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Our Participation

Centre of Excellence for Medical Textiles (CoE-Meditech) has been established at SITRA which is promoted by the Office of the Textile

Commissioner, Ministry of Textiles, Govt. of India. Among several of the activities pursued under the CoE umbrella like skill development,

consultancy assignments, preparation of detailed / bankable project reports for prospective entrepreneurs, one of the tasks is to publish an E-

bulletin. The prime reason for publishing the E-bulletin is to update entrepreneurs, textile technologists, industrialists and academicians about the

various activities of CoE like product development, progress in the ongoing projects and training programs.

Trainings Conducted

Newly Installed Instruments

1. Mr.A.Thayumanavan. G.M., Reliance Industries Ltd; Chennai.

2. Mr.D.Suresh, Director; SJS machinery India P ltd, Coimbatore.

3. Mr. M.C. Periwal,M.D; Periwal Hosieries, NOIDA.

4. Mr.B.Venkatesan;M.D; National Sewing Thread Co.Ltd, Chidambaram.

5. Mr.Paresh Patel, M.D.;Surgicotfab Textiles P. Ltd, Ahmedabad.

Training Programme on Warp Knitting - Medical Textiles

thJuly 12 -2013.

“Opening of Regional Office of

Indian Technical Textile

Association (ITTA)” at SIMA, thCoimbatore on 20 April 2013.

“Vocational training on textile

testing and equipment

handling” in Bharathiar

University, School of Distance

Education; Coimbatore th

on 25 March-2013.

Field Emission Scanning

Electron Microscope (FE-SEM)

Frazier Air-Permeability

Tester

Photometer

a. Training programme on “Face - mask th

Manufacturing” (April 6 -2013)

b. Training programme on “Compression th

Stockings Manufacturing” (May 4 -2013)

c. Training programme on “Narrow width - Crepe th

Bandage- Manufacturing” (May 28 -2013)

d. Training programme on “Surgical Gown thManufacturing”(June 13 -2013)

e. Training programme on “Non-Woven Fabric thManufacturing”(June 15 -2013)

Breakthrough Why?

This issue's questionWhy spun-lace non-woven is used in wound

dressings?

Your answers can be mailed to sitrameditech@gmail.com

Last issue’s question : Why melt blown nonwoven is used in the middle layer of 3-ply surgical facemask?

Answer: Surgical face masks are used to provide physical barriers to air borne bacteria, fluids, particulate material, etc,. The meltblown non-woven's are produced with microfibres of 0.1-30µm, which provide higher surface area thereby providing increased filtration efficiency. The bacterial filtration efficiency of any surgical face mask should be above 95% which can only be provided by using meltblown layer as middle layer in 3 ply facemask.

The web structure in melt blown non-woven is isotropic. As

air laid technique is used in web formation, fibres have a

random orientation in the machine direction as well as in

cross direction.

(We appreciate Prof. Rajanna L. Gotipamul of DKTE Textile & Engineering Institute, Maharashtra for the appropriate answer).

Instrument @ CoE

MOISTURE MANAGEMENT TESTER

The following tests can be carried out:

§Wetting time (sec)

§Absorption rate (%/sec)

§Maximum wetted radius (mm)

§Spreading speed (mm/sec)

§One way transport capability (R)

§Overall moisture management capability (OMMC)

International Standard applied: AATCC 195

Materials that can be tested: Wound dressings, nonwoven materials

used in healthcare and hygiene medical textile products, sportswear

and all kinds of woven and knitted fabrics.

Nanothin Coating Enables Bone Growth on PEEK Implants

The Swedish medical device company Promimic has announced that a new study demonstrates that its nanothin implant coating HAnano Surface enables the implant material PEEK to integrate with bone. PEEK is a popular implant material, but implants made of PEEK typically require a coating to facilitate bone integration.

Hanano Surface is based on nanothin coatings of the substance hydroxyapatite (HA). The coating can be used with various implant materials, including metals, ceramics and polymers, to enhance the anchoring strength and accelerate bone integration. Several in-vivo studies have demonstrated that the coating serves these purposes. Implants coated with the material are up to four times harder anchored just after four weeks of healing.

( , 2013)

New Parylene Coating Incorporates Antimicrobial Technology

Specialty Coating Systems has introduced a new parylene coating that integrates antimicrobial technology. SCS micro RESIST combines the benefits of biocompatible parylene with antimicrobial properties to eliminate harmful microorganisms on coated medical devices. Tested to JIS Z 2801, the material demonstrates greater than 5 Log reduction after 24 hours on 14 common microorganisms, including E. coli and Staphylococcus aureus. The coating technology also has been tested for long-term effectiveness against E. coli, also achieving greater than 5 Log reduction.

