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ABSPIE projects

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ABSPIE and COVID

The lab is deeply involved in the Global response to the COVID-19 pandemic, in three main areas:

    • regulatory framework for PPE and medical devices
    • telemedicine for monitoring of COVID19 and to provide continuity of care to chronic patients
    • AI for early detection of pneumonia
    • Training, sharing of best practices
Supporting the WHO with PPE, medical devices and training/dissemination

Dr Pecchia is part of an international team of experts helping WHO in identifying essential COVID medical devices and preparing specifications for helping Hospitals/MoH, in particular in LMICs. You can find here the WHO tools onine

As trersaurer of the IFMBE CED, I am part of an international team which organised a series of webinars on COVID-19 and medical devices in collaboration with the WHO. The program is available here.

Support Manufacturers

We have supported manufacturers who have been willing to convert their productions and move into PPE or Medical Devices. In particular, we have supported few manufacturers navigating the regulatory framework, informing their design with relevant harmonized standards and norms.

Telemedicine, AI and IoT

The main focus of our lab is on Telemedcine, AI and IoT for health. We have several projects in this area, which are described here. The last and wider is teh GATEKEEPER project (£20mil, 500,000 patients, 8 European NHSs). Telemedicine is a key instrument to fight COVID-19.

We have supported an Italian company to adapt their platform for COVID. This is now serving 20,000+ self-isolated patients and citizens in Rome Region, which use the platform to monitor their data, and transmit those to their local NHS Trust. Further details are available here.

We have supported the Bangor Hospital (NHS north Wales Trust) in respond to the NHSx call for COVID-19. With this call, the hospital will use an App and a wearable sensor to monitor, at home, cancer patients. This will ensure them the continuity of care, while keeping them at home, minimizing hospital accesses as much as possible.

AI for pneumonia detection via symptoms

We are developing an AI system to detect pneumonia from symptoms. This is not COVID specific because data on COVID are not available yet. We are using a dataset from Bosnia (one of the LMIC I have been working with) learning how to distinguish pneumonia from bronchitis and normal influence, but we believe the work we will produce can be then adapted for COVID if/when data will become available.

COVID and LMICs

The one described above are all Global Challenges. Our activities are directly/indirectly the result of our experiences in previous EPSRC GCRF and IAA funded projects. We were considering these topics for limited resources settings (i.e., telemedicine, AI, minimum requirements, regulatory framework, heath technology assessment…) and to many extends a pandemic crisis create a situation that is, de facto, a limited resource one (not enough beds, not enough devices, not enough experiences staff…)

Here our latest publication on similitude between COVID-19 and LMICs, in regard to the limits of current international regulatory frameworks for PPE. The same probably applies to medical devices. Here the paper.

Tue 05 May 2020, 18:17 | Tags: COVID, LMIC, Regulatory Science, medical device

International working group on medical devices regulatory sciences

In May 2019, the World Health Assembly of the World Health Organization (WHO) decided to start working on a free international nomenclature of medical devices, including IVDs, for facilitating and harmonising the work of regulators, procurers, supply and user around the globe. According to the WHO, this nomenclature must be a "Public Good", not subject to copyright, freely accessible to everyone, and designed to consider the real need of healthcare professionals (e.g., nurses, clinical engineers), facilitating their daily work. For instance, WHO considered aligning the nomenclature with the International Classification of Diseases 11th Revision (ICD11). This does not seem to be the case for the 2 major international nomenclatures: GMDN, developed by the European GMDN Agency, which is widely used internationally and UMDNS, developed by ECRI.

The European Union has decide to change its official nomenclature adopting the Italian nomenclature, which will be renamed EMDN (European Medical Devices Nomenclature).

However, a lot of work remains to be done, in order to male this nomenclature accessible and universal, especially to protect users from LMICs.

In order to offer a support to WHO and to the EU Commission, the EAMBES set a working group. This presentation will offer a preliminary view of the conclusions achieved from this working group.

The University of Warwick is hosting the first meeting of this working group, which will kick-off meeting the Task force in March 2020.

Experts from 8 European Countries will join this meeting, which will result in a recommendations that will be presented to the European Parliament and to the World Health Organization (WHO).

Fri 28 Feb 2020, 12:28 | Tags: Regulatory Science, medical device