Medical Plastics Data Service Magazine November - December 2015 by Medical Plastics Data Service

Table of

Contents Vol. 23

No. 6

Nov. - Dec. 2015

22 Cover Story • Global Medical Disposables Industry Scenario And Role Of Plastics Disposable Medical Devices are a very important part of the total Medical Device Industry. For the past few years, the disposables market has been growing continuously and trends predict strong growth for the near future. Global demand for raw materials used in the production of medical disposables , the vast majority of which are plastics will increase to………. • Most Widely Used Medical Disposable Products

25 Global Trends • The Eleven Most Implanted Medical Devices In America • Fecal Incontinence Device • Lubrizol To Invest $ 15 mn In Lifesciences Business

28 Book Review • Publications Related to: Medical Devices- Regulations, Standards and Practices, Biomaterials, R&D, Sterilization, Advanced Polymers in Medicine etc.

34 Product Gallery • New Swabbable Needleless Injection Sites with Barbs • New Swabbable Needleless Injection Sites With T-Ports

35 Industry News • Medical Device Sector Delinked From Pharma • AIMED Launches UdaiMed, India’s First Industry - Academia Collaboration For Medical Devices R&D • CM Promises Land For India’s First Medical Devices Park In Gujarat • Compliments To Gujarat FDCA • Arbitary MRP Printing On Imported Medical Devices Raising Healthcare Cost

20 Did You Know? • About Failure of Endotracheal Tubes

42 Article Index • Important Articles published in the magazine from Nov. - Dec. 2014 To Nov. - Dec. 2015

38 Events • Plexpo India 2016 : 07th-11th January 2016, Gandhinagar, Gujarat • 13th National Conference And Technology Exhibition on Indian Medical Devices & Plastics Disposables / Implants Industry 2016. 12-13 February, 2016, Ahmedabad. • Plastivision Arabia 2016 : February 22-25, 2016, Sharjah. • Medical Fair India 2016 : March 11-13, 2016, Mumbai. • Medicall 2016 : 22-24 July, 2016, Chennai. • Medical Manufacturing Asia : 31st Aug. - 2nd Sep. 2016, Singapore. Nov. - Dec. 2015

Flashback September 2003 From Editor’s Desk Dear Readers, First of all we wish “A VERY HAPPY DIWALI” to all our readers. The Seminar on “MEDICAL DEVICE PACKAGING” sponsored by “MEDICAL PLASTICS DATA SERVICE” and conducted by Central Institute Of Plastics Engineering & Technology, (CIPET) on September 30, 2003 was a big success with participants from Medical Devices and Medical Packaging Industries from all over India. The Seminar was inaugurated by Shri Subodhbhai Adeshara, Commissioner, Food And Drug Control Administration , Gujarat State. Mr S P Adeshara is also a member of the Regulatory Committee constituted for preparing a draft code for approval of Medica Devices. Mr Adeshara emphasised the importance of certifications including GMP. The Seminar discussed various important issues related to Medical Device Packaging like : Regulatory Aspects, Package Specifications, Packaging Materials and Machineries, Package Sterilization Methods, Bar-Code Labeling, International Standards and Compliance, Package Validation etc. Participants also benefited from the demonstrations of packaging and testing equipments. While this issue contains some of the presentations made during the Seminar, more details are available on our web site : www.medicalplasticsindia.com. We are also proud to inform our readers that Medical Plastics Data Service has been selected as one of Biomat.net’s Top 5 sites. The Biomaterials Network (Biomat.net) periodically distinguishes selected internet sites, based on their top general quality, mainly their scientific value and suitability to internet browsing. Biomat.net is aimed at linking the biomaterials community worldwide. We thank our readers for this recognition since without their support and participation, our Magazine and web sites could not have grown to this level. CONTENTS • Cover Story Medical Device Packaging • Importance and Significance of Packaging for Medical Devices • ETO Sterilizationand Role of Packaging Materials • Global Trends US demand for sterile medical packs grows. • Industry News • Did You Know ? About Complications Related to the Use of Vascular Hemostasis Devices • Events HOSPIMedica Thailand, MEDICA 2003, ComPaMED 2003

Did You Know ? About Failure of Endotracheal Tubes

Endotracheal Tubes are checked before intubation, but still device failures have been documented due to manufacturing defects, e.g. cuff valve failure. Other complications associated with the use of re-sterilized tubes, breakage of part of the tube or obliteration of the tube lumen by a foreign body, e.g. mucous plugs have also been documented. Despite the check steps or visual inspection for physical defect, incidences of device failures are commonly encountered. Laryngoscopy was done on a 1-month-old male infant and intubation was performed using a 3-mm id endotracheal tube (ETT) under vision.The child had no significant other medical complaints. On connecting the ETT to the circuit, the chest did not expand on ventilation, neither was there any air entry on auscultation. So, laryngoscopy was done and the position of the tube was assured; still the chest did not expand on ventilation. After this, the tube was taken out and without delay another tube of 3 mm id was connected. The baby was ventilated successfully, and on checking the previous tube, it was found that the T-connector of the ETT was obliterated. On inspection, it was found that this was a manufacturing defect as the tube was new. There were no complications due to this delay of intubation. In this case, ETT had obliteration in the T-connector, which caused ventilation failure. This was a manufacturing defect as the tube was neither being reused nor was re-sterilized. Usually on inspection, the obvious defects of the tubes are discovered but the defects which are visually not very perceptible are missed. This incidence signifies the importance of reviewing equipment defects for internal auditing purpose, so that complications could be avoided, because negligence could cost a life. (Ref: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2943717/)

In a Nutshell.... “Today knowledge has power, It controls access to opportunity and advancement.”

- Peter Drucker

Nov. - Dec. 2015

EDITOR D.L.PANDYA, B.E.(Chem), M.I.E.

ASSOCIATE EDITOR Mr. Rahil Engineer, B.E. (Biomedical Eng.)

EDITORIAL ADVISORY BOARD Dr. TARANG PATEL M.B.B.S., M.Ch. (ONCO) Cancer & Reconstructive Surgeon Mr. C. BALAGOPAL Director - Enter Technologies Pvt. Ltd. Chairman - Mobilexion Technologies Pvt. Ltd. Trivandrum Dr. DILIP H. RAIKER Ph.D., M.Sc., PGDBM, AMIE (Chem.Engg.) Former Chief Manager(P), CIPET - Chennai ING LOUIS C. SUHUURMAN Formerly Sales Director COLPITT B.V., Holland Dr. A.V. RAMANI Group Sr. Vice President (R&D), The TTK Group Dr. C.S.B. NAIR Director (R&D), Peninsula Polymers Ltd Dr. BHARAT GADHAVI CEO, Medisurge Hospitals Mr. A.S. ATHALYE Arvind Athalye Technology Transfer Pvt.Ltd, Mumbai Dr. SUJOY K. GUHA B.Tech.(Hon), M.Tech., M.S., Ph.D., M.B.B.S. IIT, Kharagpur Dr. G.S. BHUVANESHWAR Director - Innovation & Edn, Trivitron Healthcare Pvt. Ltd., Chennai and Jt. Co-ordinator - Regulation, AIMED, India. Dr. J. V. Tyagi Consultant, Medical Device Certification PUBLISHED BY : Classic Computer Services B-4, Mandir Apts., Opp. P&T Colony,Jodhpur Char Rasta Ahmedabad-15, India Ph:+91 79-26740611 Fax: +91 79-26754867 E-mail: mpds00@vsnl.com Website:www.medicalplasticsindia.com Reg.No.GUJ-ENG-00446/23/ALL/TC/94 dt.3/8/94 DESIGNED AND PRINTED BY : Image Virtual Creation, Ahmedabad-58 •Ph:098795 55948 Notice: Every precaution is taken to ensure accuracy of content. However, the publishers cannot accept responsibility for the correctness of the information supplied or advertised or for any opinion expressed herein.

Nov. - Dec. 2015

Editor’s Desk

From the

Recent initiatives , announcements and actions from Government and Medical Device Industry brings to the limelight the Indian Medical Device Industry and creates hope and indicates trends in the accelerating growth potential for the Industry. Few of the major initiatives include : Delinking of Medical Device Sector From Pharma : Government has accepted longstanding demand and has agreed to delink Schedule M III from the Drug rules , which deals with medical devices, from Schedule M, which deals with drugs and pharmaceuticals. Industry still demands a separate rule book and separate regulatory authority. India’s First Industry – Academia Collaboration For Medical Devices R & D launched by “AIMED” : With an objective to catalyze “Make-In-India” program, this collaboration for Industry – Academic/Research Institutes , AIMED launched “UdaiMed”, a new sunrise forum for collaborative interface between User, Developer, Academic and Research Institutes and Industry. To take forward this objective, AIMED & UdaiMed also signed its first MoU with TiMed (Technology Business Incubator), a not-for-profit registered society promoted by Sree Chitra Tirunal Institute for Medical Sciences and Technology (SCTIMST), Thiruvananthapuram, for encouraging innovation and entrepreneurship in medical technologies through technology business incubation support. Government Review For Overpricing Of Medical Devices : There is a great concern in the Industry about arbitrary MRP labeling . The Government has asked the companies to review their pricing and submit maximum retail price (MRP) details of their products to drug price regulator NPPA. It is expected that the Government would like to take remedial measures to make the pricing of medical devices reasonable. This is likely to resulting in reducing overall healthcare cost in the country. Announcements Of Medical Device Parks By Andhra Pradesh , Maharastra and Gujarat States . More States likely to follow : The key is implementation. The Association however feels that these parks can not flourish without a coordinated National Medical Device Policy, which is said to be pending with Government for quite some time. Beyond the above initiatives, the Government has also taken steps to remove some irritants like eliminating need for NOC from Port Office by DCGI for exports of Medical Devices alongwith Pharmaceuticals. These developments are on and above the previous activities covered in our July – Aug 2015 issue including removal of duty anomalies , Materiovigilance Program to monitor safety of Medical Devices etc. As per Mr. Rajiv Nath, Forum coordinator, “AIMED”, “the Government needs to focus on 6 key issues to create an appropriate Ecosystem for enabling import substitution of 23,000 crores of imports of Medical Devices for “Make-In-India” to be realized”. It includes, “Business Viability , Consumer Protection, Buy India Policy, Foreign Direct Investment, Regulations For ensuring Patient Safety and Need for a Department of Medical Devices.

