Experts in medical diagnostics are alarmed by the influx of unstandardised laboratory equipment and test-kits, which they warn pose serious risks to the general public and threaten quality healthcare delivery.
The alarm was raised by a cross-section of chief executive officers in both private and public healthcare facilities at a forum organised in Accra by Flokefama Limited, themed ‘Sustainable healthcare systems; contribution of quality laboratory diagnosis. At the event, they highlighted dangers posed by the influx of these unstandardised service centres which provide poor-quality diagnostic results.
Specifically, they mentioned that most of malaria, pregnancy and other test-kits on the market are not certified by the Food and Drugs Authority (FDA), thereby posing a serious threat to patients and the consuming public.
“The laboratory space has had standardisation, precision and quality control issues over the years. A lot of medical facilities in the country do not have quality control measures, and so often produce results that are not accurate – which has a grievous impact on health delivery because doctors depend on the outcomes of those test results to deliver treatment,” said Emmanuel Teye Kenney, Chief Executive Officer-Flokefama Ghana, a leading provider of cutting-edge medical equipment and healthcare goods.
Mr. Kenney, together with other industry players, said there has been a marked increase in the number of medical laboratory centres across the country without any proper certification and standardisation measures from the Food and Drugs Authority (FDA), Ghana Standards Authority or other relevant regulators. More disturbingly, they observed that most of them are also using low-quality point-of-care test-kits for malaria and glucose among others – which do not offer accurate results.
Touching on the recent closure of four laboratories by the regulator – Health Facilities Regulatory Agency (HeFRA) – for lack of quality standards and operation by unqualified professionals, he emphasised that beyond this certain test-tubes and self-examination products on the market lack standards.
Similarly, Chief Programme Officer-Directorate of Allied Health, Ministry of Health, Dr Ignatius A.N. Awinibuno, reiterated that indeed standardisation and laboratory certification is critical for effective healthcare delivery; especially in the area of IVD medical device automation, selection, calibration and verification for quality service.
“No method should be used without validation from the certified regulatory authority or factory of the laboratory. ISO/IEC 17025 encourages the use of methods published in international, regional or national standards; and implies that if these methods are used without deviation, then the validation requirements have been satisfied,” he said.
Need for sanity
To safeguard the public against risks of unstandardised and poor-quality medical equipment, the Flokefama CEO emphasised a need for enhanced regulation and vigilance.
He further advocated that the country urgently needs a standardisation procedure to curb the influx of point-of-care test-kits in the system.
Meanwhile, the public is advised to be conscious of what they use, always ask for FDA-certified equipment and verify personally to ensure quality is assured.
Flokefama, the licenced distribution partner of global medical research and equipment production brand Mindray, has announced that it is offering tailored sales with good deals to medical laboratories across the country. Interested facilities can opt for outright purchase at a discounted rate, payment plan and/or placement arrangement.
Mindray has on offer In-vitro Diagnostics (IVD) products such as Haematology, immuno-assay and Biochemistry diagnostic solutions.
Mindray Product Specialist, Tunde Fakoya, in a presentation mentioned that Mindray provides top-quality total IVD solutions which meet different testing needs for laboratories of all types and all levels.
“Our microbiology solutions, for instance, provide accurate bacterial identification and IVD antibiotic test reports,” he said.
Flokefama, with over 15 years of experience in medical solutions provision, also provides after-sales servicing for equipment and training staff of facilities.
