Medical Plastics Data Service Magazine September - October 2015 by Medical Plastics Data Service

Table of

Contents 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

Flashback July 2003 From Editor’s Desk Dear Readers, A recent study on Technical Support Infrastructure needs for the medical devices and diagnostics firms has clearly indicated that not only outsourcing is widely practiced but it is going to increase. Internationally as well as in India, the sector is R & D intensive and the success of the companies at a world level has been driven by innovation and technology improvement. It is obvious therefore that supplier plays a very important role and contributes significantly to the success of the medical devices manufacturing industries world over. ComPaMED 2003 is the window of technology for the medical manufacturing industry. ComPaMED, the International Trade fair for Components, Parts and Raw Materials for Medical Manufacturing. The show indicates that suppliers in the Medical Manufacturing Industry are pioneering progress and are also strengthening their role in the development sphere. ComPaMED 2003 will provide good exposure and opportunity to rise in the value chain by sourcing quality components, parts and raw materials for Medical Disposables/Equipments manufacturing. MEDICAL PALSTICS DATA SERVICE is also happy to announce a one day Seminar On Medical Device Packaging to be conducted by CIPET (Central Institute Of Plastics Engineering & Technology), Ahmedabad on September 30, 2003. Central Institute of Plastics Engineering & Technology is an autonomous institute under Department of Chemicals and Petrochemicals, Ministry of Chemicals & Fertilizers, Government of India, established in 1981 and assisted by UNDP. CIPET has been accredited with ISO 9001: 2000 certification for all its technical activities. The Seminar will discuss various important aspects regarding Medical Devices Packaging including Regulatory Aspects, Package Specifications, Packaging 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.

Did You Know ?

About Hospital Errors on Medical Tubing Killing Patients

Hundreds of deaths and serious injuries can be attributed to mix-ups with similarlooking 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 other-just as different nozzles at gas stations prevent drivers from using the wrong fuel. As the New York Times reported, a otherwise healthy young woman and her unborn daughter died after a feeding tube was mistakenly connected to an intravenous line, sending liquid food directly into her veins - a fatal, and completely avoidable, mistake. 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 hundreds of such deaths or serious injuries to tube mix-ups. However, no one knows real toll, because this kind of mistake, like medication errors in general, is rarely reported. An earlier survey of hospitals found that 16 percent had experienced a feeding tube mix-up. Medical tubing serves a variety of unique purposes in hospitals, for instance delivering medication, fluids, food, gases or blood to different areas of the body – the veins, arteries, stomach, lungs, etc. Unfortunately, many varieties of medical tubing are interchangeable and easily connectable, meaning it is very simple to mistakenly connect a feeding tube to an intravenous line, or IV fluids to an oxygen tube, leading to suffocation. 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. With nurses often working overtime or covering too many patients at once, it is all too easy to connect a tube improperly, leading to an often fatal outcome for the patient. A simple solution would be to change the design of the tubes so tubing for different functions are no longer compatible with one another. (Ref: http://articles.mercola.com/sites/articles/archive/2010/09/10/us-inactionlets-lookalike-tubes-kill-patients.aspx )

In a Nutshell.... “Knowledge is knowing that a tomato is a fruit. Wisdom is not putting it in a fruit salad.” - Miles Kington

Sept. - Oct. 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.

Sept. - Oct. 2015

Editor’s Desk

From the

The focus for this issue is the most dynamic area in the medical device sector - medical tubing and extrusion technology. The medical device industry contributes significantly to the healthcare industry as well as the patients in improving the quality of healthcare services by way of reducing procedure and hospitalization times, and patients trauma, while improving outcomes. This is possible because of advancements offered by medical 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 good understanding of polymer science and behavior of polymer materials is very important in order to get high quality medical tubings. A very detailed overview on various techno-commercial aspects related to medical tubing and extrusion technology is covered in this issue. This issue also covers the vision of Shri Rajiv Nath, Forum Coordinator, AIMED, to take India amongst top 5 manufacturing hubs of medical devices in the world. He has covered various critical issues essential for converting this slogan into successful policy implementation. Another important highlight is the recommendations by CII to the Department of Pharmaceutical related to support required by the Indian Medical Device industry to achieve “Make In India” mission. As per Mr. Himanshu Baid, Chairman of CII Medical Technology Division, “Without the availability of indigenous components, the Preferential Market Access (PMA) policy will not yield any results, as already seen 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 components manufacturing capabilities in India” CII therefore recommends promoting the components and ancillary sector. The CII MTD division has made various other important recommendations in order to further capacity building in this segment. 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 is Research and Development intensive and the success of the companies is driven 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 manufacturing industries world over”. With this in mind, the conference on “Indian Medical Devices & Plastics Disposables / Implants Industry” along with the Technology Display Show Exhibition is being organized every year since 2001. 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 environment of healthy growth”. The event is supported by all major Industry Associations in the medical devices, pharmaceuticals and plastics sectors. We hope the next event to be held in Ahmedabad on February 12-13, 2016 will also be successful like the previous events.