Cover Story Global Medical Disposables Industry Scenario And Role Of Plastics Disposable Medical Devices are a very important part of the total medical device industry. Medical Disposables are the devices which are meant for only single use and have to be discarded later. They are essential for carrying out any medical procedure in Hospital. For the last few years, the disposable market has been growing continuously and trends predict strong growth for the near future.Products with enhanced performance, infection prevention and efficacy are fuelling the demand of medical disposables globally.Demand for disposable devices is increasing in emerging economies, as these countries are modernizing their healthcare infrastructure.The growing presence of medical facilities in developing countries and growing geriatric population in developed countries are the major growth drivers for the global medical disposables market.

Market Segments The global medical disposables market is segmented on the basis of products, geography and in terms of end users. In terms of product categorization, the market is segmented into drug delivery disposables, respiratory disposables, products for dialysis, laboratory disposables, wound management disposables, nonwoven medical disposables, sterilization supplies, waste disposable supplies, and others, such as diagnostic disposables. The medical disposables market embraces a variety of sub-industries, comprising product areas such as cardiovascular and orthopedic devices, wound care products and disposable supplies. Geographically, this market is segmented into North America, Europe, Asia Pacific, and Rest of the World. While, in terms of end users, the market has been divided into hospitals, outpatient facilities, home healthcare facilities, and others such as emergency care, physician offices, etc. Hospitals are currently the leading sector in the global medical disposables market and are expected to soar due to the growing number of surgical procedures, emergency visits, and hospital admissions.

Global Medical Disposables Market The global medical disposables market is expected to increase 6.6 percent yearly to nearly $245 billion in 2018.The global market for disposable medical products has experienced robust growth over the past two decades, averaging 12.5% per year. The market will be dominated by the United States, China, Japan, Russia, Germany, France, Brazil, India, Italy, and the United Kingdom, who will comprise the 10 largest national markets, combining to absorb over two-thirds of the total value of global demand in 2018.The United States is the largest market for disposable medical devices closely followed by Europe and Asia. The market

in developing countries keeps growing, mainly due to economic growth; increased spending by the respective governments on healthcare and the increased purchasing power of the general public. Presently, North America holds the biggest share in the global medical disposables market ~ 35%. North America exhibited sturdy demand for all product segments of the medical disposables market. U.S. alone accounted for 70% of the market for medical disposables in North America. Asia Pacific is soon going to catch up due to increasing healthcare awareness. Other factors likely to drive the Asia Pacific medical disposables market are the rising disposable income, huge pool of aging population, and increasing expenditure by several governments on healthcare. The significant development of the emerging economies of India and China will also lead to growth of this region.

India India is one of the top 20 markets for Medical Devices in the world and is the fourth largest markets in Asia after Japan, China and South Korea. The Indian Medical Device market is significantly smaller than other overseas markets. However, macroeconomic factors suggest a huge potential for double-digit growth in the Indian Medical Device sector. Upcoming developments in the regulatory and policy framework are expected to accelerate growth of the Indian Medical Devices sector at an estimated 10-year CAGR of 14–15%. Currently, the medical devices market in India is dominated by imported products, including products manufactured using imported material, which comprises approximately 75% of the total sales.However, 60% of domestically manufactured devices are exported, with the disposables and consumables segment having the largest share. The Medical Disposable and Consumables sector in India is valued at approx. Rs. 15,000 Crore, While 45% Medical Disposables were being imported. In the Year 2014-2015 (April to Oct.), India imported Disposables and Consumables worth 2,170.12 Crore Rs., while, Exported Disposables and Consumables worth 1,723.02 Crore Rs. Indian disposable medical supplies demand is rising 14.3 percent annually. Syringes and inhalers, IV and urinary catheters, hemodialysis bloodlines, peritoneal dialysis kits, tissue sealants, biological wound dressings, Contact Lenses, Class IV garments and textiles, and blood glucose test strips are considered to be among the fastest growing products. Nov. - Dec. 2015

Cover Story The domestic companies are largely involved in manufacturing low-end products for local and international consumption. However lately, many multinational companies have established local presence in India.

infections, a global increase in inpatient and outpatient procedures, and rising worldwide sales of direct-to-consumer medical products will fuel growth in the medical disposables sector.

Plastic Resins for Medical Disposables

Among the major disposable medical supply product segments, dialysis disposables is expected to post the fastest increase in global demand based on an expanding prevalence of end-stage renal disorders and the high frequency of therapeutic requirements. Drug delivery is another fast growing application for disposable medical supplies.Prefillable and hypodermic syringes, IV catheters, urinary drainage, chronic wound management prefilled inhalers and transdermal patches are some the most widely used medical disposables in Hospitals.

The global medical plastics market is expected to reach USD 6,978.03 Million by 2020. This growth is fueled by the aging population increasing the demand for existing and new medical technologies and growing application sectors globally. Global demand for raw materials used in the production of medical disposables, the vast majority of which are plastics, will increase 5.4% annually to $14.3 billion in 2018. Plastic resins will represent nearly 73% of raw materials used in the fabrication of medical disposables at that time.North America will continue to account for the largest share—almost $5.3 billion in 2018—but the Asia-Pacific region will post the fastest rate of growth. Medical device manufacturers today demand plastics that are stronger, lighter, and more durable than ever before.Several factors are leading to growth in this market. Plastics are an ideal class of materials which cover large application areas in health and healthcare due to their lightweight, bio-compatibility, non-corrosive nature, chemical inertness, low cost and comparable densities with that of human organs. Many Medical Disposables Devices & Implants incorporate polymers, either as key components or as coating to improve the biocompatibility of other materials.Innovative solutions based on polymer technology play a significant role in facilitating diagnosis and treatment via incorporation in medical devices, implants and disposables. Polymers such as are Polyvinylchloride (PVC), Polypropylene (PP), Polysulfone (PS) and Polycarbonate (PC), LDPE (Low Density Polyethylene), HDPE (High Density Polyethylene), Ultrahigh-molecular-weight polyethylene (UHMWPE) and silicon hydrogel are used for manufacturing disposable medical devices. Some of the most commonly used medical disposable products where plastics are used as the major raw materials are Catheters, Masks, Infusion Set, Filters, Cannula, Surgical Gloves, Suction Pipe, IV Fluid Bottles, Syringes, Clamps, Packaging Films, Check Valves, Tubing Connectors and Urine and Blood Collection Bags.

Growth Factors A combination of upgrading and enforcement of infection prevention standards coupled with an expanding volume of hospital, surgical and outpatient procedures will promote overall gains in the market for medical disposables throughout the world. Growing geriatric population, health insurance coverage extension by affordable care act and prevalence of diseases are further expected to boost growth of medical disposable market. The emerging trend of disposable devices is driven by the factors like dwarfing up the effects of cross contamination and to ensure safety and accuracy.Similarly, rising concerns about health and safety of healthcare occupational and awareness about various allergies and infections are expected to drive growth of medical disposable market.Ongoing efforts to prevent hospital-acquired Nov. - Dec. 2015

Fastest Growing Segments

Other segments projected to command average or better worldwide revenue growth include incontinence goods, infusion and hypodermic devices, nonwoven products, respiratory supplies and devices, sterilization supplies, and various other offerings such as urinary catheters and accessories, first aid kits, ostomy appliances, transdermal patches, and waste disposal supplies.

Dialysis Market With more than 2.9 million patients worldwide, end-stage renal disease (ESRD) is the most prevalent form of kidney disease. It ranks as the seventh leading cause of death among globally prevalent diseases. The global hemodialysis & peritoneal dialysis market is valued at USD 69.45 Billion in 2015 and is expected to reach USD 93.83 Billion by 2020, at a CAGR of 6.2% from 2015 to 2020.

Respiratory Devices The respiratory devices market is growing at a significant rate since the last decade.The total respiratory devices market was valued to be USD 6.2 billion in 2013 and is anticipated to have a strong growth in the coming years of forecast.The global respiratory care devices market is estimated to reach USD 21.9 Billion by 2020 at a CAGR of 9.6% during the forecast period of 2015 to 2020.

