OTTAWA, ON, July 27, 2022 /CNW/ -
Products: Philips Respironics Continuous Positive Airway Pressure (CPAP) machines, BiLevel Positive Airway Pressure (BiLevel PAP) machines and mechanical ventilators
Issue: Medical Devices – Quality issue
What to do:
UPDATE (2022-07-27): Update on Philips Respironics recall of several models of CPAP and BiLevel PAP machines and mechanical ventilators
Health Canada is providing an update on the progress of Philips Respironics' (Philips) recall of several models of CPAP and BiLevel PAP machines and mechanical ventilators in Canada. Since communicating about the recall in July 2021 (see below), Health Canada has been receiving questions from individuals who rely on these devices. The Department wants to reassure patients and their families that their health and well-being is a priority. The Department is closely monitoring the company's progress in resolving the safety issue and implementing a repair and replacement program for affected devices in Canada. Health Canada's safety recommendations have not changed from its July 2021 advisory.
Progress on remediation plan to date:
Philips has confirmed that it is repairing or replacing all devices affected by this recall, irrespective of the age of the device. Philips may replace devices with the same model, or a different Philips device that will meet the needs of the patient. Philips has advised Health Canada that it expects to complete its repair and replacement program in Canada by the end of 2023.
As part of the company's remediation plan, Philips will submit licence amendments for any proposed device design or material changes to address the foam degradation and off-gassing issues. The submissions must provide evidence that the safety concern has been addressed and that the changes are safe. While Health Canada cannot compel a company to submit a licence amendment, or to submit it within a certain timeline, the Department is prioritizing and expediting the review of each of these amendment packages when it receives them. To date, Health Canada has authorized licence amendments for all DreamStation CPAP and Bi-level Therapy devices (other than DreamStation Go devices).
Philips has yet to submit packages to Health Canada for A-Series, DreamStation Go, OmniLab, and Trilogy devices.
Once a licence amendment is authorized by Health Canada, Philips has indicated that it may take up to a year for that product to be repaired or replaced.
Importance of working with Durable Medical Equipment Providers
If you are a user of a recalled device, or you are unsure, please see the section below on What you should do. It is important that those affected by the recall register their device with Philips if they have not done so already. Users can register on the Philips recall website or by calling 1-877-907-7508. Philips has informed Health Canada that it is working through its Canadian network of medical device providers, known as Durable Medical Equipment Providers (DMEs), to coordinate device repairs and replacements. Users who do not currently have a DME can connect with one through Philips if they have registered their device with the company.
Device supply in Canada
This recall is global and affects millions of devices. The volume of recalled devices has put a strain on the worldwide supply of Philips devices and of alternatives. To help increase the availability of alternative options in Canada, Health Canada has fast-tracked its review of submissions from companies other than Philips to add devices to the List of medical devices for exceptional importation and sale. This list enables Health Canada to respond to device shortages by allowing the exceptional, temporary importation and sale of comparable medical devices not authorized for sale in Canada, but approved by other trusted regulators. To date, the following devices have been added to the list:
Health Canada is in regular communication with Philips to monitor this recall and to ensure that timely updates on replacement and repair are provided to the Department and to device users in Canada.
At Health Canada's request, the company will update its Canadian website to provide more information to Canadians affected by this recall.
Original Advisory (2021-07-30): Philips Respironics recalls several models of CPAP and BiLevel PAP machines and mechanical ventilators
Philips Respironics (Philips) has recalled several models of its Continuous Positive Airway Pressure (CPAP) machines, BiLevel Positive Airway Pressure (BiLevel PAP) machines and mechanical ventilators in Canada and internationally. The devices include a foam component that reduces sounds from the device. This foam may degrade (break down) into particles which may be inhaled or swallowed by users, or release volatile organic compounds (VOCs) that may be inhaled, which could lead to negative health effects.
Preliminary laboratory analysis by Philips determined that extreme operating temperatures and ozone cleaning methods may increase the breakdown of the foam. The company recommends against product use in temperatures outside of the labelled operating conditions, and the use of non-validated cleaning methods, such as ozone.
Philips has issued letters to customers, patients, and distributors with instructions for the recall. Philips indicates it will replace the foam component with a material that is not affected by this issue, or it will replace affected devices altogether.
Philips reports that they have received a relatively low number of complaints, some of which relate to black debris in the device air path, including the tubing and mask. Some users have reported headache, upper airway irritation, cough, chest pressure, and sinus infection, but it is has not yet been determined if degraded foam particles or VOCs were the cause.
Health Canada considers the benefits of using the affected devices to outweigh the risks for many users, and recommends that users not stop or alter their prescribed therapy before having a discussion with their health care professional.
For ventilators only, Health Canada cautions the use of in-line bacterial filters to mitigate foam particles, as they will not protect against VOC emissions and airflow can be negatively affected if the filter becomes clogged with debris.
