Philips Respironics Recall Resources
Philips updates providers on FDA report
AMSTERDAM, the Netherlands – Philips does not anticipate a delay to its recall or replacement program as a result of a recent report from the U.S. Food and Drug Administration, the company told its provider customers in a Nov. 23 letter.
The FDA recently published the results of its inspection of Philips’ manufacturing facility, noting the silicone-based foam used in a singular, similar CPAP/BiPAP device marketed outside of the U.S. failed one safety test for the release of volatile organic compounds.
12/03/21
Philips' Replacement Foam Fails Safety Test
A recent facility inspection turned up new safety documentation on the new silicone-based foam for recalled CPAP and ventilator devices.
11/17/21
Updates on Philips Respironics CPAP, BiPAP, and Ventilator Recall
Today, the U.S. Food and Drug Administration (FDA) is providing an update related to the June 14, 2021, recall of certain Philips Respironics ventilators, continuous positive airway pressure (CPAP), and bilevel positive airway pressure (BiPAP) machines. Ensuring patients and providers have the most up-to-date information regarding the recall of these critical devices is a top priority for the FDA.
11/12/21
Clarification Of Non-FDA Approved CPAP Devices During PHE
VGM recently received this question:
Is it possible to bill a Class II Medical Device (CPAP) to insurance without a 510(k) clearance? In the context of the pandemic, supply chain shortages, and the Philips Respironics recall, we are looking at alternative vendors for our CPAP product line. The device in question has an emergency FDA authorization but has not received a 501(k) clearance at this time. The vendor has no realistic idea of the potential risk we may incur, and we are looking for guidance regarding this time-sensitive situation.
To begin, let’s define a 510(k) clearance:
Section 510(k) of the Food, Drug, and Cosmetic Act requires device manufacturers who must register, to notify the FDA of their intent to market a medical device at least 90 days in advance. This is known as Premarket Notification - also called PMN or 510(k). This allows FDA to determine whether the device is equivalent to a device already placed into one of the three classification categories. Thus, "new" devices that have not been classified can be properly identified. Specifically, medical device manufacturers are required to submit a premarket notification if they intend to introduce a device into commercial distribution for the first time or reintroduce a device that will be significantly changed or modified to the extent that its safety or effectiveness could be affected.
11/05/21
Philips Recall Lawsuits and Discovery Letters
AMARILLO, TX – Philips Respironics (Philips) has made headlines for its voluntary recall of continuous positive airway pressure (CPAP), bilevel positive airway pressure (“BiPAP”), and mechanical ventilator devices. The recall is to address issues with the devices that some plaintiffs are now alleging cause significant health risks, including respiratory tract inflammation, skin and eye irritation, headaches, asthma, and organ damage.
10/15/21
HME News Article: SOCLEAN SUES PHILIPS, BETTER HEALTH GETS INVESTMENT, MOVAIR LAUNCHES VENTILATOR
PETERBOROUGH, N.H. – SoClean Inc. has filed a lawsuit against Philips, alleging the company has sought to blame it for problems related to its recall of certain respiratory devices.
The lawsuit, filed in the United States District Court for Massachusetts, alleges Philips has misled the public and engaged in acts of deliberate misdirection, placing blame on SoClean to divert attention away from obvious design flaws, including a poor choice of sound abatement foam, which led to its recent voluntary product recall of Philips’ CPAP machines, BiPAP machines, and ventilators.
10/15/21
Updates on Philips Respironics CPAP, BiPAP, and Ventilator Recall
Today, the U.S. Food and Drug Administration (FDA) updated the frequently asked questions (FAQs) about this recall on FDA.gov: Philips Respironics CPAP, BiPAP, and Ventilator Recall: Frequently Asked Questions. The updates include answers to questions such as:
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When will the devices start to be repaired or replaced?
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What is the status of Philips Respironics’ plans for repairing or replacing the devices?
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What is the FDA’s role in the Philips Respironics recall?
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I use one of the affected devices daily. I can’t wait for a new device. What can I do now?
The FDA is committed to using every tool at our disposal to increase the availability of these medical products. The FDA is working with Philips Respironics to monitor the repair or replacement of impacted devices as expeditiously as possible and is continuing to gather information to inform our actions. We are collaborating with other manufacturers and government partners to support availability of CPAP and BiPAP machines.
09/10/21
Philips Recall Update
There has been a Press Release announcing the approval for rework for the DS1 devices with the new foam. The link to the press release is as follows: Philips starts repair and replacement program - News | Philips.
