The National Commission for Evaluation of Medical Devices and Health Technologies (CNEDiMTS) reviewed indications for number of devices on the LPPR list and made recommendations about structure of the section in the LPPR list.
Health technology assessment was performed by the French National Authority for Health (HAS). This assessment concerns following devices:
- Drainage and bladder irrigation devices
- Urine collection devices, whether they are evacuated by the urethra, by a catheter or by a stoma
- Devices for collecting fecal matter
- Non-implantable devices for preventing unintentional leakage of urine or faeces,
- Accessories associated with the devices mentioned above
The objective of current assessment was aimed to clarify following issues:
- the indications of different types of products and their technical specifications minimum, including
- the materials, including the relevance of maintaining the support of the devices, the materials of which are at the origin of allergic reactions and the type of lubrication of urinary catheters
- the sizes (gauge, length, volume, collection, etc.)
- the terms and conditions of connection
- the character is sterile or not
- the terms and conditions of use of the devices, and the suitability of the packaging, in particular according to the indications and/or the involvement of a third party during the delivery of care
- the convenience of use of the products according to the abilities or activities of persons
- the associations of products required or optional
- the provision of services
The National Commission for Evaluation of Medical Devices and Health Technologies (CNEDiMTS) recommended to change nomenclature for devices used for urinary incontinence, fecal and ostomy incontinence, and for the treatment of colorectal neurological impairment. However, CNEDiMTS emphasized a lack of recommendations as well as observational comparative studies for these devices.
See recommended changes in nomenclature in French here.
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