Our attention is drawn to the alarming allegations on testing of medical devices in particular condoms, gloves, needles as being unsafe for use, by an agency in the Ministry of Health appearing in one of the dailies on 18th February 2016.
The ministry has since established that the information was not accurate and has taken appropriate corrective measures and wishes to clarify that:
- The Pharmacy and Poisons Board is the agency mandated under CAP 244 to promote and protect public health by ensuring that medicines, medical devices and other health technologies are safe, efficacious and of accepted quality.
- In the promotion of responsible commerce of medical devices, herbal products, and dietary supplements, the Government via Legal Notice 192 of 2010 and Gazette no. 1879 of 21st March 2014, conferred the powers to regulate the above products to the Pharmacy and Poisons Board.
- The Board has established an elaborate drug registration system that ensures that only safe, quality and efficacious products are registered and are in place.
- All Government and clearing agencies have been instructed to ensure all medical products including medical devices locally manufactured and imported have permits from the Pharmacy and Poisons Board.
- This means that any medical device; apparatus, machine, appliance, implant, reagent, software, material or other related articles, Condoms, Surgical Gloves, Syringes and Needles intended for use by the manufacturer on human beings meet quality management standards (ISO 9001:2000, ISO 13485:1996, ISO 13485:2003), Good Manufacturing Practices (GMP) and other Certificates of compliance
- Medical products imported into the country pass through designated Points of Entry where PPB officers, along with other border control agencies, are deployed to inspect and authorize imports and exports.
- It is a requirement that all Importers/Manufacturers making an application to import or sell medical devices and supplies provide compliance documents and certifications from the country of origin and certificate of compliance from a prequalified laboratory in Kenya.
- The PPB works with various prequalified quality assurance laboratories, among them KEBS, KEMRI (IVD’s Validation), NQCL, MEDS that have capacity to test, Validate, and evaluate medical devices and give timely certification to enable further processing.
- The listing of the medical devices is on going and the ministry is advising all dealers’ in medical devices to come forward and list their products with the Board.
Because of demand and the need for timely service delivery, the PPB is now utilizing other WHO pre-qualified laboratories in the private sector to avoid unnecessary delays.
The PPB remains committed to engaging with multiple stakeholder groups to advance global solutions and minimize exposure of consumers to unsafe products.
In case of any suspicion, members of the public are advised to report to the PPB email email@example.com; firstname.lastname@example.org, email@example.com Facebook; pharmacy and poisons board, Twitter @ppbkenya, hotline O72060881
Dr. Nicholas Muraguri