Medical Plastics Data Service September - October 2015

CToabnletoef nts Vol. 23 No. 5 Sept. - Oct. 2015 20 Cover Story • Medical Tubing And Extrusion Technology The Medical Tubing segment comprises the most dynamic area in the medical devise landscape. Advances in extrusion technology are aiding the evolution of plastic tubing with latest developments that include……. • Tubes and Catheters Sizing The catheter sizing classification most commonly used in the medical industry is the French ( Fr ) scale, also known as……. • Medical Tubing : Materials and Applications Wide range of medical applications and respective medical grade polymers in use. • MPDS Supplier Bulletin : Medical Tubing And Extrusion Technology The bulletin features domestic and international sources for medical tubing and extruded products. 26 Manufacturing • Make In India : From Slogan To Policy Implementation - Shri Rajiv Nath, Forum Coordinator, Association Of Indian Medical Device Industry (AIMED) Shri Rajiv Nath shares his vision, “India Amongst Top 5 Manufacturing Hubs of Medical Devices”, and suggests what it takes to convert this vision into reality. 28 Product Gallery • New Winged Female Luer Lock To Barb Connectors From Qosina • Qosina Breakable Male Luer Lock Connector 33 Global Trends • Safety Considerations Related To Misconnections Between Medical Devices The use of common connector designs, such as Luer connectors, has led to unintended connections devices that have…… • Modern Medical Tubing for Medical Device Downgauging Advances in device designs is driving the need for advances in Polymer extrusion technology. 34 Industry News • Promote Components And Ancillary Industry To Achieve ‘Make In India’ For Medical Equipment And Devices, Recommends CII • CII MTD Division Wants Separate Marketing Code For Medical Device Industry 18 Did You Know? • About Hospital Errors on Medical Tubing Killing Patients 36 Events • Compamed 2015 : November 16 - 19, 2015, Dusseldorf, Germany. • 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, Expo Center, Sharjah. • Medical Fair India 2015 : March 11-13, 2016, Bombay Convention & Exhibition Center, Mumbai. • Medical Manufacturing Asia : 31st August - 2nd September 2016, Singapore. Sept. - Oct. 2015 17

Flashback ?YoDKuindow ? July 2003 About Hospital Errors on Medical Tubing Killing Patients From Editor’s Desk Hundreds of deaths and serious injuries can be attributed to mix-ups with similar- Dear Readers, looking types of medical tubing. Experts and standards groups have long advocated that tubes for different purposes be made so that they are incompatible with each A recent study on Technical Support Infrastructure needs other-just as different nozzles at gas stations prevent drivers from using the wrong for the medical devices and diagnostics firms has clearly fuel. indicated that not only outsourcing is widely practiced As the New York Times reported, a otherwise healthy young woman and her unborn but it is going to increase. Internationally as well as in daughter died after a feeding tube was mistakenly connected to an intravenous India, the sector is R & D intensive and the success of line, sending liquid food directly into her veins - a fatal, and completely avoidable, the companies at a world level has been driven by mistake. innovation and technology improvement. In cases like these, it’s difficult to say where the fault lies, but the very design of medical tubing deserves at least partially responsible. Researchers have traced It is obvious therefore that supplier plays a very important hundreds of such deaths or serious injuries to tube mix-ups. However, no one role and contributes significantly to the success of the knows real toll, because this kind of mistake, like medication errors in general, is medical devices manufacturing industries world over. rarely reported. An earlier survey of hospitals found that 16 percent had experienced a feeding tube mix-up. ComPaMED 2003 is the window of technology for the Medical tubing serves a variety of unique purposes in hospitals, for instance medical manufacturing industry. ComPaMED, the delivering medication, fluids, food, gases or blood to different areas of the body – International Trade fair for Components, Parts and Raw the veins, arteries, stomach, lungs, etc. Materials for Medical Manufacturing. The show indicates Unfortunately, many varieties of medical tubing are interchangeable and easily that suppliers in the Medical Manufacturing Industry are connectable, meaning it is very simple to mistakenly connect a feeding tube to an pioneering progress and are also strengthening their role intravenous line, or IV fluids to an oxygen tube, leading to suffocation. in the development sphere. The New York Times also reported a case where a spinal anesthetic used for pain relief during childbirth was mistakenly put into a vein, killing the 16-year-old recipient. ComPaMED 2003 will provide good exposure and With nurses often working overtime or covering too many patients at once, it is all opportunity to rise in the value chain by sourcing quality too easy to connect a tube improperly, leading to an often fatal outcome for the components, parts and raw materials for Medical patient. Disposables/Equipments manufacturing. A simple solution would be to change the design of the tubes so tubing for different functions are no longer compatible with one another. MEDICAL PALSTICS DATA SERVICE is also happy to announce a one day Seminar On Medical Device (Ref: http://articles.mercola.com/sites/articles/archive/2010/09/10/us-inaction- Packaging to be conducted by CIPET (Central Institute lets-lookalike-tubes-kill-patients.aspx ) Of Plastics Engineering & Technology), Ahmedabad on September 30, 2003. In a Nutshell.... Central Institute of Plastics Engineering & Technology is an autonomous institute under Department of Chemicals “Knowledge is knowing that a and Petrochemicals, Ministry of Chemicals & Fertilizers, tomato is a fruit. Government of India, established in 1981 and assisted by UNDP. CIPET has been accredited with ISO 9001: Wisdom is not putting it in a 2000 certification for all its technical activities. fruit salad.” The Seminar will discuss various important aspects - Miles Kington regarding Medical Devices Packaging including Regulatory Aspects, Package Specifications, Packaging Sept. - Oct. 2015 Materials, Package Sterilization Methods, Bar-Code Labeling, International Standards and Compliance, Package Validation etc. Experts and Professionals from Medical Devices Industry will also make presentations and share their rich experience. The Seminar will be participated by: Medical Devices / Disposables Manufacturers, Biomedical Engineers, Consultants, Students, Academic Institutions, Packaging Materials and Machineries Manufacturers/Suppliers, Plastic Engineers, Entrepreneurs / Executives. This issue also introduces mediNETForum, the unique networking opportunity for the Medical Device Industry in Asia. 18

