Dispositivi medici: usabilità | Note
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Dispositivi medici: usabilità | Note 2019
ID 7639 | 27.01.2019
Il Documento allegato intende fornire note e spunto normativo sul concetto di "usabilità" dei Dispositivi medici come definito da EN 60601-1-6. Allegati altri documenti d'interesse.
Usability: Con questo termine – spesso tradotto in italiano con la locuzione “facilità d’uso” – si intende quella dimensione del prodotto/servizio connessa all’interazione che si stabilisce tra utilizzatore, prodotto e contesto d’uso, la cui criticità dipende dallo sforzo richiesto all’utente nell’ambito del processo d’uso. Un prodotto usabile ha le seguenti caratteristiche:
- è facile da imparare ed è altrettanto facile ricordare come si utilizza;
- è efficace ed efficiente nel suo uso;
- permette di recuperare velocemente gli errori fatti nel suo uso;
- è piacevole da utilizzare.
Ad oggi la tematica dell’usabilità sta assumendo sempre più rilevanza in ambito europeo e, conseguentemente, anche in Italia, da cui ne deriva la necessità che le apparecchiature siano sottoposte a test di “ingegneria dell’usabilità” che ne verifichino la facilità e la sicurezza di utilizzo.
Anche per quanto riguarda i dispositivi medici (DM) è raccomandata l’esecuzione di preventive specifiche prove volte ad evitare eventi avversi connessi ad un impiego non “user-friendly”, per cui vengono prese in esame le attuali disposizioni legislative e raccomandazioni inerenti i DM ed i possibili connessi scenari di responsabilità in caso di danno. In particolare gli Autori analizzano gli scenari di contenzioso derivanti da un uso non sicuro dei DM: dall’ipotesi di “premigenia” responsabilità del Ministero della Salute per omessa vigilanza alla responsabilità del professionista sanitario e del medico da mancata segnalazione di un difetto a carico delle apparecchiature mediche utilizzate, sino a quella organizzativa della struttura sanitaria cui viene richiesto sempre più, nella quotidiana pratica operativa, di adeguarsi a protocolli e raccomandazioni internazionali.
Nel caso dei DM, quindi, non è remota l’evenienza secondo cui in caso di danno da “mal-usabilità” potrà essere richiesto alla struttura sanitaria di fornire prova di essersi dotata di dispositivi sicuri e rispondenti alle raccomandazioni più attuali in tema di usabilità.
Documento completo in allegato
CEI EN 60601-1-6:2005 - USABILITY Definition
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2.211
USABILITY: Characteristic that establishes EFFECTIVENESS, EFFICIENCY and OPERATOR learnability and satisfaction
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2.211
USABILITY: Characteristic that establishes EFFECTIVENESS, EFFICIENCY and OPERATOR learnability and satisfaction
- EFFECTIVENESS accuracy and completeness with which OPERATORS achieve specified goals
- EFFICIENCY resources expended in relation to the accuracy and completeness with which OPERATORS achieve goals
- EFFICIENCY resources expended in relation to the accuracy and completeness with which OPERATORS achieve goals
- OPERATOR PROFILE summary of the mental, physical and demographic traits of the intended OPERATOR population, as well as any special characteristics that can have a bearing on design decisio ns, such as occupational skills and job requirements
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A seguire sono riportate le norme tecniche d'interesse, riguardanti l'ergonomia e l'usabilità dei dispositivi medici:
- ISO/IEC GUIDE 71, Guidelines for standards developers to address the needs of older persons and person with disabilities; (Allegata)
- ISO/TR 22411, Ergonomics data and guidelines for the application of ISO/IEC Guide 71 to products and services to address the needs of older persons and persons with disabilities;
- ISO 20282-1, Usability of everyday products - Part 1: Universal design and the evaluation of ease -of-operation, efficiency and satisfaction
- ISO/TS 20282-2, Usability of consumer products and products for public use - Part 2: Summative test method
- ISO/TR 16982, Ergonomics of human system interaction - Usability methods supporting human centered design
- IEC 62366, Application of usability engineering to medical devices; (CEI EN 62366-1)
- IEC 60601-1-6, General requirements for basic safety and essential performance; (CEI EN 60601-1-6)
- EN ISO 14155, Clinical investigation of medical devices for human subjects
- IEC/TR 61258, Guidelines for the development and use of medical electrical equipment educational materials.
