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WHAT IS NONWOVEN FABRIC? |
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Nonwovens are unique engineered fabrics offering cost effective solutions for an increasingly wide variety of applications. Nonwovens are products with many different qualities. Products that you use every day, often without knowing it. Products whose outstanding qualities are frequently hidden from view. Products of a startling versatility. We are talking about a material with a fabric like structure. A material that can be combined with other materials. Nonwovens are a product for our time, created by a modern and innovative industry. |
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WHY IS NONWOVEN FABRIC PREFERRED INSTEAD OF TRADITIONAL TEXTILES? |
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The main reason is for the properties that are inherent in nonwovens. Some of these qualities are listed as follows: Breathable, Drapeable, Impermeable, Fluid Repellent, Sterilizable, Sewable, Lint-Free, Protective, Soft, Comfortable etc etc. The list goes on..... In fact, nonwovens provide a more cost effective, safer and hygienic alternative to traditional out-dated cotton re-usable textiles. Additionally, nonwovens can be treated for specific qualities such as anti-stacity, alcohol repellency, flame retardency etc. |
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WHAT ARE THE DIFFERENT TYPES OF NONWOVEN FABRICS? |
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The main types used in the medical field are Polypropylene (PP) Spunbond, Meltblown, SMS and Spunlace. The fabrics vary in their cost and in the properties/characteristics they offer.
PP Spunbond: This is the most basic, cheapest and widely used non-woven in the Indian market. We use a range of GSM's depending on the product. Our standard GSM's range from 12 - 40 Gsm in White, Medical Blue and Medical Green.
Meltblown: This fabric is known for its filtration qualities. It is used in the middle layer of our 3-ply mask and provides the bacteria filtration. The fabric we use provides a Bacteria Filtration Efficiency (BFE: See Below for Explanation) of minimum 98%.
SMS: SMS is a trilaminate nonwoven: 1 layer of meltblown nonwoven is in a sandwich between 2 layers of spunbond. The meltblown has a very high density web of fine fibers and is suitable for applications requiring filtration (of particulates, bacteria, fluids). The 2 layers of spunbond are added to provide the necessary strength resistance. The SMS is widely used for surgical gowns and all clothing requiring a high isolation.
Spunlace: This is a premier and more expensive nonwoven that is almost cotton like in touch. Spunlace is used when comfort is the most important factor. In the USA, most of the surgical gowns and caps are made from Spunlace, as the cost factor is irrelevant in relation to the comfort of the surgeon.
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WHAT IS THE PURPOSE OF A SURGICAL MASK? |
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Masks are primarily intended to protect the patient against airborne agents originating from the healthcare staff’s respiratory tract. Some masks are also intended to protect the staff against potentially contaminated fluid splashes. Additionally, a mask should allow easy breathing. |
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HOW DO I SELECT THE CORRECT SURGICAL FACE MASK? |
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The most important factors to consider when choosing a facemask are: -
- The length of the surgical procedure: The longer a surgical procedure, the more time you spend breathing in the operating theatre, the more bacteria you release into the air and the higher the risk that one of those infective agents may find its way to the surgical wound. Therefore consider selecting a high filtration mask for longer procedures. The higher the bacterial filtration efficiency (BFE), the lower the amount of infective agents that passes the filter.
- The risk of fluid splashes during the procedure. Some procedures carry the risk of potentially contaminated fluid splashes. These splashes may reach the staff close to the operating table. Staff should consider wearing a splash resistant facemask.