EDITOR D.L.PANDYA, B.E.(Chem), M.I.E. ASSOCIATE EDITOR FromDtheeEsdkitor’s Mr. Rahil Engineer, B.E. (Biomedical Eng.) The focus for this issue is the most dynamic area in the medical device sector - medical tubing and extrusion technology. The EDITORIAL ADVISORY BOARD medical device industry contributes significantly to the healthcare industry as well as the patients in improving the quality of healthcare Dr. TARANG PATEL services by way of reducing procedure and hospitalization times, and patients trauma, M.B.B.S., M.Ch. (ONCO) while improving outcomes. This is possible because of advancements offered by medical Cancer & Reconstructive Surgeon tube manufacturers by way of more properties, more material options as well as more precise process control which in turn results in improved medical device designs. A Mr. C. BALAGOPAL good understanding of polymer science and behavior of polymer materials is very Director - Enter Technologies Pvt. Ltd. important in order to get high quality medical tubings. A very detailed overview on various Chairman - Mobilexion Technologies Pvt. Ltd. techno-commercial aspects related to medical tubing and extrusion technology is covered in this issue. Trivandrum This issue also covers the vision of Shri Rajiv Nath, Forum Coordinator, AIMED, to Dr. DILIP H. RAIKER take India amongst top 5 manufacturing hubs of medical devices in the world. He Ph.D., M.Sc., PGDBM, AMIE (Chem.Engg.) has covered various critical issues essential for converting this slogan into successful Former Chief Manager(P), CIPET - Chennai policy implementation. ING LOUIS C. SUHUURMAN Another important highlight is the recommendations by CII to the Department of Formerly Sales Director Pharmaceutical related to support required by the Indian Medical Device industry to COLPITT B.V., Holland achieve “Make In India” mission. As per Mr. Himanshu Baid, Chairman of CII Medical Technology Division, “Without the availability of indigenous components, the Dr. A.V. RAMANI Preferential Market Access (PMA) policy will not yield any results, as already seen Group Sr. Vice President (R&D), The TTK Group in the electronics and IT hardware sectors. Before the implementation of PMA policy in Medical Devices & Equipments Sector, there is a need to properly analyze the Dr. C.S.B. NAIR components manufacturing capabilities in India” CII therefore recommends promoting Director (R&D), Peninsula Polymers Ltd the components and ancillary sector. The CII MTD division has made various other important recommendations in order to further capacity building in this segment. Dr. BHARAT GADHAVI CEO, Medisurge Hospitals It might be interesting to note that in the editorial of the July 2003 issue of this magazine, we had mentioned that, “internationally as well as in India, the Medical Device Sector Mr. A.S. ATHALYE is Research and Development intensive and the success of the companies is driven Arvind Athalye Technology Transfer Pvt.Ltd, Mumbai by Innovation and Technology improvements. It is obvious therefore that supplier plays a very important role and contributes significantly to the success of medical devices Dr. SUJOY K. GUHA manufacturing industries world over”. With this in mind, the conference on “Indian B.Tech.(Hon), M.Tech., M.S., Ph.D., M.B.B.S. Medical Devices & Plastics Disposables / Implants Industry” along with the Technology Display Show Exhibition is being organized every year since 2001. IIT, Kharagpur The mission is, “to create a platform for the Indian Medical Device industry and the technology / product / service providers with an objective to facilitate an Dr. G.S. BHUVANESHWAR environment of healthy growth”. The event is supported by all major Industry Director - Innovation & Edn, Associations in the medical devices, pharmaceuticals and plastics sectors. We hope the Trivitron Healthcare Pvt. Ltd., Chennai and next event to be held in Ahmedabad on February 12-13, 2016 will also be successful like Jt. Co-ordinator - Regulation, AIMED, India. the previous events. Dr. J. V. Tyagi 19 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: [email protected] 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. Sept. - Oct. 2015

Cover Story Medical Tubing And Extrusion Technology Currently Medical Disposables and Low-end medical equipment polymer materials is extremely important for achieving high-quality in India are led by the Domestic Manufacturers.Plastic Disposables extruded tubing. Polymer material suitable for medical tubing accounts for 25-30% of Medical Devices, while Implants accounts should have: Inertness to body tissues and fluids, Flexibility, for 20-25% of Healthcare Market in India.Today, plastics are the Resistance to sterilization conditions, Low extraction, Clarity dominant tubing materials for transferring IV Fluid, Drug and other and Low cost for high volume applications. PVC, with the best applications for Patient Feeding in hospitals and clinics. The combination of performance and cost, is the most widely used medical tubing segment comprises the most dynamic area plastic medical tubing material. PVC has been the material of in the medical device landscape.The market of Plastic Tubing choice for flexible medical tubing and respiratory masks for more is expecting significant growth due to changing global than 30 years because of its balance of cost and functional demographics and the growth of medical procedures such properties. Polyethylene is the second largest material in medical as minimally invasive surgeries. Primary drivers of the global tubing based on volumes consumed. TPE, polyamide, silicone, market for medical tubing are the increasing demand for medical fluoropolymer and PEEK also find specialized niches in tubing devices that incorporate tubing, the growing access to health care systems. PP and PC are also used as medical tubing materials. around the globe, which carries with it a Tubing quality is market for medical affected by a number devices and the of factors, including tubing associated raw material with those devices selection, material and minimally handling, and the invasive surgeries. many parameters of the tubing extrusion Critical Applications process. All of these materials have their Plastic tubing plays a pros and cons. One drawback is that many pivotal role in many of them contain gels, requiring that tubing advanced medical manufacturers have proper understanding procedures, such as of the process technology and know- vascular catheters, how to either minimize or eliminate the gels in conduits for acquiring the tubing. Another drawback is residence biopsy samples, and time in the barrel. Because these holders for stents materials have complex chemistries, being implanted into they tend to be very sensitive to excess heat, shear, and process times. Because they degrade quickly, well-established processes, heart arteries. highly trained technicians, and well-maintained equipment are key to successfully extruding precision medical device tubing Minimally invasive repeatably and reproducibly. techniques such as Advances in extrusion technology are aiding the evolution of plastic tubing with the latest developments that include special angioplasty drove the formulations offering unique combinations of desired properties such as strength, flexibility, a high gas-barrier rating and need for tubing with lubricity.The extrusion process is only as good as the manufacturer’s ability to control it. small diameters and A tube’s dimensions can affect the performance thin walls, characteristics of extruded medical tubing. However, process parameters, equipment, and material characteristics also play temperature control became critical for maintaining tight an important role in determining the end properties of an extruded tube. Tubes have also shrunk dramatically in recent dimensional tolerances.Other Examples of tubing applications include high-pressure catheter tubing, stent-delivery catheters, and balloon tubing used in medical balloons, especially stent- delivery balloons.Examples of markets that rely heavily on tubing technology include the following: • Neurovascular (e.g.,treatment of stroke). • Cardiovascular (e.g., angioplasty, stenting, cardiac ablation, and mitral valve repair). • Peripheral interventions (e.g., stent grafts, venous therapy). • Endoscopic and renal denervation applications • Implants (e.g, inferior vena cava filter, and prosthetics valves). Material & Process Requirements For High-Quality Extruded Tubing A good understanding of polymer science and the behavior of 20 Sept. - Oct. 2015

Cover Story years, to the point where a human hair is thick compared with delivers increased functionality, lower profiles, and lower costs— some tube walls. Manufacturing such products poses considerable pushing the limits of material behavior and manufacturing science. challenges, requiring special extrusion equipment, precise process Next-generation balloon catheters are expected to deliver control, and painstaking inspections. significantly higher burst pressures and better puncture resistance. They are also being designed to transport target-specific drug- Medical Tubing Configurations polymer payloads or flexible microelectronic packages to various parts of the human body. Designs are calling for ever smaller and Medical Tubes are categorized mainly by following types according more capable medical devices, and many are made to last only to Different Configurations: one operation. Smaller tubes accommodate the trend to less invasive procedures because less traumatic procedures shorten a. According to the structure : Single-Lumen, Double-Lumen, patient recovery times.The challenge is to make them tight enough Multi-Lumen, Two-Row, Multi-Row etc. for a reliable design in terms of how the product will be used, yet loose enough to facilitate assembly and avoid unneeded features b. According to the performance : High-Pressure Tube, UV and costs. Protection Tube, Flame Retardant Tube Antimicrobial Tube, Gamma Ray Protection Tube. Braiding and coiling can improve performance in medical device applications by increasing torque force or the bend c. According to the usage : High-Transparent Tube, Tube With radius of a tube. Designing and developing complex multiple- Color Line (One Or Multi-Lines), Radiopaque Tube (One Of lumen tubing can spur innovation, provided that the designer Multi-Lines Or Whole), Micro-Flow Tube, Intravascular Tube, understands the latest technology and how best to work with a Balloon Tube, High-Pressure Tube. tubing manufacturer. Single and Multi-lumen tubes No longer will a single-lumen microbore tube suffice for medical applications. What often works best is a multi-lumen tube, one with passages for several tasks. Of course, tubes need to stay the same micro-diameter but now require multiple lumens (more than one hole). Multiple lumens are designed to achieve a desired performance in the smallest space possible. Two to 12 lumens can be designed into a single tube to provide multiple activities through a single access port.”Lumens often carry fluids, wires for steering a catheter, and devices to grasp tissue for a biopsy and doctors want to monitor their progress during a surgical procedure, so there could also be a fiber optic line in another lumen,” So the tube has become a delivery system.For example, with neurovascular devices designed to reach the brain for treatment, the catheter and delivery system require micro-diameter extrusions with precisely controlled walls.Also, Lumens are no longer expected to be round, and eccentric shapes (oblong or crescent for example) are becoming more common. Advances & Limitations Advances in Medical polymeric tubing science and extrusion technology directly correlate to the evolution from surgical-based intervention to minimally invasive approaches and associated medical device design. The goal of reducing procedure and hospitalization times, and patient trauma, while improving outcomes has created a dependency on tubing and extrusion science to keep pace with clinical demands. Medical tubing plays a major role in promoting cost efficiency because cardiac and urinary catheterization that involves the use of catheter tubing, greatly reduces the time taken for the concerned medical or surgical procedure. As a result, the hospital stay is shortened, which, in turn, lowers the overall charges a patient is likely to pay for treatment. Today’s medical device engineers must understand the advances and limitations of tubing technology as defined by both the extrusion process and post-extrusion technology in order to take advantage of the best designs and ensure the success of their products. Medical device manufacturers are being challenged by strong market demand for tubing that Sept. - Oct. 2015 21

