Recalling recalls: how do we interact with our patientsCommentary on Ruoff CM, Tashman YS, Cheema KPK, et al. Interaction of positive airway pressure mask magnets with cardiac implantable electronic devices. J Clin Sleep Med . 2023;19(5):941–946. doi: 10.5664/jcsm.10478

Free AccessCommentaryRecalling recalls: how do we interact with our patients Robert L. Owens, MD, Jonathan C. Hsu, MD, MAS, FACC, FAHA, FHRS, Kevin R. King, MD, PhD Robert L. Owens, MD Address correspondence to: Robert L. Owens, MD, 9300 Campus Point Drive, Mail Code 7381, La Jolla, CA 92037; Tel: (858) 657-5258; Email: E-mail Address: [email protected] Division of Pulmonary, Critical Care, Sleep Medicine and Physiology, University of California San Diego, La Jolla, California Search for more papers by this author , Jonathan C. Hsu, MD, MAS, FACC, FAHA, FHRS Division of Cardiology, University of California San Diego, La Jolla, California Search for more papers by this author , Kevin R. King, MD, PhD Division of Cardiology, University of California San Diego, La Jolla, California Department of Bioengineering, University of California San Diego, La Jolla, California Search for more papers by this author Published Online:May 1, 2023https://doi.org/10.5664/jcsm.10556SectionsEpubPDF ShareShare onFacebookTwitterLinkedInRedditEmail ToolsAdd to favoritesDownload CitationsTrack Citations AboutINTRODUCTIONThe practice of sleep medicine has been particularly turbulent during the COVID-19 pandemic. Certainly, COVID-19 infection itself1 and restrictions on school, work, and travel all impacted sleep.2,3 Furthermore, many providers were initially forced to limit access to polysomnography or other testing while simultaneously expanding “virtual” or telehealth visits.4 In the midst of these challenges came the Philips Respironics voluntary continuous positive airway pressure (CPAP) recall in June 2021, which initially advised patients to forego therapy with their device until discussion could be had with their provider.5 In that case, use of CPAP cleaning equipment that was not prescribed but instead marketed directly to patients was implicated. Most recently, on September 6, 2022, the Food and Drug Administration issued a Class I recall (the most serious type of recall) for certain Philips Respironics masks/headgear that use magnetic clips with reports of interactions between these magnets and implantable medical devices.6 Although the list of potentially affected devices is long, interactions with implantable cardiac devices (ie, pacemakers and automatic implantable cardioverter-defibrillators) are of the greatest concern given their prevalence especially in those with obstructive sleep apnea who might use CPAP and given that magnets are typically used to temporarily disable certain functions of the devices. As of January 31, 2023, there were 43 complaints, including 14 serious injuries (not specified) and no associated deaths attributed to the use of magnet containing masks and headgear.7Thus, the work by Ruoff and colleagues in this issue of the Journal of Clinical Sleep Medicine, although limited in patient numbers, is timely and important.8 Briefly, the authors recognized the relevance of an early case report published in 2019, in which 2 patients demonstrated unexplained nocturnal magnet interactions with their cardiac implanted electronic devices (CIEDs). Investigation revealed that both patients used CPAP masks containing magnetic clips, which led to magnet interactions—ie, the device records a magnet response—but not clinical events such as initiation of asynchronous pacing, which requires a longer duration of application by the magnet.9 Interestingly, it is clear that such masks were novel to those authors (“It was found that his CPAP mask had four magnetic clips…”) who were electrophysiologists, and the report was published in an electrophysiology journal. Since that report, Ruoff and colleagues suggested that their patients with implantable devices stop using masks with magnetic clasps. If patients continued to use such masks, they would offer “safety visits” that included (1) an interrogation of CIEDs to review recent normal use, (2) monitoring of the cardiac device during simulated normal use in clinic while awake, and (3) in-clinic daytime observed direct contact between mask/headgear and CIEDs. In the 13 patients they tested, they saw no interactions during review of normal use and could only provoke one magnet response event using direct contact—with a ResMed mask. Based on prior case reports and this new report by Ruoff et al., it seems clear that there are potential risks with CIEDs and magnetic clasps from both major manufacturers, though exact risk is hard to quantify. For example, in the case of pacemakers, magnet placement causes asynchronous pacing, which is rarely problematic, but in the case of automatic implantable cardioverter-defibrillators, magnet placement may lead to inhibition of