Philips Respironics Recall 2021

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URGENT: Medical Device Recall

Philips-Respironics CPAP and Bi-Level PAP Devices

Sound Abatement Foam - Susceptibility to Degradation and Volatile Organic Compound Emission

Immediate Actions

Immediate Actions to be taken by the User (per Phillips-Respironics):

  1. Discontinue use of your device and work with your physician or Durable Medical Equipment (DME) provider to determine the most appropriate options for continued treatment. To continue use of your device due to lack of alternatives, consult with your physician to determine if the benefit of continuing therapy with your device outweighs the risks identified in this letter.
  2. Register your device on the recall website www.philips.com/src-updates
    1. The website provides you current information on the status of the recall and how to receive permanent corrective action to address the two (2) issues.
    2. The website also provides you instructions on how to locate your device Serial Number and will guide you through the registration process.
    3. Call 1-877-907-7508 if you cannot visit the website or do not have internet access.


Additional Actions

  1. Purchase an in-line antibacterial filter (search for "antibacterial filter for cpap" on Amazon or another site) to catch any and all foam particles. Note that this will do nothing for the off-gassing.
  2. Purchase a new non-affected CPAP that is the equivalent or upgrade of your current machine. It appears that at least some insurance companies are allowing replacement prior to the 5-year lifetime. We suggest patients call and ask, as they likely will need a prescription and possibly a justification (the Do NOT use Recall) note from your doctor.
  3. Philips is recommending that customers and patients do not use ozone-related cleaning products.
  4. For questions please ask on the Apnea Board forum.

What others are doing

  • using an in-line antibacterial filter as a stopgap fix
  • purchasing, out of pocket, a competing product, often a ResMed device
  • registering with Philips-Respironics Recall list
  • calling their Doctor, DME, and insurance company to evaluate options
  • some patients are attempting to 'de-foam' their DreamStation products (there have been reported failures and successes)

De-Foaming

No 'official' has said to de-foam the recalled devices, This includes Philips Respironics, FDA, Doctors Associations, etc. The "de-foaming" movement is purely a user movement. Users basically saying it is taking too long to get devices replaced or repaired, most estimates state a year to complete. Below are two threads on Apnea Board forums that discuss defoaming of the affected machines. Do so at your own risk.

Wiki Editor comments

Most likely a patient's apnea is severe enough that they would require continued treatment. An immediate response from Philips-Respironics in the form of a new machine or an immediate repair or replacement of the foam is not expected; therefore patients should take action to correct the situation.

Potential Replacement Devices

Philips-Respironics ResMed
DreamStation
  • ResMed AirSense 10 Elite (CPAP Mode only)
  • ResMed AirSense 10 AutoSet or AutoSet for Her (APAP) (Most recommend one of the AutoSets as they can also operate in CPAP mode)
DreamStation Go
  • ResMed AirMini AutoSet (Not compatible with OSCAR)
DreamStation ST
  • ResMed AirCurve 10 ST
DreamStation AVAPS
  • Example
DreamStation ASV
  • ResMed AirCurve 10 ASV


Timeline

April 26, 2021 - potential health risks

https://www.usa.philips.com/healthcare/e/sleep/communications/src-update

Philips advised of potential health risks related to sound abatement foam used in specific Philips Continuous Positive Airway Pressure (CPAP), Bi-Level Positive Airway Pressure (BiLevel PAP) devices, and Mechanical Ventilators.

Possible health risks include exposure to degraded sound abatement foam, for example caused by unapproved cleaning methods such as ozone, and exposure to chemical emissions from the foam material. High heat and high humidity environments may also contribute to foam degradation in certain regions.

June 14, 2021 - Recall

https://www.apneaboard.com/PR-Recall.pdf

As a result of extensive ongoing analysis following this announcement, on June 14, 2021, the company issued a recall notification (U.S. only) / field safety notice (Outside of U.S.) for specific affected devices.

June 23, 2021 - Health Canada posted a recall for the same products.

https://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2021/75887r-eng.php
https://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2021/75889r-eng.php

June 30, 2021 - FDA Safety Communication

Certain Philips Respironics Ventilators, BiPAP, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety Communication

https://www.fda.gov/medical-devices/safety-communications/certain-philips-respironics-ventilators-bipap-and-cpap-machines-recalled-due-potential-health-risks

July 8, 2021 - Philips - Clinical Information

Supplemental clinical information for physicians and providers for specific CPAP, Bi-Level PAP, and mechanical ventilator devices
This includes information on

  1. Foam degradation and
  2. Chemical emissions from the PE-PUR foam

https://cts-sct.ca/wp-content/uploads/2021/07/4110944.00-Global-Supplemental-Clinical-Information-document_070821_r5.pdf

July 9, 2021 - Canadian Response

From CTV news (in Canada): In July, the Canadian Thoracic Society, Canadian Sleep Society and the Canadian Society of Respiratory Therapists released a joint statement on the recall to help guide physicians, where they noted that “globally, the number of units affected is in the millions.” The included link is https://cts-sct.ca/wp-content/uploads/2021/07/CTS_CSS_CSRT-Phillips-Recall-Statement_final-07_09_2021.pdf

In brief, after discussion with their doctor, most patients should continue using the machine until it can be replaced with an unaffected machine, preferably sooner than later.

This document contains guidance from medical teams on what to do in the immediate future.