Cover Story Tubes and Catheters Sizing Problems can arise when the A second method of sizing customer and catheter or tubing catheters is the gauge supplier are not using the same measurement. Gauge is a scale when discussing catheter descending scale, opposite the tubing sizes. French scale of measurement which ascends with French scale and gauge scale corresponding size. The higher are the measures used to refer the gauge size the smaller the to the diameter of catheters and tubing. tubing. While each have certain advantages, misinterpreting Another less common method these standards can lead to for sizing catheter tubing is the confusion . “OD” and “ID” are abbreviations for outer diameter “PE” scale. It is specific to polyethylene and is an ascending scale and inner diameter, respectively, and are generally measured in used by some manufacturers to represent the OD and ID of the inches or millimeters. tubing, similar to French sizing. The catheter sizing classification most commonly used in the The most definitive method to describe a catheter’s dimension is medical industry is the French (Fr) scale, also known as the simply to state the exact measurements of both the outer and inner “Charrière’s system.” The French scale is an easy method to use diameters. While it may seem a little more difficult to communicate, to describe the basic size of a catheter, because it specifies the this method will actually give all the details necessary to the most obvious component, the outer diameter. The French size = researcher or catheter manufacturer to properly size your specific 3 times the diameter in millimeters. The disadvantage of the French catheter and catheter connections. scale is that it does not specify the inner diameter of the catheter or tubing. Thus, the French sizing used alone, is not specific (Ref: http://www.alnmag.com/articles/2011/08/french-gauge-od- enough to adequately describe small catheters, where internal id-mm-inches-what-does-it-all-mean diameter is critical. This scale is much more useful to specify larger catheter sizes . https://en.wikipedia.org/wiki/French_catheter_scale) Medical Tubing : Materials and Applications Sr. Materials Common Applicaions Sr. Materials Common Applicaions 1 Polyvinyl Chloride Containers used for blood and blood 9 High Density Polyethyl- Embolectomy, Guidewire dispensers, PVC components for urine or for ostomy products and tubing used for blood ene LDPE Introducers, Protective tubes, Throm- 2 Polytetrafluoro- taking and blood giving sets, catheters, ethylene, PTFE heart-lung bypass sets, haemodialysis bectomy, Sheaths and dilators for set etc. introducers, Coextruded perfusion Catheter liner, Electrical Insulation, Fluid transfer, Telecommunication tubing, Aspirator tips 10 Low Density Polyethyl- Embolectomy, Guidewire dispensers, ene LDPE Introducers, Protective tubes, 3 Fluorinated Ethylene, IV catheter, Regional Anesthesia, Throbectomy Propylene, FEP Vascular access 11 Polyurethane Angiography, Cardiac catheters, Central PUR(Aliphatic) Venous catheters, Dialysis, Epidural 4 Ethylene Fluid transfer, IV catheter, Electrical catheters, IV catheters, Epidural probes, Tetrafluoroethylene, insulation Catheters, High-pressure lines ETFE 5 Perfluoroalkoxy, PFA Fluid transfer, In Vitro diagnostics 12 Polyurethane Angiography, Cardiac catheters, Central PUR(Aromatic) Venous catheters, Dialysis, Epidural catheters, IV catheters 6 NYLON, 6, 11, 12 Angiography, Choloecstectomy, Epidural catheter, Laparoscopic instruments, Radiology 13 Polypropylene PP Guidewire dispenser tubes and Protective tubes 7 Polyether Block Amide, Angiography, Cholangeography, PEBA Epidural Catheter, Radiology 14 Ethylene Vinyl Acetate Endotracheal, Embolectomy, IV EVA therapy, Suction catheter 8 Polycarbonate PC Laparoscopic instruments, IV therapy, Laparoscopic cannulae, Tube packaging,Microtubes 15 ACETAL Laparoscopy, Guiding catheter 22 Sept. - Oct. 2015

Cover Story The Bulletin features domestic and international sources for medical tubing and extruded products Raumedic Extrusion consists of : • Single Lumen Tubing • Lay Flat Tubing • Micro Tubing • Thin Walled Tubing Functional polymer solutions for medical applications,precision • Coextrusion • High-Pressure Tubing thermoplastic and silicone extrusion from Lubrizol Advanced Materials India Pvt. Ltd., Mumbai, India. www.lubrizol.co.in • Multilumen Tubing • Gas Supply Tubing Exceptional healthcare products with proven performance begin with the • Silicone Tubing • Wire Inlay Tubing polymer technology of Lubrizol LifeSciences. The company works with customers to create functional polymer solutions for various medical Contact Details : applications. Lubrizol LifeSciences (including Vesta and Particle Sciences) Mr. Kamal Kurra - Sales Manager - India has significantly expanded capabilities through new products, state-of-the Rehau Polymers Pvt. Ltd. -art facilities, acquisitions and alliances. Bunglow No. 10, Sindhu Park Society, Jagtap Dairy Road, Pimple– Saudagar, Pune- 411027. Vesta, offers custom manufacturing services, including precision P: 020-45044700. M: 09850955508. thermoplastic and silicone extrusion as well as comprehensive silicone [email protected] fabrication. With decades of experience, the company’s service, engineering expertise, and commitment to quality are sought by customers worldwide. Fluoropolymer tubing for Medical Device Market from Vesta’s combined team works together to care for the life of customers’ Thai Scantube Co., Ltd, Thailand. www.scantube.com products. Scantube is a key supplier of fluoropolymer tubing for the medical device The combination of Lubrizol’s polymer expertise and Vesta’s quality contract market with more than 30 years of experience. The company have a global medical manufacturing allows LifeSciences to provide full service, presence with production in Asia (Thailand) and Europe(Finland), as well development and medical product solutions. Lubrizol LifeSciences is as sales/stock locations in USA and Asia. customers’ link to the innovative technologies that improve their products and the lives of consumers who use them. ScanTube is a specialist in fluoropolymer tubing. Scantube tubing is used in high performance applications and under severe environmental conditions. Contact Details : Fluoropolymer tubing offers properties such as chemical resistance, broad Mittal Shah - Head Strategy and Business Development temperature range, high purity, excellent electrical insulation, toughness Lubrizol Advanced Materials India Pvt. Ltd. and a low coefficient of friction. Scantube also provide rod, multilumen and Application & Business Centre, 6th & 7th Floor, Jaswanti Landmark, expanded PTFE/e- PTFE (brand name Coltex). The Company can produce Mehra Industrial Estate, LBS Marg, Vikhroli (W), most common designs, as well as custom made solutions. Mumbai – 400079. Maharashtra. Phone : 022 – 66027800. M : +91-9167702682. Other facilities available are: PTFE tubing, FEP tubing, PFA tubing, PVdF [email protected] tubing, MFA tubing, ETFE tubing, ECTFE tubing, Coltex Heat shrink tubing, Spiral cut tubing, Spaghetti tubing, AWG tubing Rod/ NidhiBarot - Marketing and Sales Support, monofilament Profile/Multi-lumen Custom-formed Fluoropolymer Lubrizol LifeSciences tubing, Convoluted tubing Marking of tubing. Phone : +91 22 66027826 M : +91-9167739613 [email protected] Contact Details : Mr. Korpong Vatavoravet - Managing Director Extrusion of plastic materials for medical and pharmaceutical Somporn / Mr. Leif Isacson industries from Rehau Polymers Pvt. Ltd., Pune, India. Thai Scantube Co., Ltd. 143 Moo 1. Bo-Kwangthong, Bothong. Cholburi www.raumedic.com 20270.Thailand. M. : 0066-84-3622699. P. :38-363221-2, [email protected]; [email protected]; [email protected] Decades of experience in extrusion of plastic materials have made RAUMEDIC to an important partner for medical and pharmaceutical industries. Based on the company’s in-house compounding and expertise in various Lay flat tubing, thin film extrusion, medical balloon technologies from extrusion technologies, they are able to offer individualised customer Polyzen, USA. www.polyzen.com solutions. At the same time, the company regularly conduct quality inspections. This ensures a sustainable high product quality. Polyzen is as an innovator in dip molding, RF welding, lay flat tubing, thin film extrusion, medical balloon technologies and more. Since 1990, Polyzen The manufacturing of a large number of production quantities is realised on has become recognized as a single source solution for many of the leading a clean room production floor of 6,500 m2 (ISO class 7). Modern production medical device manufacturers. From conception to full scale production, plants thereby ensure the required manufacturing accuracy and reliability. Polyzen has a proven track record in delivering countless, high quality Sept.-Oct. 2015 23

