Wednesday, October 5, 2011

Purchasing a Used Medical Laser

Starting or expanding a private medical or cosmetic practice can be a complicated experience. Location is of the utmost importance, followed by branding, and marketing. Staffing, clinical needs, pricing, advertising- all of these things can be an added headache to the whole process… not to mention acquiring quality equipment, and the follow up service.



While all the other parameters mentioned can be worked, and reworked, the one aspect that can make or break your entire practice is purchasing and servicing used medical lasers. There are hundreds of wholesalers, distributors, and other second source vendors offering as wide a variety of aftermarket options as there are options for new equipment, and even more. OEM’s are also in the market, and while basic supply and demand dictates that so many options should be a benefit to the consumer, the process of choosing which devices to purchase is amongst the most discussed, asked about, debated, and argued about amongst clinicians, salesmen, and repair companies alike. I have written this short guide with the hopes of assisting anyone in the market for a used medical laser in making the right decision.

Assessing Clinical Needs


One of the first things to consider when making a decision to purchase a laser is what, exactly, are your clinical needs. You should have a comprehensive list of possibilities. For some of you, this may just be one sheet of paper with two lines. Something like “hair removal,” and “non-ablative skin rejuvenation.” For others, this question may fill a couple of pages. In any case, you should consider your location, your customer base, your competition, your space and power requirements (more on this later), licenses held by your aestheticians, local and state laws (which determine who can perform what and with what device), staffing requirements, and anything else I may have missed.


One thing to remember- and I may get a lot of flak for this from this- IPL/BBL is NOT LASER! Though many of you love your IPL/BBL’s, they are NOT the equivalent of the technically superior true lasers. IPL, or Intense Pulsed Light, usually refers to a device where the treatment medium is the diode or flash lamp with the light slightly collimated through a non-radiating crystal. BBL, or Broadband Light, usually refers to a device which uses filtered white (or broadband) light to acquire a specific wavelength, and usually comes with interchangeable filters to alter the wavelength. Though the argument is constantly made that IPL and BBL are equivalent in treatment efficacy to LASER, this is “physically” impossible… that is, the laws of physics preclude non-collimated, non-amplified, non-(truly) monochromatic light from being the technical, clinical, or logical equivalent to light amplified through stimulated emission of radiation. We can debate this later, as I know many of you will be commenting on this.

Now, I’m not a clinician, so please don’t take anything I say as clinical advice. I am merely presenting clinical questions to be considered when purchasing a laser. And though you can always go to your peers for clinical advice, remember that the OEM should be your PRIMARY source of clinical advice, information, parameters, etc. Only the OEM can be held liable for giving unsound clinical advice for their device, and though many believe they are at liberty to utilize a like device for a procedure they may have knowledge of being performed by a like device, it is important to remember that any laser- cosmetic, surgical, and even industrial- is regulated by the FDA, and you should review whether or not your device is FDA approved for the procedure in question.

Space and Power Requirements


The combination of clinical needs and staffing, space and power requirements can be assessed. This is important because it may help determine whether you buy one fully loaded multi-purpose unit, one or two single use units, or a combination of single use and multi-purpose units. One thing to always keep in mind with multi-purpose units is that, often, if you lose one treatment, you are completely down. If you offer hair removal, and skin tightening from a multi-parameter unit, any problem with one can render your unit useless in delivering the other. Sometimes used lasers can be difficult to have repaired, and finding adequate technical service can take several days. Don’t make the mistake of losing days of business from hair removal because your skin tightening laser went out.


Of course, if you only have one treatment room, the point is moot. In this case I would recommend a multi-parameter unit, or in the very least a dual range laser like Nd-Yag (1064nm)/Alexandrite (755nm), Nd-Yag/KTP (532nm), or any of the various laser/IPL platforms. For those of you who have more than one room, remember- if one treatment goes down on your laser, it may put your room out of service. Single parameter, medium, or wavelength units are often cheaper, and easier to service. You have the option of purchasing more units, and even backups with the less loaded systems.

One of the furthest things from your thought process when purchasing a used laser may be (and may not be), but should NOT be, power requirements. A prime setup will allow for 220VAC (no less than 218VAC, and no more than 237VAC, though some lasers will have a lower max), and 30A of dedicated power. Dedicated power is of the utmost importance- no other device should share this power source. Though there are some nice 120VAC systems out there, the 220VAC systems often offer higher power output, and a wider pulse width range. I know 220VAC power is often referred to as 240VAC, and many units operate up to 240VAC. The problem with approaching that power range is that your power supply may be unstable, and I have seen spikes up to 247VAC. What I have never seen is a medical laser designed to be powered at voltages higher than 240VAC. Because of this, stay in the safe range: 218VAC-237VAC. A conditioner may need to be installed at your location, or you may simply have an electrician assess which 240VAC line coming into your building is the most stable.