Cover Story Medical Tubing And Extrusion Technology Currently Medical Disposables and Low-end medical equipment in India are led by the Domestic Manufacturers.Plastic Disposables accounts for 25-30% of Medical Devices, while Implants accounts for 20-25% of Healthcare Market in India.Today, plastics are the dominant tubing materials for transferring IV Fluid, Drug and other applications for Patient Feeding in hospitals and clinics. The medical tubing segment comprises the most dynamic area in the medical device landscape.The market of Plastic Tubing is expecting significant growth due to changing global demographics and the growth of medical procedures such as minimally invasive surgeries. Primary drivers of the global market for medical tubing are the increasing demand for medical devices that incorporate tubing, the growing access to health care around the globe, which carries with it a market for medical devices and the tubing associated with those devices and minimally invasive surgeries.

polymer materials is extremely important for achieving high-quality extruded tubing. Polymer material suitable for medical tubing should have: Inertness to body tissues and fluids, Flexibility, Resistance to sterilization conditions, Low extraction, Clarity and Low cost for high volume applications. PVC, with the best combination of performance and cost, is the most widely used plastic medical tubing material. PVC has been the material of choice for flexible medical tubing and respiratory masks for more than 30 years because of its balance of cost and functional properties. Polyethylene is the second largest material in medical tubing based on volumes consumed. TPE, polyamide, silicone, fluoropolymer and PEEK also find specialized niches in tubing systems. PP and PC are also used as medical tubing materials.

Plastic tubing plays a pivotal role in many advanced medical procedures, such as vascular catheters, conduits for acquiring biopsy samples, and holders for stents being implanted into heart arteries. Minimally invasive techniques such as angioplasty drove the need for tubing with small diameters and thin walls, temperature control became critical for maintaining tight dimensional tolerances.Other Examples of tubing applications include high-pressure catheter tubing, stent-delivery catheters, and balloon tubing used in medical balloons, especially stentdelivery balloons.Examples of markets that rely heavily on tubing technology include the following:

Tubing quality is affected by a number of factors, including raw material selection, material handling, and the many parameters of the tubing extrusion process. All of these materials have their pros and cons. One drawback is that many of them contain gels, requiring that tubing manufacturers have proper understanding of the process technology and knowhow to either minimize or eliminate the gels in the tubing. Another drawback is residence time in the barrel. Because these materials have complex chemistries, they tend to be very sensitive to excess heat, shear, and process times. Because they degrade quickly, well-established processes, highly trained technicians, and well-maintained equipment are key to successfully extruding precision medical device tubing repeatably and reproducibly.

• 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).

Advances in extrusion technology are aiding the evolution of plastic tubing with the latest developments that include special formulations offering unique combinations of desired properties such as strength, flexibility, a high gas-barrier rating and lubricity.The extrusion process is only as good as the manufacturer’s ability to control it.

Material & Process Requirements For High-Quality Extruded Tubing

A tube’s dimensions can affect the performance characteristics of extruded medical tubing. However, process parameters, equipment, and material characteristics also play an important role in determining the end properties of an extruded tube. Tubes have also shrunk dramatically in recent

Critical Applications

A good understanding of polymer science and the behavior of

Sept. - Oct. 2015

Cover Story years, to the point where a human hair is thick compared with some tube walls. Manufacturing such products poses considerable challenges, requiring special extrusion equipment, precise process control, and painstaking inspections. Medical Tubing Configurations Medical Tubes are categorized mainly by following types according to Different Configurations: a. According to the structure : Single-Lumen, Double-Lumen, Multi-Lumen, Two-Row, Multi-Row etc. b. According to the performance : High-Pressure Tube, UV Protection Tube, Flame Retardant Tube Antimicrobial Tube, Gamma Ray Protection Tube. c. According to the usage : High-Transparent Tube, Tube With Color Line (One Or Multi-Lines), Radiopaque Tube (One Of Multi-Lines Or Whole), Micro-Flow Tube, Intravascular Tube, Balloon Tube, High-Pressure Tube. 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.

delivers increased functionality, lower profiles, and lower costs— pushing the limits of material behavior and manufacturing science. Next-generation balloon catheters are expected to deliver significantly higher burst pressures and better puncture resistance. They are also being designed to transport target-specific drugpolymer payloads or flexible microelectronic packages to various parts of the human body. Designs are calling for ever smaller and more capable medical devices, and many are made to last only one operation. Smaller tubes accommodate the trend to less invasive procedures because less traumatic procedures shorten patient recovery times.The challenge is to make them tight enough for a reliable design in terms of how the product will be used, yet loose enough to facilitate assembly and avoid unneeded features and costs. Braiding and coiling can improve performance in medical device applications by increasing torque force or the bend radius of a tube. Designing and developing complex multiplelumen tubing can spur innovation, provided that the designer understands the latest technology and how best to work with a tubing manufacturer.

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

Cover Story Tubes and Catheters Sizing A second method of sizing catheters is the gauge measurement. Gauge is a descending scale, opposite the French scale of measurement which ascends with corresponding size. The higher the gauge size the smaller the tubing.

Problems can arise when the customer and catheter or tubing supplier are not using the same scale when discussing catheter tubing sizes. French scale and gauge scale are the measures used to refer to the diameter of catheters and tubing. While each have certain advantages, misinterpreting these standards can lead to confusion . “OD” and “ID” are abbreviations for outer diameter and inner diameter, respectively, and are generally measured in inches or millimeters. The catheter sizing classification most commonly used in the medical industry is the French (Fr) scale, also known as the “Charrière’s system.” The French scale is an easy method to use to describe the basic size of a catheter, because it specifies the most obvious component, the outer diameter. The French size = 3 times the diameter in millimeters. The disadvantage of the French scale is that it does not specify the inner diameter of the catheter or tubing. Thus, the French sizing used alone, is not specific enough to adequately describe small catheters, where internal diameter is critical. This scale is much more useful to specify larger catheter sizes .