SCS micro RESIST technology can be applied to catheters, electro-stimulators, endotracheal tubes and other medical devices where antimicrobial properties are critical during a product's use.

Parylene conformal coatings are ultra-thin, pinhole-free polymer coatings that offer many valuable surface treatment properties, including moisture, chemical and dielectric barrier properties, thermal and UV stability, and dry-film lubricity.

http://medtechinsider.com/archives/27935

(http://medtechinsider.com/archives/31583#more-31583)

Recent Innovations in Medical Textiles Seminars Organised by CoE

PhD in Medical Textiles at CoE

“Importance of Safety Evaluation on topical applications” - by Dr. B. Dinesh Kumar Deputy Director - National Institute of Nutrition - Food and Drug Toxicology Research Centre – Hyderabad, India

ston 1 April 2013.

“Introduction to Clinical Research” one day seminar by Ms. A. Nagalakshmi - Consortium Clinical Trials P. Ltd,

ndCoimbatore on 2 April 2013.

Bharathiar University Coimbatore has granted affiliation to

Centre of Excellence - Medical Textiles - SITRA, for

carrying out Research leading to PhD degree in Medical

Textiles.

New-wristband-for-blood-pressure-monitoring

The company STBL Medical Research AG has developed a device that can be worn on the wrist and records the blood pressure continuously. The measurement is carried out by several sensors which simultaneously measure the contact pressure, pulse and blood flow on the surface of the skin in the vicinity of the wrist.

This measuring device can be used for medical purposes, for example as a precaution for high-risk patients or for treating high blood pressure, but also as a blood pressure and heart rate monitor for leisure activities and sports as

well as for monitoring fitness in high-level sports. It gives the opportunity to record blood pressure in the patient's natural environment. The patient is not limited in terms of his freedom of movement. The sensor will be cheaper than the existing 24-hour monitoring devices, such as those currently used in hospitals.

3D Printing Bone replacements, Cartilage replacements, Medical devices and more with 618 Nylon (1/3)

One of the most exciting and closely watched new uses of patient specific 3D Printed components in 618 is joint cartilage replacement. These are often more difficult than bone replacements as the part must accurately conform to an existing internal bone structure, be pliable enough

to conform to unusual mounting methods, be inherently strong to keep the joint from becoming misaligned by stress, and most important, provide a long term slippery surface to the mating surface.

http://www.innovationintextiles.com/medical-health-hygiene/new-wristband-for-blood-pressure-monitoring

http://www.3ders.org/articles/20130218-3d-printing-bone-replacements-cartilage-replacements-medical-devices-with-618-nylon.html

Current Contract Research Projects

Development of Collagen coated hernia mesh funded jointly by Ministry of Textiles and industry

partner – Cologenesis Health Care Pvt Ltd.

Development of mopping pad using non-woven and woven structure, funded jointly by Ministry

of Textiles and industry partner – Care Med

LARS (Ligament Augmentation & Reconstruction System)

Material: PTFE (PolyTetraFluroEthylene) or PET (Poly Ehtylene Terapthalate)

Application: specially manufactured artificial grafts for a number of different applications – like Artificial ligament.

Latest News

Know this Product

?New 3M Healthcare India Production Facility Will Be Online by End of Year

3M Healthcare has announced that its new manufacturing facility in Pune will be operational by the end of this year. The plant will produce primarily liquids, wound dressing products, tapes and drapes. The company inaugurated an R&D facility in Bangalore in 2012, and operates a manufacturing facility in Ranjangaon, near Pune. 3M Healthcare's business in India has recorded 20% to 25% growth for the past few years and expects to maintain those numbers going forward. Business related to Wound management and infection prevention are driving the company's growth.

?Drug-Free Medical Device Regulations Coming Soon to India

Recognising the need to effectively regulate medical devices, India's Ministry of Health and Family Welfare has proposed a new bill that would differentiate medical devices and drugs and make way for the standardisation, monitoring and regulation of medical devices.