Purchase to Service Cost Ratio


This is a fairly simple concept that many tend to neglect. You see a popular brand laser- fully loaded, all the bells and whistles, and at a great price… why do you think it’s so cheap? It’s fully functional, had one owner, it’s one or two years old… yet it’s being offered at 33%-60% off of retail. The easiest way to see the folly in this is by juxtaposing your laser for a new (or used) car. If you bought a Bentley in 2009, how much do you think it’s worth in 2011? If the vehicle has been driven at a normal rate- even DOUBLE the normal rate, the vehicle would retain at least 90% of its original value. Most other vehicles retain their value in a similar manner. In fact, most other products PERIOD maintain their value greater than lasers. In fact, when you compare lasers to other medical devices (which are probably the fastest depreciating products sold), they lose their value much faster than any other device.



Why do lasers lose their value quicker than any other device? Is there anything we can do about it? The answers are simple. Lasers lose their value quicker than any other device because the upkeep is much more expensive. The lasing medium is often proprietary, or extremely expensive. Excimer lasers, for example, use proprietary blends of gases that have to be periodically recharged. Yag lasers (Nd-Yag, Er-Yag, Ho-Yag) use a yttrium aluminum garnet crystal doped with neodymium, erbium, holmium, or some other medium intended for stimulated emission of radiation. These crystals are grown in labs, and medical quality crystals cost as much as $7,000 each. KTP crystals, used to double the frequency of Nd-Yag laser and create green light at 532nm (double the frequency, halve the wavelength), are also very expensive, and one popular brand uses a crystal and mount that costs $9,000 to replace. Power supplies are equally expensive. Lasing optics, delivery optics, cooling systems, reflective cavities, and other components and accessories add to the cost of lasers.

With premium components come premium training, experience, and education requirements for technicians. And of course, as with anything premium comes the price. Manufacturers invest millions into developing their devices, approving them for sale, and training their service technicians. They protect this investment by monopolizing service, and access to service information. This practice is not only a blatant violation of FDA law, it is detrimental to their own business. Again, juxtaposing lasers for cars- the top sellers are the easiest to work on. They also retain their value.

So what can we do about this? Well, 21 CFR 1040.10-11, the FDA’s regulation on laser and light based devices, requires the provision of service information to anyone who requests it. One option is to require your seller to provide this service information. This way you can furnish it to your technician or service organization of choice, and you are ensured service pursuant to US law. Another option is to have the seller provide you with contact information to the technician or company they use to service their own lasers. A third option is to find a technician or company prior to purchase, and have them guide you on what they are capable of servicing, and learn your expected costs. You may also find a company that possesses or is willing to request service information for your preferred laser, but this should be done before purchase. The final option is to request the information yourself, and your success would be determined by your persistence.

The ideal purchase to service cost ratio is less than 10% of retail annually. If you run a large operation, your p/s cost ratio should drop to around 5%. If you are paying more, you should reconsider your service provider. If you are in pre-purchase, then you should take this into account when considering the previous paragraph. Full service agreements will generally cost anywhere from 7%-15% of retail cost, and should be strongly considered as the best option when buying used. Believe me, it is much easier to add $10,000 or so to a $30,000-$75,000 purchase (the average cost of used lasers) than it is to be surprised by a $15,000 bill for repair just months after you purchase a used laser.

In the End…


It all comes down to knowing what you want, what you should pay, who you should buy it from, who should service your new investment, and what your long term investment should be. Know who the industry leaders are, but don’t succumb to mere marketing. There are various resources for helping make this assessment- use every resource at your disposal. Be objective, and remember that technically, any two like lasers are equal. The weak points of one like laser will likely be the weak points of the other. When faced with common misconceptions like “this laser is low in power,” think about the physics, and the law.

Though it is perfectly legal for a manufacturer to label a laser as capable of putting out up to 20% less power as actual output, it would render the unit impossible to calibrate to any legal standard. In other words, if your laser is labeled as a 100J laser, and puts out a max of 80J brand new, degradation would take it out of tolerance in no time. No technician calibrates a unit to the lower limit, and units are regularly just outside of the lower limit we DO calibrate them to (usually around 5%). So if any Yag laser set to 50J/cm2 with a 10mm hand piece should read around 39W on an external power meter with slight variations due to the physical properties of the optics, hand pieces, and lenses.

Mickey A. Couvertier, CBET, CLRT is President and Senior Technician at CRC Biomedical Services. A veteran, he served in the US Army as a Biomedical Engineer. Mr. Couvertier is certified by the Association for the Advancement of Medical Instrumentation as a Certified Biomedical Equipment Technician, and by the National Council on Laser Excellence as a Certified Laser Repair Technician. He is a frequent contributor to various medical device publications. You can learn more about Mr. Couvertier here.

