraja Arumugaswami, MVSc, PhD, and Donald C. Dafoe, MD.

An illustration from the paper appears on the cover of the journal.

FDA Warns About Clobazam; Boxed Warnings Summarized

Pharmacy Focus

The U.S. Food and Drug Administration has approved changes to the drug label and medication guide for the anti-seizure drug clobazam (Onfi®) to include a warning regarding the rare but serious risk of skin reactions called Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN).

Also, a summary of FDA boxed warnings has been issued.

Regarding the clobazam warning, the FDA issued the following recommendations:

  • Monitor patients closely for signs or symptoms of SJS/TEN, especially during the first eight weeks of therapy or when reintroducing therapy.
  • Discontinue clobazam at the first sign of rash, unless the rash is clearly not drug related.

To learn more, visit this FDA Web page.

FDA Boxed Warnings Summarized

A summary of boxed warnings from the FDA has been issued. Click the PDF link below to see the summary.

FDA Boxed Warning Summary (PDF)

Circle of Friends Honorees for November

The Circle of Friends program honored 114 people in November.

Circle of Friends allows grateful patients to make a donation in honor of the physicians, nurses, caregivers and others who have made a difference during their time at Cedars-Sinai. When a gift is made, the person being honored receives a custom lapel pin and a letter of acknowledgement.

Click here for more information about the program and for a list of past honorees.

  • Tatiana T. Abrekov
  • Jamil Ahmed
  • Jose S. Amador
  • Jennifer T. Anger, MD, MPH
  • Amerine Bailey, RN
  • Lilit Baldjyan, RN, MSN
  • Babak R. Bamshad, MD
  • Rachel Berla, RN, BSN, CCRN
  • Maria Rita B. Bihis
  • Earl W. Brien, MD
  • Barry J. Brock, MD
  • Philip G. Brooks, MD
  • Neil A. Buchbinder, MD
  • Christiane Michele J. Burnison, MD
  • Marshia G. Caceres, MSW, LCSW, ACM
  • James L. Caplan, MD
  • John D. Carmichael, MD
  • Ilana Cass, MD
  • David H. Chang, MD
  • Kirk Y. Chang, MD
  • Jason S. Cohen, MD
  • Myles J. Cohen, MD
  • Stephen R. Corday, MD
  • Alice C. Cruz, MD
  • Ram C. Dandillaya, MD
  • Catherine M. Dang, MD
  • Marietta A. De Jesus, RN
  • Karan Dhir, MD
  • Enrique P. Dondonay, BSN, RN, CMSRN
  • Noam Z. Drazin, MD
  • J. Kevin Drury, MD
  • Julie A. Dunhill, MD
  • Clarke D. Espy, MD
  • Gerhard J. Fuchs, MD
  • Erwin Peter Gabor, MD
  • Steven S. Galen, MD
  • Avrom Gart, MD
  • Ivor L. Geft, MD
  • Richard N. Gold, MD
  • Sherry L. Goldman, RN, NP
  • Jeffrey S. Goodman, MD
  • Richard E. Gould, MD
  • Leland M. Green, MD
  • Lloyd B. Greig, MD
  • Adam B. Grey, RN
  • Erroll L. Hackner, MD
  • Michele A. Hamilton, MD
  • Andrew E. Hendifar, MD
  • Leonel A. Hunt, MD
  • Andrew F. Ippoliti, MD
  • Michelle Israel, MD
  • Omotola E. Johnson, MD
  • Stephanie M. Kagimoto
  • Patricia R. Kampman
  • David Kawashiri, MD
  • Ilan Kedan, MD, MPH
  • Ali Khoynezhad, MD, PhD
  • Robert Klapper, MD
  • Keith L. Klein, MD
  • Jon A. Kobashigawa, MD
  • Norman E. Lepor, MD
  • Ronald S. Leuchter, MD
  • Michael M. Levine, MD
  • Michael C. Lill, MD
  • Ning-Ai Liu, MD, PhD
  • Hillary Lux
  • Patrick D. Lyden, MD
  • Adam N. Mamelak, MD
  • Lourdes G. Manalac
  • Annalissa C. Marquez
  • David N. Matsumura, MD
  • Robert J. McKenna Jr., MD
  • Jeffrey S. Metcalf
  • Stewart Middler, MD, PhD
  • Kirk Mullins, RN
  • Ronald B. Natale, MD
  • David G. Ng, MD
  • Nicholas N. Nissen, MD
  • Onyebuchi "Michael" Nwosu, RN
  • Chisom Onwunyi, RN, BSN, MPH, CCRP, PCCN
  • Alice Peng, MD
  • Danny Ramzy, MD, PhD
  • Svetlana Raysh, RN, BSN, PCCN
  • Bella Reznik
  • R. L. Patrick Rhoten, MD
  • Bobbie J. Rimel, MD
  • Susan L. Roberts, RN, BSN, RNC
  • Russell Robinson, RN
  • Denise L. Rockcliffe, RN
  • Fred P. Rosenfelt, MD
  • Howard L. Rosner, MD
  • Paul A. Rudnick, MD
  • Bruce A. Samuels, MD
  • Robert J. Siegel, MD
  • Allan W. Silberman, MD, PhD
  • Brittany M. Smith
  • Laura Snoussi, RN, BSN, OCN
  • Thomas P. Sokol, MD
  • Karyn Morse Solky, MD
  • Marilyn A. Solsky, MD
  • Andrew Ira Spitzer, MD
  • Daniel J. Stone, MD, MPH, MBA
  • Steven W. Tabak, MD
  • David B. Thordarson, MD
  • Kamran Toluie, MD
  • Debbie Tran, PA-C
  • Tram T. Tran, MD
  • Alfredo Trento, MD
  • Mark K. Urman, MD
  • Andrew S. Wachtel, MD
  • Alan Weinberger, MD
  • Donald A. Wiss, MD
  • Sophia D. Woods
  • Amara Yob, RN, BSN, OCN