Sep 22nd 2022
Philips Respironics Headgear CPAP Magnetic Clips Advisory
On September 6, 2022,Philips Respironics made a preliminary advisory regarding their headgear CPAP magnetic clips. This announcement was due to the product’s potential risk of serious injury to individuals with metallic implanted devices or objects. Please note that this is an advisory, meaning that you can still use Philips Respironics headgear magnetic clips, although patients should abide by updated instructions when using them.
The Food and Drug Administration (FDA)also published the official announcement here.
Avoid Close Proximity to People With Implanted Metallic Devices or Objects
The leading cause of this alert was in response to the potential risk of magnetic headgear clips to individuals who have implanted metallic devices or objects within their bodies. While the patient may not have a metallic implant, when close to others, the magnetic clips can cause harm to individuals, such as bed partners, caregivers, or others who live with the CPAP user if they have metallic implants.
Reasons Not to Use Philips CPAP Magnetic Clips
- You have a metallic implant or object within your body.
- Your bed partner has a metallic implant or object within their body.
- Your caregiver has a metallic implant or object within their body.
- Others in your household have metallic implants or objects within their bodies.
Reasons to Use Philips CPAP Magnetic Clips
- You do not have any metallic implants or objects within your body.
- Your bed partner does not have any metallic implants or objects within their body.
- Your caregiver does not have any metallic implants or objects within their body.
- Others in your household do not have any metallic implants or objects within their body.
Philips Respironics Headgear and CPAP Masks Affected by This Advisory
If you use one of the below-listed Philips Respironics masks and you or a household member has a metallic implant, contact your physician immediately:
- DreamWisp Nasal Mask
- DreamWear Full Face Mask
- Amara View Full Face Mask
- Wisp and Wisp Youth Nasal Mask
- Therapy Mask 3100 NC/SP
Types of Implanted Metallic Devices Affected by Magnetic Headgear Clips
Please note, this is NOT an extensive list:
- Magnetic Resonance (MR) unsafe devices
- Implantable cardioverter defibrillators (ICD)
- Cerebrospinal fluid (CSF) shunts
- Magnetic metallic implants/electrodes/valves
- Metallic stents
- Cochlear implants
Please refer to the FDA’s official announcement here for a longer list of affected devices.
If you have questions about a specific implanted metallic device you or someone in your household has, contact your physician to discuss any necessary safety precautions.
You may contact Philips Respironics customer service if you have additional questions by calling 1-800-345-6443.
Your Next Steps:
If you or someone in your household has a metallic implant or object within their body, it is important that you stop using your magnetic clip headgear CPAP mask to discuss alternatives and if any follow-up is needed with the physician. Also, contact your physician or sleep specialist to discuss new CPAP mask options that do NOT have magnetic clip headgear.
Let’s take a look at some Philips Respironics CPAP masks without magnetic clip headgear:
If everyone in your household, including yourself, does not have any metallic implants or objects within their bodies, continue using Philips Respironics mask headgear with magnetic clips for the ease and convenience it offers!