“The bill will monitor and set standards for medical devices. When passed, it will help unify the quality of medical devices made in India. This will strengthen the domestic manufacturing industry and could make medical devices more accessible and affordable to India's population. It also will help the domestic industry gain a foothold in the global medical device market. “We still need to create a place of our own in the medical devices sector,” Joint Secretary , Ministry of MOH Shri.Panda said. He explained that the government is keen on strengthening its regulatory body—the Central Drugs Standard Control Organisation by providing more skilled manpower and improving infrastructure at its offices across the country.

For the first time in the 12th Plan, the government of India has allocated Rs.1800 crore in financial support to states and union territories to strengthen the regulatory system dedicated to medical electronics and devices. Much of this grant will be spent on hiring technically qualified employees and establishing more laboratories, training academies and diagnostic labs, and expanding capacity.

http://india.medtechinsider.com/archives/1574

http://india.medtechinsider.com/archives/1581

Featured Article

Polypropylene Nonwoven Recyclable/Disposable Hospital Curtains

Mr. TMS Mani & Mr. A. Thayumanavan

Reusable to Disposable

Concept of reusing linen/ Cotton of yester year is slowly getting eliminated and shift to single use disposable products is the norm of the day in many of the Hospitals.

Polypropylene recyclable & disposable Nonwoven Hospital curtains help the usage of such disposables greatly , owing to following benefits it offers.

· Breaks the Chain of infection,

· Ideal for single & long term continued uses in General and ICU (Intensive Care Unit)

· Effective up-to one year with Sporicidal & Flame retardant qualities

· Fitted with self- auditing & privacy label

· Tie- backs for securing curtains

· Nil laundry & maintenance cost

· 100% recyclable and Solution for OH&S (Occupational Health & safety) issues

Shift to PP Nonwoven Hospital curtains

•Reusable linen is a carrier and source of infection and proven one of the reasons for HAI (Hospital acquired infections)

•Resistant to Blood/Water coming into contact from cuts or spattering, results in exposure to pathogens•Non-linting, Burrs/loose particles will not come out from Disposable Hospital Curtains.•Resistant to flame & Infection free nature, being a barrier against microbes•Allows air and moisture to pass through for better breathing/better circulation that is resulting into comfort.•Economic aspect: Linen comes to 25 to 35 cycles, whereas disposable single use and throw Cost comes to

either equal or higher by 15% to 20% than that of linen, in case of disposables.•Time and man power are saved in maintaining the reusable curtains, as they are easy to use, hygienic and

cost effective due to elimination laundering.•Increased awareness on Hygiene among medical professionals/healthcare workers and patients.

Current Events

Panel discussion on “Opportunities and challenges in Medical textiles”

Panel discussion on “Opportunities and challenges in Medical textiles” was held after the inauguration of regional office of Indian Technical Textiles Association (ITTA) in South India Mill Association (SIMA) on 20/4/13. Eminent doctors and Industrialists took part in the discussion.

• Dr. Prakash Vasudevan, Director, SITRA started the panel discussion saying medical textiles holds Rs. 3400 crore market with a growth of 9% per annum. In US around 2 million patients are affected annually because of hospital acquired infections (HAI) which results in 99000 deaths every year. This has increased average hospital stay of the patient by 7 to 10 days. The HAI costs around $30000 per patient, $6.5billion per annum and insurance companies are no longer giving reimbursement for HAI which are deemed preventable. Hence preventing infections and cross infections are very important. The main HAI reported are catheter associated urinary tract infection, central line associated blood

stream infections, surgical site infections, multi drug resistant organism infections such as MRSA, PRSP. Insurance companies and federal agencies have made it mandatory to report these infections and it is bringing in lot of change in their approach. So now there are more professionals into infection prevention and it has become an industry in itself. One of the main reasons quoted for spread of infections are the so called soft surfaces (textiles); the textile materials used in hospitals especially privacy curtains, lab coats, cover jackets, patient gowns, uniforms, bed spreads which assist the growth of colonies of pathogenic bacteria. The problem faced is that the healthcare professionals are themselves at risk. One recent case in Coimbatore was that of the Chief of a reputed hospital who was down because of an infection

for more than 6 months. One of the reasons for spread of infections is inadequate laundering of bedspreads and uniforms whose frequency of laundering can vary from hospital to hospital. For example, a US report says that only a few of the lab coats are washed daily and frequency varies from every day to month. Hence disposables and infection resistant textiles should be bought by the hospitals to prevent such infection problems. India has no statistics of this kind which remains as threat and hospitals must come up with precautionary measures for infection prevention.

