09.10.2020

Point-of-use sterile filters – between infection prevention and sanitation products

Requirements and applications from the user’s perspective

Various different descriptions and information regarding point-of-use sterile filters frequently lead to misunderstandings. i3 Membrane helps to support logical guidance according to users' requirements and intended purpose of use – with the aim to ensure products can be compared more easily.

Point-of-use sterile filters, water filters capable of microbial retention, bacteria filters, faucet filters, shower filters, legionella filters, ... there are many different names for filters that have the ability to retain water-borne bacteria by using a membrane featuring a defined pore size. Just as varying is the information about the filter's lifespan, the rates of microbial retention and the flow rates. As a result, users feel more confused than supported in their decision-making. For these users, technical and hygienic requirements are the focus of their medical facility operations.

Requirements for medical facility hygiene:
• Defined, clinically proven filter application lifespan
• Reliable bacteria retention for temporary use
• No (or just few) findings of bacteria in the filtrate
• Disinfection by wiping using standard disinfectant agents
• Low height – no disturbances to clinical working processes
• Assured documentation based on serial numbers
• Proof of evidence for infection prevention

Requirements for medical facility devices:
• Sufficient flow
• Compliance with technical requirements (DVGW worksheet W270, TWIN 12 recommendations)
• Easy-to-use adapters when replacing filters
• Proof that bacteria is not flushed back into the piping system
• Documentation on a digital basis as much as possible

Main applications for point-of-use sterile filters
The application of sterile filters can be of reactive and temporary or preventive use:

1. Reactive and temporary use
For when the values of the drinking water ordinance have been exceeded, such as when legionella have been found (action values), or for decontamination of the piping system

2. Preventive use over time
For use at high-risk stations (e.g. transplant stations, oncology, neonatology) to protect patients with a weak immune system or immunosuppressed patients, also when values have not been exceeded

CE-mark of sterile filters
A reactive use for the purpose of bacteria retention does not justify a label as a medical device. We believe the use of sterile filters for infection prevention, however, should be treated differently. Products which are used in accordance with the regulations for infection protection of immunosuppressed and immunodeficient patients in high-risk stations, and which meet the requirements for medical devices, should consequently be brought to market with a label.

Conclusion
Manufacturers of point-of-use sterile filters should focus more strongly than ever on their product information documentation and user requirements, as well as the individual application of the filter. This makes it easier for clients to compare the products on the market and make the best buying decision.

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