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March-March 2024

32nd Year of Publication 

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

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Content Overview: March - April 2024

Cover Story

Sterility Assurance Levels Required For Medical Devices & Sterilization Methods

Contamination from microorganisms can come from various sources that could include the raw material from suppliers, the manufacturing process and the storage, handling and distribution processes. The purpose of sterilization is to inactivate the microbiological contaminants and thereby transform the nonsterile medical devices into sterile products...

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Cover Story

Medical Device Ethylene Oxide (ETO/EO) Sterilization: Validation and other challenges

An Ethylene Oxide (EO) Sterilization Validation is designed to assist the manufacturer in the development of a sterilization process that delivers the appropriate sterility assurance level and ensures repeatability for each product type developed...

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Technology

Facilitation Centre for Industrial Plasma Technologies

The Facilitation Centre for Industrial Plasma Technologies (FCIPT) as a unit of IPR, links the Institute with the industries and commercially exploits the IPR knowledgebase. FCIPT interacts closely with entrepreneurs through the phases of development, incubation, demonstration and delivery of technologies. Complete package of at broad spectrum of plasma based industrial technologies and facilitation services is offered...

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Materials

Smaller, Smarter and Sustainable : Trends that Will Define the Future of Medical Device Design

There’s never been a bigger moment for innovation in the healthcare industry than right now. Leading medical device manufacturers are in a race to develop new devices that are smarter, minimally invasive and capable of delivering better patient outcomes. But without a trusted polymers partner to offer the materials knowledge and testing capabilities necessary to give your device the performance characteristics it needs - your innovation may not be realized...

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Materials

The Emerging Trends in PVC Medical Devices (Courtsey: Shriram Polytech Limited)

Polyvinyl chloride (PVC) stands as a cornerstone in the realm of medical device manufacturing, revered for its versatility, cost-effectiveness, and compatibility with rigorous sterilization protocols. However, the landscape is evolving, with a spotlight on the polymer compounders who fuel this industry...

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Materials

50 Innovations: How Medical Polymers Revolutionized Pain Management in Diverse Medical Practices (Courtsey: SPE Medical Plastics Division)

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Professional Association

About SPE INDIA Medical Plastics Division

SPE INDIA MEDICAL PLASTICS DIVISION was virtually inaugurated by Mr. Conor Carlin SPE President 2024 during the SPE INDIA board meeting held in Mumbai on March 12, 2024. An Offline inauguration of SPE INDIA MEDICAL PLASTICS DIVISION will be shortly done at Andhra Medical Technology Zone (AMTZ), Visakhapatnam. The board meeting also selected Mr. D. L. Pandya as the Vice President, Medical Plastics Division, SPE India. This initiative is for the benefit of Indian Medical Device Industry as well as Plastic Industry Professionals...

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Global Trends

Ehylene Oxide Alternatives For Medical Device Sterilization

Finding suitable ethylene oxide alternatives for medical device sterilization is more crucial than ever with the EPA’s new emissions rule in light of the chemical’s health risks.

The new sterilization methods that don’t use EtO would not only need to be safe and effective, but also meet certain criteria for compatibility, scalability and high throughput...

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Global Market : Medical Devices

Brazil Medical Devices Market

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

Brazil is the largest medical equipment market in South America, and it is still growing. Positive factors driving the market growth for Brazil are...

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AiMeD & REGULATORY UPDATES

• Indian Embassy In Moscow Bats For Tapping Potential Of Indo-Russian Medical Device Industry Through Collaborative Efforts

• AiMeD demands separate pricing mechanism for medical devices industry

• India Changes Medical Device Application Processing System

• CDSCO to switch PSUR submission of medical devices and in-vitro devices to online system

• Health Regulator Seeks Private Labs for Quality Testing of Medical Devices

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Industry News

• AMTZ, Kyrgyzstan govt ink MoU for supply of medical equipment

• AM Naik, Madhusudan Kela invest in medical devices company S3V Vascular Technologies

• Concept medical receives USFDA IDE approval for MagicTouch AVF Indication

• Warburg buys majority stake in ophthalmic device company Appasamy

• Hindustan Syringes launches Dispojekt to reduce needle stick injuries

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Product Gallery

Combating Moisture Woes: Bry-Air's Wonder Dryer Leads the Way in Medical Plastics

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Press Release

• MEDICA 2024 + COMPAMED 2024: Know-How And Innovations For The Healthcare Business - International And Diverse With More Than 6,000 Exhibitors

• Qosina Introduces New Pharma+™ Tubing Retainers

• Qosina Welcomes New Representative in Korea

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Did You Know?

About Importance of Precise Placement of Double – Lumen Tube During Anesthesia And Surgery

A double-lumen tube (DLT) is an endotracheal tube designed to isolate the lungs anatomically and physiologically.

DLT is an essential equipment for thoracic anesthesia and its precise placement is particularly important for anesthesia and surgery...

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Did You Know?

About Importance Of Precise Placement Of Double – Lumen Tube During Anesthesia And Surgery

A double-lumen tube (DLT) is an endotracheal tube designed to isolate the lungs anatomically and physiologically. Double-lumen tubes (DLTs) are the most commonly used tubes to provide independent ventilation for each lung.

One-lung ventilation (OLV) or lung isolation is the mechanical and functional separation of the 2 lungs to allow selective ventilation of only one lung. The other lung that is not being ventilated passively deflates or is displaced by the surgeon to facilitate surgical exposure for non-cardiac operations in the chest such as thoracic, esophageal, aortic and spine procedures. It can also be used during minimally invasive cardiac surgery and in disease processes.

DLT is an essential equipment for thoracic anesthesia and its precise placement is particularly important for anesthesia and surgery.

Incidence of DLT malposition remains high and it leads to lung isolation failure and hypoxemia during one-lung ventilation.

In one such incidence, the Supreme Court directed Manipal Hospital to pay Rs 10 lakh compensation to the widow of a patient who developed hoarseness in his voice as a result of faulty insertion of a double lumen tube while administering anaesthesia. While the operating surgeon had assured the patient that the patient could regain his voice within 6-8 months with nebulization and voice therapy, the patient's voice was not restored and remained hoarse all through. The patient had virtually lost his voice.

Doctors opined that there was subluxation of the left arytenoid process, which happened due to wrong intubation during the anaesthesia procedure. It was found to be on account of the trauma caused leading to the paralysis of the vocal cord.

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