Respironics, Inc.

ResMed Chief Product Officer Justin Leong and Global Sleep Product Manager Lai Ying Ho discuss the AirFit F40 mask’s design and development. If you search FDA records for ResMed’s new AirFit F40 continuous positive airway pressure (CPAP) mask, you won’t find that name. Instead, ResMed sought and won FDA 510(k) clearance for the AirFit F40 mask using the codename Oran Park after a raceway in Australia, where ResMed was founded. ResMed is now headquartered in San Diego, but the engineering team still applies the names of Australian racetracks to the systems they develop. “High performance is what we’re looking for,” ResMed Chief Product Officer Justin Leong said in an interview with Medical Design & Outsourcing. “And that’s this mask.” The ResMed AirFit F40 mask ResMed developed the AirFit F40 to offer the comfort of smaller masks without sacrificing performance. This could, in turn, help with sleep apnea therapy compliance for users of high-pressure CPAP machines. The mask is designed to provide pressure support in a more comfortable, low-profile way. ResMed wanted to make the mask better for those who sleep on their side — an estimated 50% of the population, Leong said — and patients who are claustrophobic or want the stability and seal of a universal-fit mask in a minimalist design. ResMed’s key, Leong says, is the AdaptiSeal cushion. The soft silicone material helps to maintain a facial seal, even when the patient is moving around during sleep. Leong said it’s the first cushion of its kind made out of fully soft silicone material, eliminating a common plastic component. He says the cushion allows the mask to “float” on the user’s face. “The biggest thing we’ve done is make a small face mask that still performs well,” Leong said. “The way we’ve done that is a very innovative cushion that sits over your face. … It adapts to your face. That’s a really magical thing.” In addition to the smaller, more comfortable features, the redesigned frame of the F40 sits “a bit differently” across the top of the face for clearer vision. Patients can even keep their glasses on while using the mask. Another feature is a quick-release tube that allows users to easily disconnect the mask from the tube. The mask also has what Leong calls “simple headgear with just three points to adjust,” making it easier to remove than previous versions. “Often, if you’re waking up in the middle of the night, you need to adjust your mask or take off your mask, so you want something really simple around your head,” Leong said. “We’ve redesigned that as well. ResMed AirFit F40 mask development challenges Size was a key factor for ResMed to tackle when developing the new AirFit F40 mask. Face masks tend to be large, covering the mouth and nose. Along with the cushion, the frame was important, Leong said. Lai Ying Ho, ResMed’s global product manager for sleep, said the challenge was to “design a mask with a cushion that is soft and seals well, [that] doesn’t collapse, and can be reliable and easy to manufacture.” It was mainly a challenge of architecture, she said. With a different frame and a single tube compared to two with the previous version, the mask is flexible and sits differently than old frames, Leong said. “The technical challenge is that these masks need to work under quite high pressure — and that’s why usually they’re made with quite rigid material — and to make it keep in shape enough to seal but still be that comfortable, soft cushion,” Leong said. “We all have very different-shaped faces,” he continued. “To design something that fits most faces is very difficult. That’s where the clever engineering had to come in with the facial scanning.” For the first time, ResMed used facial scans to kick off the design of a new mask, Ho said, collecting thousands of scans to find the right design that would fit as many faces as possible. “During the development process, we do go back to patients to fit them in order to make sure that this is really fitting a wide variety of faces as we intended,” she said. Taming the supply chain Finally, given the long-running recall issues that knocked Philips Respironics out of the CPAP business, ResMed has expanded its share of the market. That increased demand came as the COVID-19 pandemic continued to disrupt supply chains. “We’ve always had big manufacturing capacity around the world,” Leong said. “But sourcing materials has been challenging over the last few years.” ResMed ramped up production while incorporating new materials in its updated mask. The company is one of the world’s largest buyers of the silicone used for the mask’s soft cushion, Leong said. “We’ve had to spend time sourcing new suppliers and working with them over the years so that we have multiple suppliers,” he said. “…We’re in a much better situation today and we have good supply — touch wood.”