Cover Story customized medical devices and specialty components sourcing for both Pragati Plastics Pvt. Ltd. is located at New Delhi, India, Operating Since large and small medical device OEM companies. 1984 as well-known Manufacturer, Trader and importer of Engineering Products such as Tubing, Sheets, Pipes, Fitting, Valves, Profiles, Machined Collectively serving the medical device industry for over 100 years, aided Parts, Rods, Raw Materials etc for Medical devices and Foodsafe Materials with an extensive portfolio of patents and know how, Polyzen has also availability in various sizes. developed specific expertise in Thin Film RF / Heat Welding, Dip Molding, Dip Coating, Extrusions, and Device Assembly.Polyzen film and tube Offered Materials from raw materials to semi-finished include PTFE, FILLED extrusion experience encompasses a wide range of extrusion methods to PTFE, HI-PURITY PTFE, PVDF, UHMWPE, PEEK, NYLON, POM, PP, include: flat-die extrusion, blown film extrusion, co-extrusion, lay-flat tubing, PCTFE, FEP, PFA, PVC, PP, PC. The large stock of Plastics enables to fulfil coating & laminations and multi-layer constructions. urgent requirement of customers to meet deadlines. Contact Details : Contact Details: Mr. Rubin Shah Mr. Niraj K. Gupta, Director Polyzen, Inc. 1041 Classic Road, Apex, NC 27539, USA. Pragati Plastics Private Ltd. P: 919-589-0303. M: 919-656-5436 [email protected] 15, Aradhana, Sector-13, R.K. Puram, New Delhi - 110066. P. No: 011-2467 1402 / 4739, M- 09810189320. [email protected] Medical Grade Tubings And Sheetings from Welset Plast Extrusions SILCIONE MEDICAL GRADE TUBINGS FOR HEALTHCARE & Pvt. Ltd., Mumbai, India www.welset.com PHARMACEUTICAL APPLICATION from Suresh Enterprises, Gujarat, India. www.sevitsil.com Welset is a well-known and highly trusted name in plastics industry making available a wide range of colouring and compounding solutions to the Advantage SEVITISIL industry. Welset is equipped with technologically most advanced ISO 9001- Suresh Enterprises is pioneer in the field of manufacturing of Silicone & 2008 certified facility to produce full range of PVC compounds, Viton Rubber Products. masterbatches, niche medical grades and specialty products like tubings and sheetings. The facility is fully automated with clean room having class Since 1975, Sevitsil has been a significant player in this industry and is 100,000 environment. known for manufacturing silicone rubber products for various applications and have achieved the repute of giving best quality products, timely deliveries Extruded Tubes and fulfilling customized requirements. The company’s experience and the With over three decades of specialised experience in precision trained and qualified team of professionals help the company to understand custom plastic extrusions, Welset Plast Extrusions today manufactures specific customer needs and thus gives them edge over competition. extruded plastic tubes to meet global regulatory standards. Some of Key Features of SEVITISIL: Markets include medical applications, gaskets & straws, automotive 1) Clean Room Class 1,00,000 applications besides a number of industrial applications. 2) An ISO 9001 :2008 Certified. 3) Complies USP Class VI & FDA 21 CFR 177.2600 Extruded Sheets 4) Temperature Range : -60°C to + 220°C ( - 110°F to + 480°F) Welset also offers custom sheet extrusions and has developed extruded 5) Resistance to Ozone oxidation, UV, Corona Discharge, Cosmic plastic sheets for blood bags and sheets for various healthcare applications and it is a fast growing product line. Radiation. 6) Material availability as per International standards. Contact Details : 7) Fully equipped with testing facilities. Mr. Jagmohan Bhamri 8) Guaranteed Delivery in 4 to 7 Days. Mr. Paresh Mehta / D’Costa Welset Plast Extrusions Pvt. Ltd. Contact Details : 8, Metalage Industrial Compound, Subhash Marg, Off. Caves, Road, Mr. Rajendra Shah Jogeshwari (E), Mumbai–400 060. P: 022-2838 7054 / 2821 5734 Contact Number : (M)+91-9825051336 (O) 02762-224814/224240 M – 09820042666. E-mail : [email protected] [email protected] [email protected]; [email protected] Tubing, Sheets, Pipes, Fitting, Valves, Profiles, Machined Parts, Rods, Clear Extrusion, Clear Injection Moulding and Rigid Injection/Blow Raw Materials for Medical devices from Pragati Plastics Pvt. Moulding from Shriram Axiall Pvt. Ltd., Haryana, India. Ltd., New Delhi, India. www.pragatiplastics.com www.shriramaxiall.com 24 Shriram Axiall is one of the largest organized players for PVC compounds in India and has been present in the medical segment for more than 45 years. PVC is a very versatile material and has a very low carbon footprint Sept. - Oct. 2015

Cover Story as compared to other engineering polymers. It finds lot of applications Medical Grade PVC compound and Tubings from PVC Colouring, worldwide in medical segment. PVC also provides excellent flexibility and Ahmedabad, India. www.pvclplastics.com rigidity while being transparent at the same time making it active in applications like tubes, blood bags, connectors etc. Moreover PVC is very The organization PVCL, is based in Gujarat; the highest developing province cost effective as compared to other transparent polymers like Polycarbonate. of India.PVCL has added many innovative Vinyl compounds & series of Polymer compounds with value addition end products. Shriram Axiall manufactures Engineered Vinyl Compounds which finds applications across multiple medical devices. All compounds are safe to Determined to scale new heights, PVCL has been ably backed by dedicated use (phthalate free) and comply with global standards (Ideal for Exports). team of highly enterprising TQM (Total Quality Management) Personnel. The medical grades adhere to Indian standards as well as biological tests prescribed under USPXXI. The compounds are manufactured in state of Compounds for Medical Application (Extrusion) the art class 100,000 facility conforming to GMP requirements. Shriram Axiall • Tubing for drip chamber supplies India’s leading OEM’s for disposable medical devices. • I. V. Tubing • Urine bag assembly tubing • X-ray opaque tubing for cathators Some of the key products by Shriram Axiall are : • Catheter tubing • Clear Extrusion - USP Class 6 Material for Tubes, Flexible tubes for IV • Stomach tubing • B. T. Sets • Infant feeding tubing sets, Catheter Tubing, Cardio Vascular Tubes • Blood bag tubing • Scalp vain tubing • Clear Injection Moulding - Oxygen Mask, Drip Chamber, Connectors • Rigid Injection/Blow Moulding - Connectors, Small Bottles, Five Gallon • Feeding & suction tubing Contact Details : Bottles, Suction Handle, Veterinary Tubes Contact Details : Mr.Prateek Dutta - ShriramAxiall Pvt. Ltd. Mr. Girish Perkar 2nd Floor, Plot No. 52, Sector - 32. Institutional Area, Gurgaon – 122003. Haryana. P.N: +91 124-4632128. M: 09717816212. PVC Colouring [email protected] 64, Phase-I , GIDC, Opp. Citizen Indistries, Naroda, Mr. Mr. Sanjay Dimri - Sales Head, [email protected] Ahmedabad -382330. P: 079-22812004. M: 9825157828. Mr. AlokKumar - Executive – Sales West [email protected] [email protected] Sept.-Oct. 2015 25