Another less common method for sizing catheter tubing is the “PE” scale. It is specific to polyethylene and is an ascending scale used by some manufacturers to represent the OD and ID of the tubing, similar to French sizing. The most definitive method to describe a catheter’s dimension is simply to state the exact measurements of both the outer and inner diameters. While it may seem a little more difficult to communicate, this method will actually give all the details necessary to the researcher or catheter manufacturer to properly size your specific catheter and catheter connections. (Ref: http://www.alnmag.com/articles/2011/08/french-gauge-odid-mm-inches-what-does-it-all-mean https://en.wikipedia.org/wiki/French_catheter_scale)

Medical Tubing : Materials and Applications Materials

Common Applicaions

Polyvinyl Chloride PVC

Containers used for blood and blood components for urine or for ostomy products and tubing used for blood taking and blood giving sets, catheters, heart-lung bypass sets, haemodialysis set etc.

Polytetrafluoroethylene, PTFE

Catheter liner, Electrical Insulation, Fluid transfer, Telecommunication

Fluorinated Ethylene, Propylene, FEP

IV catheter, Regional Anesthesia, Vascular access

Ethylene Tetrafluoroethylene, ETFE

Fluid transfer, IV catheter, Electrical insulation

Perfluoroalkoxy, PFA

NYLON, 6, 11, 12

Sr.

Materials

Common Applicaions

High Density Polyethyl- Embolectomy, Guidewire dispensers, ene LDPE Introducers, Protective tubes, Thrombectomy, Sheaths and dilators for introducers, Coextruded perfusion tubing, Aspirator tips

Low Density Polyethylene LDPE

Embolectomy, Guidewire dispensers, Introducers, Protective tubes, Throbectomy

Polyurethane PUR(Aliphatic)

Angiography, Cardiac catheters, Central Venous catheters, Dialysis, Epidural catheters, IV catheters, Epidural probes, Catheters, High-pressure lines

Fluid transfer, In Vitro diagnostics

Polyurethane PUR(Aromatic)

Angiography, Choloecstectomy, Epidural catheter, Laparoscopic instruments, Radiology

Angiography, Cardiac catheters, Central Venous catheters, Dialysis, Epidural catheters, IV catheters

Polypropylene PP

Guidewire dispenser tubes and Protective tubes

Ethylene Vinyl Acetate EVA

Endotracheal, Embolectomy, IV therapy, Suction catheter

ACETAL

Laparoscopy, Guiding catheter

Polyether Block Amide, Angiography, Cholangeography, PEBA Epidural Catheter, Radiology

Polycarbonate PC

Sr.

Laparoscopic instruments, IV therapy, Laparoscopic cannulae, Tube packaging,Microtubes

Sept. - Oct. 2015

Cover Story

The Bulletin features domestic and international sources for medical tubing and extruded products

Functional polymer solutions for medical applications,precision thermoplastic and silicone extrusion from Lubrizol Advanced Materials India Pvt. Ltd., Mumbai, India. www.lubrizol.co.in Exceptional healthcare products with proven performance begin with the polymer technology of Lubrizol LifeSciences. The company works with customers to create functional polymer solutions for various medical applications. Lubrizol LifeSciences (including Vesta and Particle Sciences) has significantly expanded capabilities through new products, state-of-the -art facilities, acquisitions and alliances. Vesta, offers custom manufacturing services, including precision thermoplastic and silicone extrusion as well as comprehensive silicone fabrication. With decades of experience, the company’s service, engineering expertise, and commitment to quality are sought by customers worldwide. Vesta’s combined team works together to care for the life of customers’ products. The combination of Lubrizol’s polymer expertise and Vesta’s quality contract medical manufacturing allows LifeSciences to provide full service, development and medical product solutions. Lubrizol LifeSciences is customers’ link to the innovative technologies that improve their products and the lives of consumers who use them. Contact Details : Mittal Shah - Head Strategy and Business Development Lubrizol Advanced Materials India Pvt. Ltd. Application & Business Centre, 6th & 7th Floor, Jaswanti Landmark, Mehra Industrial Estate, LBS Marg, Vikhroli (W), Mumbai – 400079. Maharashtra. Phone : 022 – 66027800. M : +91-9167702682. mittal.shah@lubrizol.com NidhiBarot - Marketing and Sales Support, Lubrizol LifeSciences Phone : +91 22 66027826 M : +91-9167739613 Nidhi.Barot@Lubrizol.com

Extrusion of plastic materials for medical and pharmaceutical industries from Rehau Polymers Pvt. Ltd., Pune, India. www.raumedic.com

Raumedic Extrusion consists of : • Lay Flat Tubing • Single Lumen Tubing • Thin Walled Tubing • Micro Tubing • High-Pressure Tubing • Coextrusion • Gas Supply Tubing • Multilumen Tubing • Wire Inlay Tubing • Silicone Tubing Contact Details : Mr. Kamal Kurra - Sales Manager - India Rehau Polymers Pvt. Ltd. Bunglow No. 10, Sindhu Park Society, Jagtap Dairy Road, Pimple– Saudagar, Pune- 411027. P: 020-45044700. M: 09850955508. kamalnain.kurra@raumedic.com

