STANDARDIZATION OF MEDICAL TEXTILES

J.K.GUPTA, DEPUTY DIRECTOR, BIS

INTRODUCTION

TEXTILES REPRESENT AN ABSOLUTELY IDEAL INTERFACE BETWEEN MAN AND MEDICAL TREATMENT FACILITIES

USED CLOSEST TO THE HUMAN BODY FOR ALL 24 HOURS

MEDTECH SECTOR PROBABLY OFFERS THE GREATEST SCOPE FOR DEVELOPMENT OF MOST SOPHISTICATED AND HIGH PERFORMANCE VALUE-ADDED TEXTILES FOR NICHE APPLICATIONS.

INTRODUCTION (Cond…)

WITH THE RAPID SPURT IN GROWTH OF

HEALTHCARE SECTOR IN INDIA, THE MEDICAL TEXTILE MARKET TOO IS POISED FOR A BOOM AND IS EXPECTED TO GROW ANNUALLY AT 9% AND THE MARKET SIZE OF THE SECTOR IS EXPECTED TO INCREASE TO 2263 CRORE BY 2013 FROM THE CURRENT LEVEL OF 1669 CRORE

THE MAXIMUM GROWTH IS SEEN IN HEALTHCARE TEXTILES WHICH INCLUDE SURGICAL CAPS, GOWNS, FACE MASKS, AND OTHER HOSPITAL LINEN FOLLOWED BY THE DISPOSABLE HYGIENE CATEGORY IN VIEW OF INCREASING CUSTOMER AWARENESS AND LIFESTYLE.

MAIN ISSUES OF CONCERN FOR MEDTECH IN INDIA

LACK OF AVAILABILITY OF A RANGE OF PRODUCTS

LACK OF LOCAL QUALITY PRODUCTS CHEAPER PRODUCTS FLOODING THE

MARKET LOW AWARENESS AMONG PRACTITIONERS

AND PATIENTS LACK OF SUBSTANTIAL CLINICAL DATA SUB-STANDARD PRODUCTS LACK OF REGULATION

CATEGORIES OF MEDICAL TEXTILES

DEPENDING UPON THE AREA OF APPLICATION, MEDICAL TEXTILES ARE CATEGORIZED AS UNDER:

NON-IMPLANTABLE MATERIALS IMPLANTABLE MATERIALS HEALTHCARE AND HYGIENE PRODUCTS

NON-IMPLANTABLE MATERIALS

Non-implantable materials are external to the body with or without skin contact and include wound care products such as absorbent pad; bandages, plasters, absorbent gauges, lint and wadding etc.

SPECIFIC PROPERTIES OF NON-IMPLANTABLE MATERIALS

GOOD PADDING CHARACTERISTICS NON-STICKING TO WOUND AIR PERMEABILITY VAPOUR PERMEABILITY HIGH ABSORBENCY (RATE OF

SORPTION AND SORPTIVE CAPACITY) DEMAND ABSORBENCY SOFTNESS AND PLIABILITY

IMPLANTABLE MATERIALS

The implantable textile materials are used when natural way to transplant defective body parts is not always possible and these include sutures, soft tissue implants (e.g. artificial products such as tendons, ligaments, cartilage, skin, eye contact lenses, cornea, joints, vascular grafts, heart valves, etc. Such artificial materials are required to have compatibility with the natural body systems, durability, resistance to acidic/alkaline media, functional properties related to the end use, etc.

HEALTHCARE AND HYGIENE PRODUCTS

The healthcare and hygiene products are not directly used in medical treatment but are used for healthcare and good hygiene applications and include the following:

SURGICAL CLOTHING – GOWNS, CAPS, MASKS, GLOVES, APRONS

SURGICAL COVERS – DRAPES, CLOTHES

HEALTHCARE AND HYGIENE PRODUCTS

BEDDINGS – BLANKETS, SHEETS, BED MATTRESS, PILLOW

CLOTHING GARMENTS/UNIFORMS – PROTECTIVE CLOTHING FOR BIOLOGICAL/CHEMICAL/FIRE PROTECTION, LAB COATS, OVERALLS.

