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Is That Medical Equipment?

Posted By Greg Smith , Thursday, December 17, 2009
Updated: Saturday, February 09, 2013

During an evaluation of equipment at a hair treatment doctor’s office, we found a patient device for treating hair loss with the use of lasers. With this piece of equipment, the patient sits in a chair, and the laser "hat” sits slightly above the head. To prepare for the procedure, the top of the patient’s head is covered with a special gel to make the procedure work.

As the evaluation proceeded, several deficiencies were evident, including, non-certified (and unprotected) power supplies, inadequate insulation of wiring, missing cord strain relief, incorrect plug, incorrect use of relocatable power strip, no schematics, and the unit was missing all warning markings.

Photo 1. Photo of Hair Laser system

Also, the unit was unbalanced, and for a remedy the manufacturer had placed exercise weights in the bottom to keep it from falling over on the patient.


Non-certified power supplies, inadequate insulation method

During testing, the unit failed leakage current due to the non-certified power supplies. When we provided a verbal summary to the doctor, he was very upset and declared, "Well, for one thing, that’s not medical equipment!” I pointed out that the patient room had hospital grade receptacles, and that the manual for the equipment and the manufacturer’s website advertised it as medical equipment. Also, the patient is placed in close proximity and contact with the laser head while having a conductive gel on the skin.

The trainee on the job with me was concerned about the doctor’s very angry response, and I explained that this response is common with people who don’t understand the seriousness of electrical safety or, worse, with those who don’t care. He asked me what we were going to do, and my response was, "I’ll agree it’s not medical equipment if he agrees he’s not a doctor.” This reveals how equipment owners will often try anything to keep from having to make changes and repairs.


Exercise weights to keep unit from falling over, incorrect use of power strip, no strain relief, incorrect power cord and plug.

In the end, the changes were made by the manufacturer and the equipment was labeled and placed into service, and the final certificate of occupancy was granted for the facility. It’s interesting to note that the manufacturer had contracted a private (non-NRTL) laboratory to review the equipment to meet the "CE” (Self-declaration) guidelines, supposedly it was "very close” to meeting "CE”….

The doctor also exclaimed, "I have these units in three other facilities in South Carolina and nobody ever said anything about compliance.” We recommended that he have those systems corrected to meet the U.S. safety requirements. Most likely he did not.


Read more by Greg Smith

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