Case study on post-market surveillance for HIVST IVDs WHO Workshop on Post-Market Surveillance Anita SANDS, Essential Medicines and Health Products 4th Global Forum on Medical Devices - 13 December 2018 www.who.int

World Health Organization 3 May, 2019 Case study HIVST has been successfully implemented in Caniambo using an “index testing” approach where PLHIV are given HIVST to offer an HIVST kit to their sexual or drug injecting partners A young man’s partner who was recently diagnosed with HIV disclosed her HIV- positive status to him and gave him a HIVST kit to test himself. He tests using the HIVST kit at home using Perfecto™ HIVST and read the result as non-reactive. After reading the information his partner brought home from the ANC centre, he decides to go with her to the clinic when she is getting her ART. While they are at the clinic waiting, he asks if he can get an HIV test. After receiving testing using national strategy and validated algorithm, he is diagnosed with HIV.

Audience participation Half of room will assume the role of the self-tester Half of room will assume the role of the testing provider at facility What would you do next to document this complaint?

How everyone should report to WHO? Document the problem or adverse event using the WHO IVD complaint form: https://www.who.int/diagnostics_laboratory/procurement/complaints/en/ Be available for follow-up with both WHO and manufacturer 4

How to fill an IVD complaint form Product details Problem details Product name Perfecto™ HIVST Number of test devices/analyzers involved 1 test device Product code abc-789 Has more than one user experienced the problem? 1 user Lot number(s) and expiry date ARKNS76 31/12/2019 Description of problem Client came for HTS after non-reactive HIVST result at home. We tested using our usual A1 (Quikeeze™ HIV RDT) and it was reactive. Additional testing showed he was HIV-positive. Client’s sexual partner was recently diagnosed HIV-positive. We have strong reason to believe Perfecto™ HIVST was false-negative

IVD complaint form cont’d Contact details Other supportive documentation Your name Anita Sands Instructions for use from affected test kit See attached Your email address sandsa@who.int Photos of tests See below

World Health Organization 3 May, 2019 Field safety notice The manufacturers of Perfecto™ HIVST contact the HIVST implementing partner for more information about how the HIVST kit was stored and how the HIV-positive diagnosis was established. Their investigation shows that there is a risk that the some devices from that lot were not labelled correctly. In the morning, HBsAg devices were manufactured and in the afternoon HIV devices were manufactured. There was potential for a mix-up. The manufacturer decides to recall the entire lot.

Audience participation Break into small groups How do you go about communicate the recall?

Thank you www.who.int Anita Sands WHO sandsa@who.int Safety and Vigilance Team, Essential Medicines and Health Products 20, Avenue Appia 1211 Geneva Switzerland www.who.int