INCONTINENCE DIAPER/SHEET – COVER STOCK, ABSORBENT AND OUTER LAYERS

CLOTHES/WIPES

HEALTHCARE AND HYGIENE PRODUCTS

SURGICAL HOSIERY SANITARY NAPKINS MEDICAL MATTRESS HOSPITAL LINENS – BED SHEETS, TABLE

COVERS, PILLOW COVERS, ETC. BABY/ADULT DIAPERS STERILIZATION WRAPS HEAD AND SHOE COVERS WADDINGS

SPECIFIC PROPERTIES OF HEALTHCARE AND HYGIENE PRODUCTS

HEALTHCARE TEXTILES HIGH ANTI-BACTERIAL AND VIRAL RESISTANCE AESTHETIC COLOURS SOFTNESS AND BREATHABLITY LIGHT-WEIGHT AND COMFORTABLITY HYGEINIC HIGH BACTERIAL FILTERATION CAPACITY ABRASION RESISTANCE BURSTING STRENGTH TEAR STRENGTH

STANDARDISATION OF MEDICAL TEXTILES Since the area of medical textiles involves health and

safety of the user, their standardization is of utmost importance and various performance and functional requirements are to be appropriately standardized in line with the latest technological developments at international level. In India the production and standardization of medical textiles is still at infant stage and a lot more is needed to be done by various manufacturers, technologists, R & D institutions and the government. However, the Bureau of Indian Standards, the National Standards Body of India has steadily evolved some of the common standards on medical textiles, which are discussed below:

STANDARDISATION OF MEDICAL TEXTILES Requirements for Surgical Dressings and Swabs Requirements specified include pH value of aqueous

extract for freedom from acid and alkalis, absorbency to remove puss from wound, freedom from optical brightening agent to avoid adverse impact of absorbed UV radiations from the sunlight on the affected part of the body, sufficient open construction to allow good ventilation of air, tearing strength sufficient to tear easily when needed, tensile strength for durability, moisture proof packing for prevention of infection from atmosphere and freedom from starch to avoid bacterial growth (See IS 758:1988 Absorbent Cotton gauge, IS 863:1988 Cotton bandage cloth and IS 14316:1995).

STANDARDISATION OF MEDICAL TEXTILESRequirements for Crepe BandageThe standard on crepe bandage covers

requirements such as twist and stretchability and recovery after stretch so as to provide for normal movement of body parts, chemical neutrality for resistance to acids/alkalis, breaking load for durability, etc. (See IS 4605:1981 Crepe Bandages)

STANDARDISATION OF MEDICAL TEXTILES Requirements for Hospital Blankets The various functional and performance

requirements of hospital blankets include mass per unit area for required warmth; dimensions for suitability to end use; finish for special protection such as rot proofness, fire resistance, etc.; relaxation shrinkage for dimensional stability; colour fastness to light and washing for preventing bleeding/fading of colour and staining of adjacent fabrics; pH value of aqueous extract for resistance to acids/alkalis and blend composition for warmth and aesthetics (see IS 1681:1998 Woollen Hospital Blankets, Dyed).

STANDARDISATION OF MEDICAL TEXTILES Requirements for First –Aid Dressings A first aid dressing consists of an absorbent pad

covered with an anti-stick materials fixed to a self-adhesive plaster. The pad and the adhesive margin are covered with a suitable protector. The functional and performance requirements of first-aid dressings include absence of toxic dye to prevent skin infection; shape of dressing (circular, square or rectangular) and dimensions for suitable end use; and the content of medication (70 to 130 percent) if the dressing is medicated. (See IS 11163:1985 First-aid dressings).

STANDARDISATION OF MEDICAL TEXTILES Requirements for Operating Towels The towels covered in the relevant standard is

used in operation theatres by medical staff. The important performance requirements covered in the standard include fibre composition and absorbency for soaking of liquids/water; pile density and pile height for comfort and liquid absorption; colour (opaline green or as agreed) etc. (See IS 11046:1984 Operating Towel).

STANDARDISATION OF MEDICAL TEXTILES Requirements for Cotton Cloth for Plaster of Paris

Bandages and Cut Bandages The cloth for Plaster of Paris (POP) bandages is a

woven cotton fabric dressed with starch and china clay and is used in conjunction with POP. The relevant Indian standard specifies two varieties of cotton cloth for POP bandages and cut bandages. The performance requirements covered in the standard include mass per square meter for required sett to the fabric; dimensions for suitability to end use; dressing content (20-30 percent); and ash content (7.5 percent max) etc. (See IS 6237:1971 Cotton Cloth for Plaster of Paris Bandages and Cur Bandages and IS 4738:1993 Bandage, POP).

