Workshops (v.4)

Thursday 13th

Time

Ref ID

Workshop sessions - Thursday 13th December 2018

Room

W1

Vigilance on medical devices in hospitals

08:00 - 09:00

139

Global health technology regulation issues for clinical engineers

Amravati

Thomas Maxwell Judd, Mohammad Ameel, Ajai Basil, Nicolas Pallikarakis, AlmirBadnjevic, Tobey Clark

161

Adverse event notification, investigation and regulatory reporting in the United States

John Tobey Clark

173

Medical Devices post-market surveillance experiences

AlmirBadnjevic, AlmirBadnjevic,NicolasPallikarakis, Tobey Clark, Mohammad Ameel, Ajai Basil

184

Medical Devices Vigilance: Need for a global approach

Nicolas Pallikarakis

W2

 Assessment of medical devices: IFMBE HTA methods

08:00 - 09:00

142

 HTA methods for medical devices: an in-depth dialogue

Faraday

JuliePolisena, Murilo Conto, Leandro Pecchia, Oriana Ciani, NicolasPallikarakis

W22

Biomedical Engineering

8:00 -9:00

238

Achieving Sustainable Development Goals in Good Health and Well-being through BME

 Curie

 Ratko Magjarevic,  Shankar Krishnan,  GetahunMehuria,  Luis Renjifo Martinez,  Tom Judd,  Ichiro Sakuma,  Paulo de Carvalho

W4

National biomedical equipment maintenance program of India

08:00 - 09:00

201

National biomedical equipment maintenance program of India

Visakha

AnjaneyLnu, Shashi Sinha, Ameel Mohammad, Ajai Basil, AkritiTomar

W5

National free diagnostic service of India

08:00 - 09:00

202

National free diagnostic service initiative

NTR Plenary Hall

AnjaneyLnu, Yogita Kumar, Ameel Mohammad, Ajai Basil, AkritiTomar, Shashi Sinha

W7

 Methodology for the design of health technologies

08:00 - 09:00

15

Intelligent design of global heath technologies

Tesla

John Langell, Tomasz Petelenz, Shawn Fojtik, Roger Altizer

W28

Nomenclature and classification of medical devices

08:00 - 09:00

248

Towards International Harmonized Nomenclature for Medical Devices

Celsius

Adriana Velazquez Berumen, Umberto Vitale, Rebecca Baker, Laura Velez Ruiz Gaitan, Karen Kulp,  DanielDiethei

09:00-09:30

COFFEE BREAK

W8

Management of medical equipment

09:30 - 11:00

42

Technical Specifications of Medical Devices for Procurement

Celsius

Mohammad Ameel, SB Sinha, Ajai Basil, AkritiChahar, Vigneshwaran , Bharat Dahiya, Ujjwal Kumar

124

HTM best practices from‚ FundacionCardioinfantil-FCI‚ Colombian hospital,  5th latinamerican best hospital

Andrea Rocio Garcia Ibarra, Diego Heredia Osorio, 

140

Clinical engineering-health technology management global best practices

Thomas Maxwell Judd,  AlmirBadnjevic, Andrea Garcia, Yadin David, Stefano Bergamasco, Mohammad Ameel, Ashenafi Hussein

170

Role of CE in a changing healthcare. Perspectives of Mediterranean countries

Stefano Bergamasco, Paolo Lago, Nicolas Pallikarakis, AlmirBadnjevic, Mario Medvedec, LedinaPicari, Christophe Parret

175

Management of medical equipment

AlmirBadnjevic, Tom Judd, Andrea Garcia, Stefano Bergamasco, Ashenafi Hussein, Mohammad Ameel

W9

Real-World data and evidence for medical devices HTA

09:30 - 11:00

143

The use of real-world data and evidence for medical devices

Tesla

Julie Polisena, RossellaDiBidino, Dinsie Williams, Ernesto Iadanza, Carlo Federici

W10

Open-source medical devices: safety and reliability

09:30 - 11:00

18

UBORA: safety and reliability of  innovating open-source medical devices

Curie

Carmelo De Maria,  Licia Di Pietro, Arti Ahluwalia

W11-12

WHO Essential Diagnostic List: towards implementation

09:30 - 10:15

224

The essential diagnostics list‚ developments to date and plans for the future

Amravati

Lucy Anne Hattingh, Adriana Velazquez Berumen, William Sewell, Magdalena Rabini

10:15 - 11:00

225

Building access to IVD testing worldwide

Amravati

Lucy Anne Hattingh, Adriana Velazquez Berumen, William Sewell, Magdalena Rabini

W13

Tools and resources for oxygen system planning and procurement

09:30-11:00

144

Tools and resources for oxygen system planning and procurement

NTR Plenary Hall

Michael Andrew Ruffo, Beverly Bradley, MulugetaMideksa, HetaKosonen, Kathryn Geskermann, Lisa Smith

