Developing a policy and procedure framework and manual for a national comprehensive implantable medical device registry in Saudi Arabia

Mowafa Househ*, Fahad Alshagathrh, Mohammad Khalifa, Khaled Al-Surimi, Simon Moll, Yassir Alsaab, Abdulrahman Alanazi, Abdulmajeed Alhamad, Mansoor Ali Baig, Jawad Afzal

*Corresponding author for this work

Research output: Chapter in Book/Report/Conference proceedingConference proceeding contribution

2 Citations (Scopus)

Abstract

Policy and procedure manuals provide guidance on the operation and governance of medical device registries. In Saudi Arabia, the Saudi Food and Drug Authority (SFDA) has been developing and implementing a comprehensive national registry for implantable medical devices to facilitate the monitoring of device outcomes through post-market surveillance studies. To help guide the operations of this registry, the SFDA developed a policy and procedure manual. This paper reports on the design of the framework used to develop that manual over the course of one year (2015-2016), using a variety of literature sources, and working with medical device registry and health systems experts. The policy and procedure manual included five key principal level categories, which led to the subsequent creation of seven policies and 28 relevant procedures. The five principal categories were: Staff Engagement, Information Governance, Quality and Auditing, Research, and Reporting. The results of this work could be used to guide the development of policies and procedures for other implantable medical device registries.

Original languageEnglish
Title of host publicationData, informatics and technology
Subtitle of host publicationan inspiration for improved healthcare
EditorsArie Hasman, Parisis Gallos, Joseph Liaskos, Mowafa S. Househ, John Mantas
Place of PublicationAmsterdam
PublisherIOS Press
Pages215-218
Number of pages4
ISBN (Electronic)9781614998808
ISBN (Print)9781614998792
DOIs
Publication statusPublished - 1 Jan 2018
Event16th International Conference on Informatics, Management, and Technology in Healthcare, ICIMTH 2018 - Athens, Greece
Duration: 6 Jul 20188 Jul 2018

Publication series

NameStudies in Health Technology and Informatics
Volume251
ISSN (Print)0926-9630
ISSN (Electronic)1879-8365

Conference

Conference16th International Conference on Informatics, Management, and Technology in Healthcare, ICIMTH 2018
CountryGreece
CityAthens
Period6/07/188/07/18

Keywords

  • Health Informatics
  • Medical Registries
  • Policy and Procedures

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    Househ, M., Alshagathrh, F., Khalifa, M., Al-Surimi, K., Moll, S., Alsaab, Y., ... Afzal, J. (2018). Developing a policy and procedure framework and manual for a national comprehensive implantable medical device registry in Saudi Arabia. In A. Hasman, P. Gallos, J. Liaskos, M. S. Househ, & J. Mantas (Eds.), Data, informatics and technology: an inspiration for improved healthcare (pp. 215-218). (Studies in Health Technology and Informatics; Vol. 251). Amsterdam: IOS Press. https://doi.org/10.3233/978-1-61499-880-8-215