A PRACTICAL GUIDE TO ASSESSING NEWLY PURCHASED AND EXISTING LASERS WITHIN A LASER SAFETY PROGRAM

摘要

The most common mistake a Laser Safety Officer (LSO) can make is the assumption a laser system purchased and added to a laser safety program, not only meets the requirements of the Federal Laser Product Performance Standard (FLPPS) - 21 CFR 1040, but is legally sold in the United States. That being said, manufacturers of laser systems sold within the U.S. are self-certifying; as such, paperwork is supposed to be filed with the Food and Drug Administration - Center for Device and Radiological Health (FDA CDRH) documenting the FLPPS has been met. In the spirit of due diligence, any LSO is capable of performing two simple checks to ensure a laser system is being legally sold within the U.S. and actually meets the requirements of the FLPPS. These minor, yet overlooked steps by many LSOs, can place a company, organization, or business at risk of having the laser recalled, by the FDA CDRH if it is determined the manufacturer failed to meet federal laws. This could subsequently halt operations and/or production. Additionally, manufacturers and/or distributors of lasers found to be non-compliant are at further risk of fines levied by the federal government and forced recall of all laser systems which fail to meet the federal laws.