Red and infrared light-based devices are more readily available for use in clinic. In this article, we focus on LED therapy beds, which are considered a Class II medical device. Think of these 13 considerations as a buyer’s guide or checklist for you to use in your quest to obtain the LED bed that best fits your practice.
Considerations range from clinical to technical, ergonomic, regulatory, and financial. Chiropractors should evaluate the differences before investing in a bed. Do your research and due diligence. Commercial beds are priced between $20,000 and $150,000+.
Pro Tip: Make sure that some of the features that are “nice-to-have” are worth the additional cost to obtain them.
The LEDs utilized in the variety of products all operate via photobiomodulation (PBM).
Near-infrared (NIR) therapy systems are considered to be Class II medical devices, having been granted FDA clearance for relieving pain, increasing circulation, relaxing muscles, relieving muscle spasms, and relieving the aches and stiffness caused by arthritis.
NIR therapy can be utilized without any concern about harmful side effects. A 2017 study by Dr. Michael R. Hamblin, a light therapy pioneer, concluded that, “PBM has an almost complete lack of reported adverse effects.”1
1. Space to Fit Bed and Allow Patient Access
Clinics should confirm not only the device’s external dimensions but also clearance for entering and exiting the bed, plus the lid lifting up. Please note that some beds can be over seven feet long, four feet wide, five feet tall, and weigh over 700 pounds.
Pro Tip: The larger and heavier the LED bed, the more it will cost to ship to your location.
2. Installation and Setup Time
Pro Tip: Ask these questions.
- Are your doorways wide enough to allow the box, crate or container to pass through?
- Do a team of technicians need to be onsite to unbox and assemble the LED bed?
- How much time will your office operations be impacted by the delivery and set-up?
- Will your staff need to be involved – and to what extent – for the installation and set-up?
3. Electrical Power Requirements
Some beds require 110 volt power while others run better on 220 volt power. Ask in advance to make sure there are no surprises.
Pro Tip: It is best to have a dedicated circuit of at least 20 amps to protect the bed and other equipment in your office.
4. Bed Configurations
Your first decision is whether you want top and bottom coverage or just bottom. Each style has advantages and disadvantages.
Top and bottom ensures more coverage of the body. However, some patients do not like to be enclosed and the inside may get hotter during treatment.
Bottom only eliminates the “claustrophobic” feeling, but does not treat the top without additional panels or pads to treat the top of the person.
Your next decision point is a flat or ergonomic / zero-gravity bottom.
Flat: Can be uncomfortable to lay on for longer periods of time. Top and bottom designs require a flat surface to ensure uniform coverage of the body.
Ergonomic or Zero Gravity: Improves spinal support and patient comfort, but may require more floor space.
Finally, you want to know how the healing light is being delivered inside the LED bed – panels, tubes or strips of LEDs.
Pro Tip: Whichever style of LEDs, make sure that you receive extra ones to replace any that become faulty in order to quickly get back up and running.
5. Therapeutically Relevant Wavelengths
There are thousands of studies on light’s effects on the body in repositories such as PubMed. The results show us that there are certain ranges of nanometers at which the photons cause desired biological effects.
Different wavelengths target superficial tissues (skin, lymphatics) as well as deeper muscle and joint structures. The therapeutic effectiveness of PBM is strongly linked to the absorption spectrum of cytochrome-c oxidase and other mitochondrial photoacceptors. The red (≈630-670 nm) and near-infrared (≈780-940 nm) windows are consistently supported in the literature for tissue repair and anti-inflammatory effects.1-2
Therefore, we suggest a bed offering multiple wavelengths is better than just one wavelength.
Pro Tip: You want to make sure that your LED bed has the wavelengths to treat the conditions you see in your practice.
6. LED Bed Materials
The frame should be constructed with medical-grade steel or aluminum. The surface where the patient is in contact with the device should be easy to clean and constructed of non-porous, medical grade components like HDPE.
Verify the weight capacity to make sure it is high enough for your larger patients.
Pro Tips: Seam-free designs facilitate wipe-downs and support higher patient turnover rates. Look for at least a five year warranty on the frame and at least two years on the LED components.
7. Regulatory and Quality Status
PBM beds marketed for therapeutic use typically have 510(k) premarket clearance. FDA rules were changed a number of years ago to allow for clearance without formally filing the 510(k) with the FDA. However, all the paperwork must be completed and retained by the manufacturer or importer. These beds are marketed as FDA registered. Practitioners should verify that the intended use (e.g., treatment of musculoskeletal pain) aligns with the device’s listed clearance. Some benefits may be claimed under general wellness.3
There are several certifications about the factory producing the bed and its quality processes. Ask if the bed has MDSAP and ISO 13485 certifications.
- MDSAP - The Medical Device Single Audit Program (MDSAP) is a program that allows third-party auditors to perform a single audit of a medical device manufacturer. The audit covers the manufacturer's quality management system and regulatory requirements.
- ISO 13485 - Manufactured in a facility that meets ISO international quality standards. Ensures safety and quality in medical device design, manufacturing, and installation.
Pro Tip: Beware if you buy the LED bed directly online from an overseas factory. Check the regulatory and quality measures. Buy directly from U.S.-registered companies since they will have to follow local regulations.
Editor’s Note: Part 2 of this article (October web exclusive) covers additional considerations before buying a light-therapy bed.
References
- Hamblin MR. Mechanisms and applications of the anti-inflammatory effects of photobiomodulation. AIMS Biophysics, 2017;4(3):337-361.
- Chung H, et al. The nuts and bolts of low-level laser (light) therapy. Ann Biomed Engineering, 2012;40(2):516-533.
- General Wellness: Policy for Low-Risk Devices. FDA Guidance. Read Here
