Are Surgical Drapes Safe for Laser Surgery? Current Standards and Test Methods

摘要

Since lasers have been introduced into the operating room, there has been a rapid expansion of this technology. As the applications of lasers increase, so will complications associated with their usage. Currently, there are no federal, state or local laser flammability standards for surgical drapes. In fact, there are no official flammability standards for surgical drapes with any type of ignition source. Most manufacturers, however, have adopted either 16 CFR Part 1610 or NFPA 702 to evaluate the performance levels of these products. Both of these tests use a 5/8" butane flame, not a laser, as the ignition source. The National Fire Protection Association (NFPA) has published NFPA 115, "Recommended Practice on Laser Fire Protection." It references a test developed at the University of Maryland, Department of Fire Protection Engineering to evaluate the laser ignition and flame spread of materials (in ambient or oxygen-enriched atmospheres [OEAs]). Underwriters Laboratories has recently issued UL 2154, "Tire Tests of Surgical Fabrics," which employs a CO_2 laser that produces an energy density of 200+-20W/cm~2. The International Organization on Standardization (ISO) 172/Scientific Committee 9 has a Working Group 4 (Laser Systems for Medical Application) which has drafted a proposed standard, ISO/DIS 11810, "Test Method for Determining the CO_2 Laser Resistance of Surgical Drapes and/or Other Patient Protective Covers." This method proposes a test for laser penetration, ignition, flame spread, reflectance, and thermal transfer in ambient oxygen and OEAs. The American Society of Testing and Materials (ASTM) F29 committee has established a subcommittee, F29.08, "Operating Room Fire Safety", to review laser fire statistics and to determine if new test methods are necessary.