HANDHELD DENTAL X-RAY SYSTEM                                                        H.B. 5647 (H-1):

                                                                                                    SUMMARY OF BILL

                                                                                      REPORTED FROM COMMITTEE

House Bill 5647 (Substitute H-1 as reported without amendment)

Sponsor:  Representative Ben Frederick

House Committee:  Health Policy

Senate Committee:  Health Policy

CONTENT

The bill would amend the Public Health Code to prohibit the use of a handheld dental x-ray system unless the machine was registered with the Department of Licensing and Regulatory Affairs (LARA), and the system, the personnel operating it, and the facilities in which it was used met certain requirements. "Handheld dental x-ray system" or "system" would mean an x-ray system that is used to take radiographs, is designated to be handheld during its operation, and is portable.

Under the bill, the system, the personnel operating the system, and the facilities in which the system is used met all of the following requirements:

-- The system had been approved for human use by the United States Food and Drug Administration.

-- The system had a backscatter shield that met certain requirements.

-- The system was calibrated by its manufacturer before its first use and was recalibrated at least every 24 months after the date of the last calibration.

-- When not in use, the system was stored in a manner that restricted access to it, such as by storing it in a locked area of the facility.

-- The system was not used if the backscatter shield was broken, missing, or malfunctioning.

Additionally, each individual who operated the system would have to be authorized to operate a dental radiography machine pursuant to rules promulgated under Part 166 (Dentistry) of the Code.

A handheld dental x-ray system that met the requirements described in the bill could be used for routine dental radiography in a dental office or a situation in which it was impractical to transfer a patient to a radiation machine that was stationary.

MCL 333.13521                                                         Legislative Analyst:  Tyler VanHuyse

FISCAL IMPACT

The bill would have no fiscal impact on the Department of Licensing and Regulatory Affairs or local government units. Departmental rules already require the registration of radiation devices.

Date Completed:  12-13-18                                                 Fiscal Analyst:  Abbey Frazier

                                                                                                 Elizabeth Raczkowski

This analysis was prepared by nonpartisan Senate staff for use by the Senate in its deliberations and does not constitute an official statement of legislative intent.