Surgery News - October 2007 - (Page 12)

ETHICS SURGERY NEWS • O C T O B E R 2 0 0 7 THE RIGHT CHOICE INDICATIONS FOR USE IN THE U.S.A. BioGlue Surgical Adhesive is indicated for use as an adjunct to standard methods of achieving hemostasis (such as sutures and staples) in adult patients in open surgical repair of large vessels (such as aorta, femoral, and carotid arteries). Rx only. CONTRAINDICATIONS Not for patients with a known sensitivity to materials of bovine origin. Not for intravascular use. Not for cerebrovascular repair. WARNINGS Warning: Polymerized BioGlue has space occupying properties. When used improperly, or applied incorrectly, serious adverse events have been reported relating to compression of adjacent anatomic structures. BioGlue should be used only when complete visualization of the target application location is possible, when it is properly primed to achieve optimal viscosity, and a minimal amount is used. Please see the Indications for Use and Directions for Use sections of this label. Warning: Animal studies have shown that direct application of BioGlue to the exposed phrenic nerve can cause acute nerve injury. BioGlue application to the surface of the heart can cause coagulation necrosis that extends into the myocardium, which could reach underlying conduction tissue and may cause acute, focal sinoatrial node degeneration. ® Overscheduling Imposes Conflict of Commitment Most surgeons prefer to complete the day’s operations as early as possible and clear the schedule, especially for important family obligations. We all have lives outside of medicine, and in our capacities as “A man’s got to know his limitations.” spouses, parents, children, siblings, and —Harry Callahan friends we incur moral responsibilities, (Magnum Force, 1973) just as we do in our roles as surgeons. The ethical obligations attendant to those reou are a busy surgeon in a large pri- lationships are part of what define us, vate hospital with resident staff. Your and everyone expects us to honor them. Obligations to family first two cases today members often come into took longer than expected, conflict with fiduciary reand you are rushing to start a sponsibility for our patients. third case before the elective This is known in professionschedule closes. Between casal medical ethics as a conflict es, you were consulted to perof commitment. As a rule, form a percutaneous trasuch conflicts should be recheotomy on a patient in the solved in favor of fiduciary ICU. Now you can either join responsibility to the patient. the surgery resident who is Here the conflict of comwaiting there, or start your mitment can be justifiably third elective case. The resiBY JAMES W. JONES, resolved in favor of family dent is technically skilled and M.D., PH.D., FACS obligations. One must judihas done many such procedures. You have plans to attend your daugh- ciously avoid inappropriate use of our ter’s gymnastics meet this evening, and to- “professional obligations” to sidestep nonmorrow you have a busy clinic schedule. professional responsibilities. Taking on another case that can safely be done by a How should you handle this? A) Go to the ICU and then, if the OR different surgeon is an egregious rationalwon’t allow you to start the remaining ization. Option E is wrong. Option C would delay meeting the care case promptly, declare emergency status. B) Ask a colleague to supervise the resi- needs of the ICU patient and would inconvenience many others to accommodate dent, and start the third OR case. C) Cancel your morning clinic, and do the bad judgment. Forgoing a case for an admirable reason would be unlikely to result tracheotomy tomorrow. D) Start the OR case, and tell the resident in the loss of future referrals. Rational self-interest is poorly served by option C. to go ahead with the tracheotomy. It is unlikely that the resident has inE) Go to the ICU and do the OR case latdependent hospital privileges. You have er as an “add-on.” Although adding on cases during a an obligation to the hospital staff ’s byworkday is a flattering result of having laws, which exist to assure patients that one’s skills recognized, it complicates the their physicians are qualified and trainees work process, often more for nonsurgeons properly supervised. Circumventing this than for surgeons. Agreeing to do addi- protection is morally wrong, so option D tional cases when already stretched to is out. Option B fulfills your obligation to the meet personal obligations should not be judged as laudable overachieving. Over- ICU patient to provide appropriate superscheduling should instead be understood vision of the resident. By delegating this responsibly effectively and in a timely fashas a lapse of judgment. The surgeon’s primary fiduciary re- ion, you will meet the needs of the ICU sponsibility is to the patient, but that is not patient. Completing the third case will not the surgeon’s only responsibility. Institu- prevent you from fulfilling your family tional and personal ethical obligations