KEN BARAT, LASER SAFETY SOLUTIONS
The future for laser-driven
applications is bright and poised to continue to spread globally. A significant component of this future will undoubtedly involve the use of Class 4 laser products, which are increasingly geared toward consumers. A growing number of industries demand on-site laser welding and laser stripping. The use of commercial lasers in the agricultural and autonomous vehicles sectors is a core driver of the increased use of these devices outside of traditional laboratory and research settings.
Courtesy of iStock.com/CasarsaGuru.
The nature of these applications, and many that are yet to be discovered, places a premium on the implementation of
practical and up-to-date laser safety
practices. However, establishing consistency in this area is a multifaceted challenge. It begins with product and user safety, envelops standards, and underscores the pressing need for qualified laser safety professionals.
The origins of product safety
Laser safety has historically addressed considerations of both product and user safety. In the U.S., the biggest struggle with effectively pursuing product safety is in fact not with safety requirements themselves, but instead in ensuring that manufacturers are actually complying with them.
Engaging in the sale of commercial laser products in the U.S., the Center for Devices and Radiological Health (CDRH, part of the FDA) requires companies to submit a cursory form to address 10 topics (see the Guide for Preparing Product Reports list).
Considering this form, CDRH officials determine whether the seller of the prospective product meets the necessary product safety requirements. If the
CDRH determines that the devices
meet these requirements, they become eligible to earn certified product status in the U.S.
From a consumer standpoint, buyers can purchase these products with the knowledge that these certified products have been deemed to meet established standards. Still, some filers are less than
truthful. And, due to the number of
submissions each year, a submitted form may await necessary reviews for months, if not years. Certain types of products, particularly in the medical domain, also receive priority consideration. Most users are unaware that once the CDRH file is submitted, the unreviewed product is legal to sell with the conformance label on it. The user is buying with the understanding that the product is compliant with federal requirements.
Issues concerning reporting
In the event that a user discovers an issue with a laser product, the CDRH reporting
system places the onus on the user to report the issue to the manufacturer. Responsibility then shifts to the manufacturer, which must file a CDRH noncompliance product finding.
This step gives the manufacturer an opportunity to evaluate the reported problem, which in some cases may be more accurately characterized as user error. Users can report directly to CDRH. This process offers advantages; most obviously, it enables the CDRH to discern trends in systematically reported issues, through multiple filings, versus the one-off filing from an individual facility.
Not all parties wish to take the time to complete the filings required by the CDRH reporting process. Issues that fall into the category of “counterfeit lasers,” for example, tend to raise considerable grumblings in the laser safety field. Here, concerns range from mislabeled products to unexpected performance features to missing components. These issues stem from a combination of factors. The user may lack knowledge about reporting requirements, or even foster indifference around noncompliance. No matter the case, many of the lasers that face these types of issues can be traced to online purchases from vendors with which the user is unfamiliar.
The product and user safety relationship
Training is an essential facet of product safety. In many cases, training buyers on how to safely and effectively use a product necessitates more than instructional manuals and how-to literature. Company-created videos and materials that surpass concern for the operator alone represent more comprehensive training resources. The knowledge of how to operate a
machine does not always equate to or ensure safe operation.
For user safety, standards are the first logical resource to consider — and
numerous standards must be followed. Standards for laser safety establish and define best practices, and as a result, they serve as the core of many laser safety programs. Regulatory bodies also rely on standards.
The Office of Compliance, Center for Devices and Radiological Health (CDRH) covers 10 specific topics in laser safety guide, FORM FDA 3632 (4/23). This guide is intended to assist manufacturers working with lasers in providing adequate reporting of radiation safety testing and compliance with federal performance standards.
Yet as important as they are, laser safety standards are only updated every three to 10 years. This considerable span means that, in many cases, standards fail to keep pace with technological changes.
The primary standards pertaining to laser safety, ANSI Z136.1 — Safe Use of Lasers and 60825-14 Safety of Laser Products — Part 14: A User’s Guide, clearly establish the role and responsibilities of the laser safety officer (LSO). Several additional regulatory bodies maintain responsibility for user safety, including the federal Occupational and Health Administration (OSHA) as well as a few regulatory programs in individual states. In my experience, these agencies are often intimidated by the nature of laser applications. These bodies may have only rudimentary understanding of laser standards.
A well-documented anti-regulatory atmosphere has also existed in the U.S. for years. Consider that even amid a large number of reported burns to the skin stemming from dermatology procedures using lasers in recent years, few states have taken any action to improve laser safety or accountability. OSHA laser rules do not provide much depth, and the few rules that exist focus principally on lasers for construction. OSHA’s General Duty Clause aims to push users to comply with safe lasing practices by promoting laser-user standards as the acceptable means to demonstrate laser safety. But there is a considerable gap between OSHA inspectors’ understanding of lasing practice and safety and that of the LSO. As a result, many inspectors permit the judgment of LSOs to supersede these very standards — which obviously runs counter to how inspectors typically operate.
Improving safety through training
The current growth of laser applications elucidates the increased need for trained professionals to oversee and evaluate laser safety. But how do we attract professionals to take on laser safety?
Again, appropriate training belongs at the heart of this effort. Enthusiasm for
the field coupled with a sound understanding of the importance of the LSO is a dynamic combination. When it is present in a prospective laser safety professional, it is paramount that the employer recognize the need to provide proper training.
The way that most LSOs receive training today unfortunately does not serve to heighten interest, nor does it promote
dialogue during the training stage. In-person laser safety classes may run for five days or less, and while they are based on the acceptable laser standard requirements, an overwhelming amount of information is provided. At the end of these courses, attendees can say they
have completed the course — not that they are a competent LSO.
In-house training is an alternative to an in-person class. Here, the instructor comes to the prospective laser safety professional. It is extremely important to demand site-specific training rather than an office presentation (in fact, it is best to have the instructor complete a site visit prior to the course to determine where the challenges specific to a given company may be). These training courses offer
opportunities to not only train by doing but also spark further interest and conversation.
Finally, online course offerings should not be discounted, even if their limitations are well known. Though these virtual courses (at least for laser safety) may not provide attendees with necessarily comprehensive training or sufficient experience to be a qualified laser safety professional, they still serve to introduce prospective LSOs to the discipline.
There is also a large opportunity to harness the inherent advantages to online coursework and build a more encompassing offering. The University of Utah, for example, is trialing a more comprehensive training program for university-based LSOs, but not until 2026. I look forward to evaluating its efforts.
Future thoughts
How we attract interested people to safety disciplines remains an open question. This is a relevant consideration for the majority of LSOs, for whom the position is not a stand-alone position but rather an added responsibility. I have encountered situations in which the LSO is looked upon highly — and frequently — and collaborates proactively with the user population to find solutions. But, I have seen many more situations in which an incentive to perform the job is absent, often due to insufficient training segueing into a lack of time, authority, respect, or recognition for the task.
Given that regulatory agencies are unlikely to make any changes to timelines and current product safety guidelines are insufficient for consistent user protection, the need for qualified LSOs is essential. The industry must find ways to promote interest and involvement in laser safety, as society must encourage students to become involved in STEM. Establishing a new set of laser safety controls and processes with the help of qualified LSOs may be the best way to achieve this goal.