LAUSR

Introduction: To stay at home, have social interaction, or work, people experiencing urinary retention or uncontrolled urine or feces leakages need specific medical devices (MDs). In France, the MDs used to be covered by the health insurance system if included on a specific list of products and services qualifying for reimbursement. These MDs for urinary and fecal drainage and collection are included under a generic description corresponding to a class of products with the same indications. This coverage modality offered low resistance to unnecessary or wasteful spending. Furthermore, a periodic update of the list is required whereas it has not been done for more than 10 years. Methods: In 2016, Haute Autorité de santé (HAS) assessed the actual clinical benefit of these MDs using a standard health technology assessment method (systematic literature review, opinions of health professionals and patients’ representatives). Manufacturers were asked to provide technical specifications on their MDs. Results: The lack of professional guidelines and well-conducted comparative clinical trials has to be pointed out; among 516 identified publications screened, only seven recommendations, one technological review and one randomized controlled study were selected. Despite this, HAS defined specifications for each generic description, based on users’ experience (patients and caregivers). These included specific indications, minimum technical specifications and, when applicable, conditions of prescribing and use. This assessment took into account individual preferences, the role of the natural carers and the conditions, and opportunities for patients to improve and update their self-care and rehabilitation skills. Conclusions: The HAS assessment of MDs for urinary and fecal drainage and collection provides a cornerstone for the enhancement of the access to the necessary devices for homecare. The expected benefits are an improvement of the quality of life and a reduction of health expenditure due to misuse, complications or hospitalizations.