Sleep & Respiratory Devices
Devices for diagnosis and treatment of sleep-disordered breathing and chronic respiratory disease, CPAP, BiPAP, ventilators, and home sleep tests.
Definition
The sleep & respiratory segment covers home sleep test (HST) devices, polysomnography systems, CPAP and BiPAP/auto-titrating PAP, adaptive servo-ventilation, home and ICU ventilators, and oxygen concentrators. The June 2021 Philips Respironics recall of millions of CPAP/BiPAP devices over PE-PUR foam degradation is the largest medical-device recall in MedTech history and reshaped the segment's competitive structure.What this means in practice
DME reimbursement (HCPCS E0601 for CPAP) and supplier compliance (adherence-monitoring requirements) drive product design. Adherence monitoring data is now a routine payer requirement.- •Sourcing sound-abatement foams without long-term off-gassing characterization (the Philips lesson).
- •Treating adherence data telemetry as optional, payers require it.
Related terms
Grouped by themeEditor's picks
· Hand-selected related conceptsFDA submission demonstrating a device is substantially equivalent to a legally marketed predicate.
Medicare benefit category covering durable medical equipment, prosthetics, orthotics, and supplies, billed under HCPCS Level II codes through DME MACs.
Activities to monitor device safety and performance after market release.
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Primary references
3 sources- 1
FDA, Philips Respironics RecallVerifiedFDAfda.gov
- 2
AdvaMed - Industry ReportsVerifiedAdvaMedadvamed.org
- 3
MedTech Europe - Facts & FiguresVerifiedMedTech Europemedtecheurope.org
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