STANDARDISATION OF MEDICAL TEXTILES Requirements for Wool/Polyamide Blended Hospital Flannel The wool/polyamide blended flannel is used in

fabrication of hospital clothing viz pyjama and shirts for the patients because of its softness, durability, warmth and lightness. The standard covers requirements for fineness of wool used in manufacture of flannel and mass per square meter for durability and comfort; breaking strength for durability; dimensions for end use suitability; relaxation shrinkage for dimensional stability; colour fastness to light, washing and dry cleaning for preventing bleeding/fading of colour and staining of adjacent fabrics; pilling resistance and blend composition for appearance/warmth; and requirements for packing of flannel to avoid attack by moths (see IS 12839:1989 Wool/Polyamide Blended Hospital Flannel).

STANDARDISATION OF MEDICAL TEXTILES Requirements for Absorbent, Non-Sterilized Cotton

Lint Absorbent lint is a plain cloth having a raised finish on

one side and is used as a medical dressing. The functional and performance requirements of absorbent lint include mass per square meter and dimensions; length of raised fibres from the surface of fabric for required absorbency; pH value of aqueous extract for freedom from acids/alkalis; water soluble matter for harmful impurities/finishes; ash content (after removal of water solubles); absorbency and freedom from optical whiteners to prevent harmful effect of ultra violet radiations from the sun.( see IS 757:1971 Absorbent Cotton, Lint)

STANDARDISATION OF MEDICAL TEXTILES Requirements of Absorbent Gauze used in X-ray

Detectable Swabs X-ray detectable gauze swabs consist of folded

absorbent gauze to which is attached a non-toxic and distinctively coloured mono or multi filament X-ray detectable member. The absorbent gauze is required to be plain or leno woven, bleached to white, clean and reasonably free from weaving defects, cotton leaf and shell. The other requirements of absorbent gauze include mass per unit area; absorbency; water soluble substances; foreign matter and fluorescence. (See IS 10829:1993 X-Ray Detectable Gauze Swabs and Laprotomy Sponges).

STANDARDISATION OF MEDICAL TEXTILESRequirements of Sanitary Napkins (IS 5405:1980)This standard specify the requirements for

sanitary napkins for external use. The important performance requirements covered in the standard include absorbency and ability to withstand pressure after adsorption, disposability and Ph value

STANDARDIZATION OF MEDICAL TEXTILES SUBJECT UNDER CONSIDERATION

SURGICAL GOANS SURGICAL DRAPES FACE MASKS BED LINEN BABY DIAPER VASCULAR GRAFTS INCONTINENCE PRODUCTS NON WOVEN GAUZE BANDAGE

STANDARDIZATION OF MEDICAL TEXTILESSUBJECT UNDER CONSIDERATION

VAPOUR PERMEABLE WATER PROOF PLASTICS WOUND DRESSING

ABSORBENT PAD ELASTICS ADHESIVE BANDAGE CELLULOSE WADDING IMPERMEABLE PLASTICS WOUND DRESSING SUTURES ABSORBENT COTTON PERFORATED FILM ABSORBENT DRESSINGS KNITTED VISCOSE PRIMARY DRESSINGS

CONCLUSIONS

CONCLUSION In most of the industrialized countries the trend in the various

sectors of textile industry indicates that use of conventional textiles has reached a static level and manufacture has become unviable in many cases. The recent focus has, therefore, been on the value-added high performance textiles including medical textiles that has the capability to meet functional demands for specific applications. With the new discoveries/inventions in both the textiles and the medicines, the textile materials have taken more important role and are on the increasing use for various medical applications. The high demand of medical textiles are now being met by changes in the structures of textile polymers and the new production technology. The prospects of medical textiles are bright in the Indian and export market especially for healthcare and hygiene textile product. However, greater emphasis needs to be given for their quality standards in view of health and safety of the users.

THANK YOU

FOR FURTHER QUERIES PLEASE CONTACT:

J. K. GUPTADEPUTY DIRECTOR (TEXTILES)BUREAU OF INDIAN STANDARDS9 BAHADUR SHAH ZAFAR MARGNEW DELHI 110002

EMAIL : textiles.bis@gmail.comPHONE : 011 - 23231282