Ingeniería Clínica

Presidente del capítulo: Ing. Eduardo Fernandez Sardá (eduardo.fernandez.sarda@gmail.com)

WHO Medical Devices Newsletter, June 2019

145th Session of the Executive Board, discussion on Nomenclature of medical devices:

1.1 Documents and webcast of session:

The 145th Session of the Executive Board took place at WHO headquarters, Geneva, 29 and 30 May 2019.

The agenda of the EB included discussion on Nomenclature, classification and coding of medical devices.

BACKGROUND:

You can access the WHO report on the Standardization of nomenclature that was discussed.  In it, WHO proposed that a standardized classification and nomenclature of medical devices would serve as a common language for recording and reporting medical devices across the whole health system at all levels of health care for a whole range of uses. Today, no common name is harmonized to describe the devices by  industry, regulators, procurers and final users in hospitals of by patients by all nations. WHO principles in public consultation during 2018,  can be found here.

More information on principles towards international nomenclature, classification, and coding can be found here.

EXECUTIVE BOARD SESSION:

The session was all recorded and live streaming. You are most welcome to watch and  listen the important discussion and the requests from Member States,  here,

    1. The statement by Director General is in minute 21.29-22:22 and
    2. The statements by Member States members of the Executive Board are from 1:03:47 to 2:04:25.

In the opening speech, Tedros Adhanom Ghebreyesus, WHO Director General, emphasized the importance of standardized nomenclature:

‘Developing and adapting a global standard for naming medical devices is a perfect example of WHO’s core normative standard-setting work.

Assistant Director General: “Maria Angela Simao stated: “…finally the goal is to move towards convergence and harmonization”

1.2 Actions and next steps:

As indicated by Dr Nakatani, chair of the Executive Board, WHO will proceed with an analysis,  Member State consultation and will  present a report to the next Executive Board session 146th   in January 2020″

WHO secretariat will proceed accordingly and you will hear more on this topic in future specific communications.

72th Session of the WHO World Health Assembly (WHA72)

2.1 Information:

The World Health Assembly took place in Geneva, Switzerland 20–28 May 2019.

Several topics related to medical technologies have been discussed, including:

Concerned about the high prices for medicines, vaccines, medical devices including  in vitro diagnostic tests and assistive devices, and the unequal access, the WHO member states adopted aresolution to urges the countries to publicly share information on the prices of health products, support access to costs of clinical trials (regardless of outcomes), and work collaboratively to improve the reporting of information by suppliers on registered health products.

You can read the full text of the PROPOSED resolution on Improving the transparency of markets for medicines, vaccines, and other health products.

WHA72 recognized patient safety as a global health priority and adopted the WHA Resolution on global action on patient safety, including establishment of annual #WorldPatientSafetyDay on the 17th September.

Many any of the WHA sessions have been recorded and are available to watch.

1.2 Next steps: The full text of the  resolutions will be made available in next months and WHO will disseminate .

Technical advisory group on Digital Health

WHO is establishing a global multi-disciplinary technical group to advise us on issues related to digital health.

Members of the technical advisory group will have an understanding and experience working in digital health, national or large scale digital health programs and policy, artificial intelligence and health, virtual and augmented reality in healthcare, biomedical innovation, robotic surgery, wearable technologies and health and wellness, traceability (e.g. blockchain) and health, ethics, governance and security in healthcare ecosystem with focus on digital health, health economics with focus on digital health and health law with focus on digital health technologies.

Launch of WHO Health Product Profile Directory

WHO’s new Science Division launched a free-to-use online resource to guide the development of new health products for which there are limited markets or incentives for research and development.

An essential tool for realizing universal health coverage, the Health Product Profile Directory provides a searchable database of profiles for health products needed to tackle pressing health issues in global health including those prioritized by WHO.

Building in these characteristics at an early stage of the development process is essential to ensure that the final products will be accessible to the populations that need them.

Read more about the Product Profile Directory here.  And if you have a Preferred product characteristics or target product profile, you can upload ; and you can use this directory to start the development of new technologies.

Careers at WHO

WHO Internship programme

New positions under recruitment by WHO

Technical officer P4 , work on regulations of medical devices,  in Geneva,  contract duration, one year,   apply on line, here posting open from 20 June to  11 July, 2019.  Please share with possible candidates.

Information on medical devices regulations and WHO documents can be found: https://www.who.int/medical_devices/safety/en/

Calendar of events

VIII Congreso Latinoamericano de Ingeniería Biomédica (CLAIB 2019), 2-5 October 2019, Cancun, Mexico

Phase 2 registration deadline: 31st July 2019

International Clinical Engineering and Health Technology Management Congress 2019, 21-22 October 2019, Rome, Italy

Phase 2 registration deadline: 31st August 2019

IHF 43rd World Hospital Congress 2019, 7-9 November 2019, Muscat, Oman

Early Birth registration deadline: 15th August 2019