Manufacturing MAKE IN INDIA From Slogan to Policy Implementation Rajiv Nath Forum Coordinator Association of Indian Medical Device Industry (AIMED) (Based on Presentation made by Shri. Rajiv Nath at Global Business Forum’ 2015 held in Goa in October 2015. Shri Rajiv Nath shared his vision, “India Amongst Top 5 Manufacturing Hubs of Medical Devices”, and suggested what it takes to convert this vision into reality.) 25,000.00 Imports 2. BUY INDIAN POLICY 20,000.00 Electronics & Preferential Market Access & Pricing Policy Equipment 15,000.00 Disposables and Public Health Procurement Consumables 10,000.00 Surgical Instruments • Preferential Market Access • 15% preferential pricing policy of Indian Origin Devices 5,000.00 IVD Reagents • 5% preferential pricing for IS:13485 certified manufacturers 0.00 Implants 3. CONSUMER PROTECTION 2011-12 2012-13 2013-14 Control Artificial Inflation (of MRP) source : Dept. of Pharma Control Artificial Inflation 7000 Exports • Enforce MRP on unit pack 6000 Electronics & • Impose 1% Excise Duty on MRP 5000 Equipment • Impose Excise Duty on MRP less, over 50% abatement 4000 Disposables and Consumables 4. REGULATIONS 3000 Surgical Instruments 2000 Incorrect Regulations discourage Investments IVD Reagents Regulatory Framework Implants • Separate Law Book 1000 • Separate Rule Book • Traders not be permitted to be called as Manufacturers 0 2011-12 2012-13 2013-14 • Separate Regulatory Body or Revamped CDSCO • IHPRA - Indian Healthcare Products Regulatory Authority source : Dept. of Pharma • 3rd Party Certification 16,000.00 Self Regulations 14,000.00 • AIMED & QCI Initiative • Voluntary Certification 12,000.00 • IC - MED 13485 Scheme 10,000.00 Govt. Legislation 8,000.00 Regulatory Authority- Sector Specific to 6,000.00 Enforce Law Accredition Body (NABCB) - 4,000.00 Export (2013-14) Supervises Technical Competence Import (2013-14) 2000.00 of CAB CAB (Conformity Assessment Body) - 0.00 Implants DRSieusarpggosiecsaonaltbsuIlnerssctrauenmde:CEntloDsencsetruopmnitac.bsleo&sfEqPuihpmaernmt a Support Regulator by Verification & IVD Certification 1. VIABILITY Manufacturer - Demonstrate Compliance Investors Invest if business is viable & profitable with Standards / Regulations Correct Import Duties Consumer • Withdraw all Concessional Duty Notifications • Revert Basic Duty from 0 or 5% to 10% • Revert SAD from 0% to 4% 26 Sept. - Oct. 2015

Manufacturing • Commercialization not Academic Acclaim 5. FOREIGN DIRECT INVESTMENTS • Bringing in Utility model, Expediting Patent Application processing 100% FDI restricted to Greenfield Manufacturing • Create SPV to own patents/IP infuse 100 million$ equity for Restrict 100% FDI to Green Field R&D projects • In a Manufacturing (do not permit for trading) THE VISION : • At least 60% Turnover from Manufacturing INDIA AMONGST TOP 5 • Ban Auto Route For Buying Indian Manufacturers MANUFACTURING HUBS OF 6. DEPARTMENT OF MEDICAL DEVICES MEDICAL DEVICES Coordinator & Nodal Interface - Facilitator MINISTRY OF HEALTHCARE PRODUCTS 7. PRODUCT DEVELOPMENT Incentivise Innovation Commercialising R&D • Forum for USERS, Developers & Manufacturers ® 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. • Exporting our products to almost more than 23 countries. ISO 13485 : 2003 Contact : 0434 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 : [email protected] Sept.-Oct. 2015 27

Product Gallery New Winged Female Luer Lock To Barb Connectors From Qosina Qosina is pleased to announce the addition of four new winged female luer lock to barb connectors (#11760- #11763), in stock and ready for immediate delivery. These components are offered in either a natural polypropylene (#11760, #11762) or a clear polycarbon- ate (#11761, #11763), and the female luer lock mates to any standard male luer. Barbs are available in 3/32 inch (0.093 inch, 2.4 mm) OD and 1/8 inch (0.125 inch, 3.2 mm) OD. The single-use connectors are EtO and Gamma sterilization compatible. An ergonomic wing design provides an uncompromised grip, making for easy connection or disconnection. Qosina offers a va- riety of luers and tubing along with thousands of single- use components to the medical and pharmaceutical industries.Qosina operates an ISO 9001 and ISO 14001 registered facility. Contact: Nicole Ford - Marketing Coordinator QOSINA 2002-Q Orville Drive North Ronkonkoma, New York 11779 USA . P:(631)242-3000. [email protected] www.qosina.com Qosina Breakable Male Luer Lock Connector Qosina is pleased to announce the addition of a new breakable male luer lock connector (#11759), in stock and ready for immediate delivery. A clear polycarbon- ate body and tip allows for a transparent view of fluid. The connector is E-Beam, EtO, and Gamma steriliza- tion compatible, with a 0.262 inch (6.65 mm) OD port. Breakable male luer lock connectors isolate media in a bag port until needed, eliminating the use of spikes or needles. When snapped, the break-off tip floats to the top of a bag, identifying separation and permitting flow. Qosina offers a wide selection of connectors, bags, and tubing along with a variety of single-use components for immediate delivery from our extensive inventory and offers low minimums and short lead times. Call our Customer Specialists to request a sample, obtain our latest catalog or place an order via phone +(631) 242- 3000, fax +(631)-242-3230 or e-mail [email protected]. Visit us at www.qosina.com to see our latest products. Custom sourcing services are available through our extensive network. Contact: Nicole Ford - Marketing Coordinator QOSINA 2002-Q Orville Drive North, Ronkonkoma, New York 11779 USA .P:(631)242-3000. [email protected] / www.qosina.com 28 Sept. - Oct. 2015

Sept. - Oct. 2015 29

Shree Dye Stuff AN ISO 13485-2012 CE certified Company Manufacturer of PVC Compound, (Surgical Grade, Molding & Tubing) Manufacturer & Exporter of Medical Disposable Devices & Surgical According to the customer requirment Products • Flexible PVC tubing grade compound • Flexible PVC moulding grade Range of Products : • Infusion Set compound • Blood Administration Set • Flexible PVC tube for I.V. Set, S.V. Set, • Measure Volume Set • Urine Collecting Bag X-ray opeque tube and Oxygen tube. • Urine Collecting Bag - Uro Meatry • Flexible PVC compound for Urine • Respiratory Exerciser • Twin Bore Nasal Oxygen Set bag roll • Oxygen Face Mask • Nebulizer Kit Contact Pragnesh Shah • Vaccum Suck Suction Set • Latex Surgical Gloves C-3 TPS 88, bharat Small Scale Industrial Area, • Umblical Cord Clamp B/h Gujarat Offset, Narol - Vatva Road, Ahmedabad - 382 445 Contact Yogesh Patel Mobile : +91 98246 49740, +91 93761 82700, M. : +91 98241 21383 +91 90168 13881 MEDICARE DEVICES E-mail : [email protected], 8, Maruti Industrial Estate, Nr. Sindhvai Mata Temple, [email protected] C.T.M.-Ramol Road, C.T.M. Cross Road, Amraiwadi, Ahmedabad-380 026. Gujarat (India) Phone 079-2585 5711 Our First Priourity is Customer Satisfaction E-mail : [email protected] Website : www.medicaredevices.com SHAILESH SURGICAL Leading Manufacturers and Exporters of Surgical Disposable Products PRODUCTS MANUFACTURED ISO 9001 • I.V. INFUSION SETS • SCALP VEIN SETS REGISTERED • BLOOD ADMINISTRATION SETS • BLOOD DONER SET 0434 • URINE COLLECTION BAG • RYLES/FEEDING TUBES • DISPOS ABLE SYRINGES & NEEDLES • DISPOSABLE GLOVES • SURGICAL DRESSINGS • ADHESIVE TAPES • PLASTER OF PARIS • FORMULATIONS Office: L-8, “Manhattan” Near Lion’s Hall, Mithakhali, Ellisbridge, Ahmedabad-380 006, India Phone: (91-079) 26420281, 26440236 30 Sept. - Oct. 2015