Fluoropolymer tubing for Medical Device Market from Thai Scantube Co., Ltd, Thailand. www.scantube.com Scantube is a key supplier of fluoropolymer tubing for the medical device market with more than 30 years of experience. The company have a global presence with production in Asia (Thailand) and Europe(Finland), as well as sales/stock locations in USA and Asia. ScanTube is a specialist in fluoropolymer tubing. Scantube tubing is used in high performance applications and under severe environmental conditions. Fluoropolymer tubing offers properties such as chemical resistance, broad temperature range, high purity, excellent electrical insulation, toughness and a low coefficient of friction. Scantube also provide rod, multilumen and expanded PTFE/e- PTFE (brand name Coltex). The Company can produce most common designs, as well as custom made solutions. Other facilities available are: PTFE tubing, FEP tubing, PFA tubing, PVdF tubing, MFA tubing, ETFE tubing, ECTFE tubing, Coltex Heat shrink tubing, Spiral cut tubing, Spaghetti tubing, AWG tubing Rod/ monofilament Profile/Multi-lumen Custom-formed Fluoropolymer tubing, Convoluted tubing Marking of tubing. Contact Details : Mr. Korpong Vatavoravet - Managing Director Somporn / Mr. Leif Isacson Thai Scantube Co., Ltd. 143 Moo 1. Bo-Kwangthong, Bothong. Cholburi 20270.Thailand. M. : 0066-84-3622699. P. :38-363221-2, korpong@thaiscantube.co.th; Somporn@scantube.com; Korpong@scantube.com

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 extrusion technologies, they are able to offer individualised customer solutions. At the same time, the company regularly conduct quality inspections. This ensures a sustainable high product quality. The manufacturing of a large number of production quantities is realised on a clean room production floor of 6,500 m2 (ISO class 7). Modern production plants thereby ensure the required manufacturing accuracy and reliability. Sept.-Oct. 2015

Lay flat tubing, thin film extrusion, medical balloon technologies from Polyzen, USA. www.polyzen.com Polyzen is as an innovator in dip molding, RF welding, lay flat tubing, thin film extrusion, medical balloon technologies and more. Since 1990, Polyzen has become recognized as a single source solution for many of the leading medical device manufacturers. From conception to full scale production, Polyzen has a proven track record in delivering countless, high quality

Cover Story

customized medical devices and specialty components sourcing for both large and small medical device OEM companies. Collectively serving the medical device industry for over 100 years, aided with an extensive portfolio of patents and know how, Polyzen has also developed specific expertise in Thin Film RF / Heat Welding, Dip Molding, Dip Coating, Extrusions, and Device Assembly.Polyzen film and tube extrusion experience encompasses a wide range of extrusion methods to include: flat-die extrusion, blown film extrusion, co-extrusion, lay-flat tubing, coating & laminations and multi-layer constructions. Contact Details : Mr. Rubin Shah Polyzen, Inc. 1041 Classic Road, Apex, NC 27539, USA. P: 919-589-0303. M: 919-656-5436 rubin.shah@polyzen.com

Pragati Plastics Pvt. Ltd. is located at New Delhi, India, Operating Since 1984 as well-known Manufacturer, Trader and importer of Engineering Products such as Tubing, Sheets, Pipes, Fitting, Valves, Profiles, Machined Parts, Rods, Raw Materials etc for Medical devices and Foodsafe Materials availability in various sizes. Offered Materials from raw materials to semi-finished include PTFE, FILLED PTFE, HI-PURITY PTFE, PVDF, UHMWPE, PEEK, NYLON, POM, PP, PCTFE, FEP, PFA, PVC, PP, PC. The large stock of Plastics enables to fulfil urgent requirement of customers to meet deadlines. Contact Details: Mr. Niraj K. Gupta, Director Pragati Plastics Private Ltd. 15, Aradhana, Sector-13, R.K. Puram, New Delhi - 110066. P. No: 011-2467 1402 / 4739, M- 09810189320. info@pragatiplastics.com

Medical Grade Tubings And Sheetings from Welset Plast Extrusions Pvt. Ltd., Mumbai, India www.welset.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 industry. Welset is equipped with technologically most advanced ISO 90012008 certified facility to produce full range of PVC compounds, masterbatches, niche medical grades and specialty products like tubings and sheetings. The facility is fully automated with clean room having class 100,000 environment. Extruded Tubes With over three decades of specialised experience in precision custom plastic extrusions, Welset Plast Extrusions today manufactures extruded plastic tubes to meet global regulatory standards. Markets include medical applications, gaskets & straws, automotive applications besides a number of industrial applications. Extruded Sheets Welset also offers custom sheet extrusions and has developed extruded plastic sheets for blood bags and sheets for various healthcare applications and it is a fast growing product line. Contact Details : Mr. Jagmohan Bhamri Mr. Paresh Mehta / D’Costa Welset Plast Extrusions Pvt. Ltd. 8, Metalage Industrial Compound, Subhash Marg, Off. Caves, Road, Jogeshwari (E), Mumbai–400 060. P: 022-2838 7054 / 2821 5734 M – 09820042666. mehtaparesh@welset.com dcosta@welset.com; jagmohanbhamri@welset.com

