Sometimes a laser is just a laser. Other times, the smallest change to an otherwise ordinary laser turns it into something entirely different, something that quickly brings it to the attention of federal safety regulators. A 10-mW laser pointer, for example (which is a little more powerful than most people would need) must incorporate certain safety “bells and whistles.” But if the manufacturer installs a small spinning mirror on the pointer to create a modest laser-light-show entertainment effect, the pointer enters a whole new world of federal regulation.
Because the product is to be used for entertainment or informational display purposes, the manufacturer cannot offer it for sale until the Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) reviews and approves a “variance” that allows for the sale of an otherwise prohibited product. Customers cannot buy the product until they apply for and receive a similar variance. And the end user (who also needs a variance) cannot use the product in public until a report is submitted to the CDRH that details where, when, and how the product will be used.
If someone wanted to devise a system to keep a product out of the marketplace, this would be it. The safety rules covering laser display products date back almost 30 years, and have remained virtually unchanged. The rules have undoubtedly acted as a brake on the laser-display industry in the U.S., making it more difficult to bring products to market and even more difficult to get them into the hands of customers. But have they improved safety? If I look back to the 1970s, I would say the regulations served a purpose. If I look ahead to 2007, I would say change is long overdue.
The International Laser Display Association (ILDA), which represents manufacturers and users of laser displays, is urging the CDRH to streamline the regulatory process and, at the same time, provide a higher level of safety to the public. At a recent public “stakeholders” meeting sponsored by CDRH, it was clear that agency officials were aware of the need for change. The CDRH regulates a huge gamut of emissive devices-including tanning beds, medical imagers, and equipment for laser light shows. The CDRH’s workload is growing every day, but budget cutbacks are forcing it to do more with less.
Back in the disco-crazed era of the 1970s (which gave birth to today’s regulations), laser light shows were expensive propositions that involved a heavy investment in equipment and expertise. But today, you can purchase laser projectors on eBay, plug them into a standard wall socket, and quickly start entertaining friends, family, and business clients. Of course, you’re also supposed to file that request for a variance and (before you start doing shows) a “Laser Light Show Report” detailing the when, where, and how of a typical show.
To further complicate the issue, some manufacturers outside the United States don’t build their projectors in compliance with CDRH rules and don’t require their U.S. customers to produce proof of a variance as a condition of the sale. Don’t expect the federal government to start policing eBay or other backdoor import channels-the government shows no inclination to devote resources to this problem.
And while any variance can be revoked for noncompliance, it rarely happens. Limited resources restrict safety inspections to a handful each year, and there is no systematic enforcement program to deal with scofflaws. The result: legitimate companies pay a price for safety compliance, while others skirt the law and reap the profits.
But I did see many rays of hope at the recent stakeholders meeting sponsored by the CDRH. The agency has embraced the Internet as a tool for submitting variances and for reducing the time that companies must wait to get approval. The CDRH agrees that it shouldn’t take months to get a variance. One truly innovative request for a variance has been under review for more than 16 months-which sends the entirely wrong signal to the industry.
What I’d like to see is a new approach that substitutes real training for time-consuming paperwork. Instead of cutting-and-pasting text into the CDRH variance request, I’d like to see on-line training and testing. If potential purchasers can pass a Web-based test that shows they know how to use the equipment safely, they should be able to walk out the door with a laser projector under their arm.
ILDA hopes to develop just such a test and, with the help of the CDRH, make it a real tool to promote laser safety. We’re planning to unveil the first draft of the test at our upcoming annual conference. But the conference won’t take place in the U.S.; it will be in Rimini, Italy. When it comes to laser displays, the U.S.-for now, at least-is not the friendliest place to do business.