Cardiology Devices The number of minimally invasive surgeries conducted increased globally from 669.5 thousand in 2005 to 805 thousand in 2014. The Global Interventional Cardiac Devices Market earned revenue of $1.49 billion in 2013 and estimates this to reach $6.93 billion in 2020. An estimated 28.9 million Indians suffer from at least one cardiovascular disease or disorder with disease prevalence tripling over the past 30 years. The overall interventional cardiology products market in India was valued $635.7 million in 2012 and is expected to grow at an estimated CAGR of 26.4%.

Conclusion For the past two decades, disposable medical supplies have been witnessing a steady growth and this growth seems to be a continuous one due to the importance of their uses in healthcare.Global sales of consumer medical disposables will expand due to the impact of evolving demographic and epidemiological patterns as well as trends encouraging the regular practice of preventive medicine and self-treatment.

Cover Story Most Widely Used Medical Disposables Products

Infusion & Transfusion • • • • • • • • • • • • • • • • • • •

Respiratory and Anasthesia

Infusion Set Blood Administration Set Blood Donor Set Blood Bags Disposable Syringe Intravenous Cannula I.V. Cannula Fixation A.V. Fistula Needle Scalp Vein Set Volume Burette Set Peritoneal Dialysis Transfusion Set Extension Tube IV Flow Regulator Three Way Stopcock Three Way Stopcock With Extention Tube Pressure Monitoring Line Luer Lock Injection Stopper Disposable Hypodermic Needle

Cardiology • • • • •

Introducer Sheath Cardiac Catheters Intravenous Catheters Central Venous Catheter Peripherally Inserted Central Catheters (PICC) • Delivery Catheters • Guide Wires

• • • • • • • • • • • • • • • • • • •

Nebulizer Mask Oxygen Mask and Tubing Nasal oxygen Catheter Twin Bore Nasal Oxygen Set Respiratory Exerciser Guedel Airways (oro pharyngeal airways) Laryngeal Airway Mask (LMA) Tracheostomy Tube Endotracheal Tube Ventury Mask Suction Catheter Catheter Mount Ventilator Breathing Circuit Breathing Filter T-Oxygenator Bain Circuit Epidural Catheter Manual Resuscitators Aerosol Therapy masks

Surgery • Closed Wound Suction Unit • Chest Drainage Catheter • Water Sealed Chest Drainage Bag • Chest Drainage kit • Chest Drainage Bottle • Trocar Catheter • Yanakaur Suction Set • Yankaur Suction Handle • Redon Drain Catheter

Urology • • • • • • • • • • • • • • •

Urine Collecting Bag Nelaton Catheter T.U.R. Set Foley Balloon Catheter Male External Catheter Gibbon’s Catheter [Male & Female] Female Catheter Rectal Catheter Uretheral Catheter Urine Leg Bag Paediatric Urine Collection Bag Urine Culture Bottel Measured Volume Urine Meter Urine Drainage Catheters Irrigation Sets

Gastroenterology • • • • • • • • •

Feeding Tube Ryle’s Tube Stomach Tube Levin’s Tube Kehr’s Tube Feeding Bag Set Colostomy Bag Colostomy Kit Umbilical Catheter

Miscellaneous • • • • • • • • • • • • • • • •

Micropipette Syringes Umbilical Cord Clamp Mucus Extractor Disposable HIV Kit Rectal Tube Corrugated Draiange Sheet Intra Costal Draianage Set Polyethylene Gloves Latex Surgical Gloves Disposable Cap Sputum Cup Urine Pot Urine Culture Bottle Insulin Syringes Dry Brush Nov. - Dec. 2015

Global Trends The Eleven Most Implanted Medical Devices In America Implanted medical devices are one of the most profitable businesses of the U.S. healthcare industry. 24/7 Wall St. has examined National Health Survey data, multiple professional physician services, peer-reviewed journals, and SEC filings to complete a list of the most frequently implanted medical devices today. While many of these are life saving, controversy swirls around several others. Many of the devices implanted are medically necessary and do their jobs extending lives and improving quality of life, the 24/7 Wall St. research shows.Some products, such as artificial knees may even be under-utilized.Others, like implantable cardiodefibrillators, may be over-utilized. What is certain in most of the cases reviewed is that the effectiveness of these devices is not as well researched or understood as their widespread use may imply. 11. Implantable Cardioverter Defibrillators Cardiac arrhythmia, or improper electric signaling in the heart, occurs in millions of people a year. While the vast majority are benign, a select few — usually in patients with a history of heart attack or heart failure — can be fatal if not treated promptly. Implantable c a r d i o v e r t e r defibrillators (ICDs) are devices that monitor and treat these rhythms when they are detected by sending a large jolt of electricity to the heart, and basically pressing the reset button.Newer models can also function as pacemakers, combining two devices into one. Complications of ICDs are similar to their pacemaker siblings: 1%2% rates of infection and up to a 4% rate of lead failure. While these devices are major life-saving technology, the U.S. Department of Justice has been investigating the industry due to the widespread practice of implanting the devices too soon after a major cardiac event. 10. Artificial Hips As people age and gain weight the wear and tear on their joints builds up. In particular, more than 20 million Americans suffer from degenerative osteoarthritis, which is the leading cause of chronic disability in the U.S. As one of three major weight bearing joints in the leg (the others being knees and ankles), hips are put under a lot of stress over a lifetime. This stress commonly leads to the wearing down of cartilage and the painful friction of bone rubbing against bone. Hip replacement can lead to a decrease in pain and an increase in mobility in over 90% of recipients..But when friction or a faulty manufacturing process wears down the replaced joint at a faster rate than anticipated, replacement of the hip can be

Nov. - Dec. 2015

necessary earlier than expected.These failures, in addition to requiring a new hip replacement, can leave behind fragments that can become focal points for infections, cause nerve and vessel damage, and possibly even lead to death. 9. Heart Pacemakers As with ICDs, pacemakers are used to treat abnormal rhythms in the heart. While ICDs treat otherwise fatal rhythms, pacemakers are used when the heart’s internal clock is not maintaining a fast enough pace. Pacemakers override the aberrant signals in the heart by passing small jolts of electricity to multiple parts of the heart muscle, providing its own rhythm.Modern pacemakers will increase with exercise and decrease with rest to meet the body’s minute to minute needs. Complications of the surgery include a 1%-2% rate of either shortor long-term infection and, more importantly, up to a 4% rate of lead malfunction. 8. Breast Implants Breast augmentation with implants is the most frequently performed plastic surgery procedure in the U.S., beating out nose jobs, eyelid surgery, and liposuction by a significant margin. Due to the increased public criticism, the FDA has since closely monitored breast implants in the U.S. 7. Spine Screws, Rods, and Artificial Discs (Spinal Fusion Hardware) Spinal fusion surgeries are performed for a variety of back problems, mainly for pain and weakness. The surgery essentially fuses two or more vertebrae with the help of hardware such as screws and rods. An alternative in a number of these cases and a simpler procedure overall, decompressive surgery removes part of the bone to free a trapped nerve. Patients of these fusion surgeries are most likely to have the least amount of benefit. 6. IUDs (Intra-Uterine Devices) IUDs are extremely popular worldwide and are the preferred method of contraception for almost 25% of women in the rest of the developed world. The most serious complications associated with the devices today are uterine perforation, which occurs in

Global Trends 0.1% of patients, and pelvic inflammatory disease (PID), which occurs in 0.2% to 0.9% of patients. Two forms of IUDs are available in the U.S., with an approximately even split of market share: Paragard, a generic copper-coated IUD offered by Teva Pharmaceutical Industries Ltd; and Mirena, a progesterone-releasing IUD offered by Bayer HealthCare. 5. Metal Screws, Pins, Plates, and Rods (Traumatic Fracture Repair) Bone fractures are one of the most common injuries, occurring in all age groups for a multitude of reasons. Of over one million fractures that are admitted to the hospital every year, roughly half require surgical intervention to realign and stabilize the bone, a procedure called open reduction and internal fixation. This procedure occurs on almost every bone in the body, from tiny carpals in the wrist secured with plates no more than half an inch long, to femurs (the largest bone in the body) requiring foot-long rods, screws and pins to hold the bone together. While the techniques and implants needed to perform these surgeries on the different sites of the body vary widely, the provider of those implant materials usually does not. 4. Artificial Knees As the other major, replaceable weight bearing joints in the leg, knees frequently wear down faster and in a more disabling fashion than other joints. The constant friction and shifting of weight in the joint leads to a breakdown of cartilage and bone, making knees the most frequently replaced joint in the body. Over 90% of total knee replacements lead to a reduction or elimination of pain and an increase in mobility. Over the long-term, there is a 10% failure rate (need for re-replacement) after 10 years, and a 20% failure rate after 20 years. 3. Coronary Stents

