•Kebs was allegedly barred from scrutinizing equipment by Health CS Cleopa Mailu
•Mailu said inspection would be done by the Pharmacy and Poisons Board
Image: FILE
The Ministry of Health is once again on the spot following revelations that it blocked the Kenya Bureau of Standards from testing and verifying the controversial leased medical gadgets.
Kebs managing director Benjamin Njiraini told the Senate ad hoc committee investigating the Sh63 billion Managed Equipment Service (MES) programme that the agency did not test the gadgets prior to their importation.
Kebs is a state agency mandated with testing, verifying and assessing and issuing of compliance certificate prior to importation of any item into the country.
Njiraini also told the committee that the agency was barred from scrutinizing the equipment by then Health CS Cleopa Mailu.
He disclosed that Mailu, in a letter to Kebs, advised the agency to keep off the equipment as the inspection would be done by the Pharmacy and Poisons Board.
In a letter dated August 16, 2016, presented to the committee, Mailu told Kebs that the mandate to handle medical equipment importation lay with the Pharmacy and Poisons Board.
“In view of the foregoing, please note that the codes of the World Customs Organizations harmonized systems fall within the mandate of Pharmacy and Poisonous Board. All agencies under the Ministry of Health are urged to comply accordingly until further advised,” the letter reads in part.
However, when it appeared before the same committee last month, the Pharmacy and Poisons Board said they did not inspect the gadgets because they lacked both human capacity and technical knowhow to inspect, test and verify the sophisticated equipment.
“The conformity assessment was not part of our mandate at the time of procuring MES equipment. The mandate has now been brought back to us as an agency,” said Njiraini.
Legal Notice No 78 of 2005 states that Kebs shall issue a certificate of conformity in respect of goods that conform with Kenya standards or approved specifications and a non-conformity report for those that do not.
Bungoma Senator Moses Wetang'ula asked Njiraini whether Kebs had been reduced to inspection of permits alone of companies importing various goods and equipment.
“How can Kebs be reduced to only inspecting permits from companies? A minister cannot write a letter for you to suspend the law,” Wetang'ula, the committee’s vice chair, asked.
Nominated Senator Mary Seneta wondered why the officials decided to read the Legal Notice no 78 of 2005 selectively and failed to perform one of their key functions, that is to provide testing to local or imported goods and equipment.
“Why are you reading selectively the legal notice and excluding your mandate under Standards Act which mandates you to look into the safety and quality of the medical equipment?” she posed.
Njiraini told the committee that Kebs has contracted six companies, namely Messrs Bureau Veritas, Cotecna, China Certification & Inspection (Group) Inspection Co. Ltd, Intertek International, SGS and QISJ to inspect imported items and issue certificates.
The agents undertake conformity assessment activities which include inspection, sampling, testing, sealing of full load containers and issuance of certificate of conformity (COCs) in the country of origin for products and vehicles being imported into Kenya.
Meantime, the committee grilled directors of Angelica Medical Supplies, a supplier of dialysis machines in the leasing programme.
CEO Mary Matu told the committee that the installation of dialysis equipment in 47 counties and four national referral hospitals under the MES programme had played a key role in alleviating fatalities relating to renal disease.
“This growth should, however, be seen from a lifesaving lens as failure to access such services will undoubtedly lead to death for ESRD patients and all effort should be placed to expand access,” she said.