COVID-19 | Breathing Filter Efficiency Statement
19th March 2020
With the continued spread of the COVID-19, the World Health Organisation (WHO) has now classified the virus as a pandemic. As a global manufacturer and supplier of medical devices, we have received several requests for further information on our Breathing System Filter range.
Flexicare’s range of ThermoShield and VentiShield Breathing Filters protect patients and provides an effective barrier that reduces the transmission of bacteria and viruses between respiratory equipment and the environment.
Flexicare’s Breathing System Filters have been tested for Sodium Chloride filtration efficiency by an ISO 17025 accredited third party laboratory in accordance with BS EN ISO 23328:2008 – Breathing System Filters for anaesthetic and respiratory use – Part one: Salt Test method to assess filtration performance. Testing was performed in compliance with US FDA good manufacturing practice (GMP) regulations 21 CFR Parts 210, 211 and 820.
This procedure was performed to evaluate the filtration performance of BSF. The testing was performed to comply with BS EN ISO 23328-1 (2008). The BSF was tested in the unused state as removed from the packaging and after conditioning which stimulates clinical use. Conditioning of the BSF was performed by exposing the filter to one of various positions on a conditioning apparatus prior to filtration efficiency testing.
A neutralised poly-dispersed aerosol of sodium chloride (NaCl) was generated and passed through the test article. The performance of the BSF was assessed by measuring the concentration of salt particles penetrating the BSF compared to the challenge concentration entering the BSF. The filtration performance and airflow resistance of each test article were calculated.
All test method acceptance criteria were met. Further information on individual filter performance can be provided by your local Flexicare representative.