• Dr. L P Thangavelu, Chairman, Ashwin hospital, continued the discussion saying medical fraternity need a lot of inputs from textile industries and medical industries do have a huge market. Surgical gowns, implants, dressings, coats, sheets in the hospital are the part of medical industry. Affordable cost is very important in case of medical textile products. Continuous research need to be taken up for cost effective treatments. The habit of using disposables is just growing and Indian doctors use reusable products. The laparoscopy products should not be reused but the financial situation of the patient forces doctors to reuse them after sterilizing. He added that the OT gowns should be made cost effective, light weight, comfortable, only then modern development will suit Indian doctors. Medical textile material should be designed in such a way that even poor people could afford it.

Current Events

Panel discussion on “Opportunities and challenges in Medical textiles”

• Mr. Prasanth Chandran, Executive Director, Precot Meridian Ltd, has discussed on the challenges in medical textiles industry for the medium and large scale entrepreneurs. He thinks that there are three main factors which are hampering the growth and they are domestic consumption, governmental policies on manmade fibres, procedural issues while setting up the project. About domestic consumption: first point is that the consumption of disposables in India is just one tenth of the global market which is very low and it will grow as the economy grows. The base is small and the growth is good so there is a way forward. Second point is the certification and clearance to global standards. The bulk consumption in the meditech industry is disposable items like face masks, surgical gowns and nonwoven dressings. For most of these products there are no BIS standards available which results in the development of sub-standard products by the unorganized sector. A simple product like face mask has global accepted standard and this requires a three layer thermal bonded fabric for effectiveness. But all government hospitals and most of the private hospitals use a cloth i.e. a single layer mask. So there are inadequate or can say no regulations at all which makes us to

solely rely on the exported products. Relying on exports is not the only answer for India if it wants to be a pioneer in this field. India is not competitive globally due to high duty draw back and excise duty. The next problem highlighted was there are no separate funding schemes except Textile Upgradation Fund Scheme (TUFS) which creates a huge back log. Technical textiles is classified under others in TUF scheme, there must be a separate classification and funding for technical textiles. He concluded his talk saying revision in subsidies is also very important for the new global players to come in.

• Dr. G Mirudhubashini, Clinical Director, Women's centre, started her discussion saying the domestic market for Medical Textiles is huge. She only uses disposable products in her hospital. The cost is very much comparable with the hospitals using reusable products. She uses fitted mattress disposable covers for her patients and no rubber sheets is been used in her hospital which enhances the comfort of the patients. She has shifted to disposable products just because perfect laundering is impossible. India is blamed to produce antibiotic resistant organism because of too much of usage antibiotics over longer period of time. The usage of antibiotics and the infection rates has reduced in her hospital due to the usage of disposable products. She ended her discussion saying there is a huge scope for disposables today. The manufacturers should make products in a way, that ultimately what we are spending should be economical for hospitals as well as patients.

• Mr. Sreekumar Menon, Joint Managing Director, Dynamic techno medicals P Ltd, said they are the largest manufacturers of all kind of bandages including crepe bandages, compression bandages, stockings including anti embolism and varicose vein stockings, drapes, postsurgical advanced wound care products. In 1960 and 70's big

pharmacy industries emerging out of India, in 80's big IT companies emerged out of India, and in this decade we will see some Medical Textile companies emerging out of India on to the global stage. They have a sales team consisting of 400 persons who go on to 7000 hospitals per month. We sense that there is an increased awareness of using medical textile products among people due to (National Accreditation Board for Hospitals and Health care providers) NABH accreditation, major hospitals are having dedicated infection control departments with very senior people heading them. Finally there is a realization that many times the products are looked for the value they offer and not for their price. The important

challenge is the cheap imports of medical textile products from china without any quality check. TUF scheme do eliminate the startup risks for Indian manufacturers but Chinese products in the market keeps new entrepreneurs away. The import duty structure should not be in such a way that the raw materials as well as the finished products have same level of import duties. It should be beneficial for someone who imports the raw materials and manufacture it only then we can compete in the market. He concluded there is an awareness, huge demand in the market place, advanced medical dressing even compression stockings which are priced higher are finding recognition of the utility of the product.

