CLINICAL PRIVILEGE WHITE PAPER

Transcription

1 Procedure 58 CLINICAL PRIVILEGE WHITE PAPER Harmonic scalpel tonsillectomy Background The harmonic scalpel, a surgical device manufactured by Ethicon Endo-Surgery, Inc., a Cincinnati, OH based Johnson & Johnson company, uses ultrasonic vibrations to cut through tissue and dissect the tonsils. The device provides precise, simultaneous cutting and coagulation, which greatly reduces post-tonsillectomy discomfort, and facilitates a quicker recovery. The tonsils are glandular tissues located on both sides of the throat. They trap bacteria and viruses entering through the throat and produce antibodies to help fight infections. Tonsillitis, which is a common pediatric surgical disease that may also present in adult patients, occurs when tonsils become infected and swell. If these infections are chronic, or a child shows symptoms such as loud snoring, restless sleep, poor growth, or mouth breathing, a physician may recommend a tonsillectomy, which is the removal of the tonsils. Traditionally, surgeons have used electrocautery blades to perform tonsillectomies. The devices operate at high temperatures to make incisions through human tissue. They may damage surrounding tissue and cause pain for several days during recovery. The harmonic scalpel, which vibrates at 55,000 cycles per second, uses less heat so there is less burning. This alleviates the pain that is felt immediately following such surgery. Other benefits to patients include the ability to eat and swallow sooner, receiving less pain medication immediately following surgery, and less bleeding and tissue trauma during surgery. The harmonic scalpel is also used in laparoscopic and open surgical procedures, including cholecystectomy, Nissen fundoplication, bowel resection, and adhesiolysis. Involved specialties Otolaryngologists, pediatric surgeons, general surgeons, and family physicians Positions of societies and academies AAO HNS The American Academy of Otolaryngology Head and Neck Surgery (AAO HNS) is the world s largest society of physicians who treat disorders of the ear, nose, and throat (ENT), and related structures of the head and neck. The AAO HNS and the American Academy of Facial Plastic Copyright by the Credentialing Resource Center Marblehead, Massachusetts / /01 1

2 and Reconstructive Surgery (AAFPRS) publish Official Positions on Clinical Privileges. In this document, the two academies state that they appreciate how the granting of privileges is a serious judgmental decision for a hospital credentials committee to make. In addition to consideration of fundamental matters such as the applicant s training, ability, and experience, other factors enter into the decision. The primary consideration must be the assurance of quality care. The AAO HNS and AAFPRS have adopted the following positions, which they believe reflect these common principles as benchmarks for fair and ethical practice: The ultimate responsibility for delineating clinical privileges in the hospital setting rests with the institution s governing board and is discharged through the organized medical staff Privilege delineation is essentially an institutional function aimed at matching the clinical privileges accorded to each member of the medical staff with his or her demonstrated ability to perform, thereby ensuring patient safety and promoting the quality of patient care A physician s ability to perform certain clinical procedures should be assessed on the basis of multiple criteria, including professional education, clinical training, judgment, and experience Board certification may be used to provide evidence of training and, to a certain degree, medical proficiency and judgment, but should not be used as a device for defining the scope of practice privileges to be accorded Positions of other interested parties ABOto The American Board of Otolaryngology (ABOto) defines an otolaryngologist head and neck surgeon as a physician who has been prepared by accredited residency programs to provide comprehensive medical and surgical care of patients with diseases and disorders that affect the ears the respiratory and upper alimentary systems and related structures the head and neck in general The ABOto offers certification to candidates who have satisfactorily completed a minimum of five years of training in Accreditation Council for Graduate Medical Education (ACGME) accredited programs. The programs must include 2 A supplement to Briefings on Credentialing 781/ /01

