February 05, 2024
Dear Patients,
We have been notified by ResMed that they have issued an updated safety information on certain masks with magnets for mask users.
From Resmed:
"Patient safety is ResMed’s top priority, and we will always follow our guiding principles that prioritize patient needs and safety to ensure the best care is given to the millions of people we serve worldwide.
We understand how important the right mask is to ongoing therapy for people with sleep apnea, COPD, and other chronic diseases. Over the past year, we have been engaged in discussions with Health Regulators to ensure that we are up to date with the latest recommendations around the use of magnets when in close proximity to certain implants and medical devices.
To provide patients and healthcare professionals with updated guidance on the safe use of ResMed masks with magnets, we have updated the contraindications and warnings sections in our user guides. Our actions are in response to new information obtained through the latest regulatory recommendations, post-market surveillance, and industry practices related to the potential magnetic interference of our masks with magnets when in close proximity to certain implants or medical devices.
For more information and if you have questions about your specific situation, please consult your mask provider or physician/doctor.
Does this apply to me? If you do not use a mask with magnets, the updated contraindications and warnings do not apply to you. The updated contraindications for ResMed masks with magnets only apply if you, or anyone in close physical contact with you while using the mask (e.g., bed partner), has a certain implant or medical device that is identified below. If you use a ResMed mask with magnets, you should also be aware of the updated warning noted below:
Updated Contraindications
Masks with magnetic components are contraindicated for use by patients where they, or anyone in close physical contact while using the mask, have the following:
• Active medical implants that interact with magnets (i.e., pacemakers, implantable cardioverter defibrillators (ICD), neurostimulators, cerebrospinal fluid (CSF) shunts, insulin/infusion pumps)
• Metallic implants/objects containing ferromagnetic material (i.e., aneurysm clips/flow disruption devices, embolic coils, stents, valves, electrodes, implants to restore hearing or balance with implanted magnets, ocular implants, metallic splinters in the eye)
Updated Warning
Keep the mask magnets at a safe distance of at least 6 inches (150 mm) away from implants or medical devices that may be adversely affected by magnetic interference. This warning applies to you or anyone in close physical contact with your mask. The magnets are in the frame and lower headgear clips, with a magnetic field strength of up to 400mT. When worn, they connect to secure the mask but may inadvertently detach while asleep.
Implants/medical devices, including those listed within contraindications, may be adversely affected if they change function under external magnetic fields or contain ferromagnetic materials that attract/repel to magnetic fields (some metallic implants, e.g., contact lenses with metal, dental implants, metallic cranial plates, screws, burr hole covers, and bone substitute devices). Consult your physician and manufacturer of your implant / other medical device for information on the potential adverse effects of magnetic fields.
Which ResMed masks contain magnets?
View AirFit F20
View AirFit F30
View AirFit F30i
View AirTouch F20
View AirFit N10
View AirFit N20
View AirTouch N20
View AirFit F20 NV
Are ResMed masks with magnets safe to use as directed?
ResMed’s masks with magnets are safe when used in accordance with the updated instructions for use, including the contraindications and warnings.
What is the benefit of using a mask with magnets?
Magnets are used in some ResMed masks to provide a simple and easy way for the user to attach and detach the headgear to the mask frame. This can be notably beneficial to users with disabilities, including those facing dexterity or vision impairment.
What does ferromagnetic mean?
Ferromagnetic refers to a material property that is influenced by magnetic fields (e.g., attracts/repels under magnetic fields). Materials that are ferromagnetic are generally made of iron, cobalt, nickel, or some alloys made of these elements. Not all medical implants listed in the contraindications are made from ferromagnetic materials. If you are not sure whether an implant or medical device falls under the contraindications, or you require additional information on the potential adverse effects of magnetic fields for your particular implant or medical device, please contact your physician/doctor.
What should I do if my bed partner or I have an implant or medical device that falls under the contraindications?
Replace your mask containing magnets with an alternative mask without magnets in a timely manner. Contact your mask provider for alternative mask options. Note, ResMed is making our masks without magnets available to your mask provider for replacement purposes for contraindicated patients. If an alternative mask is not available, consult your physician/doctor for appropriate next steps regarding your therapy. If you are not sure whether an implant or medical device falls under the contraindications, or you require additional information on the potential adverse effects of magnetic fields for your particular implant or medical device, please contact your mask provider or physician/doctor.
What masks can I use if I am contraindicated?
Contact your mask provider for alternative non-magnet mask options. Note, ResMed is making our masks without magnets available to your mask provider for replacement purposes for contraindicated patients.
If you have any questions or concerns or would like more information, please contact your physician/doctor or mask provider."
For specific information about whether this applies to you or which ResMed Masks contain Magnets you can find this information here.
Sincerely,
Sea Breeze Sleep and Medical Services LLC
January 27, 2022
Dear Patients:
We have been notified by Philips that they have issued a recall on System One and DreamStation One CPAP and BiPAP devices, to include all serial numbers and all dates of manufacture.
At this time, Philips has stated that there are possible health risks including exposure to degraded sound abatement foam. Because of this, they have put shipment holds on all affected products. Philips is currently advising that all patients using one of their CPAP or Bi-level devices discontinue use and consult with physicians to determine the benefits of continuing therapy and potential risks.
We have, as requested by Philips, submitted a list of all affected devices, including contact information for all affected patients. They have indicated that they will be reaching out to all affected patients and will be handling the replacement or repair of patients equipment directly, and that there will be no involvement from the HME company like us in this process. Philips recently updated their advice and indicated that the FDA is requiring all affected patients to personally register their devices on the Philips designated site, in addition to our sending in patient information.
Per written correspondence from Philips to a patient of ours that was shared with us, Philips states they are "working diligently to replace or repair devices as soon as possible. Based on current estimates of impacted devices worldwide, we are working towards completing this effort within approximately 12 months." All updates related to the recall can be found on their site: philips.com/SRC-update.
We will continue to keep you updated with any new information or instruction that we receive regarding this recall. We appreciate your patience.
If you have any questions about the use of your SoClean ozone cleaner with your equipment, please click here for an update from the FDA.
Sincerely,
Sea Breeze Sleep and Medical Services LLC