Medical lasers aren’t all complicated, but unclear maintenance guidelines can make servicing them tricky
Depending on the size of the hospital, the repair and maintenance of medical lasers can play a significant role in a typical biomedical technician’s duties.
“There are lots of different lasers out there,” says David Marlow, CBET, senior biomedical technician at the University of Michigan Health System in Ann Arbor, who over the course of his long career has worked on many of them.
But the ability of biomeds to actually handle this equipment is all across the board, Marlow says. Luckily, several resources exist for those who want to improve their training and background in medical lasers. At the same time, vague guidelines from regulatory agencies are causing confusion about who is qualified to maintain the equipment and which procedures should be followed.
In Marlow’s case, he has been working with medical lasers for decades and is based at a hospital system that uses dozens of them, so he has developed a certain amount of expertise necessary to maintain and repair many systems. “But if a hospital only has a couple of lasers, it may not be worth it to have someone build up the necessary expertise to work on them,” he says.
The Laser Training Institute is a nonprofit organization that offers training and credentialing for laser repair technicians and medical laser safety officers under the auspices of the Professional Medical Education Association, The Institute’s weeklong laser repair courses, while not make- and model-specific, do provide biomeds with training on generic types of lasers.
A repair course, says Gregory Absten, the organization’s chief executive, covers the major classes of lasers, including solid state systems, gas laser systems, liquid dye laser systems, and diode systems. Instructors explain how these different systems work, review the components that need attention and normal maintenance, and provide some hands-on training. The goal is to enable biomeds to perform tasks like preventive maintenance and basic alignments on many of the lasers within those four classes.
Laser Solutions, Inc, a third-party medical laser service, sales, and parts provider located in Basking Ridge, NJ, also offers maintenance and repair training for biomeds. Nancy Frank, the operations manager of Laser Solutions, says the idea is to get biomeds trained on the different classes of laser to the point where they can be “first-call responders” if their hospital is having a problem.
“There’s no way that you are going to be able to teach someone in a 3-day class what someone with 20 to 25 years of experience with lasers is able to do,” she says. “But if they know enough that you can get them on the phone and troubleshoot them through a problem, then that’s going to avoid any downtime that would otherwise occur if someone has to go to the hospital to service the laser.”
As with any critical piece of hospital equipment, anyone working with lasers should have proper safety training, Marlow says.
And when it comes to safety, Absten says, “The truth is that if anyone is going to get hurt, it’s going to be a biomed or technician who is working on the equipment.”
The good news, Absten says, is that while important, laser safety is pretty basic and can be easily taught during a course on laser repair and maintenance.
Another thing working in favor of the ability of biomeds to handle lasers safely is the fact that many of them have a healthy respect for—if not fear of—medical lasers. “I’ve had service calls where I’ve asked a biomed to do some troubleshooting on a laser, and they’ll tell me they don’t even want to touch it,” Frank says.
But there’s good reason to have someone on hand with at least some expertise with lasers. “We’ll get a call from an operating room nurse, or a doctor, or a biomed explaining that they have a patient on a table under general anesthesia, but the laser won’t turn on, or there’s no beam, or the operator is getting some kind of error message,” Frank says. “So it can be a little bit of a panic situation.”
How Hard Can It Be?
So how difficult is it to service and repair medical lasers?
“Some lasers are going to be more complicated than others,” Marlow says. “Simple diode lasers aren’t that complicated.” And most lasers are easy to test, he adds. If a facility has a number of similar lasers that aren’t too complex, they can be easily tested to see whether they are properly calibrated and working correctly.
“But the newer ones are getting more complicated, and the manufacturers are throwing more twists and turns to make it harder for us to check the lasers,” Marlow says. Many of the newer computerized devices are more difficult to work on, he adds, “because you don’t have the algorithms or software tools you need. But, it still isn’t hard to check them. I see a big difference between checking the calibration on a laser and actually calibrating it, because some of them can be pretty complicated.”
But there are certain types of lasers that Marlow—even with his years of experience—says are best left to the manufacturer to deal with. For example, Marlow’s hospital system uses excimer (gas-based) lasers that “are much more dangerous to work with,” he says. “I would generally recommend that you have the manufacturer take care of those.”
And his hospital also uses ultrafast diode-based lasers that are much more sophisticated and put out extremely short pulses. “They are difficult to measure, so you’re better off having the manufacturer handle those as well,” he says.
But even getting service directly from the manufacturer is no guarantee that you’re going to solve a laser problem.
Marlow recalled one situation in which a manufacturer sent out a service representative multiple times to recalibrate a laser. Marlow later determined that the reason for the repeat visits was that the information in the service manual was incorrect and the calibration procedure being followed was wrong.
Another time Marlow’s hospital received a broken laser as a demo. The manufacturer had to send out three different service representatives to work on the equipment before it was finally returned to working order. And that kind of situation may not be that uncommon, Marlow says, “particularly with new products that are somewhat complicated.”
In the past, Marlow says, manufacturers made it easier for biomeds to service lasers by offering training courses on specific makes and models. “But now a lot of them have eliminated those courses.”
To complicate matters, Marlow says, some manufacturers have tried to subvert FDA guidelines, which require them to provide owners with service information such as how to calibrate lasers. OEMs may recommend that service only be provided by factory-trained representatives. Further complicating the situation, Marlow says, the Centers for Medicare and Medicaid Services (CMS) advises that laser equipment maintenance be performed in accordance with the manufacturer’s recommendations—which often specify that their lasers be serviced by factory-trained representatives. “But the manufacturers aren’t providing that training anymore,” he points out.
