STANDARDIZATION OF MEDICAL TEXTILES

1
STANDARDIZATION OF MEDICAL TEXTILES

• J.K.GUPTA, DEPUTY DIRECTOR, BIS

2
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.

3
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.

4
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

5
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

6
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.

7
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

8
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.

9
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

10
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

11
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

12
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

13
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

14
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 7581988
  Absorbent Cotton gauge, IS 8631988 Cotton
  bandage cloth and IS 143161995).

15
STANDARDISATION OF MEDICAL TEXTILES

• Requirements for Crepe Bandage
• The 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 46051981 Crepe
  Bandages)

16
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 16811998 Woollen Hospital
  Blankets, Dyed).

17
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 111631985 First-aid
  dressings).

18
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 110461984 Operating Towel).

19
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 62371971 Cotton Cloth for
  Plaster of Paris Bandages and Cur Bandages and IS
  47381993 Bandage, POP).

20
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
  128391989 Wool/Polyamide Blended Hospital
  Flannel).

21
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 7571971 Absorbent Cotton, Lint)

22
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
  108291993 X-Ray Detectable Gauze Swabs and
  Laprotomy Sponges).

23
STANDARDISATION OF MEDICAL TEXTILES

• Requirements of Sanitary Napkins
• (IS 54051980)
• 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

24
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

25
STANDARDIZATION OF MEDICAL TEXTILES

• SUBJECT 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

26
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.

27
THANK YOU
28

• FOR FURTHER QUERIES PLEASE CONTACT
• J. K. GUPTA
• DEPUTY DIRECTOR (TEXTILES)
• BUREAU OF INDIAN STANDARDS
• 9 BAHADUR SHAH ZAFAR MARG
• NEW DELHI 110002
• EMAIL textiles.bis_at_gmail.com
• PHONE 011 - 23231282