Tubing, Sheets, Pipes, Fitting, Valves, Profiles, Machined Parts, Rods, Raw Materials for Medical devices from Pragati Plastics Pvt. Ltd., New Delhi, India. www.pragatiplastics.com

SILCIONE MEDICAL GRADE TUBINGS FOR HEALTHCARE & PHARMACEUTICAL APPLICATION from Suresh Enterprises, Gujarat, India. www.sevitsil.com Advantage SEVITISIL Suresh Enterprises is pioneer in the field of manufacturing of Silicone & Viton Rubber Products. Since 1975, Sevitsil has been a significant player in this industry and is known for manufacturing silicone rubber products for various applications and have achieved the repute of giving best quality products, timely deliveries and fulfilling customized requirements. The company’s experience and the trained and qualified team of professionals help the company to understand specific customer needs and thus gives them edge over competition. Some of Key Features of SEVITISIL: 1) Clean Room Class 1,00,000 2) An ISO 9001 :2008 Certified. 3) Complies USP Class VI & FDA 21 CFR 177.2600 4) Temperature Range : -60°C to + 220°C ( - 110°F to + 480°F) 5) Resistance to Ozone oxidation, UV, Corona Discharge, Cosmic Radiation. 6) Material availability as per International standards. 7) Fully equipped with testing facilities. 8) Guaranteed Delivery in 4 to 7 Days. Contact Details : Mr. Rajendra Shah Contact Number : (M)+91-9825051336 (O) 02762-224814/224240 E-mail : sevitsil@gmail.com

Clear Extrusion, Clear Injection Moulding and Rigid Injection/Blow Moulding from Shriram Axiall Pvt. Ltd., Haryana, India. www.shriramaxiall.com 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

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as compared to other engineering polymers. It finds lot of applications worldwide in medical segment. PVC also provides excellent flexibility and rigidity while being transparent at the same time making it active in applications like tubes, blood bags, connectors etc. Moreover PVC is very cost effective as compared to other transparent polymers like Polycarbonate. Shriram Axiall manufactures Engineered Vinyl Compounds which finds applications across multiple medical devices. All compounds are safe to use (phthalate free) and comply with global standards (Ideal for Exports). The medical grades adhere to Indian standards as well as biological tests prescribed under USPXXI. The compounds are manufactured in state of the art class 100,000 facility conforming to GMP requirements. Shriram Axiall supplies India’s leading OEM’s for disposable medical devices. Some of the key products by Shriram Axiall are : • Clear Extrusion - USP Class 6 Material for Tubes, Flexible tubes for IV sets, Catheter Tubing, Cardio Vascular Tubes • Clear Injection Moulding - Oxygen Mask, Drip Chamber, Connectors • Rigid Injection/Blow Moulding - Connectors, Small Bottles, Five Gallon Bottles, Suction Handle, Veterinary Tubes Contact Details : Mr.Prateek Dutta - ShriramAxiall Pvt. Ltd. 2nd Floor, Plot No. 52, Sector - 32. Institutional Area, Gurgaon – 122003. Haryana. P.N: +91 124-4632128. M: 09717816212. prateek.dutta@shriramaxiall.com Mr. Mr. Sanjay Dimri - Sales Head, sanjay.dimri@shriramaxiall.com Mr. AlokKumar - Executive – Sales West Regionalok.kumar@shriramaxiall.com

Sept.-Oct. 2015

Medical Grade PVC compound and Tubings from PVC Colouring, Ahmedabad, India. www.pvclplastics.com The organization PVCL, is based in Gujarat; the highest developing province of India.PVCL has added many innovative Vinyl compounds & series of Polymer compounds with value addition end products. Determined to scale new heights, PVCL has been ably backed by dedicated team of highly enterprising TQM (Total Quality Management) Personnel. Compounds for Medical Application (Extrusion) • Tubing for drip chamber • I. V. Tubing • X-ray opaque tubing for cathators • Urine bag assembly tubing • Catheter tubing • Stomach tubing • B. T. Sets • Infant feeding tubing • Scalp vain tubing • Blood bag tubing • Feeding & suction tubing Contact Details : Mr. Girish Perkar PVC Colouring 64, Phase-I , GIDC, Opp. Citizen Indistries, Naroda, Ahmedabad -382330. P: 079-22812004. M: 9825157828. info@pvclplastics.com

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.)

Imports

25,000.00

Electronics & Equipment Disposables and Consumables Surgical Instruments

20,000.00 15,000.00 10,000.00

IVD Reagents

5,000.00

Implants

0.00

2 -1 11

1 2-

1 20 20 source : Dept. of Pharma

1 3-

2. BUY INDIAN POLICY Preferential Market Access & Pricing Policy

Public Health Procurement • Preferential Market Access • 15% preferential pricing policy of Indian Origin Devices • 5% preferential pricing for IS:13485 certified manufacturers

3. CONSUMER PROTECTION Control Artificial Inflation (of MRP)

Control Artificial Inflation Exports

7000

• Impose 1% Excise Duty on MRP

6000

Electronics & Equipment Disposables and Consumables Surgical Instruments

5000 4000 3000

IVD Reagents

2000

Implants

1000 0

• Enforce MRP on unit pack • Impose Excise Duty on MRP less, over 50% abatement

4. REGULATIONS Incorrect Regulations discourage Investments

Regulatory Framework • Separate Law Book

2 -1 11

1 2-

1 20 20 source : Dept. of Pharma

1 3-

• Separate Rule Book • Traders not be permitted to be called as Manufacturers • Separate Regulatory Body or Revamped CDSCO