July 14, 2021 - ResMed Response

https://www.resmed.com/en-us/other-manufacturer-recall-2021/
Information regarding Philips' recall

A message from ResMed's CEO:
At ResMed, the leading global manufacturer in sleep apnea therapy, we know that ongoing treatment is critical to the health and wellbeing of many millions of people around the world. In light of Philips’ recent recall and field safety notices for many of its sleep and respiratory care products, I want to reassure our patients, providers, physicians, and communities that ResMed devices are safe to use and are not subject to Philips’ recall. ResMed devices use a different material than what Philips uses in their recalled machines. Patient safety is always our ResMed team’s top priority.
We rigorously test our devices against applicable standards before we launch a new product. We reevaluate our testing when other device makers raise concerns. The information we’ve reviewed from Philips’ recall of its devices and our detailed analysis of our products’ test results confirm that ResMed devices are safe to use.
At this time of considerable increase in demand for ResMed products, we are doing everything we can to increase our manufacturing of sleep and respiratory care devices, so we can get them to the patients who need them most. We will continue working closely and communicating directly with our customers and suppliers to help serve patients worldwide.
Mick Farrell
CEO, ResMed

July 21, 2021 - FDA has identified this as a Class I recall

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
There are 2 entries on the FDA site, one for Risk of Exposure to Debris and Chemicals and the other Due to Potential Health Risks from PE-PUR Sound Abatement Foam

Philips Respironics Recalls Certain Continuous and Non-Continuous Ventilators, including CPAP and BiPAP, Due to Risk of Exposure to Debris and Chemicals

Philips Respironics Recalls Certain Ventilators and BiPAP Machines Due to Potential Health Risks from PE-PUR Sound Abatement Foam

August 10, 2021 - DMEs reporting Philips to begin distributing Recall Replacements

Several DMEs have acknowledged receiving this notification. It is the first positive sign on the recall, nothing more.

Dreamstation replacements will begin shipping soon

UPDATE 8/10/2021

After 8 weeks we have finally received additional information regarding the Phillips/Respironics CPAP and BiPAP recall. Phillips is planning to start shipping their first wave of replacement CPAP devices within the next 7 business days. We have not yet been notified as to who will be receiving them or how long it will take to mitigate all the affected devices. However, if you are one of the individuals who will be receiving a device in the first wave of replacement units, you will be notified directly by Phillips and given additional information on how to complete the process. Philips will have multiple waves of replacements that will happen over time and in each case you will be contacted directly by Philips with instructions on what to do.

Health Issues

(As reported by Philips-Respironics)

These issues (degrading foam and/or off-gassing) can result in:

  • serious injury which can be life-threatening,
  • cause permanent impairment,
  • and/or require medical intervention to preclude permanent impairment.

To date, Philips-Respironics has received several complaints regarding the presence of black debris/particles within the airpath circuit(extending from the device outlet, humidifier, tubing, and mask).


Philips also has received reports of:

  • headache,
  • upper airway irritation,
  • cough,
  • chest pressure and
  • sinus infection.


The potential risks of particulate exposure include:

  • Irritation (skin, eye, and respiratory tract),
  • inflammatory response,
  • headache,
  • asthma,
  • adverse effects to other organs (e.g. kidneys and liver) and
  • toxic carcinogenic affects.


The potential risks of chemical exposure due to off-gassing include:

  • headache/dizziness,
  • irritation (eyes, nose, respiratory tract, skin),
  • hypersensitivity,
  • nausea/vomiting,
  • toxic and carcinogenic effects.

There have been no reports of death as a result of these issues.

Impacted Devices

All Devices manufactured before 26 April 2021,

All serial numbers

Continuous Ventilator, Minimum Ventilatory Support, Facility Use
  • E30 (Emergency Use Authorization)
Continuous Ventilator, Non-life Supporting
  • DreamStation ASV
  • DreamStation ST, AVAPS
  • SystemOne ASV4
  • C-Series ASV
  • C-Series S/T and AVAPS
  • OmniLab Advanced+
Noncontinuous Ventilator
  • SystemOne (Q-Series)
  • DreamStation
  • DreamStation Go
  • Dorma 400
  • Dorma 500
  • REMstar SE Auto

Unaffected Products

What products are not affected and why?

Products that are not affected may have different sound abatement foam materials, as new materials and technologies are available over time. Also, sound abatement foam in unaffected devices may be placed in a different location due to device design.

Products not affected by this recall notification (U.S. only) / field safety notice (International Markets) include:

  • Trilogy Evo
  • Trilogy Evo OBM
  • Trilogy EV300
  • Trilogy 202
  • A-Series Pro and EFL
  • M-Series
  • DreamStation 2
  • Omnilab (original based on Harmony 2)
  • Dorma 100, Dorma 200, & REMStar SE
  • V60 Ventilator
  • V60 Plus Ventilator
  • V680 Ventilator
  • All oxygen concentrators, respiratory drug delivery products, airway clearance products.

Successful Replacements

Medicare/Medicaid

  • Medicare.gov Live Chat - Live Chat with Medicare Agent (7/6/2021) "Yes you can get a replacement, as long as your supplier knows that the one you have is on recall."
  • United Healthcare - Medicare Advantage PPO policy (7/14/2021). (Call, Confirm, 3-way with DME). Status Awaiting ResMed restock.

Out of Pocket

  • Many out-of-pocket purchases of non-Philips-Respironics machines.

Standard Insurance

  • Replacements have been based on 5-Year EOL have been verified
  • Blue Cross/Blue Shield MN Aware PPO health insurance has a clause to replace a CPAP machine before 5 years due to "unusual circumstances". New Rx, Authorization Request. 4 YO DS1

Standard Insurance via Recall (none)