Coronary stents are small tubes, usually coated with a drug (drug-eluting stents), that are placed into the arteries that supply blood to the heart. Stents are regularly implanted into patients with unstable angina (unpredictable chest pain) and recent heart attack patients whose coronary arteries have been partially blocked by atherosclerotic lesions (cholesterol). Complications from stents include stent thrombosis (clots), stent fracture, and re-occlusion (blood-vessel blockage). However, the risks of these complications are hard to quantify when overall decrease in death and disability is taken into account. 2. Ear Tubes (Tympanostomy Tubes) Otitis Media, or middle ear infection, is one of the most frequently diagnosed childhood diseases with at least 80% of pre-school aged children affected. Billions of dollars are spent every year on doctor visits, medicines, and, in chronic cases, surgery. In contrast to the rise in numbers, multiple long-term studies have concluded that as many as a third of these procedures are unnecessary. The surgery itself, known as myringotomy and tube placement, is the most commonly performed pediatric operation. It’s very safe, very quick, and has very low complication rates. Due to the incredibly low cost of the tubes, and the fact that they have been evolving for well over 50 years, no one manufacturer appears to dominate the market. 1. Artificial Eye Lenses (Psuedophakos) Cataracts are a problem faced by millions of elderly Americans yearly, many of whom will require surgical replacement of their own lens with an artificial one, known as a psuedophakos or intra-ocular lens. These lenses come in many configurations, such as single-focus (like glasses for distance vision), multi-focal lenses (like bifocal glasses), and hi-tech variable-focus lenses (like real eyes). While the vast majority of cataract surgery is safe and effective, there is a 1%-2% chance of retinal detachment over the rest of the patient’s lifetime. If this occurs and is not treated promptly, patients can completely lose their vision in the effected eye. While researchers are examining nonsurgical treatments for cataracts, surgery is currently the only real treatment or cure. (Ref: http://www.247wallst.com/healthcare-economy/) Nov. - Dec. 2015

Global Trends Fecal Incontinence Device F e c a l incontinence is the inability to control bowel movements, causing stool (feces) to leak unexpectedly from the rectum. It is the inability to control bowel movements and is a common p r o b l e m , especially among older adults. The most common cause of FI is damage to the muscles around the anus (anal sphincters). Vaginal childbirth can damage the anal sphincters or their nerves, which is why FI impacts women about twice as often as men. Also called bowel incontinence, fecal incontinence ranges from an occasional leakage of stool while passing gas to a complete loss of bowel control. Common causes of fecal incontinence include diarrhea, constipation, and muscle or nerve damage. The muscle or nerve damage may be associated with aging or with giving birth. Whatever the cause, fecal incontinence can be embarrassing. Fecal incontinence is even a bigger issue than urinary incontinence. Close to 50 percent of people in long-term care suffer from it. That’s an amazing number. U.S. sales of fecal incontinence products is predicted to hit $1.9 billion by 2018.

The U.S. Food and Drug Administration has recently allowed marketing of a System for the treatment of fecal incontinence (FI) in adult women. “Current treatment options for fecal incontinence include drugs, dietary changes, exercise, and surgery,” said William Maisel, M.D., M.P.H., deputy director for science and chief scientist in the FDA’s Center for Devices and Radiological Health. “The Eclipse System provides an additional treatment option for women who suffer from this condition.” The System is intended to treat FI in women 18 to 75 years old who have had four or more FI episodes in a two-week period. The device includes an inflatable balloon, which is placed in the vagina. Upon inflation, the balloon exerts pressure through the vaginal wall onto the rectal area, thereby reducing the number of FI episodes. The device is initially fitted and inflated by a clinician (with the use of a pump) and after proper fitting, the patient can inflate and deflate the device at home as needed. The device should be removed periodically for cleaning. Adverse events associated with the device included pelvic cramping and discomfort; pelvic pain; vaginal abrasion, redness, or discharge; and urinary incontinence. All device-related adverse events were mild or moderate, and none required any significant intervention (i.e., no surgeries were needed). (Ref: http://www.mayoclinic.org/diseases-conditions/fecalincontinence/basics/definition/con-20034575 http://www.postbulletin.com/news/local/medical-tech-companyto-build-plant-in-stewartville/article_d8fb03f8-5729-58e5-b075645d443c88f8.html http://www.fda.gov/NewsEvents/Newsroom/ PressAnnouncements/ucm434130.htm)

Lubrizol To Invest $ 15 mn In Lifesciences Business With this, Lubrizol aims to expand its global manufacturing facilities, positioning lifesciences business to better serve the growing market for medical device contract manufacturing. The Lubrizol Corporation, a Berkshire Hathaway company, will invest $ 15 million in the lifesciences business to expand its global manufacturing facilities, positioning lifesciences to better serve the growing market for medical device contract manufacturing. Since 2014, Lubrizol Life Sciences has consolidated its presence in the life sciences market by introducing new products and making strategic acquisitions. This capital investment will expand multiple facilities and increase Lubrizol LifeSciences’ in-house engineering capacity for both silicone and thermoplastic products. “We have significantly enhanced our capabilities through the combination of strong polymer technology, application know-how and world-class component manufacturing. As healthcare companies look for total solution providers, we continue to invest in the right areas to provide valuable offerings to our customers,” stated Deb Langer, vice president and general manager, Lubrizol LifeSciences.

Nov. - Dec. 2015

Vesta Inc, acquired by Lubrizol in August of 2014, is a leading contract manufacturer for the global medical device industry. With the addition of Vesta, Lubrizol LifeSciences now offers disposable and implantable silicone medical components and assemblies across a wide product portfolio, as well as precision thermoplastic extruded tubing. The recent acquisition of Particle Sciences Inc, a leading contract drug development and manufacturing organization, has positioned Lubrizol LifeSciences as one of the most comprehensive drug delivery device solution providers, offering end-to-end solutions in the healthcare market. Robert Miller, global business director, medical devices, Lubrizol, said, “With a long history of polymer expertise and significant investment, Lubrizol LifeSciences is positioned to offer full-service development for next generation medical and pharmaceutical innovations.” (Ref : http://www.business-standard.com/content/b2b-pharma/ lubrizol-to-invest-15-mn-in-lifesciences-business115120900229_1.html )

Book Review Publications Related to : Medical Devices- Regulations, Standards and Practices, Biomaterials, R&D, Sterilization, Advanced Polymers in Medicine etc. Medical Devices: Regulations, Standards and Practices Author : Ramakrishna, Tian, Wang, Liao &Teo, Publication Year : 2015, Number Of Pages : 256 A useful step-by-step guide on designing medical devices to ensure regulatory approval. Key Features • Provides readers with a global perspective on medical device regulations • Concise and comprehensive information on how to design medical devices to ensure they meet regulations and standards • Includes a useful case study demonstrating the design and approval process Description Medical Devices and Regulations: Standards and Practices will shed light on the importance of regulations and standards among all stakeholders, bioengineering designers, biomaterial scientists and researchers to enable development of future medical devices.

UHMWPE Biomaterials Handbook, 3rd Edition Edited by: Dr. Steven M. Kurtz, Published: October 2015, Pages:840 pages Description The book provides a detailed examination of the science, development, properties and applications of UHMWPE in hip, knee, shoulder, elbow and ankle replacements and within the spine. Chapters are included on processing, sterilization and packaging of UHMWPE, the historical development of UHMWPE joint replacements, clinical performance of joints, the use of highly crosslinked materials (HXLPE) and the latest antioxidant technologies for their stabilization.

The Medical Device R&D Handbook, Second Edition Editor : Theodore R. Kucklick, Publication Year : 2012, Number Of Pages : 510 Features • Provides tools for quicker, more efficient development of innovative devices • Explains the basics of prototyping medical devices • Offers insights on strategic intellectual property management • Presents examples from key opinion leaders and pioneers • Discusses new rapid-turn molding technologies, medical adhesives, and more • Includes tips on time- and money-saving techniques • Contains chapters on starting and building an entrepreneurial business

The Effect of Sterilization on Plastics and Elastomers, 3rd Edition Author : L McKeen, Publication Year : 2012, Number Of Pages : 480 Key Features • Essential data and practical guidance for engineers and scientists working with plastics in applications that require sterile packaging and equipment. • 3rd edition includes new introductory chapters on sterilization processes and polymer chemistry, providing the underpinning knowledge required to utilize the data. • Provides essential information and guidance for FDA submissions required for new Medical Devices. Description This reference guide brings together a wide range of essential data on the sterilization of plastics and elastomers, enabling engineers to make optimal material choices and design decisions. The data tables in this book enable engineers and scientists to select the right materials, and right sterilization method for a given product or application.

Advanced Polymers in Medicine Editor : Francesco Puoci, Publication Year : 2015, Number Of Pages : 537 Reviews the applications of advanced polymers in a wide range of medical specialties. The book provides an up-to-date overview of the diverse medical applications of advanced polymers. The book opens by presenting important background information on polymer chemistry and physicochemical characterization of polymers. This serves as essential scientific support for the subsequent chapters, each of which is devoted to the applications of polymers in a particular medical specialty. The coverage is broad, encompassing orthopedics, ophthalmology, tissue engineering, surgery, dentistry, oncology, drug delivery, nephrology, wound dressing and healing, and cardiology.

Nov. - Dec. 2015

Alpha Medicare and Devices Ltd.