According to the American health regulator, using these devices without the necessary software update may result in serious injuries or death Philips Respironics recalls 90,905 Trilogy Evo continuous ventilators in the US owing to a software-related power malfunction. (Credit: Koninklijke Philips N.V.) Philips Respironics has recalled 90,905 Trilogy Evo continuous ventilators in the US due to a software-related power malfunction, which the US Food and Drug Administration (FDA) has identified as a Class I recall, the most serious type. According to the FDA, using these devices without the necessary software update may result in serious injuries or death. The recall, initiated on 19 March 2024, involves Trilogy Evo, Trilogy EV300, Trilogy Evo O2, and Trilogy Evo Universal ventilators distributed from 20 March 2019 to 16 February 2024. These devices, which use a microprocessor-controlled blower to provide various forms of breathing support, are essential for individuals requiring continuous or intermittent assistance. They are used in medical, home, and non-emergency transport settings, such as wheelchairs, personal vehicles, or ambulances. The recall is classified as a correction rather than a product removal. Philips Respironics is addressing the issue by providing a software update for the affected devices. Customers have been instructed to upgrade to software version 1.05.06.00 to resolve the malfunction. The issue arises from a software problem that causes the ventilators to issue a “Battery Depleted” or “Loss of Power” alarm even when sufficient power is available, potentially leading to a sudden loss of ventilation. This malfunction affects all Trilogy Evo ventilators except those with the updated software installed. The problem occurs under specific conditions when the ventilator operates in CPAP or PSV mode. It also arises when the installed software version is earlier than 1.05.06.00 and the device cannot detect the patient’s respiratory effort for at least 10 minutes and 45 seconds. Philips Respironics has notified customers to update their ventilators to the latest software version to prevent the potential hazards. The FDA stated: “The use of the affected ventilators may result in ventilator power down and no delivery of therapy to the patient, even though the battery is not depleted. This could cause serious adverse health consequences, including hypoventilation and death.”

Philips received a warning letter from the FDA in February, which the Agency posted on Tuesday, stating that an inspection of the tech giant's manufacturing facility in Suzhou, China, that makes CT and ultrasonography systems revealed it was not in compliance with the Quality System Regulation's good manufacturing requirements. The FDA said an inspection of the facility in October showed the devices were "adulterated" in that the methods used in developing the products or in manufacturing, packaging, storage or installation do not conform to good manufacturing proactive requirements, according to the Code of Federal Regulations. Specifically, the Agency said the company failed to "ensure validation of the injection molding process used by [the] supplier of the custom-manufactured Philips Incisive CT Patient Interface Monitor (PIM) data cable." Philips Incisive CT PIM is considered a medical device, and manufacturers like Philips are required to submit medical-device reports when becoming aware of a device potentially causing or contributing to a death or serious injury. The Agency said Philips failed to submit a written report to the FDA of a correction or removal of a device, specifically regarding three violations: the PIM cable-connection failure that led to an ECG gating-signal loss/error, which could result in a delayed diagnosis; software defects resulting in upside-down or reversed images; and software defects resulting in image artifacts and incorrect image orientation. Following the inspection in October, Philips responded to the FDA's complaints, but the FDA said in the warning letter that those responses were insufficient and that Philips failed to supply adequate documentation to prove the appropriate changes were made. Philips has 15 days to respond to the letter, which notes that other federal agencies may consider the company's compliance when considering awarding it federal contracts. THE LARGER TREND Philips previously came under fire by the FDA, which said that 561 deaths have been reported since 2021 pertaining to the tech giant's recalled ventilators and machines for treating obstructive sleep apnea. Philips submitted 30 medical-device reports between 2011 and April 2021, eight from the U.S., associated with the foam in their PE-PUR machine breaking down or degrading. Philips notified the FDA in April of 2021 of its intention to conduct a field action and formally submitted its Report of Correction and Removal in June 2021. The same year, Philips initiated a recall of over five million of its devices. The company said in a statement that after releasing public comments about the recall, there was "an increase by approximately 20,500 MDRs filed by Philips Respironics to the FDA between April 2021 and April 2022. In the following six months through October 2022, Philips Respironics filed approximately 70,500 MDRs, and in November and December 2022, approximately 8,300 MDRs." At the end of January this year, Philips agreed with regulators to stop selling the PE-PUR and similar devices in the U.S. Last month, a federal district court entered a consent decree against the manufacturer, requiring it to either partially refund patients impacted by the recall or provide them with a new or reworked/remediated device. The decree also restricted Philips in producing or selling new CPAP machines, BiPAP machines and other devices at Philips' facilities in California and Pennsylvania until certain requirements were met. Earlier this week, the company released its first quarter earnings report, which included notification that Philips Respironics settled claims filed in U.S. courts, as well as potential claims submitted through the census registry. The company will pay $1.1 billion to individuals who claim they were injured by the CPAP and ventilator machines, and payments are expected to be distributed in 2025.