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WHAT IS THE CORRECT METHOD TO WEAR A FACE MASK? |
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Every surgical facemask is as good as the discipline that is maintained by the user. Facemasks should be worn completely unfolded with the tie-bands pulled tight, the top tie band to the top back of the head, and the lower band to the neck. The mask will maintain its cup-formed shape and should maintain a seal against the skin in the best possible way. The mouth and nose are ideal habitats for aerobic and anaerobic microorganisms. They can easily be spread via drops of saliva when sneezed or coughed, or while somebody is speaking. The droplets will rapidly evaporate and the resulting contaminated particles may then spread through the air and finally infect the wound. Wearing a surgical mask can capture the saliva and therefore prevent mouth and nose flora from reaching the wound. To achieve this, the surgical mask is often a multiple/3-Ply mask, with an effective filter (Meltblown) and a nose clamp. The clamp has to be adjusted to the nose, and the mask is tied around so that it fits securely. After each operation, the mask should be removed and discarded. Removing a used surgical mask might pass on disease to the hands, so they must be disinfected. This should also be done before surgical masks are put on. Facemasks should be changed immediately at any indication of fluid strike- through between surgical procedures. |
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SHOULD MASKS AND CAPS BE INDIVIDUALLY POLY PACKED? |
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Even in countries such as the United States and UK, disposable surgeon’s caps and masks are NOT individually packed in PP bags. The norm for packing is dispenser boxes of 50/100 Pcs that can be opened and closed after dispensing each mask/cap. Ultrasonically sealed masks and caps manufactured in an a/c and dust-free environment should be immediately packed from the machine into dispenser boxes and sealed. This is the most hygienic method of packing. In India there is demand for masks and caps to be individually packed in PP bags, as Doctors are often misguided that these are sterile items. No product sealed in a simple PP bag would be sterile even if sterilized. The facemask is supposed to protect the patient from infection and visa versa. Sterility has no impact on its performance, as it is the technical construction of the mask that matters. A simple 2-ply mask offers zero filtration properties, and should be used by supporting/peripheral medical staff. |
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IS HEADWEAR ALSO IMPORTANT? |
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Yes! The hair and scalp area frequently contain large numbers of microorganisms. If hair is kept still from movement then less bacteria is released. The most effective way to keep hair still is to cover it entirely with surgical headwear. Touching the hair results in contamination of the hands. A cap should be put on before hands are disinfected, and hands should always be washed and disinfected after a cap is removed and discarded. Headwear that is manufactured on ultrasonic machines is more hygienic than those traditional stitched caps that encounter manual handling. |
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ARE THERE ANY NATIONAL STANDARDS FOR SURGICAL MASKS AND CAPS |
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Unfortunately no! We are trying our level best by writing to various Government departments, including the Ministry of Health and Family Welfare, Bureau of Indian Standards etc but these things often take time and money is a country such as India. However, we have identified standards and testing required for the USA and European Union countries. Our products are periodically sent for testing, in particular Bacteria Filtration Efficiency in vitro (BFE), to ensure it is above 98%. |
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ARE YOUR PRODUCTS CE MARKED FOR THE EUROPEAN UNION? |
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YES. Our nonwoven disposable masks and caps are classified as a Class 1 Medical Device as per Annexe IX of the European Union’s Medical Devices Directive (MDD) 93/42/EEC. Our products meet the Essential Requirements (Annexe I) of the MDD. Technical files for our products have been prepared covering the description of the products, raw materials and component documents, intermediate and sub-assembly documents, final product documents, packaging and labeling documents, design verification, risk analysis, clinical data and manufacturing records. Implementation and maintenance of corrective action and vigilance procedures is a necessity of the MDD also. After which, we have prepared our EC Declaration of Conformity and through our Authorized Representative in the EU, Oria Commerce Ltd (Southampton-UK) we have registered with the UK’s Competent Authority, the Medicines and Healthcare products Regulatory Agency (MHRA). |
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WHAT ABOUT THE U.S MARKET STANDARDS? |
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In order to market surgical masks in the USA a manufacturer should conform to the general controls of the Federal Food, Drug and Cosmetic Act, including the 510 (k) Pre-Market Notification submission to the FDA and a substantial equivalence determination must be sought before marketing the device. We are currently preparing our 510 (k) package for submission via Underwriter Laboratories Inc and following the guidance for Industry and FDA staff issued by the Centre for Devices and Radiological Health. |
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WHY HAVE I RECEIVED A LOWER QUOTATION FROM ANOTHER INDIAN MANUFACTURER ? |
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It is not possible for another manufacturer to supply cheaper masks and caps with our technical construction and fabric quality, as we have the largest capacity in the Indian market at this point of time. For example, we never use less than 40 Gsm in the mask ties and our fabrics are virgin medical grade. Please be very aware and careful about purchasing cheaper alternatives as they may have a lower GSM construction and be manufactured from ‘seconds/stock lot’ material. There is always the risk of the ties snapping in the Doctors hands or the Doctor receiving an allergic reaction on the face. |
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WHY ARE CHINESE MANUFACTURERS’ PRICES CHEAPER? |
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Simple answer is raw material. As much as 70% of our direct cost is nonwoven fabric. Unfortunately good medical grade fabric is not available in India so it is imported from China, so naturally this increases our cost. Our advantage over China is quality and communication. |
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WHICH MASK WILL PROTECT ME AGAINST BIRD FLU? |
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The World Health Organisation (WHO) advises that an N95 or FFP2 type mask is used, which are American and European standards of mask respectively. This is a different type of mask (cup) to a surgical mask that we currently do not manufacture. However, the WHO recommends that should N95/FFP2 masks not be readily available then a 3-Ply surgical mask with high filtration should be used. So as an ethical manufacturer we advise you to search for N95/FFP2 masks for protection against Bird Flu, but in the event of a shortage/non-availability then please use a Thea-Tex 3-Ply surgical mask. |
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If you have any other questions regarding the company or its products, please feel free to mail us directly on contact@thea-tex.com |
Technical Information / FAQ's