Per Philips, at this time, and until further notice, Philips is still focusing 100% of production towards replacement of devices that are on patients.
09/01/21
CMS Notice to Patients on Respiratory Recall Significantly Lacking in Context
On Wednesday, CMS distributed an alert on Philips respiratory products under recall. In their notice, CMS tells patients with recalled devices:
"If you would like to replace or repair your equipment, the supplier you bought the equipment from is responsible for replacing or repairing rental equipment at no cost to you when the equipment is less than 5 years old [emphasis ours]. If the equipment is more than 5 years old, Medicare will help pay for a replacement."
08/26/21
Philips Respironics Customer Letter To the community of patients, providers and practitioners.
As part of our commitment for ongoing communication regarding the recent recall notification (U.S. only) / field safety notice (outside of U.S.) of certain products in our Sleep and Respiratory Care portfolio, I wanted to take this opportunity to share some important updates with you.
In recent weeks, we have been actively working with global competent authorities and regulatory bodies to align on the remediation process. This process will enable the repair or replacement of the impacted devices while putting patient safety and speed of resolution as the top priorities.
There are three other areas of update to share with you today…
08/26/21
Recall Alert for Certain Philips Medical Devices
Philips recently issued a product recall for specific ventilators and sleep apnea devices.
If you own or rent one of the Philips products that was recalled, talk to your doctor as soon as possible about whether to continue using your recalled equipment.
If you would like to replace or repair your equipment, the supplier you bought the equipment from is responsible for replacing or repairing rental equipment at no cost to you when the equipment is less than 5 years old. If the equipment is more than 5 years old, Medicare will help pay for a replacement.
Important: Register your recalled equipment with Philips so they know you need a replacement, and can provide information on the next steps for a permanent corrective solution.
08/25/21
Respironics Recall: Latest FDA Guidance
AMARILLO, TX – Since mid-June, DME industry stakeholders have been in triage mode in responding to the Respironics product recall. With most product recalls that we have witnessed in the past, there have been substitute products manufactured by competitors that have filled the void. Unfortunately, this is not the case with the Respironics recall. Because of Respironics’ market share and because of the number of devices affected by the recall, DME suppliers are unable to find readily available replacement products. This has resulted in patients needing to wait for a number of months, if not longer, for their Respironics devices to be replaced or repaired.
07/30/21
Philips Statement on Filter Use in Relation to Affected Devices
As stated in the recall notification (U.S. Only) / field safety notification (Outside of U.S.), Philips advises patients with affected BiLevel PAP and CPAP devices to discontinue use of these units and consult with physicians to determine the benefits of continuing therapy and potential risks.
As further noted in instructions for patients, 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.
The use of bacteria filters are for use in ventilators only, and outlined in the instructions for use.
Philips Respironics CPAP, BiPAP, and Ventilator Recall: Frequently Asked Questions
The U.S. Food and Drug Administration (FDA) has posted answers to frequently asked questions related to Philips Respironics’ recent voluntary recall of certain CPAP, BiPAP, and ventilators due to potential health risks.
Check this resource to get answers to questions, including:
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I use one of the affected devices daily. I can’t wait for a new device. What can I do now?
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When a medical device is recalled, what is the FDA’s role?
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I understand the sound abatement foam may be causing the problems related to the recall. Should I try and remove the foam from my device?
VGM Sends Letter To FDA Asking To Expedite The Approval Of The Philips Respironics Alternative Sound Abatement Foam
VGM recognizes the impact that the current shortage of CPAP/RAD machines is having on your business and the DME industry as a whole. Until Philips Respironics receives approval from the FDA (Food and Drug Administration) regarding:
1) the process that will be used to repair and replace devices impacted by the recall and
2) the use of an alternative sound abatement foam in their devices,
they cannot offer any new or replacement units for those impacted by the recall. In an effort to expedite the FDA’s approval process for the alternative foam, VGM has sent this letter to the FDA outlining the implications of the recall and subsequent product shortage.
07.29.21
AASM Guidance in Response to Philips Recall of PAP Devices
This AASM guidance is to help sleep centers and sleep medicine professionals understand their options related to the Philips recall of certain PAP devices.
07.29.21
DME MACs Respond to AAHomecare Comments on Respiratory Recall and Update FAQs
DME MAC medical directors have responded to AAHomecare’s June 29 letter discussing Philips’ recall of certain PAP and ventilator devices and requesting the MACs work with the DME industry by continuing to reimburse for devices and related supplies for patients who continue to use their equipment.