W27

Regulation medical devices

09:30-11:00

122

 South East Asia Regulatory Network (SEARN) for access to quality, safe and affordable Medical Devices and diagnostics

Faraday

Manisha Shridhar, Madhur Gupta, V. Kalaiselvan ,Ravikant Sharma, Surinder Singh

W23

Procurement  and safe use of medical imaging and radiotherapy equipment

09:30 - 11:00

 

The medical physicists’ role of embedding safety culture

Visakha

 

Sunil Dutt Sharma

 

The radiographers’ role of embedding safety culture

 

Stewart Whitley

 

Key aspects of Nuclear Medicine: from procurement to decommissioning.

 

Dong Soo Lee

 

Safety culture takes a team: multidisciplinary collaborative medical imaging outreach - victories and challenges in LMIC facilities

 

Miriam Mikhail

 

Q&As, summary and conclusions

 

Stewart Whitley

11:00-16:30

Plenary Sessions and Lunch Break

W15

 Global Clinical Engineering and IT best practices

16:30-18:00

141

ICTs in health: global CE-IT best practices

Visakha

Thomas Maxwell Judd, Elliot Sloane, Ricardo Silva, Steve Grimes, Shankar Krishnan

W16

The role of biomedical engineers in HTA

16:30-17:15

146

The  role of biomedical engineers on HTA of medical devices

Celsius

Ernesto Ladanza, Leandro Pecchia, Nicolas Pallikarakis, MuriloConto, Julie Polisena

W17

3D printing, AI and design of medical devices

17:15-18:00

187

3D printing, artificial intelligence and design of medical devices for low resource settings

Celsius

Leandro Pecchia, Ashenafi Hussein, AlmirBadnjevic, Carmelo De Maria

W18- W19

WHO guidance on procurement and post-market surveillance for IVDs

 

 

How to use WHO guidance for better procurement of in vitro diagnostics (IVDs)

Amravati

16:30-17:15

185

Anita Sands, Mercedes Perez Gonzalez

 

 

Post-market surveillance of in vitro diagnostic medical devices (IVDs) for testing providers, IVD manufacturers, and regulators of IVDs

Amravati

17:15-18:00

186

Anita Sands, Mercedes PerezGonzalez

W20

Clinical and technical roll-out of oxygen therapy

16:30-18:00

216

Clinical roll-out: oxygen therapy

NTR Plenary Hall

Martha Lauren Gartley, Adebayo Bakare

W21

Guidance on blood pressure devices

16:30-18:00

220

WHO guidance and specifics on blood pressure devices

Tesla

Marc Gregory Jaffe

W14

Technologies for cervical cancer

16:30-18:00

45

Cancer technologies for cervical cancer detection, diagnosis, monitoring and treatment in low-resource settings

Visakha

Natalie Broutet,  MarthaGartley , Cai  Long, Ying Lin

W24

Regulation of Medical Devices

16:30 -17:15

 

Comparison of European union vs USA regulatory systems for medical devices

Curie

 Rodolphe Munoz (via Webex)

W26

Metrology medical devices

17:15-18:00

246

The OIML and legal metrology - international harmonisation in the regulation of measuring instruments

Curie

Ian Ronald Dunmill

W6

WHO methodology for the selection of priority medical devices for NCDs

18:00-18:45

138

Priority medical devices for cardiovascular, stroke, diabetes, and chronic respiratory disease management

Faraday

Karen Kulp, Mar Perez, Adriana Velazquez

W25

Biomedical Engineering Capacity

18:00-18:45

240

BME Capacity Building at the Global Level

Visakha

Shankar Krishnan, Leandro Pecchia, Martha Zequera Dias, Ernesto Iadanza, Ashenafi Hussein

CM1

 African francophone countries

18:10 - 19:00

 

Follow up to 2017 Senegal workshop on medical devices ( in French)

Curie

(closed meeting)

CM2

Cervical Cancer

18:10 - 19:00

 

Technical specifications for medical devices for Cervical Cancer

Tesla

( closed meeting )

CM3

Oxygen supply systems

18:10 - 19:00

 

Oxygen systems guidance development

Celsius

( closed meeting )

 

* Please send an email to global-forum-med-dev@who.int for any changes at the earliest with the Subject "CHANGE"