Current Events

Panel discussion on “Opportunities and challenges in Medical textiles”

• Dr. Sundar Ramanathan, Cardiothoracic surgeon, GKNM hospital, in his talk quoted that “Quality products cannot be bought at cheaper rates”. India is an emerging country which faces constraints such as reuse of the disposable products like gloves. The implantable materials such as vascular graft requires investment of huge volume of money and also generation of money out of implants is also huge when compared with disposable like face masks, caps, gowns. Indian manufacturers provide heart patches at a rate of Rs. 3000 whereas imported patches cost between Rs.20,000 – 1,00,000. There is no extra technology involved for such a cost. Foreign implantable products are superior to those of Indian only due to FDA approval. We will welcome Indian manufacturers only when they justify their product, listen to the customer's demand and convince them with their quality for using their products. The products should not be replicated just because it is been manufactured in US. At last, caution is that just because the product is disposable, it cannot be considered good. We should also look on the waste generation and incineration.

• Mr. Sumit Marwah, COE & Director Dispoline India pvt ltd, opened his talk, saying that his company has seen 15 years and has got 1.2 billion potential customers. He said we always think of exporting our products but

we should also look at the domestic consumption which is very huge. There may not be any quality standard in India but other countries do have proper standards and we can use such standards. We need planned approach, quality, research, trained man power to stand alone in the medical textile industry. Textile industry has its own strength, it needs a different approach in medical textiles. It needs to move little away from textile industry and build its business. Infection prevention depends on policies of the hospitals and infections cannot be prevented just by using disposables. He concluded saying we are in a great country and future is also great, we will grow at an astonishing pace.

• Dr. Ramamoorthy, Emeritus professor, A R Surgery – Moderator, started his talk on Hernia mesh saying this product has got separate portfolio in multinational company and huge opportunities. The first type of mesh material used the raw material same as that of suture material which is polypropylene. For the hernia that come out after surgery, we cannot use PP mesh wherein second type of meshes are used. Second type of meshes consisting of dual surface are called composites. The outer layer will be PP but the inner layer may be made of PTFE, cellulose, omega 3 fatty acids, titanium. Emerging new technique is the third type of hernia mesh, a biological mesh made of bovine and requires R & D.

• Mr. R. Krishna Kumar, Managing Director, Cologenesis Healthcare P Ltd, said that the greatest challenge faced by entrepreneurs is the commercialization of the product. We rely on other country standards and CE certification is very costly. Government should help us in these aspects.

• Mr. Karthikumar, Director, Sivashree medittex (I) P ltd. said that “Due to high tax and duty we are unable to provide affordable product to the customers. 29% of Import duty and higher excise duty are the two major constraints for medical textile industry”.

Dr. Prakash Vasudevan summarized the discussed points. He said that he will take up the requests of the entrepreneurs to the ministry . He added that SITRA has proposed 6 standards for this year and has also testing facilities for medical textiles. He requested hospitals and entrepreneurs to use facilities.

Contact: Mr. Sakthivel Perumalsamy Head, Centre of Excellence for Medical Textiles, The South India Textile Research Association, 13/37, Avanashi Road, Coimbatore Aerodrome Post, Coimbatore - 641 014, Phone:0422-421533, 2574367-654188, Fax: 0422-4215300, 2571896 E-mail: coemed@sitra.org.in Website: http://www.sitra.org.in/ sitrameditech.org.in ã The South India Textile Research Association, Coimbatore

Testing Services offered by CoE - SITRA in Medical Textiles

Surgical Gown/Drape

Sl. no Test Parameter International Standards 1 Hydrostatic resistance AATCC 127

2 Water impact penetration test AATCC 42 3 Synthetic blood penetration resistance ASTM F1670 4 Viral penetration resistance ASTM F 1671 5 Linting ISO 9073-10 6 Water vapour transmission rate ISO 11092

7 Bursting strength IS 1966

8 Weight/square metre ASTM D 3776 & ISO 9073-1

9 Tensile strength MD & CD ASTM D 5034 & ISO 9073-18

10 Air permeability ASTM D 3737 & ISO 9073 – 15

11 Tear resistance ASTM D 5587 & ASTM D 5733

12 Seam strength ASTM D 751

Surgical Dressings

1 Fibre identification ASTM D 276

2 Threads/unit length ASTM D 3775

3 Yarn count ASTM D 1059

4 Tensile properties ASTM D 5035

5 Weight/unit area ASTM D 3776

6 Elasticity IS 14944

7 Water vapour permeability ISO 11092

8 Water soluble substances IS 3456/AATCC 97

9 Ether soluble substances IS 4390

10 Presence of fluorescence In-house

11 Absorbency IS 2369 & AATCC 79

12 Water retention capacity IS 14944