(taking care…Since1984)

Manufacturers & Exporters of Disposable Medical Devices

GMP, ISO 13485 : 2003 & CE CERTIFIED COMPANY Product Range : • Infusion Set • Blood Transfusion Set • Measured Volume Burette Set • Scalp Vein Sets • Urine Bags • Uromeasure Urine Bags • Mucus Extractors • Cord Clamp • Guedel Airway • Three Way Stop Cocks • Extension Tubes with 3 way Stop Cock • High pressure Monitoring Tubes • Feeding Tubes • All kinds of Catheters • Closed Wound Suction Unit • Yankaur Suction Set • A.D. Kit Sets • Water Sealed Drainage Bags • Other Diagnostic Products like • Urine Culture Bottles Screw Type [30ml. 45ml. & 60ml.] • Petri Dish (55mm & 90mm) • Class 10000 Assembly NEW PRODUCTS • In house Imported Injection Molding Machines • Easy Morning Walker • Adult Diapers • Latest ET.O. Sterilization Facilities • Blood Pressure Monitors • Dial Flow Controllers with I.V. Set • Own certified laboratory to perform Physico • Personal Weigh Scales • Nebulizers Chemical, Sterility & Micro Biological Tests. ISO 13485 : 2003 • Exporting our products to almost more than 23 countries. Contact : Mr. Dinesh Shah (Manager) (M) 9638979798 97, Alpha Estate, Near Abad Estate, Opp. Kashiram Textile, Narol, Ahmedabad-382 405. (Guj.) INDIA Phone : +91-79-25390601/25390832 • Fax : +91-79-25353680 Website : www.alphamedicare.com • E-mail : contact@alphamedicare.com Nov. - Dec. 2015

0434

AN ISO 13485-2012 CE certified Company Manufacturer & Exporter of Medical Disposable Devices & Surgical Products Range of Products : • Infusion Set • Blood Administration Set • Measure Volume Set • Urine Collecting Bag • Urine Collecting Bag - Uro Meatry • Respiratory Exerciser • Twin Bore Nasal Oxygen Set • Oxygen Face Mask • Nebulizer Kit • Vaccum Suck Suction Set • Latex Surgical Gloves • Umblical Cord Clamp

Contact Yogesh Patel M. : +91 98241 21383

Leading Manufacturers and Exporters of Surgical Disposable Products PRODUCTS MANUFACTURED ISO 9001

REGISTERED

0434

• • • • • • • • • • • •

I.V. INFUSION SETS SCALP VEIN SETS BLOOD ADMINISTRATION SETS BLOOD DONER SET URINE COLLECTION BAG RYLES/FEEDING TUBES DISPOS ABLE SYRINGES & NEEDLES DISPOSABLE GLOVES SURGICAL DRESSINGS ADHESIVE TAPES PLASTER OF PARIS FORMULATIONS Office:

MEDIC ARE DEVICES

8, Maruti Industrial Estate, Nr. Sindhvai Mata Temple, C.T.M.-Ramol Road, C.T.M. Cross Road, Amraiwadi, Ahmedabad-380 026. Gujarat (India) Phone 079-2585 5711 E-mail : bhagwatimedicaredevices@gmail.com Website : www.medicaredevices.com

SHAILESH SURGICAL

L-8, “Manhattan” Near Lion’s Hall, Mithakhali, Ellisbridge, Ahmedabad-380 006, India Phone: (91-079) 26420281, 26440236 Nov. - Dec. 2015

Nov. - Dec. 2015

VIRTUE CERTIFICATION SYSTEMS PVT. LTD We are entrusted with the responsibility to manage in India on behalf of the world renowned accredited certification Body G2S Italy, ASCE (E) from IASPL & ACS Registrars – UKAS Accredited. We are involved on the certification activities in the following areas : • ISO 9001:2008 - QMS • ISO 14001:2004 – EMS • OHSAS 18001:2007 – OHSAS • ISO 22000:2005 – FSMS • ISO/IEC 27001:2005 – ISMS • ISO 13485 : 2003 – QMS for Medical Devices • ISO 30000 – Ship Building & Repairing • CE Marking • GMP We have collaboration with European Notified Body for CE Marking & SA 8000 certifications. We have assisted over 6500 clients all over the country, as an expansion plan we also require well qualified personnel’s in various districts to conduct the audits and provide after sale services, for Business Associates kindly apply for your location with complete details. Business Plan preferred.

We are a leading Consulting organization providing an integrated services with focus on project technology :

Quality Management System as per ISO 9001, ISO 13485, Medical Devices CE marking as per MDD/93/42, FDA 510k, Audit, Documentation, training and c-GMP. Sanjay Y .Shah – Owner Promoter M : +91 98240 17850

Obelis European Authorized Representative Center (O.E.A.R.C) based in Brussels, Belgium since 1988 is one of the largest Regulatory Centers in Europe, assisting non-European manufacturers’ successful endeavors into Europe.

For further details OR clarification pleases contact :

Virtue Certification Systems Pvt. Ltd. “Virtue House” 28, Defence Co-Op Society, Nr. Navrachana School, Sama Road, Vadodara – 390008. Gujarat. Ph. : 91-265 – 2794158 / 98250 43523 Email: shankarbkm@gmail.com OR virtueinternationals@gmail.com

F/6, Goyal Plaza, Vastrapur, Ahmedabad-380 015. INDIA. Tel. : +91 79 66090225 E-mail : unikal@unikalindia.com, unikal@hotmail.com Website : www.unikalindia.com

GMP. & ISO 9001 – 2000 Certified Company

AMIGO SURGI CARE PVT. LTD. Manufacturer of Disposable Surgical Products:

Products • Flexible Packaging Material • Paper Pouch • Aluminium Foil • Foil Seal • Ribbon Pack Pouch

Contact : Jignesh Patel : +91 94265 25388 +91 90163 36699

Kavya Packaging Plot No. 5313, Opp. Alankar Boiler, Ramol Bridge Road, Phase-4, G.I.D.C. Vatva, Ahmedabad-382445. Gujarat E-mail : kavyapack@yahoo.com

I.V.CANNULAS / B.T.SETS / I.V.SETS / SURGICAL LATEX GLOVES / CORD CLAMPS / URINE BAGS / MEASURE VOLUME SETS ETC.

Manufacturers / Exporters / Hospital Suppliers Dealer are requested to Contact : Mr.Chandrakant Sayal , B.E. (Mech. & Elec.) (DIRECTOR) Mobile:0091-9825057180 Tel.:0091-2764-268249 E-mail : • cannulaexpert2001@yahoo.co.in • amigo.surgicare@gmail.com Website:www.amigo-india.com Plant Address Plot No.780, Opp.: Kemron Lab Sola Santej Road, Rakanpur (Santej) – 382721 Gujarat, India Nov. - Dec. 2015

Manufacturers and Suppliers of Medical Disposable & Surgical Products Product Range: • TRANSFUSION / DIALYSIS RANGE • UROLOGY RANGE • GASTRO - ENTROLOGY RANGE • ANAESTHESIA RANGE • SURGERY RANGE • MISCELLANEOUS RANGE

Specialized in Handling Large Quantity & Contract Manufacturing Manufacturing Address : HINDUSTAN SURGICAL Hasmukhbhai B. Patel 749/2, Sarali Pithal Road, N.H.59 Road, Village - Pithai - 387630. Ta.: Kathlal, Dist. Kheda, Gujarat. Email : hindustansurgical@yahoo.com Website : www.hindustansurgical.com Tele/Fax : (O) ++91-25440223 Cell :9824060964

Corresponding Address: HINDUSTAN SURGICAL Hasmukhbhai B. Patel 23, Manav Mandir Bungalows, Taxshilla Colony, Old Aradhana School Circle, B/h Ramannagar, Sukhipura, Maninagar, Ahmedabad - 380008 Email : info@hindustansurgical.com

SANIDHYA ENTERPRISE Manufacturers of : Medical Plastic Injection Molded Articles & Job Works Our Product Range Includes Medical Components like : • • • • • •

Urine Container Adaptors (PP) Regulators / Cord Clamp All types of Urine Bag parts like H.D. - ABS & PVC Connectors / Covers, PVC Closures PP Mucas Container And many other Surgical Medical Components

Contact : Contact Person : Kamlesh Shah Mobile : 9825474789 / Chitan Shah Mobile : 9722612646 SANIDHYA ENTERPRISE Office : 28/29, Yogeshwar Estate, Near Laliteshwar Mahadev. B/h. New Cotton Mills, A. E. C. Road, Amraiwadi, Ahmedabad-380026. Ph. : (F) 22731656 (M) 9825474789 E-mail : sanidhya.ent@gmail.com Nov. - Dec. 2015

Product Gallery New Swabbable Needleless Injection Sites with Barbs From Qosina

New Swabbable Needleless njection Sites With T-Ports From Qosina

Ronkonkoma, NY – December 17, 2015 - Qosina is pleased to announce the addition of three new barbed swabbable needleless injection sites (#80209-#80211), in stock and ready for immediate delivery. The barbs are available to fit 1/8 (0.125 inch, 3.2 mm), 3/16 (0.187 inch, 4.7 mm) or ¼ (0.25 inch, 6.4 mm) inch ID tubing, and feature a swabbable luer activated female luer lock for aspiration or injection. Made of a tinted polycarbonate housing and a latex-free silicone valve, these injection sites are EtO and Gamma sterilization compatible. Qosina offers a variety of IV bags, syringes, tubing, and injection sites in addition to thousands of stock components.

