Assessment and non-clinical impact of medical devices.

Medical devices (MDs) cover a wide variety of products. They accompany changes in medical practice in step with technology innovations. Innovations in the field of MDs can improve the conditions of use of health technology and/or modify the organisation of care beyond the strict diagnostic or therapeutic benefit for the patients. However, these non purely clinical criteria seem to be only rarely documented or taken into account in the assessment of MDs during reimbursement decisions at national level or for formulary listing by hospitals even though multidimensional models for the assessment of health technologies have been developed that take into account the views of all stakeholders in the healthcare system In this article, after summarising the background concerning the assessment of health technologies in France, a definition of non-clinical criteria for the assessment of MDs is proposed and a decision tree for the assessment of MDs is described. Future lines of approach are proposed as a conclusion.

What should be done to combat misinformation about health products?

The increasing role of digital technology, social media, the wide range of channels and the volume of information, the role of medicine as a societal subject, public information that is insufficient and poorly suited to situations of uncertainty are all observations which led to the theme of this round table. After discussing the definition of disinformation, which is not limited to fake news, and talking about contributors who misinform, whether intentionally or not, the participants of this round table made nine recommendations (R) to combat disinformation about health products: create a collaborative platform, information/training on health products, a platform with five major characteristics, namely accessibility, flexibility, objectivity, transparency and independence, as well as media suited to the different targets (R1); promote basic knowledge on health products: education/training to restore the particularly poor image of medication, and teach the public how to use basic concepts appropriately (R2); improve communication to the public based on the observation that information is the main weapon against misinformation and entails, in particular, coordinating communication from the different institutions to make public information more audible, making institutional messages clearer, ensuring they are more factual and prioritising them (R3); know how to communicate using the correct codes and tools (R4), because, to be understood, the substance and the form are inseparable; develop research on communication in the field of health products (R5); acquire tools to identify and regulate as soon as possible (R6); keep check of content by developing critical thinking (R7); define quality criteria for information sources (R8); identify, assess and reference initiatives for the public that could be placed on the platform (R9).

Dermal equivalents in oncology: benefit of one-stage procedure.

BACKGROUND: In oncology, dermal equivalent may be indicated to cover losses of substance related to skin tumors or after the removal of skin flaps. OBJECTIVE: To report our experience of two dermal equivalents, Matriderm 1 mm with a one-stage graft (DE1) and Integra DL with a two-stage graft (DE2) in oncology. PATIENTS AND METHOD: Retrospective, single-center study involving 16 patients. RESULTS: Sixteen patients received dermal equivalents as an alternative to flaps (7 cases), over tendinous areas (7 cases), and for cosmetic purposes (2 cases). Twelve patients received DE1 and four DE2. Wound healing times with DE1 were 4 weeks less than those with DE2. Three cases of infection were noted with DE2. The use of dermal equivalents as an alternative to skin flaps was effective, and no adhesions were found over the tendinous areas. CONCLUSION: The learning curve, the two-stage graft required with DE2, and not using a vacuum-assisted closure system can explain the high infection rate. The use of dermal equivalents is particularly indicated in the treatment of skin defect in oncology. The possibility of a one-stage graft with DE1 and combination with negative pressure therapy is beneficial.

Why and how can we improve patient and caregiver information for the proper use of their medical devices throughout the care pathway?

Information is generally a major pillar in the relationship of trust between the patient and their healthcare team. In the case of medical devices, which are operator-dependent and for which the proper "handling" of the device will directly affect its performance, information on the proper use becomes a major therapeutic issue. To do this, patients must have access to quality information about health products. Twenty years after the Kouchner Act introduced a right to information for patients, our panel questioned the quality of information provided to patients about the medical devices they use during their care pathway. We mapped off the information process throughout the life of the medical device (manufacturer, prescription, dispensing, use and monitoring) to identify deficiencies and potential corrective solutions. Thus, the device could respond to the 5B as for the drug (right device, right patient, right indication, right time, and right use). Seven recommendations have emerged and are proposed in this article.

Disposable versus reusable biopsy forceps in GI endoscopy: a cost-minimization analysis.

BACKGROUND: The use of disposable biopsy forceps seems to be effective and safer than reusable biopsy forceps with respect to the risk of infection transmission. The results of cost analysis studies comparing reusable versus disposable biopsy forceps are conflicting. This study compared the cost of reusable versus disposable biopsy forceps. METHODS: A cost-minimization analysis was carried out from the viewpoint of a hospital. Direct costs were included. The study design was retrospective. For reusable biopsy forceps, the evaluation of costs included purchase prices, cleaning (chemicals, equipment, technician time), and a fee for sterilization in a centralized facility. The cost evaluation for disposable biopsy forceps included acquisition and destruction costs. Costs were expressed in United States dollars. RESULTS: The mean number of uses was approximately 90 per reusable forceps. The cost per use of reusable biopsy forceps was 6.84 US dollars (acquisition 3.59 US dollars, cleaning 2.28 US dollars, centralized sterilization fee 0.97 US dollars). The cost per use of disposable biopsy forceps varied from 10.72 US dollars to 15.63 US dollars. Additional cost per use of disposable biopsy forceps ranged from 3.88 US dollars to 8.79 US dollars. CONCLUSIONS: From a strictly economic point of view, the use of reusable biopsy forceps is advantageous. However, additional factors should be considered. It would be essential to take into account the potential risk of infectious disease transmission related to the use of both types of forceps, which remains uncharacterized.