16,000.00 14,000.00 12,000.00 10,000.00

• IHPRA - Indian Healthcare Products Regulatory Authority • 3rd Party Certification

8,000.00 6,000.00 4,000.00 2000.00 0.00

Export (2013-14) Import (2013-14)

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Self Regulations • AIMED & QCI Initiative • Voluntary Certification • IC - MED 13485 Scheme

source : Dept. of Pharma Govt. Legislation

1. VIABILITY Investors Invest if business is viable & profitable

Correct Import Duties • Withdraw all Concessional Duty Notifications • Revert Basic Duty from 0 or 5% to 10% • Revert SAD from 0% to 4%

Regulatory AuthoritySector Specific to Enforce Law Accredition Body (NABCB) Supervises Technical Competence of CAB CAB (Conformity Assessment Body) Support Regulator by Verification & Certification Manufacturer - Demonstrate Compliance with Standards / Regulations Consumer

Sept. - Oct. 2015

Manufacturing 5. FOREIGN DIRECT INVESTMENTS 100% FDI restricted to Greenfield Manufacturing

Restrict 100% FDI to Green Field • In a Manufacturing (do not permit for trading) • At least 60% Turnover from Manufacturing • Ban Auto Route For Buying Indian Manufacturers

6. DEPARTMENT OF MEDICAL DEVICES Coordinator & Nodal Interface - Facilitator

• Commercialization not Academic Acclaim • Bringing in Utility model, Expediting Patent Application processing • Create SPV to own patents/IP infuse 100 million$ equity for R&D projects

THE VISION : INDIA AMONGST TOP 5 MANUFACTURING HUBS OF MEDICAL DEVICES

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. 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 Sept.-Oct. 2015

0434

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 polycarbonate (#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 variety of luers and tubing along with thousands of singleuse 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. nford@qosina.com 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 polycarbonate body and tip allows for a transparent view of fluid. The connector is E-Beam, EtO, and Gamma sterilization 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) 2423000, fax +(631)-242-3230 or e-mail info@qosina.com. 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. nford@qosina.com / www.qosina.com 28

Sept. - Oct. 2015

Shree Dye Stuff Manufacturer of PVC Compound, (Surgical Grade, Molding & Tubing)

According to the customer requirment • Flexible PVC tubing grade compound • Flexible PVC moulding grade compound • Flexible PVC tube for I.V. Set, S.V. Set, X-ray opeque tube and Oxygen tube. • Flexible PVC compound for Urine bag roll Contact Pragnesh Shah C-3 TPS 88, bharat Small Scale Industrial Area, B/h Gujarat Offset, Narol - Vatva Road, Ahmedabad - 382 445 Mobile : +91 98246 49740, +91 93761 82700, +91 90168 13881 E-mail : shreedyestuff@gmail.com, Pritishah777@gmail.com

Our First Priourity is Customer Satisfaction

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 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 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: L-8, “Manhattan”

Near Lion’s Hall, Mithakhali, Ellisbridge, Ahmedabad-380 006, India Phone: (91-079) 26420281, 26440236

Sept. - Oct. 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 Sept. - Oct. 2015

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 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 : 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 32

Sept. - Oct. 2015

Global Trends Safety Considerations Related To Misconnections Between Medical Devices Safety Considerations To Mitigate The Risks Of Misconnections With Small-Bore Connectors Intended For Enteral Applications Small-bore connectors provide a mechanism for the connection between a variety of medical devices including those with enteral and non-enteral (e.g., intravenous) applications. Small-bore Luer connectors can freely connect to many different medical devices. Connectors can be used for the following device types: • Intravascular Devices • Hypodermic Applications; • Breathing Systems And Driving Gas Devices; • Urethral/Urinary Devices; • Limb Cuff Inflation Devices; The use of common connector designs, such as Luer connectors, has led to unintended connections between devices that have different intended uses and has resulted in serious and sometimes fatal consequences to patients. Following are few Safety Considerations to Mitigate the Risks of Misconnections with Small-bore Connectors Intended for Enteral Applications • Misconnections can occur when a connector on a medical device performing a specific function is unintentionally or intentionally attached to a connector from another medical device that performs a completely different function. • Human factor errors coupled with widespread use of Luer connectors may promote misconnections of enteral to nonenteral devices. • Regarding testing, to demonstrate non-inter-connectable characteristics, the proposed connector should not provide a secure connection with a non-enteral connector when assembled with moderate force. Threaded connectors should be tested clockwise and counter clockwise. • Color-coding, labeling, and tagging or imprinting (e.g., “feeding only,” “medication only”) on the device, by themselves, are not sufficient to mitigate health concerns from enteral misconnection. For connectors for which noninter-connectability has been demonstrated, color-coding, 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 noninterconnectability 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.

