The U.S. FDA posted an update to the ongoing recall of respirators and positive airway pressure devices by Philips Respironics Inc., a subsidiary of Amsterdam-based Royal Phillips NV, which are associated with more than 21,000 medical device reports (MDRs) between Aug. 1 and Oct. 31, 2022. However, these MDRs are also associated with 91 patient deaths, which while they cannot be attributed directly to these devices, are nonetheless a stain on the reputation of the company’s products going forward.
For a company that dominates the market for devices designed to improve breathing during sleep, Royal Philips NV has had the devil of time catching its own breath over the last 15 months as it has issued wave after wave of recalls.
A variety of positive airway pressure (PAP) devices made by Philips Respironics Inc. have been subject to a lengthy and expensive recall due to the use of a problematic material in acoustic insulation foam, but now the company has a new headache in connection with its offerings. The FDA said this latest safety notification is due to the possible presence of a plastic that is contaminated with a non-compatible material, although this recall affects fewer than 400 units.
The recall of CPAP, BiPAP and ventilator devices made by Philips Respironics Inc., of Murrysville, Pa., is now in its second year, but the rate of reported adverse events was exceedingly low prior to the onset of the June 2021 recall. Those numbers continued to climb in May, June and July of 2022, however, reaching 48,000 medical device reports and 44 deaths said to be associated with the recalled devices, a pace that would easily overwhelm the volume of reports seen in the 12 months ending April 30, 2022.
Device servicing by third parties has been topical of late, although not in the context of continuous positive airway pressure (CPAP) systems. That seems likely to change thanks to the ongoing recall of CPAP machines made by Philips Respironics Inc., of Murrysville, Pa., which was driven by reports of degradation of foam used in the device for insulation.
Murrysville, Pa.-based Philips Respironics Inc. has had its share of troubles with its devices for respiratory use, including several CPAP machines. The FDA reported March 21 that the company’s V60 and V60 Plus respirators are now the subjects of a class I recall due to the use of an expired adhesive that could ultimately lead to a shut-down of the devices, including instances in which the shut-down would not be accompanied by an alarm.
Philips Respironics Inc., of Murrayville, Pa., was compelled to engage in multiple recalls over the use of a supplier’s polyester-based polyurethane (PE-PUR) sound abatement foam, and the latest victim of this problem is the company’s Trilogy Evo ventilator.
The U.S. Centers for Medicare & Medicaid Services (CMS) finally laid to rest the rule for Medicare Coverage of Innovative Technology (MCIT), a policy proposal that found favor with industry and with several patient groups. However, the news comes shortly after a bipartisan group of 10 senators had penned a letter to the agency to reissue the rule, reinforcing the prospect that the MCIT proposal will find widespread support in the halls of Congress in 2022.
The FDA reported that Boston Scientific Corp. has recalled several models from the Ingenio line of cardiac electrophysiology devices in a class I action that affects 48,000 devices. The recall was triggered by the risk that these devices will inappropriately shift into safety mode and thus be unable to provide pacing, as demonstrated by 65 such incidents and three instances in which patients needed external pacing in response to the problem.
