Does Your Chiropractic Electrotherapy Equipment Need Serviced?

We can help!

HES offers expert Electrotherapy Calibrations. Your Equipment must be tested once a year Especially UltraSound & E-Stim Units.

Annual calibration of your ultrasound & e-stim devices is required.

According to the Health Care Finance Administration regulations [ (42 CFR CH iV) 485.723 Condition of participation subchapter (b) Standard of Maintenance: Equipment]......

According to the FDA, subchapter 5 of the FD&C Act Section 514 [360d] paragraph (A)......

According to the State Board of Chiropractic, in accordance with the Chiropractic Practice Act.....

FDA, STATE BOARD, HCFA & MALPRACTICE

The circle of regulation regarding calibration and safety of your treatment devices.

We are often asked whether or not and how often should medical devices such as adjusting tables, ultrasounds, stim units, traction heads, hydrocollators etc. be calibrated and safety checked. We did some research and discovered a circle of regulation that is compelling.

The FDA was given authority by the Food, Drug and Cosmetic Act in 1971 to administer the Radiation Control for Health and Safety Act. This act gives the FDA authority to establish performance standards which include inspection mechanisms to protect the public from the dangers of electronic devices that emit radiation which include ionizing electromagnetic, sonic, infrasonic, and ultrasonic waves.

Subchapter 5 of the FD&C Act Section 514 [360d] paragraph (A) requires anyone utilizing an emitting device to provide assurance to the public of a device's safe and effective performance. Subsection (iii) provides a requirement for the "measurement" of the performance characteristics of a device and subsection (iv) requires the test results be displayed that show the device to be in conformity to the FDA Standard.

The Health Care Finance Administration regulations [ (42 CFR CH iV) 485.723 Condition of participation subchapter (b) Standard of Maintenance: Equipment] which are imbedded in all private insurance contracts, Act 6 and 57 state: The organization must establish a written preventive maintenance program to ensure that the equipment is operative and properly calibrated.

Interestingly, the State Board of Chiropractic, in accordance with the Chiropractic Practice Act requires that modalities of these types be used within the scope of practice and accordance with the manufacturers labeling regarding safety and usage. Your malpractice carrier requires (due diligence) that you practice within the confines of the Practice Act which is another way of saying that you must comply with the regulations associated with the devices you use within the scope of your practice.

Another interesting issue is a little known reporting requirement that requires users of medical devices (where injury occurs) report to the FDA any adverse device experience. Under the Safe Medical Devices Act of 1992 a user of a medical device which malfunctions must fill out form 3500A and return it to the FDA. This information is held in confidence and according to Federal Law "cannot be admissible into evidence or otherwise used in any civil action". This is to encourage truthfulness and compliance; the goal being to correct a problem not to punish.

What are the checks and tolerances? Any electrical device like an adjusting table or hydrocollator is supposed to have a safety check every year. These devices are checked for stray voltage. 100 ma or less is acceptable. They are also checked for safety and stability ie. hydraulics and condition of bolts and welds. Electrical Stim units are checked for calibration, wave-form output, leadwires, and stray voltage. Ultrasound units are checked and calibrated. Ultrasounds must be +/- 10% of the FDA performance standard.

This service does not take much time, is inexpensive and has the potential of preventing a disaster.

Why risk hurting a Client?

For more information about this required annual calibration of your ultrasound & e-stim devices, please call HES at (800) 253-5555.

For Service Call (800) 253-5555 and speak with our Service Department to schedule a calibration.