PAP Device, Mask, Cleaning, and Other Important Information and Updates

Breathing Device Recall Information:  

Device Recall information from Penn Medicine (also see below)

Philips link to CPAP/BiPAP/ventilator breathing device recall UPDATES 

Philips link to other other BiPAP/Ventilator recalls (8/29/22)

Philips link to more patient and caregiver information

Philips link to Quick tips to guide you through the device remediation process

FDA Update: Philips PAP and Ventilator Update link (6/2/23)

Discontinuation of V30 and V60 Ventilators (10/31/23)

American Academy of Sleep Medicine recall resources (11/20/23)

*PHILIPS LINK TO DISCONTINUED PHILIPS DEVICES (1/24/24)

UPDATE: FDA LINKS TO THE PHILIPS CONSENT DECREE AND OTHER FDA RELEASES (1/29/24)

UPDATE: FDA SAFETY COMMUNICATIONS ON CERTAIN PHILIPS DEVICES (1/31/24)

Important Medical Device Information For Philips Respironics Devices

Update: Nov. 30, 2021

Dear Patient,

Penn Medicine has been made aware of a medical device recall by Philips Respironics, the company that manufactured your BiPAP, CPAP or mechanical ventilator device.

On Monday June 13, 2021, Philips Respironics issued a recall of the vast majority of their sleep apnea devices, including all SystemOne, DreamStation, Trilogy 100, and Trilogy 200 devices. This recall does not include the Trilogy Evo or oxygen equipment.

There is a significant chance the CPAP or BiPAP device you are using is included in this recall. Therefore, it is important to take appropriate steps in response to this information. If your device was manufactured by ResMed, then the contents of this message do NOT apply to you and you can safely continue to use your device. If you are unsure about if your unit is on the Philips recall list, please contact your equipment company.

More information on the included devices can be found on the Philips website and FDA website. Those websites are updated as new information becomes available.

Why the Devices Have Been Recalled

These devices have been recalled due to concern for the breakdown of the PE-PUR sound abatement foam used inside the machine to make it quieter.

This breakdown is more likely to happen if exposed to certain cleaning products, life ozone cleaners, or high heat and humidity. If a breakdown like this happens, some of the particles or gases may enter your body through the tubing that connects to the mask, and have an effect on, at least, but not limited to, your respiratory health.

The short and long-term impact of inhaling these particles and chemicals is not fully known. Some of these compounds may be carcinogenic, however, no data has been published regarding how time of exposure reduces or increases this risk. No life-threatening events have been reported. The company has shared that the reported number of complaints related to the use of Philips devices is 0.03%. More information is available on the Philips recall website and from the U.S. Food and Drug Administration.

What You Should Do

Confirm and register your device
  • Please confirm if your device is affected by visiting the Philips website or contact your equipment company.
  • Register your device on the recall website as soon as possible. Philips has started an online registration process for all users that will allow your device to be included in any future remediation program the company will develop.

Continue use by device type

  • For patients on a ventilator (Trilogy 100, Trilogy 200, or EVO) DO NOT DISCONTINUE THERAPY AT ANY TIME as stopping treatment may impose significant risk to your health, including death. Please contact your provider to discuss your case in further detail or make a follow-up appointment at your earliest convenience.
  • For patients on BiPAP, do not discontinue use of your device until you contact your provider or make a follow-up appointment by sending a myPennMedicine message or calling your doctor's office.
  • For patients on CPAP, you should continue therapy until an appropriate and safe alternative is found.

Clean and care for your device

  • Do not use any ozone-based or UV light cleaning system or any other unapproved cleaning agents as this may increase any health risks associated with this recall or improper device cleaning. Read an FDA safety communication on the risks associated with ozone-based and UV light cleaning.
  • Keep the equipment in a temperature-controlled room, like a bedroom or living room.

Masks, supplemental oxygen and non-FDA approved devices

  • If your mask is manufactured by Philips Respironics, you can continue to use it, as it is not part of this recall. HOWEVER THERE HAS BEEN A DIFFERENT RECALL FOR PHILIPS MASKS WITH MAGNETS.
  • If you are using supplemental oxygen, you can and should continue to use it as the oxygen concentrators and other oxygen delivery devices are not part of this recall and do not impose a risk.
  • Sleep devices are manufactured by a limited number of FDA-approved companies. Some of these companies are actively ramping up their production and distribution, to fill the void left by this recall. In the event of a device shortage, we strongly discourage the purchase of non-FDA approved devices online or in retail stores, as we do not have any information regarding their manufacturing process or effectiveness in treating your sleep disorders.

Philips Respironics is working to resolve this issue. Corrective actions taken by Philips include the deployment of updated instructions for use and a repair and replacement program for affected devices.

Philips is aiming to address all affected devices as expeditiously as possible. Visit the Philips website to stay informed of up-to-date information about how Philips will manage this recall and what options will be offered in the near future to repair or replace your device.