VIRTUE CERTIFICATION SYSTEMS PVT. LTD We are a leading Consulting organization providing an integrated services with We are entrusted with the responsibility to manage in India on focus on project technology : behalf of the world renowned accredited certification Body G2S Italy, ASCE (E) from IASPL & ACS Registrars – UKAS Quality Management System as per Accredited. ISO 9001, ISO 13485, Medical Devices We are involved on the certification activities in the following CE marking as per MDD/93/42, FDA areas : 510k, Audit, Documentation, training • ISO 9001:2008 - QMS and c-GMP. • ISO 14001:2004 – EMS • OHSAS 18001:2007 – OHSAS Sanjay Y .Shah – Owner Promoter • ISO 22000:2005 – FSMS • ISO/IEC 27001:2005 – ISMS M : +91 98240 17850 • ISO 13485 : 2003 – QMS for Medical Devices • ISO 30000 – Ship Building & Repairing Obelis European • CE Marking • GMP Authorized Representative Center (O.E.A.R.C) based in We have collaboration with European Notified Body for CE Mark- Brussels, Belgium since 1988 is one of the largest ing & SA 8000 certifications. Regulatory Centers in Europe, assisting non-European We have assisted over 6500 clients all over the country, as an manufacturers’ successful endeavors into Europe. expansion plan we also require well qualified personnel’s in vari- ous districts to conduct the audits and provide after sale services, F/6, Goyal Plaza, Vastrapur, Ahmedabad-380 015. INDIA. for Business Associates kindly apply for your location with com- Tel. : +91 79 66090225 E-mail : [email protected], [email protected] plete details. Business Plan preferred. Website : www.unikalindia.com 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: [email protected] OR [email protected] Products GMP. & ISO 9001 – 2000 Certified Company • Flexible Packaging Material • Paper Pouch AMIGO SURGI CARE PVT. LTD. • Aluminium Foil • Foil Seal Manufacturer of • Ribbon Pack Pouch Disposable Surgical Products: Contact : I.V.CANNULAS / B.T.SETS / I.V.SETS / Jignesh Patel : +91 94265 25388 SURGICAL LATEX GLOVES / CORD CLAMPS / URINE BAGS / MEASURE +91 90163 36699 VOLUME SETS ETC. Kavya Packaging Manufacturers / Exporters / Hospital Suppliers Plot No. 5313, Opp. Alankar Boiler, Ramol Bridge Road, Dealer are requested to Phase-4, G.I.D.C. Vatva, Ahmedabad-382445. Gujarat E-mail : [email protected] Contact : Mr.Chandrakant Sayal , B.E. (Mech. & Elec.) (DIRECTOR) Mobile:0091-9825057180 Tel.:0091-2764-268249 E-mail : • [email protected] • [email protected] Website:www.amigo-india.com Plant Address Plot No.780, Opp.: Kemron Lab Sola Santej Road, Rakanpur (Santej) – 382721 Gujarat, India Sept. - Oct. 2015 31

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 : Corresponding Address: HINDUSTAN SURGICAL HINDUSTAN SURGICAL Hasmukhbhai B. Patel Hasmukhbhai B. Patel 749/2, Sarali Pithal Road, N.H.59 Road, 23, Manav Mandir Bungalows, Village - Pithai - 387630. Taxshilla Colony, Ta.: Kathlal, Dist. Kheda, Gujarat. Old Aradhana School Circle, Email : [email protected] B/h Ramannagar, Sukhipura, Website : www.hindustansurgical.com Maninagar, Ahmedabad - 380008 Tele/Fax : (O) ++91-25440223 Email : [email protected] Cell :9824060964 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 : [email protected] 32 Sept. - Oct. 2015

Global Trends Safety Considerations Related To Modern Medical Tubing for Medical Misconnections Between Medical Device Downgauging Devices Today advances in minimally invasive techniques are extremely important to medical industry and the clinical community.The Safety Considerations To Mitigate The Risks Of challenge is to forge a different path for accessing anatomy that Misconnections With Small-Bore Connectors was previously accomplished via open surgery procedures. From Intended For Enteral Applications an end-user perspective, minimally invasive techniques offers huge benefits in terms of cost, procedure time, recovery, patient Small-bore connectors provide a mechanism for the connection comfort and improved efficacy. Better yet, the idea isn’t limited between a variety of medical devices including those with enteral to the vascular procedures, such as stenting and balloon and non-enteral (e.g., intravenous) applications. Small-bore Luer angioplasty, that are most often associated with minimally connectors can freely connect to many different medical devices. invasive, catheter-based procedures.Advances in device design that afford improved access require delivery catheters with lower Connectors can be used for the following device types: profiles, i.e. smaller outer diameters, without sacrificing real estate inside the catheter. • Intravascular Devices • Hypodermic Applications; This is driving the need for advances in polymer extrusion • Breathing Systems And Driving Gas Devices; technology and other processes and components for minimally invasive devices.This paradigm shift in approach from open • Urethral/Urinary Devices; • Limb Cuff Inflation Devices; surgery to minimally invasive access would not be possible without the co-evolution of polymer extrusion technology. The use of common connector designs, such as Luer connectors, has led to unintended connections between devices that have Today, Medical tube manufacturers offer more properties, more different intended uses and has resulted in serious and material options, and more precise process control than ever sometimes fatal consequences to patients. before. At the same time, there’s a lot less to their products than there used to be.Tubes have also shrunk dramatically in recent Following are few Safety Considerations to Mitigate the Risks years, to the point where a human hair is thick compared with of Misconnections with Small-bore Connectors Intended for some tube walls. Enteral Applications Though small, specialty tubing can cost many times more than • Misconnections can occur when a connector on a medical conventional high-volume tubes. By far, the biggest trend in the device performing a specific function is unintentionally or device industry is downgauging. These diminutive tubes are used intentionally attached to a connector from another medical to make catheters that can be inserted into the cardiovascular device that performs a completely different function. system. The smaller the catheter, the farther it can travel in a network of arteries of diminishing size. Supersmall catheters • Human factor errors coupled with widespread use of Luer also cause less trauma when inserted into the body. connectors may promote misconnections of enteral to non- enteral devices. Precision Extrusion makes tubing with walls about a quarter as thick as a human hair. And some of Advanced Polymers’ tubes • Regarding testing, to demonstrate non-inter-connectable have such thin walls that they can take the place of coatings. characteristics, the proposed connector should not provide While reducing the outside diameter (OD) of their products, tubing a secure connection with a non-enteral connector when manufacturers want to maintain as large an inside diameter (ID) assembled with moderate force. Threaded connectors as possible. Larger IDs give doctors more room to insert tools should be tested clockwise and counter clockwise. or deliver drugs into the body.Multilayer tubes are sometimes made in a series of steps. “It’s an extrusion process combined • Color-coding, labeling, and tagging or imprinting (e.g., with an assembly process. Although multilayer tubes offer “feeding only,” “medication only”) on the device, by valuable combinations of properties, they’re “astronomically themselves, are not sufficient to mitigate health concerns expensive” compared with conventional tubes. from enteral misconnection. For connectors for which non- inter-connectability has been demonstrated, color-coding, (Ref: http://www.medicaldesignandoutsourcing.com labeling, and tagging or imprinting on the connector could also be incorporated into the product design. • Side port connectors that are used for flushing and/or drug administration be tested similarly to the enteral connectors. • The Enteral labeling, including the instructions for use, should not include the terms “enteral-only” and “Non-IV.” • In addition, for the connectors for which non- interconnectability is demonstrated, labeling and tagging or imprinting (e.g., “feeding only,” “medication only”) on the connector could be incorporated into the product design. • Information regarding the potential to misconnect with other device applications should be included as a warning in the instructions for use. (Ref: http://www.fda.gov/MedicalDevices/Safety/ AlertsandNotices/TubingandLuerMisconnections/ Sept. - Oct. 2015 33