Ronkonkoma, NY - December 18, 2015- Qosina is pleased to announce the addition of three new t-port swabbable needleless injection sites, in stock and ready for immediate delivery. The portsare availableto fit0.079 inch OD tubing (2 mm) (#80172), 0.122 inch OD (3.1 mm)(#80174) or 0.157 inchOD tubing (4 mm) (#80171) and feature a swabbable luer activated female luer lock for aspiration or injection.The t-ports are designed to be bonded in-line and the valve offers high flow rates. Made of a tinted polycarbonate housing and a latex-free silicone valve, these injection sites are EtO, and Gamma sterilization compatible. Qosina offers a variety of syringes, tubing, and needleless injection sites to fit your project needs.

Qosina is a worldwide supplier of thousands of stock OEM disposable components to the medical and pharmaceutical industries including connectors, luers, clamps, adapters, clips, valves, needle hubs, stopcocks, hemostasis valves, tuohy borst adapters, swabs, and spikes. Qosina operates an ISO 9001 and ISO 14001 registered facility. Qosina offers low minimums and short lead times. Call our Customer Service Specialists to request a sample, obtain our latest catalog or place an order via P.No.:+1(631)2423000, fax +1(631)242-3230 or email: info@qosina.com. Visit us at www.qosina.com to see our latest products. Custom sourcing services are available.

Quality Medical Devices ISO 9001 : 2000 & ISO 13485 : 2003 Products available with CE marking

Contact: Ryan Edwards, Qosina, 2002-Q Orville Drive North, Ronkonkoma, NY 11779, Email: redwards@qosina.com

Qosina is a worldwide supplier of thousands of stock OEM disposable components to the medical and pharmaceutical industries including connectors, luers, clamps, adapters, clips, valves, needle hubs, stopcocks, hemostasis valves, tuohy borst adapters, swabs, and spikes. Qosina operates an ISO 9001 and ISO 14001 registered facility. Qosina offers low minimums and short lead times. Call our Customer Service Specialists to request a sample, obtain our latest catalog or place an order via phone +1(631) 242-3000, fax +1 (631) 242-3230 or email info@qosina.com. Visit us at www.qosina.com Custom sourcing services are available Contact: Ryan Edwards, Qosina, 2002-Q Orville Drive North, Ronkonkoma, NY 11779. Email: redwards@qosina.com.

Manufacturer And Exporter Of a wide range Of Medical Devices

Facilities : Controlled Molding Area, Clean Room of Class 10000, ETO Gas Sterilization Pla nt along with all other amenities and equipments required for manufacturing and testing of Medical Devices. The Company also have certified Laboratory to perform Physico-Chemical, Sterility, Micro-Biological Tests. Products : Infusion Sets, IV Cannula, Burette Set, Scalp Vein Set, Extension Lines, Three Way Stopcock, Peritoneal Dialysis Set, Blood Administration Sets, Blood Lines, Feeding Tube, Ryle’s Tube, Levin’s Tube, Stomach Tube, Colostomy Bag, Urine Bag, Urine Meter, Nelaton Catheter, Male External Catheter, Oxygen Mask, Nebulizer Mask, Suction Catheter, Endotracheal Tube, Tracheostomy Tube, Guedel Airways Wound Suction Set, Yankaur Suction Set, Thoracic Catheter, Mucucs Extractor, Umbilical Cord Clamp etc... The company markets products its own brand name ANGELTOUCH. Certification : ISO 9001 : 2000, ISO 13485 : 2003, CE marking & GMP. Expertise & Experience : – OEM/Contract Manufacturing. – Supply of Components for Medical Devices.

ANGIPLAST Private Limited

ISO 9001-2000

REGISTERED FIRM Wide Range Of Products :

The company manufactures a wide range of Medical devices, which fall under the main domains of : Infusion Therapy, Transfusion Therapy, Dialysis, Gastroenterology, Urology, Anesthesia, and Surgery.

Plot No. 4803, Phase IV, G.I.D.C. Vatva, Ahmedabad-382 445. India. Phone : +91 79 25840661 / 25841967 (O) 9662004148 / 49, Fax : 2584 1009 E-mail: angiplast@gmail.com/angiplast@angiplast.com Website : www.angiplast.com

Nov. - Dec. 2015

Industry News Medical Device Sector Delinked From Pharma The government has accepted the long-standing demand of the medical devices sector to delink it from the pharmaceutical sector. The health ministry has agreed to delink schedule M III of the Drug Rules, which deals with medical devices, from schedule M, which deals with drugs and pharmaceuticals.The revised schedule is being put up on the website of the Central Drugs Standards Control Organization (CDSCO) inviting comments from the public after which a notification will be issued through the law ministry for changing the Drug Rules. Schedule M III provides requirements of factory premises for manufacture of medical devices under the Drugs and Cosmetics Rules (DCR), 1945. However, it relates only to three medical devices, namely sterile perfusion and blood collection sets and syringes and needles. A large number of notified devices are

currently being regulated under the provision of DCR, 1945. The Drugs Technical Advisory Board (DTAB) in its August 2015 meeting recommended that Schedule M III be incorporated under DCR 1945 and the rules amended so that it was exclusively for medical devices, while schedule M was applicable only to drugs. “Nowhere in the world are pharmaceutical and medical device sector governed by the same set of legislations as has been historically happening in India,” said a statement of the Association of Indian Medical Device Industry (AIMED). This has had a detrimental impact on the medical devices sector, it added. But there needs to be a separate law book, separate rule book and separate regulatory authority. (Ref: http://timesofindia.indiatimes.com/india/Medical-devicesector-delinked-from-pharma/articleshow/50130958.cms)

AIMED Launches UdaiMed, India’s First Industry - Academia Collaboration For Medical Devices R&D The Association of Indian Medical Device Industry (AIMED) has launched ‘UdaiMed’, a new sunrise forum for collaborative interface between user, developer, academia, industry and medical device development in India. The objective of this momentous milestone collaboration for academic-industry in India is to make on-campus research more aligned to medical device industry’s needs and catalyze ‘Makein-India’ programme. To take forward this objective, AIMED & UdaiMed also signed its first MoU with TiMed (Technology Business Incubator), a not-forprofit registered society promoted by Sree Chitra Tirunal Institute for Medical Sciences and Technology (SCTIMST), Thiruvananthapuram, for encouraging innovation and entrepreneurship in medical technologies through technology business incubation support to innovators, start-ups and industry. TiMed will offer office and laboratory space with several common facilities like internet access, library, canteen, video-conferencing facilities for taking forward this collaboration. “I am absolutely positive that the new collaboration will construct

a better synergy between industry needs and academic research while taking care of fund shortages for research,” added Nath. Explaining the need for such an initiative, Nath pointed towards the ground realities of campus R&D in India stating that, “R&D institutions and engineering colleges do product development in isolation while industry has little or no idea of work being done there, and often such researches have no relevance for industry. Collaboration between institutions and industry is completely absent even as most development is for peer academia acclaim rather than meeting industry’s needs or contributing to country’s competitive prowess.” As a next step, Dr Jitender Sharma, head of Healthcare Technology Division of NHSRC, MOH&FW (also party to this initiative) said “AIMED/UdaiMed could request the government to auction all patents which are not yet commercialised so that these can be put to use by Indian manufacturers for the benefit of Indian consumers and medical fraternity.” (Ref : http://pharmabiz.com/ ArticleDetails.aspx?aid=91645&sid=1)

CM Promises Land For India’s First Medical Devices Park In India Gujarat chief minister Anandiben Patel on Wednesday agreed to provide land in the state for country’s first medical devices park. She was speaking during the stone-laying function of the permanent campus of National Institute of Pharmaceutical Education and Research (NIPER) at Gandhinagar. Earlier in his address, Union minister of chemical and fertilizers Ananth Kumar announced that his ministry is planning to set up country’s first medical devices park in Gujarat. “We will set up the medical devices park if chief minister Anandiben Patel allots us land for the same,” he said. “We are ready to give land for the proposed park. The central government can send officials for land survey and, later, we can decide on the area for the land. We will give all possible help to the Centre,” said the CM. Ananth Kumar said India is exporting medicines to approximately Nov. - Dec. 2015

Industry News 200 countries but we are still dependent on other countries for medical devices. “We want to make India self sufficient in the field of medical sufficient in the field of medical devices. The medical devices park will have a `Centre of Excellence’ where research for medical devices will be conducted,” said Kumar. “The Centre is planning to expand the Central Institute of Plastic Engineering and Techno-

logy campus at Sanand, soon after it receives additional land from the state government. Around 12,000 students will get training in plastic engineering following the expansion of CIPET,” said Kumar. The Union minister also promised a Pharma Park in the state. (Ref: http://timesofindia.indiatimes.com)

Compliments To Gujarat FDCA Mr. Lahouari Belgharbi, Scientist Group Lead, NRA assessment and Policy, Regulatory System Strengthening [RSS], Regulation of Medicines and Other Health Technologies [RHT], Department of Essential Medicines and Health Products [EMP], World Health Organization, visited Gujarat to understand the working of Gujarat FDCA and went back highly impressed giving following compliment. “I came to visit Gujarat because I was told that Gujarat Team in the FDC is a very effective and Committed team and I found a strong & well developed system, highly committed leaders and proud of their achievements. I was amazed to see how much a small team can do for 60 million of people and also contribute to ensure the quality

and safety of about 50% of the medicines in India. I just want to wish you to continue this journey of your regulatory work in the best manner and hope my visit that was an enlightenment for me about your state will be also fruitful in our future co-operation.”

