WHO workshop on post-market surveillance of IVDs (for end-users) and external quality assessment schemes
World Health Organization
No invitations necessary; open to all conference registrants
Tuesday, 6 December
CTICC room location: 1.6
End-users including policy makers, national HIV programme managers, managers of laboratories and other testing services, and procurement agencies.
The lack of regulatory oversight of in vitro diagnostics (IVDs) in many countries, both for pre-market assessment and post-market activities, has widely been acknowledged as a shortcoming for assuring the safety, quality and performance of IVDs. Post-market information on IVDs empowers end-users to detect issues, and for national regulatory authorities to investigate, communicate and contain events that threaten public health security, and for authorities to take appropriate action.
- Post-market surveillance for IVDs is:
Proactive post-market surveillance through independent lot verification testing; evaluation of data from external quality assessment (EQA) schemes; and
- Reactive post-market surveillance through reporting and evaluation of complaints, including adverse events, and any required actions to correct and prevent recurrence.
End-users typically identify testing errors through reports generated by EQA schemes (also known as proficiency testing), therefore participation in EQA schemes is a critical component of assuring quality of testing. All sites providing testing services, including community-based testing, should participate in an EQA scheme that allows for end-users to be evaluated for their proficiency and secondarily for information about IVDs in use to be gathered and evaluated.
At this workshop, WHO will present normative guidance and simplified systems for post-market surveillance, including lot verification testing, use of EQAS reports, and how to document and report complaints. We will also present revised WHO guidance on how to establish and run external quality assessment schemes.
SESSION LEARNING OBJECTIVES:
- WHO requirements and guidance for post-market surveillance of in vitro diagnostics (IVDs).
- WHO guidance on external quality assessment schemes (EQAS).
Anita Sands, World Health Organization, Technical Officer
Anita Sands is responsible for post-market surveillance for in vitro diagnostics and medical devices and facilitating finalisation of prequalification decisions for the Diagnostics Assessment group of the WHO Prequalification Team. She began working for WHO in 2004, evaluating diagnostics for bloodborne serology. She provides technical support related to implementation of testing services for bloodborne viruses to WHO Member States, with a particular emphasis on resource-limited settings. Her specific areas of expertise are product selection, quality assurance and procurement. Previously, she worked as a research scientist and as a laboratory team leader at the National Serology Reference Laboratory, Australia. She has a BSc and an MPH.
Willy Urassa, World Health Organization, Scientist
A clinical immunologist, Dr Willy Urassa joined WHO in 2007. His responsibilities with the in vitro diagnostics assessment group of the WHO Prequalification Team include coordination of the laboratory evaluation of HIV, syphilis, hepatitis B, hepatitis C, Ebola serology assays and CD4 technologies. He also provides technical support on quality assurance of laboratory testing.