Collaborative instrumentation standards; fire protection standards; sterilizers; medical gas fittings; borrowing instruments

AORN Journal, Oct, 2005 by Sharon Giarrizzo-Wilson

QUESTION: Our supply, processing, and distribution department (SPD) says they follow Association for the Advancement of Medical Instrumentation (AAMI) standards for instrument care. What are AAMI standards? Shouldn't they be following AORN's guidelines for care and handling of instruments? Is it necessary to abide by both sets of standards?

ANSWER: The AAMI is a partnership of health care professionals and organizations committed to developing best practice guidelines for medical device technology. (1) The AAMI standards, developed collaboratively by the partner alliance, are a compendium of medical device production and performance standards and recommended practices for use; care; evaluation; or processing of medical devices, including hospital and industrial sterilization practices. (2)

Compliance with AAMI standards and recommendations is voluntary unless they are adopted by a regulatory agency (eg, the US Food and Drug Administration [FDA]). Even though compliance is not mandatory, the documents greatly influence medical device manufacturing and practices within the health care community. These research-based documents are developed using a stringent peer and public review process. The Centers for Disease Control and Prevention, the FDA, and other government agencies and professional organizations, including AORN, frequently cite the AAMI standards and recommendations because of their quality and authoritative strength. (2)

AORN has had a collaborative relationship with AAMI for more than 30 years. A perioperative nursing specialist from AORN Headquarters holds an appointed position on the AAMI sterilization standards committee and also participates in 12 different work groups charged with the developing and reviewing associated AAMI documents. This relationship is reciprocal; an AAMI representative is appointed as a liaison to the AORN recommended practices committee. Documents from both organizations complement one another and are supported by similar research and expert opinions. Perioperative nurses should be familiar with both AAMI and AORN standards and recommended practices to ensure that current best practices are in place and to promote safe patient care. For more information, see pages 653-655 in this Journal.

QUESTION: At AORN's 2005 Congress, I heard that the state of Nebraska has banned all alcohol skin preparations. This directive was based on the National Fire Protection Association (NFPA) revised standard that does not permit the use of alcohol-based agents in the presence of electrosurgical or laser equipment. What is the intent of this standard and how will it affect my practice?

ANSWER: The intent of the NFPA 99: Standard for Health Care Facilities--2005 edition is to reduce the likelihood of fire in perioperative settings resulting from the ignition of alcohol vapors in oxygen enriched environments when laser or electrosurgical units are used. The NFPA, a nonprofit agency, is dedicated to reducing

   the worldwide burden of fire and other
   hazards on the quality of life by developing
   and advocating scientifically
   based consensus codes and standards,
   research, training, and education?

On March 31, 2005, the Nebraska state fire jurisdiction issued a letter to state hospitals and ambulatory surgery centers explaining that flammable liquid germicides or antiseptics used in anesthetizing locations in combination with electrosurgery, electrocautery, or laser technology violated NFPA 99. (4) In an immediate response to Nebraska's interpretation of the standard, the American Society for Healthcare Engineering (ASHE) of the American Hospital Association (AHA), with support and contributions from AORN, the Association for Professionals in Infection Control and Epidemiology, the AHA, the Centers for Medicare and Medicaid Services, the Joint Commission on Accreditation of Healthcare Organizations (JCAHO), and other professional societies, issued a tentative interim amendment (TIA) to NFPA 99.

The ASHE TIA proposes continued use of alcohol-based surgical prep solutions in the presence of ignition sources and provides guidance to health care organizations for reducing the risks of fire in these settings. The following TIA language helps to strengthen existing perioperative strategies to reduce fire hazards.

* Apply alcohol skin prep solutions from a unit dose style applicator.

* Emphasize the critical need for appropriate drying time before surgical drapes are applied or a heat-producing source is employed.

* Remove solution-soaked materials from the area to avoid a potential oversight.

* Establish and enforce a procedure to deal with solution pooling, although this should not be an issue if unit-dose application and drying time are enforced.

* Establish a policy mandating a time-out period before draping or using electrosurgery, electrocautery, or lasers; this procedure is similar to JCAHO's Universal Protocol for Preventing Wrong Site, Wrong Procedure, Wrong Person Surgery and mandates that an "all clear" be announced by a selected staff member before proceeding.