obligation, so the conflict of commitment is effectively managed. You can justifiably must also be honored. Attempts to game the scarce resource of proceed with the last OR case within the OR time creates the risk of denying oth- elective schedule as you first intended. er patients access to the OR when they These considerations make option B the need it. This ethical analysis has important ethically preferable choice. A busy surgeon’s dexterity is whetted to implications for surgeons’ advocacy for their patients. Advocacy for an individual its sharpest, and there is no incentive to expatient justifiably is limited when patients tend indications for therapies. There exists, with more compelling needs are put in however, a flash point where stress and fatigue hamper rather than help, when fiduclinical peril by an overscheduled OR. Declaring the case an emergency would ciary obligations to one’s patients are jeopheighten its priority and ensure rapid ac- ardized unnecessarily, and when conflicts cess to an operating room. Nevertheless, of commitment are unnecessarily created this patient’s acuity level does not meet or poorly managed. ■ standards set by the Association of Perioperative Registered Nurses for a surgical DR. JONES is a visiting professor at the emergency. Option A, with its self-cen- Center for Medical Ethics and Health Policy, tered dishonesty and misuse of physician Baylor College of Medicine, Houston, and an autonomy and authority, is invalid. ACS Fellow (jwjones@bcm.tmc.edu). Editor’s note: The following is condensed from an article published in the Journal of Vascular Surgery ( Jones, J.W.; McCullough, L.B. 2007;45:635-6). Y Do not use BioGlue as a substitute for sutures or staples. Do not expose valve leaflets or intracardiac structures to BioGlue. Do not allow BioGlue in either the uncured or polymerized form to contact circulating blood. BioGlue entering the circulation can result in local or embolic vascular obstruction. Avoid exposing nerves to BioGlue. Avoid contact with skin or other tissue not intended for application. Minimize use of BioGlue in patients with abnormal calcium metabolism (e.g., chronic renal failure, hyperparathyroidsim). Glutaraldehydetreated tissue has an enhanced propensity for mineralization. Laboratory experiments indicate that unreacted glutaraldehyde may have mutagenic effects. Do not use BioGlue if staff are not adequately protected (e.g., wearing gloves, mask, protective clothing, and safety glasses). Unreacted glutaraldehyde may cause irritation to eye, nose, throat, or skin, induce respiratory distress, and cause local tissue necrosis. Prolonged exposure to unreacted glutaraldehyde may cause a central nervous system or cardiac pathology. If contact occurs, flush the affected areas immediately with water and seek medical attention. Do not use BioGlue in the presence of infection and use with caution in contaminated areas of the body. Avoid repeat exposure of BioGlue in the same patient. Hypersensitivity reactions are possible upon exposure to BioGlue. Sensitization has been observed in animals. BioGlue contains a material of animal origin, which may be capable of transmitting infectious agents. PRECAUTIONS Safety and effectiveness of BioGlue in minimally invasive procedures have not been established. Safety and effectiveness of BioGlue in coronary artery bypass grafting (CABG) and other use on small diameter vessels has not been established. Do not use blood saving devices when suctioning excess BioGlue from the surgical field. Clamp and depressurize vessels prior to applying BioGlue to targeted anastomoses. Avoid suctioning BioGlue into the vessel when applying it to targeted anastomoses. It is recommended that surgical gloves, sterile gauze pads/towels, and surgical instruments be maintained moist to minimize the potential for BioGlue inadvertently adhering to these surfaces. BioGlue solutions cartridges, applicator tips, and applicator tip extenders are for single patient use only. Do not re-sterilize. Do not use if packages have been opened or damaged. Take care not to spill contents of the solutions cartridge. Do not compress the main delivery unit trigger mechanism while attaching the solutions cartridge to the delivery device. Do not apply BioGlue in a surgical field that is too wet. This may result in poor adherence. Avoid tissue contact with material expelled from applicator during priming. BioGlue polymerizes rapidly. Priming must occur quickly, followed immediately by the application of BioGlue. Pausing between priming and application can cause polymerization within the applicator tip. Do not peel away BioGlue from an unintended site, as this could result in tissue damage. 1655 Roberts Boulevard NW • Kennesaw, GA 30144 phone (888) 427-9654 • fax (770) 590-3753 www.cryolife.com • e-mail: usbioglue@cryolife.com http://www.cryolife.com http://www.cryolife.com

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Surgery News - October 2007

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