WHO widens medical device quality review to contraception and TB screening tools
The World Health Organization announced on 25 September that it is expanding its medical device prequalification programme to a wider range of products, including contraceptive devices and software used to help screen for tuberculosis.
The expansion transfers the prequalification of male and female condoms and intrauterine devices from the UN Population Fund to WHO. Male circumcision devices are also moving into the broader WHO medical device framework from a separate assessment process.
The programme will include computer-aided detection software that analyses digital chest X-rays to identify people who may need further TB testing. Such screening is a step toward diagnosis; a software flag alone is not a confirmed TB diagnosis.
Prequalification assesses products against quality, safety and performance standards to inform procurement and access. WHO says it is beginning an assessment wave for the added categories. The announcement does not mean that every device in those categories has already passed review or is available in every country.