Arbitary MRP Printing On Imported Medical Devices Raising Healthcare Cost Association of Indian Medical Device Manufacturers (AIMED), has expressed grave concern over the raging malpractice of arbitrary MRP printing on imported medical devices leading to fleecing of unsuspecting Indian consumers. This is forcing Indian manufacturers to respond similarly raising the overall healthcare cost in the country. Industry experts want government to curb this malpractice and put in place a transparent and stringent MRP regime for imported goods so that average Indian consumers are not fleeced and retail price parity between domestically produced medical devices and imported products is maintained. and will help bring down healthcare costs in the country . Government has a duty to protect the Indian patients from undue enrichment by unscrupulous traders and manufacturers whereby retail prices go up when ex factory prices are going down and to ensure that there is level playing field between domestically produced medical goods and imported ones,” said Rajiv Nath, forum coordinator of Association of Indian Medical Device Manufacturers. Nathadded,”The current system helps in maintaining huge price disparity of imported and Indian goods as Indian manufactures can’t increase their MRP by over 10% for those items covered under drug regulation like stents. Consumers can’t access these lower cost devices as hospital and retailers may not stock these lower priced devices. So we have a healthcare system thriving on higher costs on pretext of US FDA approved or American Origin and resultant high prices to consumers”. Bejon Misra a consumer policy expert and also the Founder of

the Partnership for Safe Medicines (PSM) India Initiative, explained that imported medical devices like many other items are imported in bulk and the duty is also paid on bulk and importers claim these are not consumer goods but for hospital use. The government and customs must ensure that all individually packed units for sale of any medical device - big or small even if X-ray machine, should have the MRP preprinted on the unit pack. There needs to be an import duty of at least 1% on this MRP and the bill of entry and invoice should have the transaction price per unit as well as the MRP per unit to ensure no malpractices of switching of labels post import are adopted by the Indian importers. Currently importers pay tax on transaction invoice value and not on basis of the MRP. Gurmit Singh Chugh MD of Translumina Therapeutics, an indigenous stent manufacturer added, “The scenario of Indian manufacturers making high-end medical devices like drug eluting stents is extremely discouraging. We are concerned with the discriminatory pricing policies in this sector which creates an impression that anything “American” should have higher pricing and higher reimbursements. It is important for various stakeholders to be aware that a medicinal and medical product need to be evaluated on the basis of quality and the extent of clinical trials performed. However, the patients are impressed by the hospitals to go for American products which limits the ability of Indian manufacturers to offer their products at much lower cost to the patients in India”. (Ref: http://www.pharmabiz.com/ NewsDetails.aspx?aid=91878&sid=1 )

Nov. - Dec. 2015

National Healthcare An ISO 9001 : 2008 Company

Manufacturing & Exports of Medical Disposables : I.V. Set, B.T. Set, Urine Bag, Measured volume set, Cord Clamp, Surgical Gloves etc.

Injection Moulded Medical Components and Extended Tubes :

PACK-EQUIP (Mfg. Packaging Machinery) Office / Communication : 91, Avnish Society, Opp. Pavitrakunj Society, CTM Cross Road, Amraiwadi, Ahmedabad-380 026. Phone : 25855027 (M) 9825380739 Works : 16, Arbuda Estate, Near Nidhi Bank, CTM Cross Road, Amraiwadi, Ahmedabad-380 026.

I.V. Set components, Urine bag Components, Connectors for Catheters, I.V. Set / B. T. Set / Urine Bag Tubes etc.

Contact : Naresh Patel 5/4, Anand Estate, Opp. Ravabhai Estate, C.T.M., Ahmedabad (India) Ph. : 079-25857530, Fax : 079-25862206 E-mail : nationalhealthcarectm@yahoo.com Website: nationalhealthcare.in

ISO : 13485 : 2012

JIMIT MEDICO SURGICALS PVT. LTD. AN ISO 13485 : 2012 &

CERTIFIED COMPANY

Manufacturers & Exporters of Disposable Medical Devices Infusion Set, Blood Administration Set, IV Cannula, Urine Bag, Catheters, Gloves, HIV KITs, Ophthalmic KITs, Ophthalmic Knives (Blades), Cap, Mask, Gown, Drapes, Bandages, Dressings etc.

Specialized in Handling Large Quantity & OEM / Contract Manufacturing Factory : 16, Ranchodnagar, Near Vinzol Railway, Crossing, Vatva, Ahmedabad-382445, INDIA Tele : +91-79-25835567, +91-79-25834850 E-mail: info@jimitsurgicals.com • Web: www.jimitsurgicals.com Nov. - Dec. 2015

Events

The event website www.imdiconferences.com gives most of the • Medical Surgical And Healthcare Industry Trade Association • The All India Plastics Manufacturers’ Association (AIPMA) information, the highlights of the events are as follows: • Gujarat State Plastics Manufacturers Association (GSPMA) Theme: • Indian Plastics Institute (IPI) The Theme of the Conference is: “Indian Medical Device Industry: Integrating Market, Technology, Innovation and Agenda: Ecosystem”. The “Technology Display Show Exhibition” to The two day programme includes presentations from be held in conjunction with the Conference will showcase, knowledgeable eminent speakers from Industry, Government, “Materials, Adhesives, New Technologies, Manufacturing / Testing Research Institutions, Professionals and Academic Institutes from Equipments, Packaging / Sterilisation Equipments and Services India and abroad. A “Technology Display Show Exhibition” will be held in conjunction with the Conference. For Medical Device Industry. We have already received about 25 confirmations from industry Our Mission is to create a platform of interactions for the Indian experts and leaders. Medical Device Industry as well as the technology / products / Lists of confirmed expert speakers and exhibitors are available at services providers with an objective to facilitate an environment event website, www.imdiconferences.com. We are expecting more confirmations from Industry Leaders as well as Regulatory, of healthy growth. Research, Academic and Government Institutions in the coming Footfalls / Visitors: months. Visit Conference website for more details. During the previous event held in January 2015, more than 45 experts shared their rich experience, knowledge and vision with Events Calender more than 450 delegates. About 40 Companies showcased their Products and Services in the ”Technology Display Show • Plexpo India 2016 Exhibition”. Expert Speakers, Exhibitors and Delegates came 7th International Plastic, Packaging, Printing, Converting & from various countries including USA, UK, Germany, China, The Rubber Industries Exhibition Netherlands as well as from various cross sections of Indian Date : 07th-11th January, 2016. Medical Devices and allied industries. The leaders of the Industry Venue : Exhiition Centre, Near Town Hall, Gandhinagar. / CEOs of leading Companies also participate as speakers during • 13th National Conference And Technology Exhibition on the two day conference. We are expecting more participations in Indian Medical Devices & Plastics Disposables / coming event. Objective:

Organisers: This annual conference for the Indian Medical Devices and Plastics Disposables Industry is being organized by publishers of a magazine, “MEDICAL PLASTICS DATA SERVICE” and promoters of the medical technology internet Websites, www.medisourceasia.com and www.medicalplasticsindia.com, since 2001 with close involvement and support of the Leading Industry, Associations in Medical Devices, Pharma and Plastics Sectors as well as Government Regulatory, Export Promotion and Research Organizations include: • • • • •

Association Of Indian Medical Device Industry (AIMED) Medical Disposables Manufacturers Associations (MDMA) Society of Biomaterials & Artificial Organs National Biomedical Engineering Society (NBES) Food and Drugs Control Administration, Government of Gujarat • Indian Drug Manufacturers’ Association (IDMA), GSB • Association of Diagnostics Manufacturers of India (ADMI) • Engineering Export Promotion Council (EEPC INDIA)

Implants Industry 2016.

Date: 12-13 February, 2016 Venue: Ahmedabad Management Association, A’bad.

• Plastivision Arabia 2016 Region’s Leading Plastics Event Date: 22-25 February, 2016 Venue: Expo Center, Sharjah.

• Medical Fair India 2016 22st International Exhibition and Conference Date: 11-13 March, 2016 Venue: Bombay Convention & Exhibition Center, Mumbai.

• Medicall 2016 15th Edition Date: 22-24 July, 2016 And Venue: Chennai.

