1. 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 December 2018

2. 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.

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:
Be available for follow-up with both WHO and manufacturer 4

5. 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

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

7. 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.

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

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