Safety standards evolving for nonhospital laser use

Boston - Among the most important developments in safety standards that impact dermatology practices are changes involving laser use in non-hospital settings and development of international standards for intense pulsed light (IPL) devices, according to Penny J. Smalley, R.N., a Chicago-based safety consultant.

In the former area, "Many people are not aware what the requirements are in the private office," Ms. Smalley says. However, she adds that a recent improvement and expansion of the American National Standards Institute (ANSI) standard regarding laser use in the nonhospital environment directly impacts private physicians' offices.

"In order to be in compliance with the standard," Ms. Smalley says, "one must meet all of its requirements, regardless of where the laser is in use." This means both private physicians and those in hospital settings are responsible for knowing the expanded standards, as well as for implementing ANSI requirements regarding staff training and education, she explains.

Changes to International Electrotechnical Committee (IEC) standards for laser use also will impact physicians' practices drastically over the next year or so, she says. Whereas these standards used to apply only to lasers used for diagnostic and therapeutic use, Ms. Smalley says, "Their scope has been expanded to include cosmetic lasers, specifically those used in spas."

Additionally, she says, "There is a new standard - not yet published but under development - for the use of IPL devices. That's going to have the most impact" of any upcoming change. The first document regarding this standard will be presented for committee approval later this year, Ms. Smalley reports.

When that standard is published, "It will be the basis for changing our standards here in the United States. And it goes along with what some of the states are starting to do" in terms of regulating IPL devices, Ms. Smalley says.

National regulation coming

"There are numerous injuries, accidents and incidents reported all over the world related to the use of IPLs, mostly because they've been largely unregulated," she explains.

She says that often, users lack qualifications, supervision and, in many cases, "any education whatsoever beyond a manufacturer's in-service."

Therefore, Ms. Smalley predicts that there soon will be a national effort toward regulating IPL devices. In Texas and Arizona, in order to use a laser or IPL device for cosmetic or nonablative purposes, Ms. Smalley says physicians must document that they've received the required number of training hours - 24 in Texas, 40 in Arizona - covering safety and other issues.

"They are the first two states to require specific education for IPLs," although many states already require both registration and education for laser use, she says.

Medical laser laws

Currently, two kinds of laws govern medical lasers, Ms. Smalley adds. The first reside under state administrative codes. They require users to register their lasers with the state and to document other information, including their laser safety policies.

Under state medical boards, she says, "There's another whole set of rules regarding who can use a laser and under what circumstances. People often get the two kinds of rules confused. And in some places, they must satisfy both."

Accordingly, she advises physicians who are offering or adding laser services to check with their states' regulations, generally under the department of radiation safety, for the latest requirements.

"One should also check with one's medical boards to see what their requirements are; for instance, for nonmedically qualified personnel operating lasers," Ms. Smalley adds.