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Septmeber-October 2023

31st Year of Publication 

A Techno-Economic News Magazine For Medical Plastics, Medical Devices, Diagnostics And Pharma Industry

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Content Overview: September - October 2023

Cover Story

Medical Plastics Knowledge Pavilion

The theme Pavilion is conceptualized by “Plastivision India 2023” in association with “MEDICAL PLASTICS DATA SERVICE”, a Techno-Economic News Magazine for Medical Plastics, Medical Devices, Pharmaceuticals, Diagnostics & Healthcare Industry...

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Evolution Of Polymers As Catheter Tubing Materials

The catheter and tubing market can be classified based on the technicalities of usage and is then further divided into distinct anatomical application areas, each with its own set of property criteria...

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Manufacturing

• Reciprocal Die Assembly Streamlines Medical Tubing Extrusion

A reciprocal extrusion die assembly for medical wound-drain tubing developed by Guill Tool is an alternative to traditional tip and die assemblies...

• Filler-Sealer Machine for Single-Dose Plastic Vials

In addition to the enhanced sterility afforded by fully automatic mechanisms, the machine does not require preheating with hot air, significantly mitigating any risk of compromising the filled product...

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Medical Device Translation And Compliance

Dr. Manoj Komath, Scientist G, Biomedical Technology Wing, Sree Chitra Tirunal Institute for Medical Sciences and Technology, Trivandrum

The design and development process of a medical device is basically a translation activity of converting the requirements of an unmet need into a physical product. To ensure consistent translation, a set of policies and practices could be adopted, known as the ‘medical device design controls’. Good design controls help...

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Quality

Materiovigilance programme of India and its reporting tools

Mr. V. Hari Haran, Senior Materiovigilance Associate, Materiovigilance programme of India (MvPI), Indian pharmacopoeia Commission (IPC) Posted in National Institute of Mental Health and Neurosciences (NIMHANS), Bengaluru. (Ministry of Health & Family Welfare) Govt of India

Mrs Abirami N Materiovigilance associate  Materiovigilance programme of India Indian pharmacopoeia
commission Ghaziabad

The Ministry of Health and Family Welfare, Government of India, approved and commenced the Materiovigilance Programme of India (MvPI) in the country with the sole objective of monitoring the safety and ensuring the quality of medical devices used in the country...

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Global Trends

Radiation Effect On Polymer Materials Commonly Used In Medical Devices

The purpose of this proposal is to expand our understanding of radiation effects on polymer materials commonly used in medical devices by comparing gamma, e-beam, and X-ray irradiation...

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Global Market : Medical Device

Guatemala : Medical Devices Market

Mr. Amit Dave, M. Pharm, MBA, Former CEO – Brazil operations/ Vice President Export - Zydus Cadila Claris Lifesciences

Guatemala is the largest country in the Central American region (which has seven countries). The other countries in this region are Belize, Costa Rica, El Salvador, Honduras, Nicaragua, and Panama...

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AiMeD & Regulatory Updates

• High-risk Medical Device Makers Get Six Months Reprieve On Mandatory Licensing Norms

• CDSCO Approves Nine More MDTLs Taking Total Labs To Test Medical Devices To 39

• Education Scheme For Medical Devices Sector Approved

• Faced With Backlogs, Medical Devices Industry Suggests Third-party Audits

• DoP Amends NIPER Statutes To Appoint Director Of Institute On Contract Basis

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Industry News

• Govt rolls out Rs 5,000 cr scheme for innovation in pharma, medtech

• Gujarat’s Medical Device Park At Nagalpar Near Rajkot To Be Operational By End Of 2024

• Country’s Geriatric Care Services Market Including Medical And Non-medical, Personal Care Services is projected to grow

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Book Review

Plastics in Medical Devices : Properties, Requirements and Applications (Third Edition) By Vinny R. Sastri, PhD

This new edition (third edition) has been thoroughly revised and updated with new plastic materials, applications, and requirements. The book has been updated with the changes to global regulations and standards since the last edition...

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Press Release

• British Deputy High Commissioner Visits Carclo India Manufacturing Facility

• Qosina Introduces RondelO™ Stopcock Manifolds

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Did You Know?

About Potential Complications Associated With Haemodialysis Catheters

Haemodialysis is a treatment used when kidneys fail (Stage 5 Kidney Disease) and can no longer clean blood and remove extra fluid from your body. A haemodialysis access or vascular access is a way to reach your blood for haemodialysis.

Haemodialysis Catheters are implanted and used in haemodialysis (treatment to filter waste and water from the blood), apheresis (a technology that separates donated blood components to treat certain illnesses), and infusion (a method of putting fluids into the bloodstream) for up to 21 days.

A 2018 estimate put the number of patients on chronic dialysis in India at about 175,000, giving a prevalence of 129 per million population.

Dialysis catheters are used either as temporary solutions or as a bridging device while patients wait for fistula or graft maturation or kidney transplantation, or as the sole chronic access method. Complications associated with dialysis access, and especially with dialysis catheters, are on the rise as patients diagnosed with end stage renal disease (ESRD) are increasing both in age and in co-morbidities.

Complications of Haemodialysis Catheters include infection, thrombosis, cardiac arrthymia, entrapped guide wire and malposition.

Recently, based on complaints of injuries, US FDA ordered recall for a Dual Lumen High Flow Catheters manufactured by a leading medical device company due to a potential catheter hub defect that may cause leaks across the catheter’s tubes. During treatment, this leak could result in mixing of the arterial and venous blood, lead to increased recirculation and poor dialysis, or cause the development of blood clots in the blood vessels.

The use of the defective catheter may cause serious adverse health outcomes, including bleeding or the need for surgical removal and replacement of the affected catheter.

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