How Penn Medicine Can Help

We at Penn Medicine do not have information yet on the timing or details of repair or replacement of devices. This is a worldwide recall of the listed Philips CPAP and breathing type devices, and there currently is a general shortage of all brands of new and replacement devices. We are here to support you as much as possible and will be working with your Durable Medical Equipment companies as we learn more. Please understand that this is a fluid situation and our recommendations may or may not change as more data is shared by the manufacturer, medical professional societies, and government regulatory agencies. This statement will be updated accordingly.

If you have any questions, please do not hesitate to contact your doctor's office for medical questions and your equipment company for equipment questions. You may also send us non-urgent questions through myPennMedicine.

FDA Safety Communication on the Dreamstation 2 (11/28/23, FDA website): Carefully Monitor Philips DreamStation 2 CPAP Machines for Signs of Overheating

Philips Statement on the Dreamstation 2 Safety Notice from the FDA (11/29/23, Philips website) 

*PHILIPS LINK TO DISCONTINUED PHILIPS DEVICES (1/24/24)

UPDATE: FDA LINKS TO THE PHILIPS CONSENT DECREE AND OTHER FDA RELEASES (1/29/24)

UPDATE: FDA SAFETY COMMUNICATIONS ON CERTAIN PHILIPS DEVICES (1/31/24)

 

The FDA issued warnings against using ozone or UV light methods for cleaning your breathing equipment (2/27/20)

11/21/23 Update: SoClean Voluntary Recall (FDA website) 

Potential Risks Associated With The Use of Ozone and Ultraviolet (UV) Light Products for Cleaning CPAP Machines and Accessories: FDA Safety Communication

Date Issued: February 27, 2020 

The U.S. Food and Drug Administration (FDA) wants to make consumers and health care providers aware that, to date, the FDA has not authorized for market any products using ozone gas or ultraviolet (UV) light to clean, disinfect, or sanitize continuous positive airway pressure (CPAP) devices and accessories (for example: hoses, masks, tubing and headgear).

CPAP machines are devices prescribed to patients with obstructive sleep apnea to keep their airways open during sleep. Most often, CPAP manufacturers recommend regular cleaning of CPAP device accessories with mild soap and water.

Important Recommendations for Consumers, Family Members and Caregivers:

  • Follow the CPAP manufacturer’s instructions and recommended cleaning and replacement guidelines for your CPAP machine and accessories. If you cannot find the owner’s manual or instructions, or have questions, contact the CPAP device or accessory manufacturer.  You also can contact your health care provider with any questions. 
  • Be aware that the FDA has not evaluated the safety and effectiveness of ozone gas or UV light products claiming to clean, sanitize or disinfect CPAP machines and accessories in the home or healthcare setting. 
  • Understand the potential risks from exposure to excessive amounts of ozone gas or UV light as described below include irritation to breathing passages (that is nose, throat, and lungs), particularly for those who have respiratory sensitivity such as asthma or allergies.
  • Seek medical attention if you suspect you have experienced injuries or irritation from using products claiming to clean your CPAP machine or accessories. 

Potential Risks Associated with Using Ozone Gas or Ultraviolet (UV) Light Products that claim to Clean, Sanitize, or Disinfect CPAP Machines and Accessories:

Using Ozone Gas Products that claim to Clean CPAP Machine Equipment and Accessories

Ozone (O3), sometimes called “activated oxygen”, is a gas that can be used to kill harmful bacteria. However, for ozone to be effective in destroying harmful bacteria, it must be present at a concentration above levels considered safe for humans.

Although products that claim to use ozone gas to clean CPAP machine equipment are designed to keep the ozone generated inside the machine and its accessories, leaks can occur at tubing connections, filters or through fabric containers used to house CPAP accessories. When leaks occur, ozone gas in the nearby space may temporarily rise to unsafe levels, especially if the space is not well ventilated. Ozone gas concentrations within the CPAP machine and tubing can also remain above safe levels even after the recommended waiting periods for ozone gas products that claim to clean. If the CPAP accessories are used without first allowing fresh air to circulate through the entire CPAP machine to remove any remaining ozone gas, this could lead to nasal, lung or any other type of irritation to the user’s breathing passages. Exposure to high levels of ozone gas also may worsen chronic respiratory diseases, such as asthma, or increase vulnerability to respiratory infection.  

The FDA has received reports from patients experiencing cough, difficulty breathing, nasal irritation, headaches, asthma attacks and other breathing complaints when ozone gas-based products were used to clean, sanitize or disinfect CPAP devices and accessories. 

Using UV Light Products that claim to Clean CPAP Machine Equipment and Accessories

UV light may be used to disinfect surfaces in a setting where UV light does not escape to the surroundings.  If products generating UV light do not shield the user from exposure, they pose a potential health hazard depending on the wavelength, intensity, and exposure time.

Although FDA has not received any problem reports associated with using UV light products that claim to clean CPAP devices and accessories, unintentional or excessive exposure to UV light during cleaning may put a user at risk of eye injury, skin burns or even an increased risk of skin cancer.  Additionally, when UV light is used with the purpose of disinfecting CPAP machine equipment and accessories, UV light may be unable to penetrate all areas of the CPAP accessories such as the hoses, masks and connectors. This may result in inadequately disinfected CPAP devices and accessories that may not be safe for reuse.  

