WHO expands prequalification programme for medical devices

The World Health Organization (WHO) has expanded its prequalification programme to include more life-saving medical devices, including contraceptives and tuberculosis screening technologies, to improve access globally.

The organisation said on Friday in a statement that the expansion aimed to increase access to safe, effective and quality-assured medical devices, particularly in countries with limited regulatory capacity.

WHO said its independent, standardised assessment helped governments, donors, procurement organisations and UN agencies identify medical devices meeting international quality, safety and performance standards across various healthcare settings.

“The programme will now cover male and female condoms, intrauterine devices (IUDs), male circumcision devices and computer-aided tuberculosis detection software,” it said.

WHO said prequalification of condoms and IUDs was transferred from UNFPA, strengthening quality assurance for products supporting sexual and reproductive health, family planning and disease prevention.

“Condoms also help prevent HIV and other sexually transmitted infections, while IUDs support prevention of unintended pregnancies and informed family planning decisions.

“WHO has incorporated male circumcision devices into its broader medical device prequalification framework, supporting standardised and safe voluntary medical male circumcision services,” it said.

According to WHO, voluntary medical male circumcision can reduce men’s risk of acquiring HIV through heterosexual exposure by approximately 60 per cent, supporting broader HIV prevention efforts.

“The programme will also assess computer-aided detection software that uses digital chest X-rays and artificial intelligence to identify people requiring further tuberculosis testing,” it said.

It quoted WHO as saying the technology could support earlier tuberculosis detection and faster referral for diagnosis and treatment, particularly in countries with high tuberculosis rates.

According to WHO, Dr Sylvie Briand, WHO Chief Scientist and Assistant Director-General a.i. for Health Systems, Access and Data, said quality standards would strengthen confidence in essential medical devices.

“The expansion is particularly important as many countries face weak regulatory systems, with WHO estimating that about 70 per cent report inadequate regulation of medicines and vaccines,” it said.