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Dr Maria del Rosario Pérez Department of Public Health, Environmental and Social Determinants of Health Radiation Safety, Health Technology and Health Information Systems

Radiation Safety, Health Technology and Health Information ... · All the BSS requirements for medical exposures are relevant for the use of medical devices R. 34: Authorizations

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Page 1: Radiation Safety, Health Technology and Health Information ... · All the BSS requirements for medical exposures are relevant for the use of medical devices R. 34: Authorizations

Dr Maria del Rosario Pérez

Department of Public Health, Environmental and Social Determinants of Health

Radiation Safety, Health Technology and

Health Information Systems

Page 2: Radiation Safety, Health Technology and Health Information ... · All the BSS requirements for medical exposures are relevant for the use of medical devices R. 34: Authorizations

International Radiation Basic Safety Standards (BSS)

Global benchmark for radiation safety,

cosponsored by 8 international organizations.

The safety requirements in new International

BSS and in the new EURATOM BSS are

consistent.

In both- the new international and EURATOM

BSS- the safety requirements on medical

exposures have been substantially expanded

A key challenge today: to implement the new

BSS in medical uses of radiation.

Page 3: Radiation Safety, Health Technology and Health Information ... · All the BSS requirements for medical exposures are relevant for the use of medical devices R. 34: Authorizations

Bonn Call for Action

10 actions to improve radiation protection in medicine

Page 4: Radiation Safety, Health Technology and Health Information ... · All the BSS requirements for medical exposures are relevant for the use of medical devices R. 34: Authorizations

Radiation safety, health information

systems and health technology

Are the BSS and the Bonn Call for Action

relevant for those who work in the field of

health technology and medical devices?

Which are the links between universal health

coverage (UHC), access to health technology

and medical devices and radiation safety?

Is it possible to integrate radiation safety

into policies, strategies, regulations on health

technology and medical devices?

Page 5: Radiation Safety, Health Technology and Health Information ... · All the BSS requirements for medical exposures are relevant for the use of medical devices R. 34: Authorizations

All the BSS requirements for medical exposures

are relevant for the use of medical devices

R. 34: Authorizations to relevant parties to assume roles/ responsibilities

R. 35: Education, training and competence of health professionals.

R. 36: Appropriate referral, protection & safety, information to patients.

R. 37: All medical exposures shall be JUSTIFIED

R.38: Protection & safety shall be OPTIMIZED for each medical exposure

R.39: Protection of pregnant and breast-feeding patients

R.40: Release of patients after radionuclide therapy

R.41: Prevention of unintended and accidental medical exposures

R.41: Radiological reviews performed and records maintained

Page 6: Radiation Safety, Health Technology and Health Information ... · All the BSS requirements for medical exposures are relevant for the use of medical devices R. 34: Authorizations

BSS and the optimization of protection &

safety for the use of medical devices Design considerations (medical radiological equipment and software)

Operational considerations (cooperation between rad. medical practitioner,

medical physicist and rad. technologist to ensure that appropriate

equipment/ software, and appropriate techniques/parameters are used)

Particular considerations (children, research, health screening,

pregnancy, breastfeeding, high-dose procedures).

Patient dosimetry performed and documented and diagnostic reference

levels (DRLs) established and periodically reviewed

Quality assurance by, or under the supervision of a medical physicist

(acceptance of the equipment, commissioning prior use, maintenance,

installation of new software, verifications, calibrations, records, …)

Page 7: Radiation Safety, Health Technology and Health Information ... · All the BSS requirements for medical exposures are relevant for the use of medical devices R. 34: Authorizations

Implementing the Bonn Call for Action to

enhance safety and quality in the use of

health technology and medical devices

We will see now some examples of actions

and related sub-actions which have links

with health technology, medical devices

and health information systems …

Bonn Call for Action & medical devices

Page 8: Radiation Safety, Health Technology and Health Information ... · All the BSS requirements for medical exposures are relevant for the use of medical devices R. 34: Authorizations
Page 9: Radiation Safety, Health Technology and Health Information ... · All the BSS requirements for medical exposures are relevant for the use of medical devices R. 34: Authorizations
Page 10: Radiation Safety, Health Technology and Health Information ... · All the BSS requirements for medical exposures are relevant for the use of medical devices R. 34: Authorizations
Page 11: Radiation Safety, Health Technology and Health Information ... · All the BSS requirements for medical exposures are relevant for the use of medical devices R. 34: Authorizations
Page 12: Radiation Safety, Health Technology and Health Information ... · All the BSS requirements for medical exposures are relevant for the use of medical devices R. 34: Authorizations
Page 13: Radiation Safety, Health Technology and Health Information ... · All the BSS requirements for medical exposures are relevant for the use of medical devices R. 34: Authorizations

Good health services are those

which deliver safe and

effective health interventions

to those that need them,

when and where needed, with

minimum waste of resources.

Radiation safety is embedded

in the safety and quality of

health services and is

therefore linked to Universal

Health Coverage.

Good medical practice encompasses

radiation safety

Page 14: Radiation Safety, Health Technology and Health Information ... · All the BSS requirements for medical exposures are relevant for the use of medical devices R. 34: Authorizations

Thank you very much! [email protected]