What you should do
Register your device on the Philips recall website or call its recall hotline at 1-877-907-7508. Philips has established a registration process where you can look up your device serial number and begin a claim if your unit is affected.
If you have an affected product talk to your physician, or medical device provider first before stopping or changing how you use your product, as the benefits of using these devices may outweigh the risks for many users.
Be sure to clean your device only according to the manufacturer's Instructions for Use, as the use of non-validated cleaning methods (e.g. ozone) could contribute to potential foam degradation.
Do not attempt to remove or replace the foam yourself.
What Health Canada is doing?
Health Canada is monitoring the recall and the availability of devices in Canada. The Department continues to work with the manufacturer to further assess potential health risks, any future design or material changes that may be proposed, and the appropriateness of the company's corrective actions.
The Department is also working with Philips to identify strategies to address any device shortages. If additional products or safety concerns are identified, Health Canada will take appropriate action and inform Canadians.
The recall affects several models manufactured before April 26, 2021. Device photos are available on the company's recall website.
Model or catalog number
BIPAP A30 SYSTEM-VENTILATOR
BIPAP A30 SYSTEM-VENTILATOR & SYSTEM ONE A-SERIES HEATED HUMIDIFIER
BIPAP A40, CANADA
BIPAP A40, CANADA, CORE PACKAGE
BIPAP AUTO BI-FLEX, WITH HUMIDIFIER, WITH SMARTCARD, CANADA
BIPAP AUTO BI-FLEX, WITH SMARTCARD, CANADA
BIPAP AUTOSV ADVANCED SYSTEM ONE
BIPAP AUTOSV ADVANCED/ENCORE SMARTCARD
BIPAP AUTOSV ADVANCED/ENCORE SMARTCARD/HEATED HUMIDIFIER
BIPAP AUTOSV WITH SMARTCARD INT
BIPAP AUTOSV WITH SMARTCARD INT, CORE PKG
BIPAP AVAPS CORE PACKAGE, NORTH AMERICA
BIPAP AVAPS VENTILATORY SUPPORT SYSTEM-CANADA
BIPAP AVAPS VENTILATORY SUPPORT SYSTEM-CORE PKG, CANADA
BIPAP AVAPS, C SERIES VENTILAROTY SUPPORT SYSTEM-CORE PKG, DOMESTIC
BIPAP AVAPS, C SERIES VENTILATORY SUPPORT SYSTEM-DOMESTIC
BIPAP PRO BI-FLEX, WITH HUMIDIFIER, WITH SMARTCARD, CANADA
BIPAP PRO BI-FLEX, WITH SMARTCARD, CANADA
BIPAP ST, C SERIES VENTILATORY SUPPORT SYSTEM, CORE PKG, CANADA
BIPAP ST, C SERIES VENTILATORY SUPPORT SYSTEM-CANADA
BIPAP ST, C SERIES VENTILATORY SUPPORT SYSTEM-CORE PKG, DOMESTIC
BIPAP SYNCHRONY VENTILATORY SUPPORT SYSTEM WITH SMARTCARD
BIPAP SYNCHRONY VENTILATORY SUPPORT SYSTEM WITH SMARTCARD-CORE PACK
DREAMSTATION BIPAP PRO
DREAMSTATION AUTO BIPAP
DREAMSTATION AUTO CPAP
DREAMSTATION BIPAP AUTO SV W/HUMID/HEATED TUBE, CA
DREAMSTATION BIPAP AUTOSV, CA
DREAMSTATION BIPAP AUTOSV, W/HUMIDIFIER, CA
DREAMSTATION CPAP PRO
DREAMSTATION GO AUTO CPAP
DREAMSTATION GO AUTO CPAP WITH HUMIDIFIER, CANADA
DREAMSTATION GO CPAP
DREAMSTATION GO CPAP WITH HUMIDIFIER, CANADA
OMNILAB ADVANCED, DOMESTIC
OMNILAB ADVANCED, DOMESTIC CORE
REMSTAR AUTO WITH HUMIDIFIER, WITH SD CARD, A-FLEX, CANADA
REMSTAR AUTO WITH SD CARD, A-FLEX, CANADA
REMSTAR PLUS WITH HUMIDIFIER, WITH SD CARD, C-FLEX, CANADA
REMSTAR PLUS WITH SD CARD, C-FLEX, CANADA
REMSTAR PRO WITH HUMIDIFIER, WITH SD CARD, C-FLEX +, CANADA
REMSTAR PRO WITH SD CARD, C-FLEX +, CANADA
REMSTAR, WITH SMARTCARD, CANADA
REMSTAR, WITH HUMIDIFIER, WITH SMARTCARD, CANADA
TRILOGY 100 VENTILATOR, CANADA
TRILOGY 100 VENTILATOR-INTERNATIONAL
TRILOGY 200, CANADA
Également disponible en français
SOURCE Health Canada
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