Paid for by 3B Medical

The 3B Lumin at-home mask and water chamber cleaner opts for ultraviolet light instead of activated oxygen. 3B Medical’s Alex Lucio explains why.

Patients don’t always follow instructions.

From being too busy to dismissing warning labels as unimportant, there are seemingly as many reasons as there are patients to explain why protocol adherence is hit or miss.

So when sleep apnea patients buy convenient at-home CPAP cleaners to lessen manual hand washing of masks and accessories, they may not follow the manufacturer’s directions every time. And in the case of ozone-based CPAP cleaners, that can have undesired consequences.

“I spoke with several pulmonary physicians who expressed considerable concern about residual ozone being inhaled by COPD patients,” says Alex Lucio, CEO of 3B Medical, which made available its Lumin at-home CPAP cleaner this month—the Lumin uses ultraviolet light to disinfect, instead of ozone, as a response to concerns raised about ozone having the ability to cause chest pain, coughing, shortness of breath, and throat irritation if inhaled in even low amounts.

Lucio cites the U.S. Food & Drug Administration’s Code of Federal Regulations, which limits residual ozone to 0.05 parts per million. “In order for ozone to be effective as a germicide, it must be present in a concentration far greater than that which can be safely tolerated by man and animals,” states the code. “Although undesirable physiological effects on the central nervous system, heart, and vision have been reported, the predominant physiological effect of ozone is primary irritation of the mucous membranes. Inhalation of ozone can cause sufficient irritation to the lungs to result in pulmonary edema.”

Lucio says, “In a sleep lab, it is fine. Sleep lab employees have protocols and understand how to follow instructions in working with chemicals and gases. But there is a risk that patients won’t follow instructions, such as waiting 2 hours before using their mask. For that reason, we had no choice but to stay clear of ozone. I strongly felt that the other products on the market did not properly disclose and label risks.”

Lucio recently explained the development process behind the Lumin, as well as some of the company’s other recent launches.

Sleep Review (SR): Why not ozone?

Lucio: As a CPAP device and masks manufacturer, we felt that ozone risks damaging silicone seals, gaskets, and corroding the electronics of the device.

We also knew that California’s Air Resources Board has passed strict standards for ozone use in the home and did not want to encounter hidden regulatory risks with either that state board or the Environmental Protection Agency on a federal level.

Finally, pulmonary physicians have expressed concerns to us about residual ozone being inhaled by their patients.

The combination of concerns over the longevity of CPAP devices exposed to ozone, potential hidden regulatory issues, and potential serious patient respiratory health issues were enough to dissuade us from using ozone. It is a great disinfectant, but it has unknown potential liabilities with household use.

SR: Did you consider a dry heat-based disinfectant instead?

Lucio: Heat alone isn’t usually adequate. With plastics and silicone, it is difficult to reach disinfection levels with low level heat, unless the duration is extended. An industrial version of the Lumin employs heat in combination with ultraviolet light. For home use, nothing beat ultraviolet light for speed of disinfection and convenience.

SR: How does ultraviolet light work as a disinfectant?

Lucio: Ultraviolet (UV) light encompasses light with wavelengths shorter than that visible to the human eye but longer than X-ray radiation. Scientists further subdivide it into UVA (400 nm-315 nm), which is used in tanning beds; UVB (315 nm-280 nm), which causes sunburns, and UVC (280 nm-100 nm), which is what the Lumin uses.

At UVC wavelengths—the Lumin specifically employs 254 nm—the DNA of biological microorganisms is damaged to a point where it can’t repair itself, resulting in cell death. A white paper about the Lumin found it has a 99.9% kill rate for harmful bacteria, viruses, mold, and fungus.

SR: So does the user need to ensure a particular placement of the equipment to make sure that all of it is exposed to the light?

Lucio: The interior cavity of the Lumin is lined with highly polished aluminum ensuring a 360-degree reflection from the UVC source. However, to ensure optimal results, mask and water chamber are presented face up.

SR: What items can the Lumin disinfect?

Lucio: The Lumin disinfects CPAP masks, hoses, and water chambers.

In addition, the Lumin stands apart and does double duty as a general disinfecting device for any personal items, including hearing aids, oral appliances, toys, toothbrushes, etc. Our mindset was a multipurpose cleaner could be used in a variety of ways, earning the real estate on a patient’s countertop. It can be used daily by every member of the household.

SR: Is redundancy built into the Lumin?

Lucio: Redundancy is built into the exposure time. Basically the kill dose was achieved with a 3-minute exposure. This time was extended to allow for overkill.

SR: Considering that many CPAP parts are made of plastics, how is using UVC (which can degrade plastics) OK?

Lucio: The UVC cycle duration is 5 minutes. While it is true that UVC degrades some polymers over time, the short duration of UVC exposure ensures there is no degradation within the life of the mask or accessory. Generally, degradation starts to occur after 200 hours of exposure. By comparison, one year of daily use with the Lumin is equivalent to 30 hours of UVC exposure.

SR: What safeguards are in place to ensure users aren’t exposed to the UVC?

Lucio: The Lumin was engineered with a magnetic switch that only operates when the chamber drawer is fully closed. Opening the drawer will automatically power off the device.

SR: Other than mechanism of cleaning, are there any other distinctions between the Lumin and other CPAP cleaners on the market?

Lucio: Yes, we believe that UVC is a safer and healthier option. We developed the Lumin in response to quite a few pulmonary physicians expressing concern over their patients using an ozone-based cleaner. Our goals were well defined: (1) select a means that did not cause damage to the device, as ozone does, and (2) select a means that was both effective and healthy for patients to use.

 

3BNewMasks2018

SR: Switching gears, 3B Medical has released 3 new masks within the last few months. What can you tell us about your new mask line?

Lucio: We recently launched 3 new masks, resulting in an entirely new mask line up. Our Viva Nasal, Numa Full Face, and Rio Nasal Pillow masks are all extremely light, extremely comfortable, and patient acceptance has been nothing short of phenomenal. We attribute the high patient acceptance to a new generation of materials that allows us to reduce the weight. As an example, the Rio mask weighs in at only 2.3 ounces.

Beyond that, as part of our mission, 3B is determined to assist durable medical equipment providers (DMEs) recover lost profitability. 3B Medical is pricing masks, mask cushions, and pillows at price points that will allow our DME base to regain their financial strength and profitability in servicing this segment. Compare these 3 masks against the best in the market in a blind line up, and we are confident that patients would find our line equal in both quality perception and comfort.

SR: Does 3B anticipate any other product launches this year?

Lucio: This is the busiest product development year in our history. We have two major products under development. But you will have to stay tuned and wait another 3 or 4 months before we’re at liberty to discuss those. 2018 is definitely 3B Medical’s breakout year.

The Lumin Specs

CPAPCleanerNoOzone

Warranty: 2 years
Estimated Useful Life: 5 years
Power: 13W
Cycle Time: 5 minutes
Watt Hours: 0.91
Reimbursement: Not reimbursable as of press time

Purchase Lumin at your local durable medical equipment provider or online at 3BLumin.com.

This content is paid for by:

3B Medical

 

Partner with Sleep Review on content marketing.