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CPAP Device Certification

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.
 
 
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 the 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 the 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 the 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' does not yet provide testing methodology for devices in anything other than fixed pressure mode for pressure stability, noise and humidifier performance.   ARTP is working 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.
 

CPAP Certified Devices

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