Modern Medical Tubing for Medical Device Downgauging Today advances in minimally invasive techniques are extremely important to medical industry and the clinical community.The challenge is to forge a different path for accessing anatomy that was previously accomplished via open surgery procedures. From an end-user perspective, minimally invasive techniques offers huge benefits in terms of cost, procedure time, recovery, patient comfort and improved efficacy. Better yet, the idea isn’t limited to the vascular procedures, such as stenting and balloon angioplasty, that are most often associated with minimally invasive, catheter-based procedures.Advances in device design that afford improved access require delivery catheters with lower profiles, i.e. smaller outer diameters, without sacrificing real estate inside the catheter. This is driving the need for advances in polymer extrusion technology and other processes and components for minimally invasive devices.This paradigm shift in approach from open surgery to minimally invasive access would not be possible without the co-evolution of polymer extrusion technology. Today, Medical tube manufacturers offer more properties, more material options, and more precise process control than ever 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 years, to the point where a human hair is thick compared with some tube walls. Though small, specialty tubing can cost many times more than conventional high-volume tubes. By far, the biggest trend in the device industry is downgauging. These diminutive tubes are used to make catheters that can be inserted into the cardiovascular system. The smaller the catheter, the farther it can travel in a network of arteries of diminishing size. Supersmall catheters also cause less trauma when inserted into the body. Precision Extrusion makes tubing with walls about a quarter as thick as a human hair. And some of Advanced Polymers’ tubes have such thin walls that they can take the place of coatings. While reducing the outside diameter (OD) of their products, tubing manufacturers want to maintain as large an inside diameter (ID) as possible. Larger IDs give doctors more room to insert tools or deliver drugs into the body.Multilayer tubes are sometimes made in a series of steps. “It’s an extrusion process combined with an assembly process. Although multilayer tubes offer valuable combinations of properties, they’re “astronomically expensive” compared with conventional tubes. (Ref: http://www.medicaldesignandoutsourcing.com

(Ref: http://www.fda.gov/MedicalDevices/Safety/ AlertsandNotices/TubingandLuerMisconnections/

Sept. - Oct. 2015

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 Confederation of Indian Industry (CII), has submitted several key recommendations to the Department of Pharmaceuticals (DoP) with regards to the infrastructure support required to boost manufacturing in the medical technology sector in line with the Government’s “Make in India” mission. The Chairman of CII Medical Technology Department, Mr Himanshu Baid, said “Without the availability of indigenous components, the PMA policy will not yield any results, as already seen in the electronics and IT hardware sector since the last four years. Before the implementation of PMA policy in medical devices and equipment sector, there is a need to properly analyze the components manufacturing capabilities in India.” CII has emphasized the importance of recognizing the fact that the manufacturing business case in India is quite challenging. While the labour costs are lower in the country, the capital investment and productivity of the labour are critical limiting factors to the manufacturing business case. Combined with approval delays, this makes the manufacturing environment quite challenging for entrepreneurs. “Access to lowcost capital through soft loans, subsidized land, and assured power & water supply combined with tax incentives and single-window clearance, would certainly build a stronger business case in India,” said Mr Pavan Choudary,

Co-Chairman, CII Medical Technology Department. Recommendations: • Attracting big global medical technology companies to India will help create a base which will then build up the components ecosystem. • This, in turn, will enhance local capabilities, enable Indian companies to get access to components and greatly enhance the local manufacturing capability. • Once the ancillary industry is established, there will be significant value addition in finished medical equipment and device. • To begin with, only MSME / SME industry components can be given preference in the PMA policy. • The process of setting up manufacturing facilities needs to be streamlined by designating medical technology hubs all over the country with the right infrastructure in place to support complex medical technology manufacturing. • Establish medical technology hubs in each zone (north, suth, east and west). • Manufacturing incentives like tax support and low-cost funding (5% lower rate than the bank lending rates) to spur investments and make the busi-ness case attractive. • Concessional power tariff in manufacturing hubs. • Subsidised land prices for setting up

medical devices industry in medical technology hubs. • Inverted duty structure should be corrected. Customs import duty on raw materials should be lower than finished goods. • 4% Exports Incentives for the sector should be given. • The three year market standing required for new manufacturing units to participate in Government tenders should be done away with India is already a large producer of disposables and consumables in India, and export incentives are available for some products. CII has emphasised the need for further capacity building in this segment and focus on quality enhancement for further reduction in imports. The industry needs to get exposed to the learnings of evolving quality standards from countries which have had a head-start in innovations in this space. There are several misconceptions being spread about the medical technology industry amongst stakeholders. Therefore, it is important to build a positive environment which makes a business case and opens doors for investors to start manufacturing in this sector, thus paving the way for the ‘Make in India’ initiative. (Ref: http://www.cii.in)

CII MTD Division Wants Separate Marketing Code For Medical Device Industry Confederation of Indian Industries’ medical technology division –CII-MTD has termed the Universal Code for Pharm- aceutical Marketing Practices (UCPMP) as detrimental to the medical device industry and urged the government to form a separate code for medical device industry. CII representation, led by Himanshu Baid, chairman of CII-MTD and Pavan Choudary, co-chair of CII-MTD, focused on the fact that medical device industry is an innovation driven industry and needs to work with medical practitioners as well as paramedical professional in close proximity and therefore, provision of

current UCPMP not allowing industry to engage medical practitioner for continued medical education on latest technologies may be detrimental to the medical device industry. “CII-MTD recommends a distinct marketing practices code for medical device industry, which supports training, education and awareness programmes that improve patient outcome and would be pleased to work with department of pharmaceuticals in developing an appropriate UCMMP,” said Baid. “Medical devices have a short product life cycle (18 to 24 months) and have

