To support Ukrainian producers and help increase the production of local PPE that meets appropriate quality standards, in December last year the WHO in Ukraine initiated an evaluation of Ukrainian PPE manufacturers and invited them to participate in testing their products in a European certified laboratory.
11 companies registered to participate in the project. Manufacturers had to provide relevant documents confirming the introduction into circulation in Ukraine, and accompanying documents on the quality management system of the enterprise. 4 manufacturers provided documents that did not meet the requirements, and 7 manufacturers were able to participate in the project and send samples of manufactured PPE to a European laboratory.
The WHO project helped to confirm the declared product quality of 5 Ukrainian manufacturers of medical devices and personal protective equipment. In total, out of 12 tested PPE products, 8 products were successfully tested and confirmed the compliance of the quality of their products with WHO and EU standards. Currently, manufacturers have the opportunity to use the results of these tests to confirm the quality and safety of their products both in Ukraine and to enter the European market.
WHO thanks all project participants. Manufacturers who have not received quality confirmation or have not been admitted to testing have received recommendations to improve the quality management system of the enterprise. WHO communicated the results of this assessment to the Ministry of Health and partners, and recommended that quality assurance procedures be strengthened at all stages of procurement. Adherence to the quality assurance procedure in the procurement process is mandatory to confirm the quality of PPE manufactured by a local or foreign manufacturer. An important step in this procedure is to verify the test reports for compliance with the stated standard issued by an accredited laboratory.
List of PPE that has confirmed compliance with WHO recognized standards:
1. Respirator FFP2 (manufacturer LLC “TECHNICAL FILTERING MATERIALS”) – model TFM A P2 (compliance with standards EN 149 and EN 14683 (test for resistance to splashes)
2. Respirator FFP2 (manufacturer LLC “TECHNICAL FILTERING MATERIALS”) – model TFM U P2 (compliance with standards EN 149 and EN 14683 (test for resistance to splashes)
3. Medical mask for a medical worker (manufacturer LLC “MEDICAL STREAM”) – compliance with the standard EN 14683: 2014 (type IIR)
4. Medical mask for a medical worker (manufacturer of LLC “MED PROM”) – compliance with the standard EN 14683: 2014 (type IIR)
5. Medical mask for a non-medical worker (manufacturer of LLC “MED PROM”) – compliance with standard EN 14683: 2014 (type II)
6. Medical mask for a medical worker (manufacturer of “Main Manufactory”) – compliance with standard EN 14683: 2014 (type IIR)
7. Medical mask for a non-medical worker (manufacturer of “Main Manufactory”) – compliance with standard EN 14683: 2014 (type II)
8. Overalls (manufacturer LLC “VENETO GROUP”) – compliance with standards EN 13034, EN 14126, EN 11092 *
* EN ISO 11092 (water vapor resistance of fabric) corresponds to the EU parameter m2Pa / W <30, but the WHO recommends m2Pa / W <6.