The technological innovation of the cidaltex® FFP-endo maskrdbbk
TECHNICAL LEAD TEXTILE R&D, BIOSERENITY
THE R&D PROCESS FROM DESIGN TO PRODUCTION OF THE CIDALTEX® FFP-ENDO MASK
The CIDALTEX® FFP-Endo mask was designed to meet the protection needs of practitioners performing endoscopic procedures against viruses, bacteria or more generally micro-organisms to which they may be exposed.
Firstly, the constraints imposed by the medical act were evaluated and a set of specifications allowing the good development of the mask was established including 3 main axes:
- Protect the practitioner from possible contamination. To do this, it is necessary to ensure a good seal of the mask and to avoid leaks to the outside, but also to ensure sufficient filtration to retain particles in the device.
- To develop a product that is compatible with a maximum number of endoscopes and fiberscopes on the market, making it possible to create a unique range that can be used by most practitioners
- Not to alter the practitioner’s gestures necessary for the proper conduct of the endoscopy procedure by proposing a simple, easy-to-use solution that is not restrictive for the practitioner and the patient.
To meet these specifications, each element has been carefully selected.
Firstly, the mask itself, since it is the basic element of protection for the practitioner at this stage. Since in the case of endoscopy procedures it is the wearer’s environment that we wish to protect, the mask selected is an FFP mask since it limits leakage by its close fit to most faces. The mask fits the wearer’s face perfectly and maintains the flow of air exhaled by the patient inside the device. The air exhaled through the patient’s mouth and nose then passes through the mask. In order to ensure optimal protection for both the practitioner and the patient, the filter layer used in the special endoscopy mask is an innovative filter layer that not only provides the same filtration capacity as FFP2 masks tested to EN 149, but also eliminates pathogens by reducing their presence by over 99.9%. This is the role of the CIDALTEX® technology that we have included at the heart of the structure of the special endoscopy mask. This mask has been developed in accordance with the standards for medical devices (EN 14683), respecting in particular the specifications for microbiological compatibility with the environment in which they will be used, (i.e. in hospitals and medical practices). For the protection of the patient, it also complies with splash protection tests, thus ensuring that no external element can contaminate the patient.
The second step was to adapt this CIDALTEX® mask for use in endoscopy. For this purpose, an 8 mm hole was made, judiciously placed as far away from the wearer’s nostrils as possible and at the right height for an ideal insertion of the endoscope. In order to limit leakage during the procedure, a pre-punched elastic polyurethane diaphragm is placed over the hole. The pre-formed hole allows for easy insertion of the endoscope, while the elasticity of the diaphragm allows it to fit all endoscope sizes between 3 and 5mm in diameter. When the endoscope is not inserted into the mask opening, the diaphragm is covered with a cover which provides a perfect seal and protects the practitioner by limiting leakage.
In order to facilitate the introduction of the endoscope, a handle is added on each side of the mask allowing the practitioner to maintain the mask in the desired position and thus to proceed with the intervention in the best conditions.
This was followed by an industrialization stage enabling us to produce a large number of masks in a repeatable manner. This stage also enabled us to carry out the CE marking of our FFP-Endo mask according to the standards and regulations in force for medical devices. The masks are currently manufactured in a process that includes manual steps to transform the mask into a special endoscopy mask, but we are currently working on adapting the tooling of our mask manufacturing machines to allow us to automate the manufacturing process and thus be able to respond to market demand in an efficient manner.