FDA Activities:

The FDA is working with manufacturers of products that claim to clean, sanitize or disinfect CPAP machines and accessories with either ozone gas or UV light to submit the recommended testing to support use of these devices as claimed. 

Recently, the FDA conducted preliminary laboratory research on a few products claiming to use either ozone gas or UV light to clean, sanitize, or disinfect CPAP machines and accessories:

  • For ozone gas products that claim to clean CPAP machines and accessories, tests performed in a minimally ventilated space with a volume representative of a small enclosed bathroom showed that several marketed ozone gas products generated ambient ozone levels above stated regulatory limits. Ozone levels were also elevated inside CPAP tubing even after recommended wait times in ozone gas products that do not perform an automatic clean air purge towards the end of the cleaning cycle.
  • For UV light products that claim to clean, sanitize, or disinfect CPAP machines and accessories, tests showed the power of the UV light and the amount of time CPAP accessories were exposed to this light varied considerably among marketed UV cleaning products, based on the design of the product. If CPAP machines and accessories are exposed to insufficiently strong UV light, this could lead to inadequate disinfection and subsequent safety and performance issues.

The FDA will continue to monitor adverse events associated with the use of ozone gas or UV light products with claims to clean, sanitize, or disinfect CPAP machine and accessories.  When new information becomes available, we will update this communication.  

Additional Resources:

Reporting Problems to the FDA:

Prompt reporting of an injury or problem can help the FDA identify and better understand the risk associated with products marketed to clean CPAP machines and accessories.

If you experience respiratory difficulty or other symptoms after using any UV light or ozone gas products to clean, disinfect or sanitize CPAP machines or accessories, please use the MedWatch Voluntary Reporting Form to report the problem.

If you are a health care provider employed by facilities subject to the FDA's user facility reporting requirements, follow the reporting procedures established by your facilities.

Please include the following information in your reports, if available:

  • CPAP machine manufacturer and model
  • Name of the product used to clean your CPAP machine and/or accessories
  • How often the product is used
  • Place of purchase
  • Details of the adverse event, such as symptoms, duration, onset

Contact Information:

If you have questions about this communication, please email the FDA’s Division of Industry and Consumer Education (DICE) at DICE@FDA.HHS.GOV or call 800-638-2041 or 301-796-7100

 

 

Recall for Philips Mask-with-magnet clips:

9/6/22 FDA website information 

9/6/22 Philips website communication

On 9/6/22, the FDA posted a mask recall warning for Philips masks that use magnet strap clips.

What is the mask recall about?

  • The FDA has warned that Philips masks that have magnets may cause a potential serious injury or death to users, or to nearby persons such as bedpartners, who have any implanted metallic medical devices or metallic objects in the body. A list of possible implanted metallic devices or metallic objects is available on the FDA webpage.
  • A full list and pictures of the recalled masks can be found on the same FDA webpage. The affected masks include the Amara full face, DreamWisp Nasal, DreamWear full face, Wisp and Wisp Youth, and Therapy Mask 3100 NC/SP.
  • Philips masks without magnets have not been recalled.
  • While the recalled masks with magnets are made by Philips, these masks may be used with any brand of CPAP/ BiPAP/ ventilator device.
  • Note that this mask recall has nothing to do with device recalls of certain CPAP, BiPAP, ventilators. These are separate FDA recalls.
  • There are other brand masks with magnet clips which have not been recalled, but caution is advised for persons with implanted metallic devices or objects until there is further clarification from the FDA.

What should I do if I or someone physically near me has an implanted metallic device or object?

  • If you or your bedpartner DO have an implanted metallic device or object AND you are using an affected mask with magnet clips, then immediately STOP using the recalled mask with the magnet. As soon as possible, call your Home Equipment Company (also called Durable Medical Equipment company) to report that you have an affected recalled mask that requires urgent exchange with a well-fitting mask WITHOUT magnets. You may use masks without magnets as you have used in the past.  
  • If you or your bedpartner are unsure that either of you have an implanted metallic device or object that is on the FDA list, then call your treating physician(s) as soon as possible to confirm.  
  • The FDA also states to contact your health care provider immediately, if you experience any issues related to your medical device and report the issue through the FDA’s MedWatch Voluntary Reporting Form
  • Additional information is available through Philips Respironics’ customer service at 1-800-345-6443 or visit their website at www.usa.philips.com for more information about non-magnetic mask options.

What if I do NOT have any implanted metallic devices or implants?

Per the FDA webpage, “you may continue using the recalled mask with magnets, if you or someone near you when using the recalled mask, do not have any of the implanted metallic medical devices or metallic objects in the body listed above that may be affected by the magnets in the masks.”

Affected recalled Philips masks with magnets (9/6/22)

FDA List of Types of Implanted Metallic Devices and Metallic Objects in the Body

 

ResMed Masks-with-Magnet Clips: Recall and Urgent Field Safety Notice and Recall

Update on ResMed Masks-with-magnet clips (ResMed website)

Resmed Masks-with-Magnet Recall (FDA website- 1/11/24)