Update: on July 27, 2022, Health Canada announced that it is “closely monitoring” the Philips CPAP recall in Canada. Health Canada has not changed the safety recommendations issued in its July 2021 advisory. Philips has indicated that it is in the process of repairing or replacing all Philips Respironics Continuous Positive Airway Pressure (CPAP) machines, BiLevel Positive Airway Pressure (BiLevel PAP) machines and mechanical ventilators, regardless of age of the device.
According to an online news report posted on drugtopics.com, Philips is failing to issue replacement CPAP devices and repair kits to customers. The recall and poor efforts have caused a shortage of CPAP breathing devices. The report states that Philips announced its recall of millions of positive airway pressure machines and ventilators occurred more than a year ago. Yet, thousands of patients who depend on these breathing devices are still waiting for their replacement or repaired device.
In June 2021, Philips declared that it was issuing a voluntary recall of continuous positive airway pressure machines (CPAP), ventilators, and bi-level positive airway pressure machines (BiPAP) after finding the sound abatement foam used on some models was toxic. This recall only affects breathing machines made from 2009 through April 2021. Philips stated that the affected machines might expose users to toxic foam particles or chemical fumes. Philips announced a voluntary Field Safety Notice (outside U.S.) and a voluntary recall notification (U.S. only).
According to Aeroflow Healthcare’s national sales director Eric Mongeau, it has been 12 months, and the crisis continues to be very difficult. Mr. Mongeau also stated that the negative impact has become even worse. Aeroflow, a North Carolina durable medical equipment company, sells Philips breathing devices, among other brands of breathing machines. Mr. Mongeau states that the shift of manufacturing resources toward the recall created a supply reduction.
Philips reports that it has manufactured 2.4 million replacement devices and repair kits globally and shipped over one million replacement devices in the United States. Philips also blames the pandemic-related supply chain difficulties.
Customers who depend on Philips breathing devices now have a difficult decision. The American Academy of Sleep Medicine is encouraging medical providers to prescribe different devices if practical. If not, the academy advises physicians and patients to carefully weigh the benefits and risks of continuing device usage against the dangers of suspending their breathing machine therapy. When Philips reported the recall last June, it had received reports of upper airway irritation, headaches, cough, sinus irritation, and chest pressure, which may be linked with the toxic sound abatement foam. However, Philips stated that the foam could cause medical illnesses.
This breathing machine recall and the rush to replace the breathing machine devices has led to a shortage of the semiconductors needed to build the cloud-connected breathing machines. Another manufacturer has begun to re-marketing its devices that utilize SD storage cards. The devices record data that can be downloaded by the doctor or the patient to get actionable data.
Mongeau said Aeroflow has worked to cut its backlog of orders by sourcing other FDA-approved equipment. He said right now, there is about a 4-week lead time between an order being placed and being fulfilled, but he said his company hopes to cut that in half by the end of this month.
Medical professionals are hoping the U.S. Food and Drug Administration will give emergency use authorizations to permit other breathing machine devices into the U.S. marketplace on an emergency basis. This action was used to boost the supply of ventilators during the COVID-19 pandemic. Mr. Mongeau believes that this would create an influx of new machines available in the U.S. market.
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