Ausili, medicale e largo consumo: gli orientamenti dell Organizzazione Mondiale della Sanità

Transcription

1 Convegno Qualitàe sicurezza del dispositivo medico: l ausilio nella vita quotidiana Padova, 7 novembre 2015 Ausili, medicale e largo consumo: gli orientamenti dell Organizzazione Mondiale della Sanità Ing. Renzo Andrich Centro per l Innovazione e il Trasferimento Tecnologico IRCCS Fondazione Don Carlo Gnocchi, Milano

2 Qualità del prodotto? Quality of product? Sicurezza Safety Affidabilità Reliability Funzionalità Functionality Marcatura E certificato rispetto a standard? Mark certification according to given standards Test di laboratorio Quali sono le prestazioni? Laboratory tests measuring performance Test funzionali in pratica va bene? Functional testing does it work in practice? Usabilità Usability Test sul campo E gradito all utenza? Field tests is it well received by users

3 Sicurezza Safety using the device in a way that (a) does not harm the user (e.g. does not cause injuries, sores etc) (b) is reliable and (c) gives the user the feeling of being safe l uso dell ausilio non danneggia chi lo utilizza, risulta affidabile, da chi lo utilizza una sensazione di sicurezza (OMS/GATE Consultation, Milano 27 aprile 2014) Sicurezza >>> rispetto ad un rischio Rischio >>>> oggettivo, soggettivo, ambientale

4 Rischio?

5 Il caso dei comunicatori

6 Comunicatori certificati come dispositivi medici

7 La rivoluzione delle APP

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12 Pace of Ageing % % of Population Age 65+ S Korea Brazil Thailand 7% France Sweden UK USA Japan China

13 Joint family to nuclear family 20 Century 21 Century

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16 Need: More than 1 Billion people now & 2 Billion by 2050 But only 1 in 10 can access Assistive Products (10%)

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18 Need for change Need for Innovation Learn from other successful initiatives Essential Medicines List (EML) Disruptive Innovation Creating a new market and value network Displacing an earlier concept Setting an example of change

19 A familiar scenario of the past WHO Model list of essential medicines 1977 Some medicines are more essential than others Essential medicines needs to be available at an affordable cost Not restrictive, flexible and adaptable in different context selecting the list of medicines those are essential is a national responsibility A peaceful revolution in International Public Health

20 What WHO is doing? Ensuring access to assistive technology a global priority Redefining assistive technology/products Working towards implementing the article 32 of the CRPD - International cooperation on assistive technology Taking appropriate initiatives to assist the Member States to improve access to high-quality affordable assistive products

21 WHO model Priority Assistive Products List (APL) Proposed definition Priority Assistive Products (APP) may be defined as: those products, which are highly needed, a must/absolutely necessary to maintain or improve an individual s functioning and health; they should therefore be available at a price the community/state can afford.

22 Proposed criteria Priority Assistive Products for Community Level (APPc) those priority assistive products, which can be provided at the community level by the health workers/nurses/community-based rehabilitation (CBR) workers and others (non-specialists) with a short comprehensive training programme. Priority Assistive Products for Referral Level (APPr) those priority assistive products, which can be provided at the referral level by the specialist professionals on the subject matter.

23 25 APL

24 Regional/global consultation consensus meeting

25 Support and stimulate a vibrant and innovative supply-side market by providing a conduit for innovation and promoting the take-up of technology solutions; Support and stimulate informed, active, participant-led demand by empowering participants to choose technology that best supports their needs; L approccio Australiano Deliver a financially robust, sustainable scheme that generates economic and social value with the Agency only intervening to optimise outcomes for participants andeconomic value for the Scheme.

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