Usability and Labelling


What is usability ?  

The new Regulation, MDR, strengthens the rules regarding labelling and usability.  

Usability is the characteristic of the user interface that facilitates use and establishes effectiveness, efficiency and user satisfaction in the intended use environment. 

In parallel, usability engineering is defined as Human Factors Engineering. It is applying knowledge about human behavior, abilities, limitations, and other characteristics to the design of medical devices (including software), systems and tasks to achieve adequate usability. 

Usability have an impact on safety and performance of MD. Indeed with the right usability, some medical errors, injuries can be avoid. 

MDR :  

“Reduce, as far as possible, the risks related to the ergonomic features of the device and the environment in which the device is intended to be used (design for patient safety)” 

What is the current harmonized standard regarding usability?  

IEC 62366 

The latest standard is IEC 62366-1:2015 but the harmonized standard is IEC 62366:2007  

So the latest version may not be used for the statement of compliance 

Usability dimensions  

  • The intended use : the purpose for what the device has been designed  
  • The users : person operating or handling the medical device  
  • The use environment : the intended contest for using the device (expected worst conditions) 
  • The user interface : design define based on user requirements  

Usability engineering process  

II. Labelling : Unique Device Identifier  

UDI = DI (Device Identifier) + PI (Production Identifier) + Database  

DI : specific to a manufacturer and a device group  

PI : specific to a particular device  

Databases : Europe = EUDAMED, US = GUDID  

3 accredited agencies for assignment of UDIs according to UDI rule: 

GS1 :  Global Trade Item Number + Application Identifier 

HIBCC: Health Industry Business Communication Council  

ICCBBA: International Council for Commonality in Blood Banking Automation  

USA and EU : labelling = stickers + instruction for use  

Purpose of labelling :  

  • identify the medical device and its manufacturer 
  • communicate safety and performance-related information to the user, professional or lay, or other people as appropriate 

Prohibited to use text, names, trademarks, pictures and figurative or other signs that may mislead the user with the intended purpose of the device.  

So labelling must be verified (meet all the requirements) and validated (check with a real user, including usability). 

Author: Alix Auter Life Science Consultant, KVALITO 

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