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FGMM Report 2020

Nov 18, 2020

Chaired by Dr. Ding Xiang, NIM

Co-chaired by Dr. Il Doh, KRISS

and Dr. Sheng-Rui Chen, CMS/ITRI

EC Liaison, Dr. Eleanor Howick, NML

Activities of FGMM in 2020

1. Survey in response to COVID-19 (FGMM & DEC)

2. Webinar on ventilators

3. Proposal for APMP COVID-19 Response Program

4. FGMM workshop 2020

5. Draft work plan 2021

1. Survey among FGMM and DEC members

Several months after COVID-19 broke out, it became a global

pandemic and it was hard to tell when it would come to an end.

➢ FGMM initiated a survey in June, 2020:

✓ To find out member’s urgent need in medical metrology

✓ To take a series of measures to support members in the fight

against COVID-19 in their economies

1. Survey among FGMM and DEC members

Different from the survey in 2019, this survey is much simpler

and focused on the members’ need in response to COVID-19:

1. Will your NMI participate the webinar of the calibration technique of

ventilators? If you do, please leave the contact information of the

participant.

2. If you think the FG should provide technical courses or training on any

medical devices besides ventilators, please list their names:

3. If you think the FG should provide calibration guidelines on any medical

devices, please list their names:

4. Could you please provide the contact details of your institute’s

nominated representative to the Medical Metrology Focus Group (name,

position and e-mail address)?

The following NMIs responded to the survey:

NBSM, NML-ITDI, NIMT, KRISS, CMS-ITRI, SNSU-BSN, NMIA, NIM

They listed the names of the medical devices of their concern, based

on which we identified a list of medical devices and ordered them by

roughly the attention-degree:

1. Ventilator

2. Patient monitor

3. Infrared thermometer

4. Infusion/syringe pump

5. Blood oximeter

6. Blood pressure monitor

7. Anesthetic machine (Anesthetic gas)

8. …

1. Survey among FGMM and DEC members

2. The webinar on ventilators

➢ The survey results provided a , MMFG planned to take a series of

measures to support the members.

➢ The webinar on ventilators:

• 22nd Sep, 2020, hosted by NIM

• Supported by TCFF

• Invited speakers from hospital, manufacturers and the ISO

committee

• Session 1: Quality Management of Ventilators (Stakeholders)

• Session 2: Metrological Technique of Ventilators (NMIs/DIs)

2. The webinar on ventilators

➢ The webinar on ventilators:

• More than 50 attendees from 14 NMIs/DIs: SNSU-BSN, CMS-ITRI,

ITC, KRISS, MSL, NBSM, NIMT, NMC A*Star, NMIA, NMISA，NML-

ITDI, NPLI, NIM, VMI.

3. Project Proposal

➢ Proposal for APMP COVID-19 Response Project

Proposal: Comparison measurement and training courses on the

ventilator tester

• Comparison

To verify existing methods for calibrating the ventilator tester;

To draft a guideline for calibrating the ventilator tester;

• Training:

To share the results and the guideline for those NMIs who plan to

establish their capability of ventilator tester;

To provide technical training on calibration of ventilator testers,

based on the guideline drafted in the comparison measurement.

3. Project Proposal

➢ Proposal for APMP COVID-19 Response Project

Proposal: Comparison measurement and training courses on the

ventilator tester

• Comparison plan

Period: Dec 2020 ~ Nov 2022

Transfer standard: a ventilator test & a test lung

Measured parameters: the tidal volume, the airway pressure, etc.

• Training plan: Online / Onsite (when possible)

• Supported by: DEC ,TCFF, NPL

• Participating NMIs/DIs

Comparison: NIM, NMIA, SNSU-BSN, CMS/ITRI, NPLI

Training: MASM, NIMT, NIS, NMIM, NMISA, NML-ITDI, NPLI,

SNSU-BSN, VMI, etc.

4. The 6th FGMM workshop 2020

Non-technical session : How NMIs Support the Medical Industry

• Focus on the quality management of medical devices and how NMIs serve the

medical industry.

