Electrode and sensor makers report more sample requests for their disposable options.
By Lisa Spear
As the coronavirus emerged across the country in March, many sleep labs closed their doors, and many ushered in a new era of higher infection control measures that could continue to permeate the industry well into the future. The pandemic has left sleep medicine specialists and others in the medical field with a keen awareness that reusable equipment could harbor harmful viruses and bacteria if not properly disinfected.
The COVID-19 virus can remain active on certain surfaces for up to three days, according to correspondence published in the New England Journal of Medicine on April 16.1 Therefore, the American Academy of Sleep Medicine (AASM) has issued recommendations that as a precaution, providers should consider removing reusable devices from service for at least 72 hours in addition to disinfection before their next use. A statement issued by the AASM also asked providers to consider using disposable devices and components.2
“When all of this began, there was variable data regarding how long the coronavirus could survive on different surfaces. Therefore, disposable devices seemed a reasonable initial approach for optimal safety,” says Kelly Carden, MD, MBA, AASM president and a sleep medicine physician with Saint Thomas Medical Partners – Sleep Specialists in Nashville, Tenn.
Since that time, however, experts have noted that appropriate infection control procedures can prevent spread from contact with contaminated surfaces or objects, and the CDC recommends that standard cleaning and disinfection protocols are appropriate for reusable medical equipment.3 “Therefore, we have re-considered the use of reusable devices but strongly recommend appropriate cleaning and disinfection standards be upheld,” says Carden.
Still, the industry had already pivoted toward disposables in sleep testing. In the years prior to the coronavirus outbreak, infection control was already top of mind for many in sleep medicine.
Medical device manufacturer CleveMed has long supplied throwaway components, including respiratory belts and nasal cannulas. Iceland-based sleep diagnostics device maker Nox Medical has also taken steps in this direction, deploying several single-use components with its sleep tests, including filter tube connectors, mask pressure tubes, and others. Last year, sleep diagnostics company Itamar Medical received 510(k) clearance from the US Food and Drug Administration for the first fully disposable home sleep apnea test called the WatchPAT One. Nihon Kohden launched disposable gold cup EEG electrodes in April.
Many clinical sleep labs have already turned to disposables as a way to mitigate cross-contamination. Boston Children’s Hospital’s Department of Neurology transitioned to single-use EEG electrodes in 2018 after emerging research showed that microscopic traces of human tissues and bacteria are left on reusable EEG electrodes, even after they have been cleaned. The study published in the American Journal of Infection Control in December of 2018 uncovered that 25% of cleaned reusable electrodes still had bacteria present.4
Other sleep centers seem to be adding to this trend. According to a Sleep Review survey conducted from mid-March to early April, 26.7% of 221 sleep medicine professional respondents reported that they were buying or trying to buy more disposable sleep study equipment.5
For many, the switch has been a no-brainer. “It just makes more sense,” says Barbara Ludwig-Cull, RPSGT, RST, chairperson of Stony Brook University’s polysomnographic technology program. “It is out of an abundance of caution.”
The sleep lab where she works at Stony Brook University Medical Center Sleep Disorders Center started to move to disposables about 10 years ago, first with CPAP masks, then switching to disposable hoses and EEG wires.
Dymedix Diagnostics reports that it has seen the largest bump in demand for its disposable diagnostic sleep sensors over the last two years. Ambu, a Danish medical technology company focused on providing disposable solutions to hospitals, reported an increase in sales of disposable electrodes over the last five years. Some companies attributed this growth in sales to pressures from The Joint Commission and other accrediting organizations relating to the efficacy of sensor sterilization methods.
Another sleep sensor manufacturer, SleepSense, reported a significant increase in new inquiries in the initial days when the coronavirus swept through the United States. On the other hand, when many sleep labs across the country closed their doors to patients during the pandemic, Brett Alpaugh, senior market manager for Ambu, says that its overall sales numbers dropped. However, among those that remained open, the company saw a surge in requests for samples of cup electrodes, which could signal a growing interest in disposables going into the future as more sleep disorders centers reopen.
“I think more people have become sensitive to the infection control issues that are out there, and with the pandemic, they have seen how quickly things can spread, even when you are careful,” says Sarah Paddock, director of sales and marketing at SleepSense.
While there is a potential for greater expense to using disposables, Ludwig-Cull says there are also many unexpected benefits. She’s found that staff members on her team can now focus more on the patients and less on cleaning equipment.
When they used reusable CPAP masks, over the years they spent hours on washing, drying, and sending the masks to the facility’s central sterilization center. Now, the CPAP masks go home with the patients. An added benefit is that the patient now has a backup mask.
“I believe this may be a tipping point for the use of disposable sensors in sleep medicine,” says Todd Eiken, RPSGT, FAAST, vice president of product development at Dymedix Diagnostics. “Labs that have already made the switch to disposables are in an advantageous position to rapidly reinitiate sleep testing with limited risk of cross-contamination or spread of infection.”
Lisa Spear is the associate editor of Sleep Review.
1. Van Doremalen N, Morris DH, Holbrook MG, et al. Aerosol and surface stability of HCoV-19 (SARS-CoV-2) compared to SARS-CoV-1. N Engl J Med. 16 Apr 2020;382:1564-7.
2. American Academy of Sleep Medicine. COVID-19 mitigation strategies for sleep clinics and labs – updated. 8 Apr 2020: https://aasm.org/covid-19-resources/covid-19-mitigation-strategies-sleep-clinics-labs. [updates are ongoing]
3. Centers for Disease Control and Prevention. Disinfection and sterilization. 24 May 2019: https://www.cdc.gov/infectioncontrol/guidelines/disinfection/index.html
4. Albert NM, Bena JF, Ciudad C, et al. Contamination of reusable electroencephalography electrodes: A multicenter study. Am J Infect Control. 2018 Dec;46(12):1360-4.
5. Roy S. How is the coronavirus impacting sleep medicine professionals? Sleep Review. 2020 Apr;21(4):12-5.