Thursday, July 21, 2011

Superior Laser Repair Service

Laser Repair Service

Laser Repair


Are you aware that most laser repair service technicians don't actually know what they're doing? Sure, they know how to clean optics. Sure, they may know the basic rules for optical alignment. Sure, they may know how to check individual components. And, sure, they know how to replace parts. However, laser repair is expressly governed by 21 CFR 1040.10-11. Any and all laser repair service performed on a medical laser or light emitting device needs to be performed in accordance with manufacturer specifications. Though not all of the manufacturer specifications always exceed local, state, and Federal guidelines, some do. This may mean your tech is calibrating your laser to arbitrary numbers- ie. 20% by ANSI standards, vs. 10% tolerance by manufacturer standards. Some manufacturers set their standards as tight as 5% for output power measurements. This may also mean your tech lacks specific laser repair service software, special tools, or instructions only found in the service information provided by the manufacturer.

Laser Repair Facts

The problem is most third party laser repair and service companies have no idea how to legally acquire service information directly from manufacturers. CRC Biomedical does! We are the industry leaders and innovators of a process we call "21 CFR Requests." Through this process, we have acquired service information from secretive companies like Sciton, Cutera, Candela, Cynosure, Iridex, AMS, Spectranetics, and others! We are the only service company that adheres to FDA requirements, is completely open to FDA oversight, AND is staffed by Certified Biomedical Equipment Technicians with certifications as Certified Laser Repair Technicians! We have broken the illegal monopolization of the laser repair and service industry by laser manufacturers, and this means you don’t have to rely on manufacturers for laser repair service, service contracts, and their exorbitant costs.

Laser Repair Safety

Because our techs have a background in Biomedical Electronics, we look for things most others don't. We keep patient safety as our number one priority; most laser repair service techs don't even consider your clients as "patients." We assist our customers in FDA reporting of adverse events. We assist our customers in equipment procurement, and ensure the proper 510k or Pre-market Approval paperwork has been filed, reviewed, and accepted by the FDA. We will not advise you to purchase equipment that is not FDA approved, nor will we allow our customers to use equipment serviced outside of FDA regulations. We will do everything within our power to ensure that your service offerings are in accordance with local, state, and federal laws, and that the equipment you are using is cleared for the procedures they are marketed for. We will never sell you a laser we cannot service, nor will we recommend a device we cannot acquire replacement parts and accessories for. If you become a member of our mailing list, you will receive periodic notices regarding FDA warning letters, FDA recalls, adverse events listed in the FDA’s MAUDE database, and time to time we will send you coupons you will be able to use on your next laser repair or periodic maintenance. 
 
If you want to work with a company that will save you time and money by doing things right the first time, improves efficiency and delivery of service, ensures patient safety and regulatory compliance- a company that cares for YOU AND YOUR PATIENTS, contact CRC Biomedical Services! We are your laser repair specialists.
 
Mickey A. Couvertier, CBET, CLRT
President/Senior Technician
202-679-8357



Generated by: Tag Generator

Summer Laser Service Special

Greetings! Please take the time to become familiar with CRC Biomedical Services. As an incentive, we are currently offering a Summer Special to all of our customers. We hope you will consider us for your laser service needs. If you are considering purchasing a used laser, we can help!


WHO WE ARE


Laser Certification
CRC Biomedical Services is a veteran owned independent service organization formed by an Army veteran trained in the military as a Biomedical Equipment Repairer, or 91A (now 68A). Our staff possess certifications by the Association for the Advancement of Medical Instrumentation, and the National Council on Laser Excellence, and various OEM certifications. Our mission is to provide the highest quality of maintenance at the most reasonable price.

OUR COMMITMENT


At CRC Biomedical we are committed to providing the highest quality in all of our service offerings. We provide comprehensive care for a wide variety of medical equipment specializing in cosmetic lasers. We can help your facility meet it's mission of providing quality patient care by making sure all your laser service is up to date, and that all your equipment is functional and safe. We advise our clients by giving expert assistance in equipment procurement from an objective third party perspective.

WHAT WE DO


We offer maintenance and repair on a wide variety of medical equipment including, but not limited to surgical and cosmetic lasers, various diagnostic imaging modalities including ultrasound, mammography, and vascular imaging, electrosurgical units, ventilators, and much more. Our preventive maintenance services are geared to ensure patient safety, and to extend the life of your equipment. We adhere to the strictest standards when servicing your equipment, and follow Original Equipment Manufacturer guidelines. We offer one time service as needed, scheduled service at intervals dependent on the type of equipment, and preventive maintenance packages which cover multiple items at your facility, and ensure prompt response time.


OUR SUMMER SPECIAL


With the purchase of one full price laser service. Offer only valid on PM's to be performed the same day as regular priced service, with some exceptions at the discretion of the management staff at CRC Biomedical Services. Customer must present brochure coupon at time of arrival of tech. If customer has only one device, customer may use this coupon towards a fifty percent discount on PM labor only as a biannual follow up to purchased service. This coupon expires August 31, 2011 with the exception of customers using the fifty percent option. Acceptance of coupon or fulfillment of any duties herein remain the sole discretion of CRC Biomedical, LLC.


We look forward to doing business with you!

Sincerely,

CRC Biomedical Services


Generated by: Tag Generator