FDA inspection turns up more problems for Philips Respironics

Regulatory NewsRegulatory News | 16 November 2021 |  By 

Hundreds of thousands of complaints from users of Philips Respironics’ breathing assistance devices have been inadequately addressed by the firm, according to recent information released by the US Food and Drug Administration (FDA). The release of an inspection report and FDA’s accompanying statement provides more detail on what Philips knew, and what the firm did – or did not do – to remedy known problems with degradation of foam components in its breathing devices.
The report follows a June Class I recall of some of Philips’ ventilators and continuous and bilevel positive airway pressure (CPAP and BiPAP) machines because of concerns that sound abatement foam in the devices could break down, posing a risk for serious harm, including increased risk of cancer.
FDA conducted an inspection of the Murrayville, PA Philips Respironics plant in response to the recall that began in late August and wrapped up on 9 November. FDA’s Form 483 from that inspection, released on 12 November, found that “There is no documented investigation, risk analysis, or design failure mode effect analysis to support your firm’s rationale for which polyester polyurethane foam-containing products were affected, included, or not included in your firm’s ongoing recalls.”
The investigation also found that Philips had ignored earlier red-flag signs that foam was breaking down and entering the breathing tube of their products, with executive-level managers having been aware of “potential foam degradation issues concerning CPAPs, BiPAPs and Trilogy ventilators since at least 1/31/2020,” wrote FDA investigator Katelyn Staub-Zamperini.
Field reports and complaints had prompted testing of the foam components as far back as 2016, with an April 2016 field sample showing “base polymer cleavage and embrittlement of the returned foam material” from the samples. The inspection found that although there were at least 14 tests or assessments, or reported incidents, from 2016 to the present when Philips was aware of problems with foam degradation or concerns about volatile organic compound (VOC) emissions, the firm made no design changes and took no field or corrective actions.
The Form 483 details all 14 known incidents. Additionally, some of Philips’ breathing equipment with silicone foam unaffected by the ongoing Class I recalls for the polyurethane foam degradation also failed VOC testing, noted Staub-Zamperini.
FDA also queried consumer complaints for Philips Respironics for relevant keywords from 2008 to the present. Using such terms as “contaminants,” “particles,” “foam,” “black,” and others, the agency found over 222,000 complaints, with more than 20,000 of those involving the recalled Trilogy devices.
However, a Health Hazard Evaluation conducted by Philiips related to reports of foam degradation reached the conclusion that the probability of harm was unlikely, falling into the “possible but improbable” harm score category. Citing the many known instances of foam degradation that had been evaluated by Philips or other entities, Staub-Zamperini observed that “Therefore, potential foam degradation in Trilogy ventilator devices is not an isolated incident, and you also have not documented a detailed rationale for why harm is not likely to occur again, as required by your Health Hazard Evaluation’s instructions.”
In addition to finding inadequate risk analysis procedures, the investigator also found that Philips had not established adequate procedures for corrective and protective action (CAPA). A CAPA was opened in 2018, but never formalized or implemented. That CAPA also investigated only two types of ventilators, without looking at related products that used similar air path assemblies and components.
The investigation also tracked down email correspondence between Philips Respironics and the raw foam supplier going back as far as 2015 asking about the potential for foam degradation, based on a customer inquiry. The foam supplier responded in a fashion that “implied that degradation of polyester polyurethane foam is likely and could occur in as little as [redacted].”
The inspection report details a total of eight observations that continue to march down the line of problems found, including a failure to report corrective actions to FDA, a lack of procedures for design changes, inadequate design validation, poor managerial oversight of quality, failure to ensure conformity of received products, and failure to retain appropriate consultants.
Patients are advised to consult with their health care providers on whether they should continue using their Respironics devices while they await repair or replacement, according to FDA’s statement.
“We recognize that patients rely on these devices, and we are closely monitoring the company’s actions to ensure that the issues are resolved in a timely manner given the impact on patients,” said FDA’s head of the Center for Devices and Radiological Health, Jeff Shuren. “We are committed to continuing to regularly update the public about the status of this recall, including any new recommendations or actions regarding Philips Respironics’ devices.”
FDA announcement
Form 483


© 2023 Regulatory Affairs Professionals Society.

Discover more of what matters to you