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Report on Post-Market Surveillance of Personal Protective Equipment in the Kenyan Market

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Report on Post-Market Surveillance of Personal Protective Equipment in the Kenyan Market

Surgical face masks are key tools utilized to control and prevent the spread of the novel SARS-CoV-2 (corona virus)
The quality and compliance of specifications of surgical face masks is critical in their efficacy in prevention and control of the spread of COVID 19 pandemic. In light of the above, there is need to monitor and ensure quality of products circulating in the market in order to effectively combat COVID-19 pandemic.

The objective of the activity was to assess the quality status of surgical masks circulating in the Kenyan market.

The field activity entailed collection of

samples of surgical masks. The products were sampled from healthcare facilities and other stores in both public and private sector (pharmaceutical outlets, hospitals, supermarkets, central stores and from hawkers) in the following Counties; Kirinyaga, Muranga, Nyeri, Nyandarua, Kiambu, Marsabit, Isiolo, Meru, Embu, Tharaka-Nthi, Laikipia, West Pokot, Trans- Nzoia, Baringo, Elgeyo-Marakwet, Uasin-Gishu, Kericho, Bomet, Nakuru, Nandi, Narok, Kisumu, Migori, Homabay, Siaya, Nyamira, Kisii, Bungoma, Busia, Kakamega, Vihiga, Mombasa, Kwale, Kilifi, Taita-Taveta, Makueni,

Kitui and Machakos.

A total of two hundred and thirty-six (236) samples have been collected so far. Two sets of surgical masks collected from Nyanza, Western, North and South rift regions have been subjected to laboratory analysis at the KEBS laboratory and the results have been obtained. The products were tested against the

KEBS standard

(KS 2636:2016).

The results from analysis of the first set of thirty-five samples (35) found that 33 samples (94.3%) complied with the specification for surgical masks (KS 2636:2016) on aerosolized bacterial filtration efficiency in % (min 98%). The results for the second set of samples (45) found that all the samples (100%) complied with the specification for surgical masks (KS 2636:2016) on aerosolized bacterial filtration efficiency in % (min 98%).

The first set of samples that were subjected to laboratory analysis comprised of secondary sample (N=35) that was drawn from a pool of primary sample (P=88). The second set of samples comprised of a secondary sample (N=45) which was drawn from a pool of primary sample (P=57)

Regulatory actions for products that fail to comply with specifications include removal of harmful/sub-standard products from the market and building the capacity of the manufacturers through physical visits and training on Batch Manufacturing Records (BMR) and labeling requirements in order to enhance compliance for the subsequent batches.

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PPE Report_Dec 2020.pdfDownload

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