• Different modes of medical metrology practice and successful cases in

coordinating with stakeholders and supporting the medical industry

• NMIs’ contribution in the fight against COVID-19

Technical session: Special Talks in Response to COVID-19

• Focus on medical devices that are widely used in the prevention and treatment

of COVID-19.

• Effective testing and calibration of medical devices helps improving medical

safety and precision of diagnosis and treatment.

• Technical introductions to calibration techniques and traceability systems

• Reference for the NMIs planning to develop their measurement capabilities

➢ Two special sessions:

4. The 6th FGMM workshop 2020

Session 1: How NMIs Support the Medical Industry

• KRISS

• NIM

Session 2: Special Talks in Response to COVID-19

• Patient Monitor

• Face mask

• Infusion pump

• Infrared thermometer & imager

• Germicidal UV Radiation

➢ Two special sessions:

• NMIA

• NMC A*STAR

4. The 6th FGMM workshop 2020

• Co-Chair Dr. Yong Tae Kim (KRISS) was succeeded by Dr. Il Doh (KRISS).

• 80 registered attendees from 17 economies.

• Delegates from EC, DEC, MEDEA

APMP Focus Group of Medical MetrologyEconomy NMI/DI Delegate Email

Australia NMIA Dr. Mark Ballico Mark.Ballico@gmail.com

China NIM (Lead NMI) Dr. Xiang Ding dingxiang@nim.ac.cn

Chinese Taipei CMS/ITRI (Support NMI) Dr. Sheng-Jui Chen SJ.Chen@itri.org.tw

Egypt NIS Dr. Rasha Sayed rasha.sayed@nis.sci.eg

Hongkong SCL Dr. CM Tsui cmtsui@itc.gov.hk

India NPLI Dr. Rajesh rajesh_csir@yahoo.com

Indonesea SNSU-BSN Ms. Renanta Hayu renanta@bsn.go.id

Japan NMIJ Dr. Yasushi Sato yss.sato@aist.go.jp

Korea KRISS (Support NMI) Dr. Il Doh il.doh@kriss.re.kr

Malasia NMIM Dr. Faridah Hussain faridah_hussain@sirim.my

Mongolia MASM Dr. Narangerel Dalaijamts narangerel@masm.gov.mn

Nepal NBSM Dr. Manish Kumar Das ermkdas@yahoo.com

New Zealand MSL (EC Liaison) Dr. Eleanor Howick eleanor.howick@measurement.govt.nz

Philipines NML-ITDI Ms. MaryNess Salazar misalazar@itdi.dost.gov.ph

Singapore NMC A STAR Dr. Chua Sze Wey chua_sze_wey@nmc.a-star.edu.sg

South Africa NMISA Dr. Brian Yalisi byalisi@nmisa.org

Thailand NIMT Mr. Tassanai Sanponpute tassanai@nimt.or.th

Thialand TISTR Ms. Nuthnapa Tripaichayonsak nuthnapa@tistr.or.th

Viet Nam VMI Dr. Nguyen Viet Thang nvthang05@gmail.com

4. The 6th FGMM workshop 2020

18 member economies (8 more economies than in 2019).

5. Draft Work Plan 2021

1. International cooperation on the ventilator

• Submission of the proposal for APMP COVID-19 Response Project

• Comparison measurement

• Cooperation with manufacturers and hospitals

2. Potential cooperation on other critical medical devices in response to COVID-19

• Patient monitor

• Cooperation with manufacturers and hospitals

3. The guideline for calibrating blood pressure monitor with new method

4. Strengthen the link with DEC and TCs

• Link with DEC on developing NMI issues

• Link with TCFF on the ventilator and the infusion pump

• Link with TCAUV on acoustic and ultrasonic medical devices…

5. Incorporate more stakeholders in case by case workshops

• standard bodies, manufacturers, hospitals, health organizations, etc.

6. Networking between member NMIs via FGMM

7. Explore the possibility of face-to-face workshop on enhancing the awareness of

metrology and coordination with stakeholders

• Calibration guideline • Technical training

• Infusion pump • Other devices

LOGO

Thank you

FGMM, APMP

Nov 18, 2020