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  4. Endoscopy Filtration Case Study #2 – Improving Endoscope Reprocessing

Endoscopy Filtration Case Study #2 – Improving Endoscope Reprocessing

March 30th, 2021

Quick Disconnect and Improved Hot Water Sanitation Cycles

Overview:  A company that produces endoscope reprocessors partnered with Saint-Gobain Life Sciences to design a customized solution for their sterilizing-grade filter capsule needs.

The Application: Sterilizing filters are used within endoscope reprocessors to ensure the cleanliness of fluids that contact an endoscope as it is being cleaned.  The filters were required to be capable of removing high levels of microbial contamination and were to be changed out on a routine basis – more than one time per year. The filters also were required to be compatible with thermal sanitization cycles and to not interfere with the system’s ability to reach sanitizing temperatures quickly. This lead to unique challenges which were not met by a standard filter design.

The Challenge: Typical cartridge filters often used within endoscope reprocessors are installed within a reusable housing.  The replacement of cartridge filters requires special tools, training, and can result in spillage of liquid within the equipment. It also requires direct contact between the operator and a potentially contaminated filter and fluid.  Also, when hot water for sanitization is introduced into filters with traditional flow paths, a significant amount of time is required for the whole filter to achieve the sanitizing temperature.  This delay led to an unacceptable increase in the cycle time of the reprocessor.

The Solution: Saint-Gobain designed a solution that allows for easy filter replacement and can achieve the required temperature profile across the entire filter in a very short amount of time. The use of quick connect fittings in a linear arrangement improves ease of use for technicians who have to change the filters routinely, prevents spillage, and reduces contact with the contaminated filter cartridge and fluid.  By arranging the fittings at the top of the capsule, all liquid held up within the filter capsule remains safely inside and allows the technician to easily disengage the quick connect fittings with one hand while safely holding the filter capsule in the other hand.

To improve the speed at which the temperature within the capsule filter uniformly reaches the target sanitization temperature, a patented dip-tube was added to the inlet of the filter.  The dip-tube directs the influent fluid flow downward to more evenly distribute temperature within the capsule, rapidly achieving thermal equilibrium to the set point. This ensures the desired cycle time of the reprocessor is achieved.

An additional advantage of the Saint-Gobain solution is that the custom nature of the capsule helps to ensure the correct and approved part is installed by users of the endoscope reprocessor.  Specifically, the unique fitting configuration on this capsule is not available on typical off the shelf filters and therefore it is extremely unlikely that a user would install a non-approved replacement filter. An additional aspect to this solution enabled a space in the design for an RFID security system to be easily incorporated.  This further safeguarded only approved filters can be used with the reprocessor.

  

 

 

                                   Left. Traditional filter.                                                                                 Right. Filter with the downspout that ensures confluent stream                                                                                                                                                                                                       of liquid across full filtration media.

 

 

 

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Saint-Gobain designs, manufactures and distributes materials and solutions which are key ingredients in the wellbeing of each of us and the future of all. They can be found everywhere in our living places and our daily life: in buildings, transportation, infrastructure and in so many industrial applications.

 

Saint-Gobain Performance Plastics' group of businesses gather solutions to save energy, provide protection, improve comfort and sustain the environment for a variety of markets.

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Saint-Gobain’s medical products are distributed exclusively to medical device manufacturers for use in the manufacture, assembly or distribution of their medical devices. Saint-Gobain cannot authorize the sale of its medical products directly to device user facilities (e.g. hospitals, surgery centers, nursing home, clinics, etc.), nor directly to end users (e.g. patients, patients’ caregiver, prescribing physician, nurse, pharmacist, etc.), including distributors serving device user facilities and end users directly. In accordance with every jurisdiction globally, Saint-Gobain’s customers are responsible for determining that any medical device they manufacture and market that incorporates a Saint-Gobain’s medical product, is compliant with each country-specific medical device regulations and has received proper country-specific clearance, certification or registration authorizing the sale of this medical device.


Saint-Gobain’s medical products offer covers:
- Medical Components [21 CFR 820.3(c)], intended for processing or use in the manufacture or assembly of medical devices before the finished medical device is packaged/labeled; Medical Components are intended to be included as part of the finished, packaged, and labeled device [21CFR820.3(c)].
- Finished Devices [21CFR820.3(l)] made on behalf of medical device manufacturers [21 CFR 807.20(a)(2)] under contract-manufacturing agreement. In accordance with the United States’ jurisdiction, Saint-Gobain complies with the FDA’s requirements for contract manufacturers of finished devices.

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