needed therapy in the event of an arrhythmia.What the current research by Ruoff and colleagues and both the recent recalls emphasize are the missing interactions between patients, physicians, and durable medical equipment (DME) providers and manufacturers. Presumably, patients who use CPAP want something comfortable and easy to use, which manufacturers will provide. Physicians and DME providers would like to help improve adherence to CPAP. Thus, many physicians suggest trying masks that offer the greatest comfort and ease of use for patients with few restrictions or caveats. But, at any given time, it is hard to know exactly what equipment belongs to which patient. For example, some patients may be given full face masks by DME providers even when a nasal mask might be more effective.10 In the current recall, how would a patient who has been using the same mask (with magnetic clasps) for years know that it is now contraindicated after getting a pacemaker? How would a DME provider know that a patient has had a pacemaker implanted before sending over the same mask? How would the sleep clinic know what mask a patient and DME have settled on together?In the wake of these recalls, some of the conclusions are clear. CPAP must be considered to have (minor) risks and benefits. These risks and benefits from CPAP need to be individualized to each patient.11 Based on the current recall and data presented by Ruoff and colleagues, patients with CIEDs should be warned against CPAP masks with magnetic clasps regardless of manufacturer. Other devices that might have magnet interactions, eg, deep brain stimulators that are also listed in the Food and Drug Administration recall notice, should be referred to experts with knowledge of those devices and evaluated on the likelihood of an interaction and the potential magnitude of harm from that interaction. Finally, there needs to be more clear testing of positive airway pressure machines as well as adequate systems for reporting of events, including for peripheral devices such as cleaning devices that were marketed to reduce infections with very little data.12,13 In both recalls, events were noted years before action was taken.While these conclusions are clear, the steps needed to implement changes are not. Technology likely plays a role, whereby details about masks might be more up to date in cloud-based tracking systems, where available, that are visible to providers. Those patients who use apps to track their CPAP data might then be able to receive notifications about recalls or other substantial updates. In addition, DME providers could be more integrated into the health systems of the patients they care for. Ultimately the solutions for these and future problems will rely on better interactions between patient, DME providers and manufacturers, and clinicians.ABBREVIATIONSCIEDcardiac implanted electronic devicesCPAPcontinuous positive airway pressureDMEdurable medical equipmentDISCLOSURE STATEMENTAll authors have critically reviewed the manuscript and approve its submission. RLO reports research grant funding from Nitto Denko Asia, Samsung, and Masimo, all outside the scope of the current work. The other authors report no conflicts of interest.REFERENCES1. Quer G, Radin JM, Gadaleta M, et al.. Wearable sensor data and self-reported symptoms for COVID-19 detection. Nat Med. 2021;27(1):73–77. CrossrefGoogle Scholar2. Blume C, Schmidt MH, Cajochen C. Effects of the COVID-19 lockdown on human sleep and rest-activity rhythms. Curr Biol. 2020;30(14):R795–R797. CrossrefGoogle Scholar3. Rezaei N, Grandner MA. Changes in sleep duration, timing, and variability during the COVID-19 pandemic: large-scale Fitbit data from 6 major US cities. Sleep Health. 2021;7(3):303–313. CrossrefGoogle Scholar4. Johnson KG, Sullivan SS, Nti A, Rastegar V, Gurubhagavatula I. The impact of the COVID-19 pandemic on sleep medicine practices. J Clin Sleep Med. 2021;17(1):79–87. LinkGoogle Scholar5. Owens RL, Wilson KC, Gurubhagavatula I, Mehra R. Philips Respironics recall of positive airway pressure and noninvasive ventilation devices: a brief statement to inform response efforts and identify key steps forward. Am J Respir Crit Care Med. 2021;204(8):887–890. 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FDA reminds patients that devices claiming to clean, disinfect or sanitize CPAP machines using ozone gas or UV light have not been FDA authorized. https://www.fda.gov/news-events/press-announcements/fda-reminds-patients-devices-claiming-clean-disinfect-or-sanitize-cpap-machines-using-ozone-gas-or. Accessed February 27, 2023. Google Scholar Next article FiguresReferencesRelatedDetails Volume 19 • Issue 5 • May 1, 2023ISSN (print): 1550-9389ISSN (online): 1550-9397Frequency: Monthly Metrics History Submitted for publicationMarch 2, 2023Accepted for publicationMarch 2, 2023Published onlineMay 1, 2023 Information© 2023 American Academy of Sleep MedicinePDF download