Comments on: Shining a Light on Medical Laser Training and Repair

By: Jesus Guerra

Jesus Guerra — Tue, 14 Mar 2017 15:06:42 +0000

In reply to Joe Mandell.

Hello Joe.

I need medical laser training in FL Area. May you help me contact an organization in FL that offer this training?

shorai2013@gmail.com

Best Regards.

By: Ed Krivanek

Ed Krivanek — Wed, 30 Dec 2015 13:37:32 +0000

As usual, however, whenever government agencies get involved, they usually make a mess of things. In this case regulations in which they are vaguely familiar with equipment and protocols. If they would just regulate that Biomeds receive the necessary training from the manufacturers, most problems would be solved before they surface. The problem is exposed by the governments interfacing with the big money corporations who are more concerned with profit than patient safety.

By: Joe Mandell

Joe Mandell — Fri, 29 May 2015 21:48:11 +0000

Great article. Last year I was working for a third-party service provider that tried to break into the local laser market. In the San Antonio area alone there are over 30 laser hair and tattoo removal clinics around the city. The general consensus among the owners and operators of these clinics is that when they purchased the equipment, they got locked into a service contract that charges way too much money for very little service or support.

If you are looking to lower your OEM contract costs but lack the expertise, test equipment, or as the article pointed out, OEM service literature, take the Preventative Maintenance on yourself and let the OEM take care of the calibrations. Lasers get very hot so PMs consist of cleaning filters, removing dust from heat sinks, and checking coolant levels. Ensure that the operator is cleaning the handpiece after every treatment. Laser use in dermatology procedures burn tissue and the smoke can be messy.

Last bit of advice… check your state laws before jumping into laser repairs. Many states like Texas require organizations to register with the state and to maintain records, much like a radiation safety program.

By: Stephen Glassic

Stephen Glassic — Tue, 28 Apr 2015 18:57:03 +0000

Thank you Michael for spelling this all out so well. This is an issue for many other types of medical devices as well. Far too often, when new regulations are written, the impact on older devices that are currently in use is not taken into account. Another problem is consistency in application, interpretation and enforcement to include all involved parties in a logical roll out progression. Imagine if people were required to use seat belts in all automobiles one or two years after manufacturers were required to install them in new vehicles.

In the case of older devices, there should be provisions spelled out to accommodate these devices. There should be a way to satisfy the requirements for older equipment such as allowing the use and development of test and maintenance procedures by the hospitals or professional organizations such as ECRI based on available specs, clinical requirements, risk factors and device age, performance and reliability history.

In my opinion CMS should not be involved writing medical device management regulations.