Disclaimer: The information in this document is solely for reference material. Regulations change often. To be sure of the most up-to-date laws, contact your local and state agencies.
The global portable x-ray devices market is expected to be worth $12.25 billion by the year 2027. Today, it stands at $6.7 billion, growing at a rate of 14.6%. It’s a lucrative industry with a bright future.
Are you looking to start a mobile x-ray business? Or perhaps you are looking to upgrade your current operations. Whatever the case, after the cost of equipment, the most important factor to getting started is understanding the federal, state, and local regulations regarding radiation, and specifically, portable x-ray equipment.
In this article, we’ll explore which departments handle the licensing and registration of portable and mobile x-ray machines, where your operator can be licensed, and the rules that apply to portable equipment in each state.
What Defines a Portable X-ray Machine?
Before looking into state regulations for your equipment, make sure it is defined as “portable” in the rule books.
Portable x-ray equipment is a wireless, digital x-ray imaging device that’s used by mobile health professionals. This includes doctors and first aid workers in the field, at home, or in nursing homes. It also includes medically focused groups, ships, and offshore locations.
Essentially, a portal x-ray machine is smaller than a fixed unit and can be easily moved from place to place. Medical personnel will find a portable x-ray useful because it doesn’t require a large setup. The devices can be folded up and transported in a small package. You can then connect them to a computer (later on in an x-ray lab) to view and analyze images on display.
Market Drivers for a Portable X-ray Machine Business
There are a variety of factors that are driving this industry to exponential success. Evolving technological advancements and a rising number of patients with chronic diseases, paired with an increasing awareness of the product, have accelerated the growth of the market for global portable x-ray machines.
An increase in the elderly population and a growing number of accidents also fuel the portable x-ray industry. Other factors include:
- - Fast development of image rates
- - Good image quality
- - Fewer radiation risks
- - Rise in disposable income
- - Increasing occurrences of orthopedic diseases and cancer
The development of cost-effective devices has provided an opportunity for more people to enter the x-ray devices market.
Other major drivers in the industry include advancements in healthcare services and the rise in popularity of digital systems.
There are also significant restraints when it comes to opening a portable x-ray business, thus the existence of this guide.
Market Restraints for a Portable X-ray Machine Business
An increase in interest rates, ongoing ethical concerns, and privacy laws concerning data transfers have all worked to hinder the market. Additionally, high costs in manufacturing and clinical trials, as well as insufficient imaging infrastructures in third-world countries, also inhibits global market growth.
Who Regulates Portable X-Ray Machines?
The quick answer is…everyone. There are federal, state, and local laws that regulate how you can use a portable x-ray machine. Imaging systems are regulated by the FDA under two statutes:
- Radiation-emitting electronic products under the Radiation Control for Health and Safety Act
- Medical devices under the Medical Device Amendments to the Food, Drug, and Cosmetic Act.
Under Title 21, Sec. 1020.31 Radiographic equipment, there are very specific instructions on portable x-ray systems.
Federal Regulations
In the section on field limitation and alignment for mobile and portable x-ray systems, the following Code of Federal Regulations applies:
Variable X-Ray Field Limitation
There is a means for stepless adjustment of the size of the x-ray field, with each dimension equal to or less than 5 cm.
Visual Definition
There must be a means for visually defining the perimeter of the x-ray field. The total misalignment should not exceed 2% of the distance from the source to the center of the field.
If the light localizer is used to define the field, it shall provide an average illuminance of 160 lux (15 footcandles) at 100 cm or at the maximum SID (whichever is less).
Additionally, the edge of the light field shall have a contrast ratio of 3 or more in the case of beam-lighting devices for mobile or portable equipment.
Laws And Regulations
Laws provide in general terms the authority and responsibilities that state agencies have. The General Assembly passes legislation that then becomes law and is incorporated into the Code of that state.
Regulations provide specific requirements that are authorized/required by law. State agencies seek comments from the public and those interested parties who are affected by how a law is implemented. This process is called the Administrative Process Act. All regulations are then compiled into a single document called the Administrative Code.
Portable X-Ray Regulations by State
Just like any other industry, the laws for x-rays can vary greatly by state. In some cases, it can be pretty clear what the expectations are, while other states might take a little digging.
Some places will allow for the use of a portable x-ray whenever needed, while other states require an urgent care situation. In some cases, laws revolve around circumstances, like whether or not the patient is able to make it to a hospital setting or COVID social distancing laws.
If you’re starting a portable x-ray business, or perhaps updating equipment, it’s critical to understand the rules and regulations that specifically apply to you.
In this list, we’ve compiled detailed information on laws and regulations for a portable x-ray machine when available. It’s broken down by each state in alphabetical order.
- 1. Alabama
- 2. Alaska
- 3. Arizona
- 4. Arkansas
- 5. California
- 6. Colorado
- 7. Connecticut
- 8. Delaware
- 9. Florida
- 10. Georgia
- 11. Hawaii
- 12. Idaho
- 13. Illinois
- 14. Indiana
- 15. Iowa
- 16. Kansas
- 17. Kentucky
- 18. Louisiana
- 19. Maine
- 20. Maryland
- 21. Massachusetts
- 22. Michigan
- 23. Minnesota
- 24. Mississippi
- 25. Missouri
- 26. Montana
- 27. Nebraska
- 28. Nevada
- 29. New Hampshire
- 30. New Jersey
- 31. New Mexico
- 32. New York
- 33. North Carolina
- 34. North Dakota
- 35. Ohio
- 36. Oklahoma
- 37. Oregon
- 38. Pennsylvania
- 39. Rhode Island
- 40. South Carolina
- 41. South Dakota
- 42. Tennessee
- 43. Texas
- 44. Utah
- 45. Vermont
- 46. Virginia
- 47. Washington
- 48. West Virginia
- 49. Wisconsin
- 50. Wyoming
Conclusion
For any states that do not license portable x-ray devices or radiation therapy personnel, you can refer to the state's radiation control program for more on radiation-emitting equipment standards.
If you’re ready to purchase a portable and/or mobile x-ray system for your office, we can help you get started. Maven Imaging has mobile solutions for all types of budgets and clinical applications. We offer nationwide support and in-house financing for as low as $285/month!
Contact us today and speak with one of our experts to learn more.