HJNO Jan/Feb 2024

BREATHING MACHINES RECALL 32 JAN / FEB 2024 I  HEALTHCARE JOURNAL OF NEW ORLEANS   agency has not yet provided a response. In a statement, the FDA said more tests are needed on the foam before determining if the devices pose “risks to patients.” Experts who reviewed the test results for the news organizations said the find- ings revealed troubling markers, includ- ing the presence of formaldehyde at levels that exceed safety thresholds established by multiple organizations. Thresholds vary, they said, and those cited by Philips allow for far higher formaldehyde levels than others. Safety thresholds also do not take into account patients who are already suffer- ing from chronic illnesses and breathing from devices that emit fumes directly into the lungs. The experts said that one of the most vex- ing concerns is that formaldehyde — linked to respiratory problems and certain cancers — showed up in multiple tests and at vary- ing levels, at times low and at others higher. “Who knows what a patient could be exposed to?” said an engineer familiar with the testing who still works in the industry and did not want to be identified for fear of reprisals. “If you had grenades and you’re not sure where they’re going to go off, that’s a problem.” After questions from ProPublica and the Post-Gazette — and more than two years after the problem surfaced — the company put out a more detailed explanation about the issue late last week. Documents related to the company’s test- ing have been turned over to the Depart- ment of Justice, which launched an inves- tigation of the recall last year, according to sources familiar with the probe. Philips has said that it is cooperating with investigators and that the company initially did not believe that complaints dating back more than a decade about the recalled machines needed to be reported. The com- pany said it took action as soon as it learned of the significance of the problem. Breaden, the Portland physician, said she had no idea that new problems have emerged and nowworries that doctors and patients have been once again left to fend for themselves. “There’s just a lot of things that we’re all being kept in the dark about,” she said. “Compounds of Concern” The trouble with the replacement machines surfaced shortly after the June 2021 recall, which sent the company’s stock prices tumbling and led to hundreds of law- suits by Philips customers. An FDA inspection of the firm’s manu- facturing plant near Pittsburgh turned up a surprise discovery: a copy of a test that an independent lab conducted on a CPAP machine with the new foam showing results that the agency had not previously seen, public records show. An inspector later noted in a report that the machine failed emissions testing because it produced “compounds of con- cern”with carcinogenic properties and that pediatric patients who use the machines could be especially vulnerable. At the time, the FDA said it carried out a “benefit-risk assessment” and decided that until more information became available, not using the devices at all “may be more harmful to a patient’s health.” One of the chemicals that turned up in the testing was formaldehyde, which also showed up on a second set of test results from another lab in August, records and interviews show. That fall, the company opened an inter- nal investigation after receiving complaints about the DreamStation 2. Engineers evalu- ated 97 devices and found that about 1 in 5 showed evidence of moisture and that nine had experienced “thermal events,” accord- ing to the company’s report. Though the investigation concluded the problem could cause the machines to stop working or shock patients while in use, Phil- ips deemed the risk “acceptable” and said “containment activities” were unnecessary, the records show. In the months that followed, Philips forged ahead. With pressure mounting to meet the needs of customers, the company promised that everyone affected by the recall would get a replacement machine or a repaired one within a year. At the time, hospitals and medical prac- tices were waiting on the devices. So was the Department of Veterans Affairs, where an urgent alert in late 2021 warned that the supply of CPAPs was “critically low.” “Warehouses are currently out,” the agency said in an internal email. “Level red.” The wait forced some sleep apnea patients to place a dangerous bet. In sub- urban Pittsburgh, Callender continued to use his recalled CPAP for months. He said he couldn’t get a new one fromPhilips even though he had a double lung transplant in 2015 and a kidney transplant in 2021. “I told them I was in dire need,” said Cal- lender, a former mayor of Lower Burrell, Pennsylvania, who eventually started using an old machine that he had stashed in a bedroom closet. “Never heard back from Philips.” Callender said he had no idea he was waiting on a machine that was fitted with a foam still under review by federal regulators. “They failed me on so many levels,” said Callender, who received a replacement machine from Philips several weeks ago. In the spring of 2022, as Philips continued to ship out replacements filled with the new foam, the company had a series of meetings with the FDA to discuss the ongoing testing. Jeff Shuren, the agency’s chief regulator of medical devices, was directly involved, writing to Philips in May about test results that the company had promised but not yet delivered to the agency, according to emails