• Medical Manufacturing Asia 3rd Manufacturing Processes for Medical Technology Exhibition and Conference Date : 31st August - 2nd September 2016. Venue : Singapore Nov. - Dec. 2015

Nov. - Dec. 2015

: Attention :

MEDICAL PRODUCTS MANUFACTURERS FOR

Surgical Peelable & Tearable Pouches, Lids & Reels For Sterilized Medical Disposables & Devices Contact :

Surgi Pack India Pvt. Ltd. PLANT : J/49, MIDC Tarapur Indi. Area, Boisar, Taluka : Palghar, Thane - 401 506 India. • Tel. No. : 93245 51325 OFFICE : 102, Pran Kutir, Ram Lane, Off. S. V. Road, Kandivali (West), Mumbai - 400 067 India. Contact Person : BIRJU TANNA (CEO) Cell : +91 98199 70333 E-mail : birju.t@surgipackindia.com • Sales@surgipackindia.com

Airways Surgical Pvt. Ltd. Manufacturer of Oxygen Therapy & Critical Care And Anaesthesia Therapy Critical Care & Anaesthesia Therapy Products T-Oxygenator • Endotracheal Tube(Plain & Cuff) Catheter Mount(Standard Double • Endotracheal Tube Reinforced Swivel Mount & Expandable Double • Endotracheal Tube Holder With Bit Swivel Mount) Block Ventilator Circuit • Inflatable Anaesthesia Mask Ventilator Circuit with Single Water • Anaesthesia Mask Silicon Trap(Adult, Pediatric, Neonatal) • Trachostomy Tube With Cuff Ventilator Circuit with Double Wa• Endotracheal Tube Holders ter Trap(Adult, Pediatric, Neonatal) • Yankaures Suctions Systems Breathing Filters(HME & BVF) • Airovent T-Humidifier Resuscitator(Ambu Bag) • Dialflow Regulator Anaesthesia Circuits (Mapleson D, • Airopap Full Face Mask Mapleson F, Bain Circuit with APL • Close Ventilation Suction System Valve) • Incentive Spirometer Stylet • 3 Ball Spirometer Guedel Airway • Three-way Stopcock Nasopharyngeal Airway • Extension Tubing for Infusion Laryngeal Mask Airway Systems Mallaeble gum Bougie • Pressure Monitoring Line

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Contact : Dr. Inder Jain +91 9820321901 Head Office : 106, Vijay Industrial Estate, I. B. Patel Road, Goregoaon (E), Mumbai - 400 063, INDIA. Tel.-Fax : 91-22-2685 2973 / 2686 9090 Works : Airway House, Plot No. 2209 & 2210 Phase IV, GIDC Vatva, Ahmedabad - 382 446. INDIA. Tel. : 91-79-2584 2525 / 2584 0905 Email : airwaycorporation@rediffmail.com info@airwayssurgical.com • Web : www.airwayssurgical.com

High Concentration Mask

Oxygen Therapy Products • Nasal Cannula • Oxygen Mask • Multi flow Venturi Mask • Single Dial Venturi Mask • High Concentration Mask • Nebulizer Set • Nebulizer Chamber

Breathing Filters

Airovent T-Humidifier

Anaesthesia Circuits

Incentive Spirometer

ET Holder with Bite Block

Expandable Catheter Mount Nov. - Dec. 2015

GMP ISO - 9001-2008 Certified Company

MANUFACTURER & EXPORTER OF MEDICAL DISPOSABLE PRODUCTS

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I.V. Infusion Sets

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Blood Administration Sets

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Scalp Vein Set

Excellence in Quality

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Urine Collection Bags

Manufacturer & Exporter of Surgical Disposable Products since 1980

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Ryles / Feeding Tubes

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Catheters and Tubes

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Surgical Gloves.

S. Nath & Co.

IDEAL® • Infusion Set • Blood Administration Set • Urine Collection Bag • Urine Specimen Container • Umblical Cord Clamp Address

S. Nath & Co. B. N. Estate, Near Uttam Dairy, Sukhramnagar, Ahmedabad-380021, Gujarat, India. Contact No. : +91-79-22743246, 9825360531 Website : www.snathco.com • snathco@hotmail.com

Contact : Mr. Bhavin Shah MANUFACTURER & EXPORTER OF MEDICAL DISPOSABLE PRODUCTS

4-5, Khodiyar Ware House Estate, B/h. Mahalaxmi Mill, Narol - Isanpur Highway, Narol, Ahmedbad-382405. (India) Phone : (O) 07925733318 (R) 079-25430211 (M) +91-9825018952 Email : info@mescosurgical.com, mesco@rediffmail.com Website : www.mescosurgical.com

BASIL manufacturers PVC COMPOUNDS according to the customer requirements of strength, flexibility, x-ray traceability, transparency, colour and extraction resistance. BASIL POLYMERS are patronized by Health Care Industries For • Flexible Extrusion Grade PVC Compounds • Flexible Injection Moulding Grade Pvc Compounds • Flexible PVC Tube For I.V.Set, S.V.Set.X-Ray Opaque Tubes • Flexible PVC Layflate Film For Medical PVC Bags • RF Welded Medical Bags for I.V. Fluid, Enema etc. • DEHP free Medical Grade PVC Compound • Injection Moulded Parts like PVC Chambers, Roller Clamp, Adapter etc. for I.V.Set and other Medical Disposable Products.

BASIL POLYMERS 3-B, Verdan Exclusive, Near Stadium Petrol Pump, P. O. Navjivan, Navrangpura, Ahmedabad – 380014. Phone : 079-26565981 - 82 - 83 Mobile : 9909036411 / 9824045178 E-mail : basilpolymer@gmail.com www.basilpolymers.com Nov. - Dec. 2015

November 2014 to December 2015 Column

Content

Column

November- December 2015 Cover Story

• Global Medical Disposables Industry Scenario and the Role of Plastics • Most Widely Used Medical Disposable Products Global Trends • The Eleven Most Implanted Medical Devices In America • Fecal Incontinence Device Book Review • Medical Devices: Regulations, Standards and Practices • UHMWPE Biomaterials Handbook • The Medical Device R&D Handbook, • The Effect of Sterilization on Plastics and Elastomers • Advanced Polymers in Medicine Did You Know • About Failure of Endotracheal Tubes September-October 2015

Cover Story

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Manufacturing • Global Trends • • Product Gallery • • Did You Know •

Medical Tubing And Extrusion Technology Tubes and Catheters Sizing Medical Tubing : Materials and Applications MPDS Supplier Bulletin : Medical Tubing And Extrusion Technology Make In India : From Slogan To Policy Implementation Safety Considerations Related To Misconnections Between Medical Devices Modern Medical Tubing for Medical Device Downgauging New Winged Female Luer Lock To Barb Connectors Breakable Male Luer Lock Connector About Hospital Errors on Medical Tubing Killing Patients July-August 2015

Cover Story

• Indian Medical Device Industry : Government Initiatives For Regulations, Safety &Competitiveness - Department Of Pharmaceutical To Study Factors Affecting Competitiveness Of Indian Medical Devices In Domestic Market - Government to Soon Remove Duty Anomalies in Medical Devices Sector - Ministry Of Health Launches Materiovigilance Programme To Monitor Safety Of Medical Devices Technology - AdvaMed Demands Passage Of D&C Amendment Bill To Delineate Medical Devices From Drugs • Cold Plasma Treatment For Biomedical Applications • Plasma Treatment Improve Adhesion To Polymers Global Trends • Impact Of New European Regulations On Outsourcing Of Medical Devices Did You Know • Balancing Product Development Effectiveness with Regulatory Compliance May-June 2015

Cover Story

• Medical Device Manufacturing : Components Bonding and Joining Techniques

Content

Mfg. Policy

• National Medical Device Authority (NMDA)Recommended By Task Force To Strengthen “Make In India” Drive Global Trends • Medical Disposables Market Worth $245 Billion By 2018 Product Gallery• New Kynar Connectors Did You Know • About Welding of Thin Polymeric Films For Medical Applications March- April 2015 Cover Story

• Promotion Of Domestic Production Of High End Medical Devices • The Medical Devices Sector In India : Task Force Recommendations · • “Medical Plastics Data Service” Thanks And Welcomes Mr. C. Balagopal To The Editorial Advisory Board Market • Drug Device Combination Products : Market Review And Future Trends Global Trends • Global Biomaterials Market For Implantable Devices Driven By Polymers Did You Know • About Challenges Of Using Combination Products January- February 2015 Cover Story

• Manufacturing Medical Devices In India : Many Opportunities - Mr. Himanshu Baid, Managing Director, Poly Medicure Ltd. • How Do We Balance Between Compliance, Quality And Innovation? - Mr. C. Padmakumar, Chairman & Managing Director, Terumo Penpol Limited Global Trends • Understanding Barriers to Medical Device Quality • China : Medical Technology Potentials Are Enormous Product Gallery• New Sanitary Flanges With Barbs Did You Know • About Trends In Medical Device Adverse Events November -December 2014 Cover Story

• 12th National Conference & Exhibitionon “Indian Medical Devices & Plastics Disposables/ Implants Industry 2015” Technology • Exhibitors Offering Material, Display Exhibition Adhesives, New Technologies, Manufacturing/Testing Equipments. • Packaging/Sterilization Equipments And Services For Medical Devices, Implants & Diagnostics Industry. • Presentations • Speakers’ Profiles • Exhibitors’ Profile • Advertisers Profile....etc. Book Review • Regulatory Affairs for Biomaterials and Medical Devices • Polymeric Biomaterials : 2 Volume Set Nov. - Dec. 2015