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Case study on post-market surveillance for HIVST IVDs

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

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Case study on post-market surveillance for HIVST IVDs

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

  2. 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.

  3. 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?

  4. 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

  5. How to fill an IVD complaint form

  6. IVD complaint form cont’d

  7. 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.

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

  9. Thank you Anita Sands sandsa@who.int Safety and Vigilance Team, Essential Medicines and Health Products WHO 20, Avenue Appia1211 Geneva Switzerland • www.who.int

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