- ISO/IEC TR 25060:2010 - Systems and software engineering - Systems and software product Quality Requirements and Evaluation (SQuaRE) - Common Industry Format (CIF) for usability: General framework for usability-related information
Allegati altri Documenti d'interesse sulla usabilità dei MD:
- Linee guida usabilità DM FDA 2016
- Usabilità dispositivi medici - CCIA PD 2011
- Sviluppo metodologia valutazione delle tecnologie sicurezza pazienti - MIn Salute 2011
- ISO IEC Guide 71 2014 Guide addressing accessibility in standards - ISO 2014
- Raccomandazione n. 9 - Raccomandazione per la prevenzione degli eventi avversi conseguenti al malfunzionamento dei dispositivi medici/apparecchi elettromedicali - Min. Salute 2009
- Procedura implementazione Raccomandazione n. 9 aprile 2009 - AOL Federico II 2015
- Aspetti normativi e medico-legali usabilita DM - Bonelli, De Luca 2014
Raccomandazioni agli operatori Min Salute - Update 13 Dicembre 2018
Il Ministero della Salute, Direzione generale della programmazione sanitaria, ha elaborato, in collaborazione con esperti di Regioni e Province Autonome e altri stakeholder, le raccomandazioni elencate di seguito, ossia documenti specifici con l’obiettivo di offrire strumenti in grado di prevenire gli eventi avversi, promuovere l’assunzione di responsabilità e favorire il cambiamento di sistema.
Le raccomandazioni sono oggetto di revisione ed aggiornamento da parte dell’Ufficio 3 - Direzione generale della programmazione sanitaria, in collaborazione con Regioni e Province Autonome, Agenas, AIFA, ISS,Coordinamento delle Regioni e Province Autonome per la Sicurezza delle Cure – Sub Area Rischio Clinico, Società scientifiche e altri stakeholder.
Ultimo aggiornamento 13 dicembre 2018
CEI EN 60601-1-6:2005
INTRODUCTION
MEDICAL ELECTRICAL EQUIPMENT
This Collateral Standard describes a USABILITY ENGINEERING PROCESS, and provides guidance on how to implement and execute the PROCESS to provide MEDICAL ELECTRICAL EQUIPMENT SAFETY. It is intended to be useful not only for manufacturers of MEDICAL ELECTRICAL EQUIPMENT , but also for technical committees responsible for the preparation of particular standards.
IEC 60601-1-8:2003, Medical electrical equipment – Part 1-8: General requirements for safety – Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
ISO 14971:2000,
2.201
NOTE 1 See also Annex BBB. Examples are given in Annex
2.204
[ANSI/AAMI/HE 74:2001, definition 3.24 modified]
NOTE The ACCOMPANYING DOCUMENTS are considered part of the EQUIPMENT and the OPERATOR-EQUIPMENT INTERFACE.
[ISO/IEC Guide 51:1999, definition 3.14, modified]
2.209
NOTE 1 USE ERROR includes slips, lapses, mistakes, and REASONABLY FORESEEABLE MISUSE.
2.211
2.212
2.213
2.214
2.215
NOTE 1 The term “validated” is used to designate the corresponding status.
Variata da:
CEI EN 60601-1-6/A1:2016
Apparecchi elettromedicali Parte 1: Prescrizioni generali relative alla sicurezza fondamentale e alle prestazioni essenziali - Norma collaterale: Usabilità
Apparecchi elettromedicali Parte 1: Prescrizioni generali relative alla sicurezza fondamentale e alle prestazioni essenziali - Norma collaterale: Usabilità
CEI EN 60601-1-6/EC:2010
Apparecchi elettromedicali Parte 1: Prescrizioni generali relative alla sicurezza fondamentale e alle prestazioni essenziali - Norma collaterale: Usabilità
INTRODUCTION
Medical practice is increasingly using
MEDICAL ELECTRICAL EQUIPMENT
for observation and treatment of PATIENTS. USE ERRORS caused by inadequate MEDICAL ELECTRICAL EQUIPMENT USABILITY have become an increasing cause for concern. The USABILITY ENGINEERING PROCESS is intended to achieve reasonable USABILITY, which in turn is intended to minimisen USE ERRORS and to minimise use associated RISKS. Some, but not all, forms of incorrect use are amenable to control by the manufacturer. The USABILITY ENGINEERING PROCESS is part of the PROCESS of RISK CONTROL.
This Collateral Standard describes a USABILITY ENGINEERING PROCESS, and provides guidance on how to implement and execute the PROCESS to provide MEDICAL ELECTRICAL EQUIPMENT SAFETY. It is intended to be useful not only for manufacturers of MEDICAL ELECTRICAL EQUIPMENT , but also for technical committees responsible for the preparation of particular standards.
1.202.3 Normative references
The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
IEC 60601-1:1988, Medical electrical equipment – Part 1: General requirements for safety
Amendment 1 (1991)
IEC 60601-1:1988, Medical electrical equipment – Part 1: General requirements for safety
Amendment 1 (1991)
Amendment 2 (1995)
IEC 60601-1-8:2003, Medical electrical equipment – Part 1-8: General requirements for safety – Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
ISO 14971:2000,
Medical devices – Application of risk management to medical devices
Amendment 1 (2003)
NOTE An Index of all defined terms used in this collateral standard is found at the end of the document
2 Terminology and definitions
For the purpose of this collateral standard, the terms and definitions given in Clause 2 of IEC 60601-1:1988, as amended by the other collateral standards, Clause 3 of
ISO 14971:2000 and the following apply.
