Working with industry members on a voluntary basis scheme to independently certify technical and performance standards for CPAP devices sold in the UK
CPAP Device Certification Process
The CPAP Device Certification Scheme is open to members of the ARTP Sleep Apnoea Consortium (ARTP SAC) only. If your company wishes to take part in the CPAP Certification Scheme but is not currently a member of ARTP SAC, please contact sleepadmin@artp.org.uk for further details.
The process for CPAP Device Certification is set out in the document 'ARTP Standards of Care - CPAP Device Certification Policy’ which can be downloaded below
ARTP Standards of Care - CPAP Device Certification Policy
An electronic form will also need to be downloaded, completed and submitted, as specified in the policy, for either a Fixed Pressure or Auto-Adjusting Device, available from the links below:
Fixed Pressure Device or Auto-Adjusting Device
Members of the ARTP Sleep Apnoea Consortium can send their completed forms to sleepadmin@artp.org.uk
Certified Devices
The devices specified below have been subject to independent evaluation for ARTP and have met the required standard as outlined in the position paper, ARTP Standards of Care - CPAP Devices (Technical and Performance) found here. Please click on the relevant section to reveal more information:
Certified CPAP Devices - Fixed Pressure
Certified CPAP Devices - Auto-adjusting Pressure
Devices no longer available/supported
Disclaimer without Prejudice
Appearance of any device in this section of the ARTP web site does not imply any endorsement of that device, trademark or company by ARTP. It simply documents that the devices listed have met the requirements of the ARTP Standards of Care - CPAP Devices (Technical and Performance).
If a CPAP device is not listed here this is because either it has been tested and failed to reach the required ARTP Standards, or it has not been submitted by the manufacturer or authorised distributor (with the manufacturer's written permission). ARTP will be pleased to test any device independently provided that the manufacturer of that device (or their authorised distributor with written permission) is a subscribing member of the ARTP SAC.
Where CPAP devices fail to reach the ARTP standard on independent testing, ARTP SAC will perform testing of additional devices of the same series with the full cost of such testing being borne by the manufacture/distributor and agreed prior to the testing.
Risk of unregulated provision of CPAP devices
The risk to patients of unregulated provision of CPAP devices without regard to technical and performance quality standards is real and significant. There is the possibility of sub-optimal patient care being delivered, albeit unwittingly, due to ineffective and inappropriate treatment being delivered by the provision of poorly performing CPAP devices. Whilst the majority of CPAP device manufacturers and distributors strive to provide quality products and service, there is no way of minimising the potential for poorly performing devices to be sold without a robust, independent testing regimen.
Relevant minimum technical and performance standards for CPAP devices have existed in Germany for over a decade. GKV-Spitzenverband, as the central association of the health insurance funds at federal level, maintains the 'Hilfsmittelverzeichnis', the 'List of Aids', known within the medical device industry as the 'Red Book'. Under Product Group 14 - Inhalation and Breathing Aparatus, Sub Groups 20 and 21 refer to Fixed Pressure CPAP and Auto CPAP devices respectively.
The 'Medizinische Anforderungen' - 'Medical Requirements' for Sub Groups 20 and 21 identify the technical standards of performance required before CPAP devices can be placed upon the official 'List of Aids' available via the German Statutory Health Insurance System. The standards set out a recognised and agreed testing procedure for verification of compliance of any device with these standards in respect of operational noise level, stability of the static and dynamic airway pressure accuracy, gas purity, warming the inhaled air and, where appropriate, proof of humidification performance.
Voluntary Independant Device Certification
ARTP's Sleep Apnoea Consortium (SAC) has been working for some time with industry members to agree and implement on an entirely voluntary basis a scheme to independently certify technical and performance standards for CPAP devices sold in the UK. This has now been achieved and is operational. The independent testing laboratory commissioned by ARTP is that of Professor Thomas Netzel who is Professor of Control Engineering and also Vice-President of the University of Applied Sciences in Hamburg, Germany. Professor Netzel has extensive test facilities and is working collaboratively with ARTP SAC.
Under the German standards, technical standards of performance are documented as compliant either by submission of manufacturer in house testing data or independent laboratory testing. ARTP's technical standards of performance for CPAP devices always requires that independent laboratory testing according to the requirements of the 'Red Book' is performed on a sample device to ensure compliance with the requirements for pressure stability, noise and humidifier performance. CPAP device manufacturers, and distributors where the manufacturer does not have a presence in the United Kingdom, who are members of ARTP Sleep Apnoea Consortium (ARTP SAC), may submit CPAP devices to ARTP of their own volition for independent laboratory testing against the technical and performance standards set out in ARTP Standards of Care - CPAP Devices (Technical and Performance).
ARTP will maintain and publish a register via this web site of those sampled devices which meet or exceed the technical and performance standards set out in the Standards of Care document. Where a submitted device does not meet the required standards of performance, a detailed report of the independent testing outcome will be shared with the submitting organisation. There is no intention by ARTP to publish details of submitted devices which do not meet the required standards. Where manufacturers are able to provide test reports from independent laboratories, this may be accepted as sufficient evidence for a device to meet the requirements for the register of certified devices.
The register of CPAP devices which have been tested in an independent laboratory commissioned by ARTP and which meet or exceed ARTP technical and performance standards will serve as a reference to all providers of CPAP therapy that such devices have been verified to meet internationally recognised standards of performance and which are therefore satisfactory to provide to patients.
The 'Red Book’ provides a testing methodology for devices in anything fixed pressure mode for pressure stability, noise and humidifier performance. A test was added in 2018 to provide information on performance of Auto-Adjusting CPAP devices for Obstructive events only. ARTP continues to work with interested professionals and organisations internationally to develop standards specifically relating to the additional performance features of Auto-Adjusting (commonly known as Auto-Titrating) CPAP devices.