The DME MAC response addresses concerns we shared regarding language on some of the FAQs they published on June 28. The MACs have incorporated their response to us for Question 9 (What impact does the voluntary recall have on New to Medicare patients? Specifically, if the supplier inspects beneficiary-owned equipment that is affected by the recall, is the supplier under any obligation to replace that machine?) in the July 16 update of the FAQs.
The update also revises the answer to Question 5 (What should DME suppliers do if a beneficiary wishes to return their Philips Respironics product that is impacted by the voluntary recall?) and adds two new questions (#11 & #12) regarding patients who refuse warranty support and temporary replacement devices.
See the DME MAC response letter and updated FAQs for more information.
07/22/21
Frequently Asked Questions - Philips Respironics Respiratory Products Recall - Revised
On June 14, 2021 Philips Respironics announced the voluntary, global recall of an estimated 4 million continuous positive airway pressure (CPAP) devices, bilevel respiratory assist devices (RADs), and ventilators. The situation is quite fluid; consequently, impacted beneficiaries and DME suppliers should check the Philips Respironics website for the most up-to-date information.
07/16/21
AAHomecare/PAMS Communication to Payers – Philips Voluntary Recall
PAMS sent the attached letters regarding the Philips Voluntary recall to the PA Department of Human Services and the Office of Long-Term Living (OLTL), and also to the PA Community HealthChoices and Physical HealthChoices MCOs. We thank AAHomecare for their assistance, and we will keep members updated as new information becomes available.
- AAHomecare Philips Recall Letter for all Medicaid Programs
- AAHomecare Philips Recall Letter for all Payer
Link to Philips Website
Contains information regarding communications, Q&A, and additional guidance:
President's Message - Made for the Challenge
The extensive recall for a broad range of Philips ventilator and PAP devices presents challenges for HME suppliers, clinicians, caregivers, and millions of individuals who depend on these products. For many individuals on ventilators, these are literally life-support systems.
Respiratory suppliers in our industry have a long-standing record of providing a high level of service, support, and guidance to go along with these products, and I am sure many of you are frustrated that you can’t assure your patients that there is a clear and quick path to getting the recalled equipment repaired or replaced.
Philips and other respiratory stakeholders are working hard to address issues and impacts related to the recall. AAHomecare is engaged in this process by keeping the HME community informed of new developments and guidance, and also in working with Medicare and other payers to clarify billing and adherence requirements for your current patients. We are also supporting industry efforts to have the FDA help prioritize respiratory manufacturers in the still-stressed global supply chain.
The supply chain issues underscore the need for policies that fully recognize how critical maintaining access to respiratory products and other HME are in managing care for millions of individuals with serious medical conditions. We are making strides in growing awareness of the integral role our industry plays in the care continuum, but that perception should be even stronger to support our advocacy priorities.
The HME community – and particularly respiratory suppliers – once again showed our willingness to rise up and “meet the moment” during the COVID-19 pandemic. Our work providing home-based respiratory support for acute conditions was shown to be effective and essential – and, as a result, CMS is proposing a revised oxygen NCD to allow this care on a permanent basis, as you’ll see in another article below.
Our industry is built on providing high-quality care to seniors and other individuals who also benefit from the empathy and reassurance that is a hallmark of HME professionals. Respiratory suppliers, manufacturers, and other HME stakeholders are proven in their ability to deliver exceptional care and personal support under difficult circumstances. I know that, once again, we’ll show that we are made for this kind of challenge.
AAHomecare Pulls Together Recall Resources
AAHomecare is collecting news, guidance, and other materials related to the respiratory device recall. The new online resource includes a link to Philips’ recall page, the recent FDA Safety Communication, AAHomecare letters to DME MACs and major payers, along with webinars and other materials from respiratory clinician groups. We will continue to keep this page updated with the latest developments on the recall.
Frequently Asked Questions - Philips Respironics Respiratory Products Recall - Revised
On June 14, 2021 Philips Respironics announced the voluntary, global recall of an estimated 4 million continuous positive airway pressure (CPAP) devices, bilevel respiratory assist devices (RADs), and ventilators. The situation is quite fluid; consequently, impacted beneficiaries and DME suppliers should check the Philips Respironics website for the most up-to-date information.
Based on questions received by the DME MACs, we have developed the following FAQs…
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