Industry News Promote Components And Ancillary Industry To Achieve ‘Make In India’ For Medical Equipment And Devices, Recommends CII New Delhi, August 10, 2015: The Co-Chairman, CII Medical Technology medical devices industry in medical Confederation of Indian Industry (CII), has Department. technology hubs. submitted several key recommendations to Recommendations: • Inverted duty structure should be the Department of Pharmaceuticals (DoP) corrected. Customs import duty on raw with regards to the infrastructure support • Attracting big global medical materials should be lower than required to boost manufacturing in the technology companies to India will help finished goods. medical technology sector in line with the create a base which will then build up Government’s “Make in India” mission. the components ecosystem. • 4% Exports Incentives for the sector should be given. The Chairman of CII Medical Technology • This, in turn, will enhance local Department, Mr Himanshu Baid, said capabilities, enable Indian companies • The three year market standing “Without the availability of indigenous to get access to components and required for new manufacturing units components, the PMA policy will not greatly enhance the local to participate in Government tenders yield any results, as already seen in the manufacturing capability. should be done away with electronics and IT hardware sector since the last four years. Before the • Once the ancillary industry is India is already a large producer of implementation of PMA policy in medical established, there will be significant disposables and consumables in India, devices and equipment sector, there is value addition in finished medical and export incentives are available for a need to properly analyze the equipment and device. some products. CII has emphasised the components manufacturing capabilities need for further capacity building in this in India.” • To begin with, only MSME / SME segment and focus on quality enhancement industry components can be given for further reduction in imports. The industry CII has emphasized the importance of preference in the PMA policy. needs to get exposed to the learnings of recognizing the fact that the manufacturing evolving quality standards from countries business case in India is quite challenging. • The process of setting up which have had a head-start in innovations While the labour costs are lower in the manufacturing facilities needs to be in this space. country, the capital investment and streamlined by designating medical productivity of the labour are critical limiting technology hubs all over the country There are several misconceptions being factors to the manufacturing business case. with the right infrastructure in place to spread about the medical technology Combined with approval delays, this makes support complex medical technology industry amongst stakeholders. the manufacturing environment quite manufacturing. Therefore, it is important to build a challenging for entrepreneurs. positive environment which makes a • Establish medical technology hubs in business case and opens doors for “Access to lowcost capital through soft each zone (north, suth, east and west). investors to start manufacturing in this loans, subsidized land, and assured power sector, thus paving the way for the ‘Make & water supply combined with tax • Manufacturing incentives like tax in India’ initiative. incentives and single-window clearance, support and low-cost funding (5% would certainly build a stronger business lower rate than the bank lending rates) (Ref: http://www.cii.in) case in India,” said Mr Pavan Choudary, to spur investments and make the busi-ness case attractive. • Concessional power tariff in manufacturing hubs. • Subsidised land prices for setting up CII MTD Division Wants Separate Marketing Code For Medical Device Industry Confederation of Indian Industries’ medical current UCPMP not allowing industry to frequently upgraded versions. Every new technology division –CII-MTD has termed engage medical practitioner for product which comes into market requires the Universal Code for Pharm- aceutical continued medical education on latest physicians to undergo sufficient trainings. Marketing Practices (UCPMP) as technologies may be detrimental to the The proposed code shouldn’t constraint detrimental to the medical device industry medical device industry. industry’s ability to provide no-frills training and urged the government to form a to medical practitioners,” said Baid. separate code for medical device industry. “CII-MTD recommends a distinct marketing practices code for medical device industry, “While CII-MTD welcomes any such code, CII representation, led by Himanshu Baid, which supports training, education and at the same time we recommend that the chairman of CII-MTD and Pavan Choudary, awareness programmes that improve code should be appropriate for medical co-chair of CII-MTD, focused on the fact patient outcome and would be pleased to device companies and industry that medical device industry is an work with department of pharmaceuticals practices, which are significantly innovation driven industry and needs to in developing an appropriate UCMMP,” said different from pharma industry” said work with medical practitioners as well Baid. Pavan Choudary. as paramedical professional in close “Medical devices have a short product (Ref: http://www.pharmabiz.com/ proximity and therefore, provision of life cycle (18 to 24 months) and have NewsDetails.aspx?aid=89809&sid=1) 34 Sept. - Oct. 2015

PACK-EQUIP National Healthcare (Mfg. Packaging Machinery) An ISO 9001 : 2008 Company 91, Avnish Society, Opp. Pavitrakunj Society Manufacturing & Exports of CTM Cross Road, Amraiwadi Medical Disposables : Ahmedabad-380 026 I.V. Set, B.T. Set, Urine Bag, Phone : 25855027 (M) 9825380739 Measured volume set, Cord Clamp, Surgical Gloves etc. Injection Moulded Medical Components and Extended Tubes : 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 : [email protected] 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: [email protected] • Web: www.jimitsurgicals.com Sept. - Oct. 2015 35

