Service Swiss Medtech Expo 2021

Blockchain: Empowered Quality For Medical Device

MedQuality is a project to improve the quality of medical devices and healthcare services. With the implementation of blockchain technology in the supply chain, complaint tracking, training, and maintenance, safety and quality can be increased.

We are developing a comprehensive set of modular solutions to address some of the most critical traceability needs of medical device and pharma industries

 

Basic working principle

  • A RFID identification (tag or label) is placed on the device
  • RFID contain static data and the UDI
  • UDI is coupling RFID tag and Blockchain
  • Scanning the device with will give immediate access to all public information via MQ app
  • Device information are stored on the MQ Software and validated on the blockchain to provide audit trail and tamper proof evidence
  • Additional variable information (location, temperature, position etc..) can be collected with specific customized interfaces, sensors and stored on blockchain

 

This tool can be integrated in order to be used in different environment and application field. Every business is different and has specific challenges, we work with our clients to customize the solution on the needs.

 

Example of application: Monitor Use of Device in the Hospitals/clinics

  • Reusable Device/Instrument tagged with RFID or Laser etched with QR code
  • Device will be scanned prior to use and or resterilization
  • Blockchain will mantain immutable trace
  • Hospital/small practice (eg. dentist) will be able to know which device have been used more times 
  • Mantainence could also be recorded in the system 
  • Additional information in relation to complaint or malfuntion could be recorded and analyzed in relation to lifecycle of the device

 

EUDAMED READY

We are working on our tool so it will also help you comunicate and transfer required device information directly into the European Centralized Database: EUDAMED

 

Why Blockchain can be game changing

Blockchain technology allows to store data with timestamp and keep the information safe and not changeable. The possibility to keep the same information across different nodes of the network prevents from any attempt to manipulate or change the data and keeps data safe from loss or down.

  • Safe storage of information due to network nodes redundancies
  • Immutability and unchangeable timestamp of recorded information
  • Easy share and retrieval of information
     

Focus features in scope

UDI
Unique device identification (UDI) tracked on blockchain.

Complete Device identification data and important information immediately ready (Ex. IFU, contacts, storage info, materials…)

Traceability
Our application can support in tracking medical device from manufacturing to clinics, until final disposal.

Audit Trial
Our application can be used to support company in recording Quality Control and audit trails, on private secure company database linked to blockchain. Once coupled to UDI this will help creating a device specific comprehensive historical book.

Device Mantainence
Our application can be used to alert and record device and equipment mantainence to enhance safety and quality.

Cold Chain
Our application could be integrated with device and datalogger to track temperature and assure the cold chain is preserved. This is critical for drugs and organs delivery.