NOTE An Index of all defined terms used in this collateral standard is found at the end of the document
2.201
ABNORMAL USE
intended act or intended omission of an act by the USER or OPERATOR of EQUIPMENT as a result of conduct that is beyond any reasonable means of RISK CONTROL
by the manufacturer
NOTE 1 See also Annex BBB. Examples are given in Annex
NOTE 2 It is possible for the PATIENT to be the OPERATOR, e.g. when EQUIPMENT is used in the PATIENT’S home
NOTE 3 A BNORMAL USE is not considered REASONABLY FORESEABLE MISUSE
2.202 EFFECTIVENESS
accuracy and completeness with which OPERATORS achieve specified goals
[ISO 9241-11:1998, definition 3.2, modified]
2.203 EFFICIENCY
resources expended in relation to the accuracy and completeness with which OPERATORS achieve goals
[ISO 9241-11:1998, definition 3.3 modified]
2.204
*OPERATOR-EQUIPMENT INTERFACE means by which the OPERATOR and the EQUIPMENT communicate
[ANSI/AAMI/HE 74:2001, definition 3.24 modified]
NOTE The ACCOMPANYING DOCUMENTS are considered part of the EQUIPMENT and the OPERATOR-EQUIPMENT INTERFACE.
2.205
OPERATOR PROFILE
OPERATOR PROFILE
summary of the mental, physical and demographic traits of the intended OPERATOR population, as well as any special characteristics that can have a bearing on design decisio ns, such as occupational skills and job requirements
2.206
*PRIMARY OPERATING FUNCTION
function that involves OPERATOR interaction that is either frequently used or related to the SAFETY of the EQUIPMENT in NORMAL USE
2.207
2.207
*REASONABLY FORESEEABLE MISUSE
use by the OPERATOR in a way not intended by the manufacturer but which can result from readily predictable human behaviour
[ISO/IEC Guide 51:1999, definition 3.14, modified]
NOTE 1 REASONABLY FORESEEABLE MISUSE is an intended action.
2.208
TRAINING application-specific OPERATOR-oriented instruction or exercises required for the safe and effective use of the EQUIPMENT
2.209
USE ERROR
act or omission of an act that has a different EQUIPMENT response than intended by the manufacturer or expected by the OPERATOR
NOTE 1 USE ERROR includes slips, lapses, mistakes, and REASONABLY FORESEEABLE MISUSE.
NOTE 2 See also Annex BBB and DDD.1.3.
NOTE 3 The physiological response of the PATIENT is not considered part of USE ERROR.
2.210
USE SCENARIO
sequence of events and tasks used to specify and test the USABILITY of the EQUIPMENT
2.211
*USABILITY
Characteristic that establishes EFFECTIVENESS, EFFICIENCY and OPERATOR learnability and satisfaction
2.212
USABILITY ENGINEERING
application of knowledge about human behaviour, abilities, limitations, and other characteristics to the design of tools, machines, EQUIPMENT, devices, systems, tasks, jobs,
and environments to achieve adequate USABILITY
2.213
*USABILITY ENGINEERING FILE
set of RECORDS and other documents that are produced by USABILITY ENGINEERING activities
set of RECORDS and other documents that are produced by USABILITY ENGINEERING activities
2.214
USABILITY SPECIFICATION documentation defining the OPERATOR-EQUIPMENT INTERFACE requirements related to USABILITY
2.215
VALIDATION confirmation, through the provision of objective evidence, that the requirements for a specific intended use or application have been fulfilled
NOTE 1 The term “validated” is used to designate the corresponding status.
NOTE 2 The use conditions for VALIDATION can be real or simulated.
[ISO 9000:2000, definition 3.8.5]
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Certifico Srl - IT | Rev. 00 2019
©Copia Autorizzata Abbonati
Collegati
Usabilità e personalizzazione del Dispositivo Medico
Linea guida sull’usabilità dei dispositivi medici FDA
CEI EN 60601-1-6
CEI EN 62366-1
EN ISO 14971 Dispositivi medici: Gestione e Valutazione del rischio
Regolamento (UE) 2017/745
MDR Regolamento dispositivi medici | Reg. (UE) 2017/745
Il Regolamento Dispositivi Medici (UE) 2017/745 - (MDR)
Raccomandazioni agli operatori | Min. Salute
Linea guida sull’usabilità dei dispositivi medici FDA
CEI EN 60601-1-6
CEI EN 62366-1
EN ISO 14971 Dispositivi medici: Gestione e Valutazione del rischio
Regolamento (UE) 2017/745
MDR Regolamento dispositivi medici | Reg. (UE) 2017/745
Il Regolamento Dispositivi Medici (UE) 2017/745 - (MDR)
Raccomandazioni agli operatori | Min. Salute
Tags: Marcatura CE Abbonati Marcatura CE Regolamento Dispositivi Medici