3 at least one year of general surgical training (the general surgical residency should be taken prior to otolaryngologic training) at least four years of residency training in otolaryngology head and neck surgery, which must involve increasing responsibility each year and must include a final year of senior experience The board requires that all residents maintain a log of their surgical procedures on the ABOto Web site during otolaryngology head and neck surgery training. The ABOto is also authorized to issue subspecialty certificates in pediatric otolaryngology. Exams are under development. No certificates have been issued, and specific dates for administration of these exams are not known at this time. In regard to certification, the board states that it is neither its intent nor its purpose to define requirements for membership on the staffs of hospitals or similar institutions, or to confer special privileges upon its diplomates. Ethicon Endo-Surgery, Inc. Cincinnati, OH According to Bonnie Ribb, group product director for energy products at Ethicon Endo-Surgery, the company sends out representatives to train ENT surgeons how to use the harmonic scalpel for tonsillectomies. These are physicians who already perform tonsillectomies, so they simply learn how to use a new instrument. The company representative explains how the technology works and then the surgeon actually uses the device on a chicken breast to learn how different parts of the scalpel blade create different tissue effects. The representative is present in the operating room to observe and advise surgeons when they perform their initial cases. Typically, it takes five to 10 cases for surgeons to feel comfortable with the technology, says Ribb, and the rep stays with them for as long as they need guidance. She does not consider that maintaining competence in the procedure is an issue because once surgeons understand the benefits of the technology, she believes that they ll use it on a continuing basis. It s not unusual for an ENT to do 10 or more tonsillectomies a week, she says. A supplement to Briefings on Credentialing 781/ /01 3

4 Lapeer (MI) Regional Hospital Otolaryngologists are the physicians who would predominantly perform harmonic scalpel tonsillectomies, says Douglas Hegyi, DO, an ENT specialist and facial plastic surgeon at the Lapeer (MI) Regional Hospital. In addition, there are pediatric surgeons, general surgeons, and family doctors who have the tonsillectomy training and experience to perform the procedure. The prerequisite for learning the harmonic scalpel technique is a working knowledge of how to do tonsillectomies. Hegyi recommends that surgeons perform of these procedures in whatever method they were previously using. Then they should conduct an inservice with an Ethicon Endo- Surgery representative who can explain what the harmonic scalpel can and cannot do. The representative may also be present in the operating room during initial cases to give surgeons advice on how to use the scalpel most effectively. Unlike an electrocautery device, I ve found that you need to move slowly with the harmonic scalpel, Hegyi explains. When I go slowly and use the appropriate blade, I m able to stop the majority of the bleeding. The harmonic scalpel can be used with most patients who need to have their tonsils taken out. The only exception for me personally is the patient who has a hot peritonsillar abscess, says Hegyi. That s because it is a bloody kind of case and you need cautery right away. The surgeon also has to move along rapidly, and the harmonic scalpel doesn t work that way. For maintaining competence, Hegyi considers performing one case per month to be adequate. It s not that difficult a technique, he says, so if you do one harmonic scalpel tonsillectomy a month, you would be fine. CRC draft criteria Minimum threshold criteria for requesting core privileges in harmonic scalpel tonsillectomy The following draft criteria are intended to serve solely as a starting point for the development of an institution s policy regarding harmonic scalpel tonsillectomy. Basic education: MD or DO Minimum formal training: Completion of an ACGME/American Osteopathic Association (AOA) accredited residency training program in otolaryngology or general surgery followed by training with the harmonic scalpel for tonsillectomy. The training should include proctoring by an Ethicon Endo- 4 A supplement to Briefings on Credentialing 781/ /01