Events Events Calender Plastindia foundation elected its new Managing Committee for • COMPAMED 2015 the term 2015-18 on 22 September 2015. High - Tech Solutions For Medical Technology Date : 16th - 19th November, 2015. Details of the new elected members are as follows: Venue : Dusseldorf, Germany. President: Mr. K. K. Seksaria • 13th National Conference And Technology Exhibition A Chartered Accountant by Qualification, he has over 33 years of on Indian Medical Devices & Plastics Disposables / experience in Plastics & Engineering Industry. He is the Managing Implants Industry 2016. Director of Uma Plastics Ltd., apart from being director in various Date: 12-13 February, 2016 Companies. He is the past President of Indian Plastics Federation, Venue: Ahmedabad Management Association, Kolkata and has served as Hon. Treasurer for Plastindia Ahmedabad. Foundation for the term 2009-12. He is associated with various other Federations & NGO’s • Plastivision Arabia 2016 Region’s Leading Plastics Event Vice President : Mr. Rajiv Raval - Executive Director Date: 22 - 25 February, 2016 Vishakha irrigation Pvt Ltd Venue: Expo Center, Sharjah. A second generation entrepreneur, engaged in drip irrigation • Medical Fair India 2016 activities, committed to Go Green,Live Green. He is the past 22st International Exhibition and Conference President of Gujarat State Plastics Manufacturers Association and Date: 11-13 March, 2016 has served as Hon. Treasurer for Plastindia Foundation for the Venue: Bombay Convention & Exhibition Center, Mumbai. term 2012-15. • Medical Manufacturing Asia Treasurer : Mr. Raju Desai, Senior Executive Director – Marketing 3rd Manufacturing Processes for Medical Technology and HR at Jyoti Group a leading Plastics Design and Processing Exhibition and Conference firm in India since 1959, Director of Intercontinental Polymer Date : 31st August - 2nd September 2016. Pvt. Ltd. an Indo American joint venture focusing on plastics Venue : Singapore compounding and distribution. Available Mr. Raju Desai had been The All India Plastics Manufacturers Association (AIPMA) nominee in the Managing Committee of Medical Devices Business Development Plastindia Foundation and also nominated to Plastindia Executive Looking For Change International University (PIU) Committee. He is the past Chairman of Plastivision 2013 and past President of The All India Plastics Background Manufacturers Association (AIPMA). The quality and ability to relate to people has fetched him immense popularity in the • Over 10 years’ experience in handling Sales professional and social circle. operations, Business Development, in Health care Medical devices in product range of ICU Monitoring, Imm. Past President : Mr. Subhash Kadakia - Managing Director Gynacecology, Orthopedic Implants. Kadakia Plastics & Chemicals Pvt. Ltd. • Worked in various Medical device companies, in Mr. Pradip Nayyar - Kumar Engineering Works, Mr. Nitin Shah - Sales and Marketing division. Parth Packaging, Mr. Jayesh K. Rambhia - Premsons Plastics Pvt. Ltd., Mr. Atul H. Kanuga - Sudip Industries, Dr. E. Sundaresan • Over 3 years of experience in Clinical Research - Reliance Industries Limited, Mr. Thakkar - Mechemco Industries, Industry, Monitored 2 Clinical Device Trials as a CRA Mr. Rajeev Chitalia - Electrofocus Electricals Pvt. Ltd., Mr. Paresh V. Parekh - National Plastic Industries Ltd., Mr. Gautam H. Gandhi • Excellent communication, relationship building and - Jolly Containers, Prof. (Dr.) S. K. Nayak - Central Institute of interpersonal skills. Adapt in handling professional Plastics Engineering & Technology (CIPET), Mr. M. K. Mandal - pressure. Central Institute of Plastics Engineering & Technology (CIPET) • Strong analytical, problem solving and organizational abilities. • Strong understanding and experience in handling national level roles and regional business dynamics, having worked and traveled across the country. Interested Companies may please contact : Medical Plastics Data Service Phone: 079-26740611. Email: [email protected] 36 Sept. - Oct. 2015

Sept. - Oct. 2015 37

: 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 : [email protected] • [email protected] 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 Swivel Mount) • Endotracheal Tube Holder With Bit • Ventilator Circuit • Ventilator Circuit with Single Water Block Oxygen Therapy Products Trap(Adult, Pediatric, Neonatal) • Inflatable Anaesthesia Mask • Nasal Cannula • Ventilator Circuit with Double Wa- • Anaesthesia Mask Silicon ter Trap(Adult, Pediatric, Neonatal) • Breathing Filters(HME & BVF) • Trachostomy Tube With Cuff • Oxygen Mask Breathing Filters • Resuscitator(Ambu Bag) Airovent T-Humidifier • Anaesthesia Circuits (Mapleson D, • Endotracheal Tube Holders • Multi flow Venturi Mask Mapleson F, Bain Circuit with APL Valve) • Yankaures Suctions Systems • Single Dial Venturi Mask • Stylet • Guedel Airway • Airovent T-Humidifier • High Concentration Mask • Nasopharyngeal Airway • Dialflow Regulator • Nebulizer Set • Laryngeal Mask Airway • Airopap Full Face Mask • Nebulizer Chamber • Mallaeble gum Bougie • Close Ventilation Suction System • Incentive Spirometer • 3 Ball Spirometer • Three-way Stopcock • Extension Tubing for Infusion Systems • Pressure Monitoring Line Contact : Anil Gupta +91-90999 15731 Anaesthesia Circuits Incentive Spirometer Head Office : 106, Vijay Industrial Estate, I. B. Patel Road, High Concentration ET Holder with Bite Expandable Catheter Goregoaon (E), Mumbai - 400 063, INDIA. Mask Block Mount 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 : [email protected] [email protected] • Web : www.airwayssurgical.com 38 Sept. - Oct. 2015

GMP MANUFACTURER & EXPORTER OF MEDICAL DISPOSABLE PRODUCTS ISO - 9001-2008 Certified Company • I.V. Infusion Sets • Blood Administration Sets S. Nath & Co. • Scalp Vein Set • Urine Collection Bags Excellence in Quality • Ryles / Feeding Tubes • Catheters and Tubes Manufacturer & Exporter of • Surgical Gloves. Surgical Disposable Products since 1980 Contact : IDEAL® Mr. Bhavin Shah • Infusion Set MANUFACTURER & EXPORTER OF MEDICAL DISPOSABLE PRODUCTS • Blood Administration Set • Urine Collection Bag 4-5, Khodiyar Ware House Estate, B/h. Mahalaxmi • Urine Specimen Container Mill, Narol - Isanpur Highway, Narol, • Umblical Cord Clamp Ahmedbad-382405. (India) Phone : (O) 079- Address 25733318 (R) 079-25430211 (M) +91-9825018952 S. Nath & Co. Email : [email protected], [email protected] B. N. Estate, Near Uttam Dairy, Sukhramnagar, Ahmedabad-380021, Gujarat, India. Website : www.mescosurgical.com Contact No. : +91-79-22743246, 9825360531 Website : www.snathco.com • [email protected] Venus manufacturers PVC COMPOUNDS according to the customer requirements of BASIL manufacturers PVC COMPOUNDS ac- strength, flexibility, x-ray traceability, transpar- cording to the customer requirements of strength, flexibility, x-ray traceability, transpar- ency, colour and extraction resistance. ency, colour and extraction resistance. VENUS MEDICAL DISPOSABLE are pa- tronized by Health Care Industries For BASIL POLYMERS are patronized by Health Care Industries For • Flexible Extrusion Grade PVC Compounds • Flexible Injection Moulding Grade Pvc Compounds • Flexible Extrusion Grade PVC Compounds • Flexible PVC Tube For I.V.Set, S.V.Set, X-Ray • Flexible Injection Moulding Grade Pvc Compounds • Flexible PVC Tube For I.V.Set, S.V.Set.X-Ray Opaque Tubes • L. D. Tube For Carman Cannula Opaque Tubes • P. P. Stick For Urinbag. • Flexible PVC Layflate Film For Medical PVC Bags • Henging Tube For Urinebag • RF Welded Medical Bags for I.V. Fluid, Enema etc. • DEHP free Medical Grade PVC Compound Venus • Injection Moulded Parts like PVC Chambers, Roller MEDICAL DISPOSABLE Clamp, Adapter etc. for I.V.Set and other Medical Disposable Products. 15/a, Bhagirath Estate, Vibhag - 3, Jawaharnagar, B/h. Indiranagar, Amraiwadi, Ahmedabad–380026. BASIL POLYMERS Phone (F) : 079-22749329 3-B, Verdan Exclusive, Near Stadium Petrol Pump, (R) : 079-26621269 P. O. Navjivan, Navrangpura, Ahmedabad – 380014. Mobile : 098240 32063 Phone : 079-26565981 - 82 - 83 E-mail : [email protected] Mobile : 9909036411 / 9824045178 39 E-mail : [email protected] www.basilpolymers.com Sept. - Oct. 2015

Manufacturer And Exporter Of a ISO 9001-2000 Quality Medical Devices wide range Of Medical Devices ISO 9001 : 2000 & ISO 13485 : 2003 Products available with CE marking 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, REGISTERED FIRM 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 Wide Range Of Products : Suction Set, Yankaur Suction Set, Thoracic Catheter, Mucucs Extractor, Umbilical The company Cord Clamp etc... manufactures a wide range of Medical devices, which The company markets products its own brand name ANGELTOUCH. fall under the Certification : ISO 9001 : 2000, ISO 13485 : 2003, CE marking & GMP. main domains of : Expertise & Experience : Infusion Therapy, – OEM/Contract Manufacturing. Transfusion Therapy, – Supply of Components for Medical Devices. Dialysis, Gastroenterology, Urology, Anesthesia, ANGIPLAST and Surgery. Private Limited 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: [email protected]/[email protected] Website : www.angiplast.com 40 Sept. - Oct. 2015