Is Philips Respironics DreamStation being recalled?

Is Philips Respironics DreamStation being recalled?

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Sound attenuation foam can degrade over time and release toxic particles into the airway of the machine and be inhaled directly into the lungs of your customers. Philips admits that the degraded particles and gases can be toxic to patients and potentially cause cancer.

Philips has advised customers using its CPAP and Bi-Level PAP machines to stop using them immediately and consult with their physician to discuss the best options for continued treatment.

Philips Respironics has received many complaints about the presence of black debris or black particles within the airway circuit (extending from the device outlet, humidifier, tubing and mask).

The chemicals in the foam particles can be measured in blood and urine. Because these chemicals leave the body fairly quickly (within a few days), testing should be performed soon after exposure. These tests are not routinely available in a physician’s office, but your physician can send samples to special laboratories for analysis.

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This information is intended exclusively for healthcare professionals empowered to prescribe or dispense medication, specialized training is necessary for its correct interpretation.

Chronic diseasesThe FDA recalls some models of CPAP, BIPAP and respirators to mitigate possible health risksThe health problems detected, which would be of different nature, are related to the presence in the devices of a foam used to reduce noise17/06/2021BACK TO BACK

The foam, the source of the problemThis risk is related to the fact that this foam can degrade into particles or gases that would enter the device’s pathway and could be ingested or inhaled by the patient. Degradation of the foam could be aggravated by the use of unapproved cleaning methods, such as ozone. Other factors such as the passage of time, high temperature and/or high humidity environments could also contribute to the degradation of this foam. SEPAR is currently in close contact with Philips and the healthcare technology companies in order to have all the existing information on the subject and thus maintain its commitment to the respiratory health of those affected. Specifically, SEPAR recommends as of today:

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Cpap that is

In effect, through the document the Chilean regulator echoed a safety notification that the brand itself – specifically the Philips Respironics division – had voluntarily issued a week earlier and which was also replicated by the US FDA.

All as a result of the detection of possible health risks for users of various continuous positive airway pressure (CPAP) devices; bi-level positive airway pressure (BiLevel PAP) and mechanical ventilation equipment.

Specifically, the company – and subsequently the ISP – warned that the noise-insulating foam used in the devices tended to degrade to produce particles that can enter the airflow of the device and be inhaled or ingested by the user.

“This from a health standpoint is a serious problem and the brand itself says so. Then they mention in countless meetings that we have had with them that these are isolated effects and that they are very infrequent effects… and that is what causes us a lot of noise, because then why did they publish it,” says Cisternas.

Respironics cancer

Philips has not received reports of deaths, but is aware of consumers finding black residues in the airway tubing and feeling sick. Potential risks from exposure to foam include headache, irritation, inflammation, respiratory problems and possible toxic and carcinogenic effects. Risks from chemical exposure include headache, irritation, hypersensitivity, nausea/vomiting, and possible toxic and carcinogenic effects. The company has not received reports of patient exposure to chemical emissions.

Pending indications from Philips Respironics Mexico and COFEPRIS; Mercado CPAP, looking out for the health and interests of patients, has initiated a formal petition through the Change.org platform to take the necessary actions in our country.

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