In Europe, the guideline is the IEC-60825 document which offers non-regulatory guidance for identification and control of major hazards associated with medical lasers. ANSI standards are also used as the basis for evaluation of safe practice with lasers, by The Joint Commission, (formerly known as JCAHO) which awards accreditation of healthcare facilities, and ensuing government funding for Medicare patients. ANSI standards are the basis for laser safety requirements as determined by the Occupational Safety and Health Administration (OSHA) which is a governmental branch of the Department of Labor, and carries the authority to issue citations and/or legal action, for non-compliance. In the United States, a number of states have regulations requiring registration of laser systems, and proof of administrative controls as defined in the American National Standard (ANSI Z136.3). National licensure requirements, based on international (IEC) standards, is currently being considered, and if initiated, every user of Class 3b, or Class 4 medical laser systems, and Intense Pulsed Light Systems, will need to register for a license with validation that they have met specific criteria for education and training. It has been incorporated into state regulations, such as those adopted in Tasmania, Western Australia, and in Queensland under the Radiation Safety Act 1999. In Australia, the AS/NZ 2211(Laser Safety), and the 4173, (Guide to the Safe Use of Lasers in Healthcare), have become the expected standard for laser safety in healthcare, and though not regulatory, have taken on the impact of regulation through its wide acceptance. This serves as a strong motivation for laser users to gain knowledge of the established rules for safety, and mandate compliance with them. As such, they are often considered as the usual and customary practice in a given area, and are the basis for medical-legal decisions in cases of patient or staff injury, accident, or untoward occurrence. Standards are non-regulatory, but serve as consensus documents for best practice. In some countries (USA, Australia, Canada), these standards are harmonized with the national standards, and are mandated as the basis for all additional regulations and professional recommended practices. They are used as the foundation for most country's national standards. These standards are the global benchmarks for laser safety, and include normative and informative guidance for manufacturers, professional clinicians, and administrators of laser use facilities. International standards are available through the International Electrotechnical Commission (IEC), documents 60601, 60825, and 60825-Part 8. Risk Management Step One: Knowledge of Standards, Regulations, and Practice Guidelines Proper safety management requires a fourfold approach including: knowledge of standards, identification of hazards and risks, implementation of appropriate control measures, and consistent program audit to demonstrate quality assurance. Of all hazards, complacency is the most dangerous, and it is imperative to develop a risk management perspective on laser safety. Laser safety is EVERYONE'S concern! A laser is as safe or as hazardous as the user–and that user's knowledge and skill, defines how well laser safety is managed. This should be the goal of all who are involved with the sale, purchase, application, and management of all medical laser systems–under all circumstances. What remains, regardless of the practice site, application, or system in use, is the constant goal of establishing and maintaining a laser safe environment for the patient, the staff, and the user, at all times. Now that laser technology has emerged from hospital operating rooms, and has become available to office practices, clinics, and private enterprises, the burden of responsibility for safety has shifted from hospital staff to the individual user, often without benefit of appropriate or adequate resources.
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