5 Harmonic scalpel tonsillectomy Procedure 58 Surgery clinical representative or by a surgeon experienced in the procedure. Required previous experience: The applicant must be able to demonstrate that he or she has performed at least 12 harmonic scalpel tonsillectomies in the past 12 months. Note: A letter of reference should come from the proctor of the applicant s initial harmonic scalpel tonsillectomy cases. Or a letter of reference should come from the chief of surgery at the institution where the applicant most recently practiced. Reappointment Reappointment should be based on unbiased, objective results of care according to the organization s existing quality assurance mechanisms. Applicants must demonstrate that they have maintained competence by showing evidence that they have performed at least 24 harmonic scalpel tonsillectomies in the past 24 months. In addition, continuing education related to tonsillectomy surgery should be required. For more information For more information regarding this procedure, contact: American Academy of Otolaryngology Head and Neck Surgery One Prince Street Alexandria, VA Telephone: 703/ Fax: 703/ Web site: American Board of Otolaryngology 3050 Post Oak Boulevard, Suite 1700 Houston, TX Telephone: 713/ Fax: 713/ Web site: Ethicon Endo-Surgery, Inc Creek Road Cincinnati, OH Telephone: 513/ A supplement to Briefings on Credentialing 781/ /01 5

6 Fax: 513/ Web site: Lapeer Regional Hospital 1375 North Main Lapeer, MI Telephone: 810/ Fax: 810/ Web site: Clinical Privilege White Papers Advisory Board James F. Callahan, DPA Executive vice president and CEO American Society of Addiction Medicine Chevy Chase, MD Sharon Fujikawa, PhD Clinical professor, Dept. of Neurology University of California, Irvine Medical Center Orange, CA John N. Kabalin, MD, FACS Urologist/Laser surgeon Scottsbluff Urology Associates Scottsbluff, NE Publisher/Vice President: Suzanne Perney Executive Editor: Dale Seamans John E. Krettek Jr., MD, PhD Neurological surgeon Vice president for medical affairs Missouri Baptist Medical Center St. Louis, MO Michael R. Milner, MMS, PA-C Senior physician assistant consultant Phoenix Indian Medical Center Phoenix, AZ Associate Editor: Noelle Shough Managing Editor: Edwin B. Niemeyer Beverly Pybus President The Beverly Group Georgetown, MA Richard Sheff, MD Practice director Quality and credentialing The Greeley Company Marblehead, MA The information contained in this document is general. It has been designed and is intended for use by hospitals and their credentials committees in developing their own local approaches and policies for various credentialing issues. This information, including the materials, opinions, and draft criteria set forth herein, should not be adopted for use without careful consideration, discussion, additional research by physicians and counsel in local settings, and adaptation to local needs. The Credentialing Resource Center does not provide legal or clinical advice; for such advice, the counsel of competent individuals in these fields must be obtained. Reproduction in any form outside the recipient s institution is forbidden without prior written permission. Copyright 2001 Opus Communications, a division of HCPro, Marblehead, MA A supplement to Briefings on Credentialing 781/ /01

7 Privilege request form Harmonic scalpel tonsillectomy In order to be eligible to request clinical privileges for harmonic scalpel tonsillectomy, an applicant must meet the following minimum threshold criteria: Education: MD or DO Minimum formal training: Completion of an ACGME/AOA accredited residency training program in otolaryngology or general surgery, followed by training with the harmonic scalpel for tonsillectomy. The training should include proctoring by an Ethicon Endo-Surgery clinical representative or by a surgeon experienced in the procedure. Required previous experience: The applicant must be able to demonstrate that he or she has performed at least 12 harmonic scalpel tonsillectomies in the past 12 months. References: A letter of reference should come from the proctor of the applicant s initial harmonic scalpel tonsillectomy cases. Or a letter of reference should come from the chief of surgery at the institution where the applicant most recently practiced. Reappointment: Reappointment should be based on unbiased, objective results of care according to the organization s existing quality assurance mechanisms. Applicants must be able to demonstrate that they have maintained competence by showing evidence that they have performed at least 24 harmonic scalpel tonsillectomies in the past 24 months. In addition, continuing education related to tonsillectomy surgery should be required. I understand that by making this request I am bound by the applicable bylaws or policies of the hospital, and hereby stipulate that I meet the minimum threshold criteria for this request. Practitioner s signature: Typed or printed name: Date: A supplement to Briefings on Credentialing 781/ /01 7