frequently upgraded versions. Every new product which comes into market requires physicians to undergo sufficient trainings. The proposed code shouldn’t constraint industry’s ability to provide no-frills training to medical practitioners,” said Baid. “While CII-MTD welcomes any such code, at the same time we recommend that the code should be appropriate for medical device companies and industry practices, which are significantly different from pharma industry” said Pavan Choudary. (Ref: http://www.pharmabiz.com/ NewsDetails.aspx?aid=89809&sid=1) Sept. - Oct. 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) 91, Avnish Society, Opp. Pavitrakunj Society CTM Cross Road, Amraiwadi Ahmedabad-380 026 Phone : 25855027 (M) 9825380739

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 Sept. - Oct. 2015

Events Events Calender • COMPAMED 2015 High - Tech Solutions For Medical Technology Date : 16th - 19th November, 2015. Venue : Dusseldorf, Germany.

• 13th National Conference And Technology Exhibition on Indian Medical Devices & Plastics Disposables / Implants Industry 2016. Date: 12-13 February, 2016 Venue: Ahmedabad Management Association, Ahmedabad.

• Plastivision Arabia 2016 Plastindia foundation elected its new Managing Committee for the term 2015-18 on 22 September 2015. Details of the new elected members are as follows: President: Mr. K. K. Seksaria A Chartered Accountant by Qualification, he has over 33 years of experience in Plastics & Engineering Industry. He is the Managing Director of Uma Plastics Ltd., apart from being director in various Companies. He is the past President of Indian Plastics Federation, Kolkata and has served as Hon. Treasurer for Plastindia Foundation for the term 2009-12. He is associated with various other Federations & NGO’s Vice President : Mr. Rajiv Raval - Executive Director Vishakha irrigation Pvt Ltd A second generation entrepreneur, engaged in drip irrigation activities, committed to Go Green,Live Green. He is the past President of Gujarat State Plastics Manufacturers Association and has served as Hon. Treasurer for Plastindia Foundation for the term 2012-15. Treasurer : Mr. Raju Desai, Senior Executive Director – Marketing and HR at Jyoti Group a leading Plastics Design and Processing firm in India since 1959, Director of Intercontinental Polymer Pvt. Ltd. an Indo American joint venture focusing on plastics compounding and distribution. Mr. Raju Desai had been The All India Plastics Manufacturers Association (AIPMA) nominee in the Managing Committee of Plastindia Foundation and also nominated to Plastindia International University (PIU) Committee. He is the past Chairman of Plastivision 2013 and past President of The All India Plastics Manufacturers Association (AIPMA). The quality and ability to relate to people has fetched him immense popularity in the professional and social circle. Imm. Past President : Mr. Subhash Kadakia - Managing Director Kadakia Plastics & Chemicals Pvt. Ltd. Mr. Pradip Nayyar - Kumar Engineering Works, Mr. Nitin Shah Parth Packaging, Mr. Jayesh K. Rambhia - Premsons Plastics Pvt. Ltd., Mr. Atul H. Kanuga - Sudip Industries, Dr. E. Sundaresan - Reliance Industries Limited, Mr. Thakkar - Mechemco Industries, Mr. Rajeev Chitalia - Electrofocus Electricals Pvt. Ltd., Mr. Paresh V. Parekh - National Plastic Industries Ltd., Mr. Gautam H. Gandhi - Jolly Containers, Prof. (Dr.) S. K. Nayak - Central Institute of Plastics Engineering & Technology (CIPET), Mr. M. K. Mandal Central Institute of Plastics Engineering & Technology (CIPET)

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.

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

Available Medical Devices Business Development Executive Looking For Change Background • Over 10 years’ experience in handling Sales operations, Business Development, in Health care Medical devices in product range of ICU Monitoring, Gynacecology, Orthopedic Implants. • Worked in various Medical device companies, in Sales and Marketing division. • Over 3 years of experience in Clinical Research Industry, Monitored 2 Clinical Device Trials as a CRA • Excellent communication, relationship building and interpersonal skills. Adapt in handling professional pressure. • 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: mpds00@vsnl.com Sept. - Oct. 2015

Sept. - Oct. 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

• • • • • • • • • • • • •

Contact : Anil Gupta +91-90999 15731 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 Sept. - Oct. 2015

GMP ISO - 9001-2008 Certified Company

S. Nath & Co.

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.

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

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 Sept. - Oct. 2015

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

Venus manufacturers PVC COMPOUNDS according to the customer requirements of strength, flexibility, x-ray traceability, transparency, colour and extraction resistance. VENUS MEDICAL DISPOSABLE 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 • L. D. Tube For Carman Cannula • P. P. Stick For Urinbag. • Henging Tube For Urinebag

Venus

MEDICAL DISPOSABLE 15/a, Bhagirath Estate, Vibhag - 3, Jawaharnagar, B/h. Indiranagar, Amraiwadi, Ahmedabad–380026. Phone (F) : 079-22749329 (R) : 079-26621269 Mobile : 098240 32063 E-mail : vs.6163@rediffmail.com 39

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

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

Sept. - Oct. 2015

Medical Plastics Data Service Magazine September - October 2015

Articles inside

Cover Story