The CMS directives that Marlow cites, issued in December 2013 and February 2014, have actually created considerable confusion among biomeds and third-party service providers about who is going to service medical lasers and how it should be done.
In December 2013, CMS issued a guidance memo on “Hospital Equipment Maintenance Requirements.” When it comes to medical lasers, a key paragraph of that directive reads, in part, “Hospitals comply with this regulation when they perform equipment maintenance in accordance with manufacturer’s recommendations.”
David Ohland, manager of Precision Laser Specialist, an independent laser service organization in Lake Zurich, Ill, points out that many hospitals have old laser systems that are still functional, but whose manufacturers have since gone out of business. “So there is not documentation available on the laser,” he says. “I have one customer with an 8-year-old laser, but with no documentation, who was wondering whether he had to get rid of it.”
That situation is further complicated by a challenge familiar to many biomeds—the difficulty in obtaining service manuals.
“I can’t emphasize this point too strongly,” Absten says. “Federal law requires the manufacturers to make this information available, along with [guidelines on] full alignment and calibration.”
The regulation in question is CFR 1040.10, under the heading, “Purchasing and servicing information.” The code requires manufacturers of laser products to provide or cause to be provided catalogs, specification sheets, and descriptive brochures pertaining to each laser product, as well as adequate instructions for service adjustments and procedures for each laser product model.
“But you know what happens,” Absten says wryly. “You call [the manufacturer] up and they’ll tell you, ‘We can’t give you that information—it’s proprietary.’ Not all of them, but some of them, are like that, so it could be a fight.”
Ohland says that while some manufacturers are “great” when it comes to providing servicing and maintenance information, others will be totally resistant. “OEMs aren’t making their money selling the boxes,” Ohland says. “They make their money servicing them, so they don’t want to do anything that will interfere with that. And if you try calling them up and telling them that the law says they are required to provide the information, they’ll say, ‘So sue me.’ ”
Another CMS directive, the “Revised State Operations Manual (SOM) Hospital Appendix A,” was issued in February of 2014. It contains a clarification of interpretive regulations and guidelines for hospitals concerning equipment maintenance requirements.
There are, however, a couple of confusing sections in this document, Absten says. The first refers to who is qualified to maintain hospital equipment:
“Equipment maintenance activities may be conducted using hospital personnel, contracted services, or through a combination of hospital personnel and contracted services. Individual(s) responsible for overseeing the development, implementation, and management of equipment maintenance programs and activities must be qualified. The hospital maintains records of hospital personnel qualifications and is able to demonstrate how it assures all personnel, including contracted personnel, are qualified.”
As Absten points out, this paragraph’s only requirement for personnel who service and maintain equipment such as medical lasers is that they “must be qualified.” However, the agency provides no definition for what “qualified” means. CMS apparently leaves it to hospitals to maintain personnel records in order to demonstrate that certain individuals are qualified to service particular pieces of equipment.
“So everyone is scrambling a little bit here,” Absten says.
According to Absten, the American National Standards Institute has two requirements that fulfill the basic qualifications for individuals to service medical lasers: that they receive documented training in laser safety and documented technical training commensurate with the class of laser serviced and the level of work being performed.
Absten says that hospitals could also go the route of getting personnel trained by third parties, either by the manufacturers themselves or groups like the Laser Training Institute. Absten points out that since CMS issued these recommendations, it appears that a number of biomeds—who seem to be otherwise qualified to work on lasers—are taking laser maintenance and repair courses in order to add to their credentials.
Another potentially confusing section of the February 2014 document regarding equipment maintenance reads as follows:
“Hospitals comply with this regulation when they follow the manufacturer?recommended maintenance activities and schedule. Hospitals may choose to perform maintenance more frequently than the manufacturer recommends, but must use the manufacturer?recommended maintenance activities in such cases. When equipment is maintained in accordance with the manufacturer’s recommendations, the hospital must maintain documentation of those recommendations and the hospital’s associated maintenance activity for the affected equipment.”
According to Absten, the phrase “following the manufacturer-recommended maintenance activities and schedule” is problematic.
“This isn’t an issue if we do things the way everyone has been doing them for the last 30 years of so,” Absten says. “We look at the laser once or twice a year, make sure it is calibrated at least once a year, respond to error messages, and perform service out of the service manual. So this shouldn’t be hard to do.”
But, Absten says, it seems that The Joint Commission has taken things a step further. “I was talking to one third-party service guy who had The Joint Commission come in, and it seems that The Joint Commission is now interpreting CMS standards—which in turn interpret federal law—to require the use of preventive maintenance checklists. Well, these checklists just don’t exist.”
Most laser manufacturers don’t provide simple lists of maintenance activities or maintenance schedules, Absten points out. Instead they more often provide laser service manuals, which service personnel can use to follow guidelines for repair.
“Yet The Joint Commission is insisting that they want this [specific checklist],” Absten says. “But having a complete service manual available should be enough to comply with the CMS requirement to document a manufacturer’s recommendations.”
Another problem, Absten says, is that an interpretation involving the provision of maintenance schedules is going to be confusing because the CMS directives use the terms “maintenance” and “service” interchangeably, whereas federal law defines the two terms differently.
The result of all of this is that biomeds and third-party service providers are scrambling to make sense of what is being required of them. “I don’t know what the answer is,” Ohland says. “But at some point I think these recommendations are going to have to be revised.”
Michael Bassett is a contributing writer for 24×7. For more information, contact editorial director John Bethune at [email protected].