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July-August 2024

32nd Year of Publication 

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

Content Overview: July - August 2024

Cover Story

About Plastic Materials, Components & Packaging Used For Drug Device Combination Medical Devices

Apart from performance properties including disinfection or sterilization requirements, the most important material consideration is biocompatibility (ISO 10993 test results). The selection of materials also depends on the level and duration of body contact...

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Medical Device Sector, VUCA & Comparison with Pharma

VUCA denotes Volatility, Uncertainty, Complexity and Ambiguity, a perfect cocktail prevailing in the medical devices sector in India. Entrepreneurs always thrive in such a testing time, and the same is happening in India...

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Manufacturing

Developing Drug / Device Combination Products : Concept to Commissioning

Dr. Atul Sardana, Chairman, Alfa Corpuscles Pvt. Ltd., New Delhi

The Development of Drug/ Device Combination entails the following steps :
Unmet Need Identification, Design Development, Classification of Drug/Device combinations in the currently prevailing law in India, Regulatory Approvals such as EU MDR-, Legal and Intellectual Property Right Issues...

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A Tribute

A Tribute To Prof. M S Valiathan, The Pioneer Of Medical Devices Development In India

As founder Director of Sree Chitra Tirunal Institute for Medical Sciences & Technology (SCTIMST), Trivandrum, he identified the need and took unprecedented efforts to develop high quality medical devices and implants meeting international standards. Had a vision of establishing a world class Biomedical Technology Wing campus in the country along with a hospital...

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Quality

Ensuring Patient Safety: A Comprehensive Guide to the Biological Evaluation of Medical Devices

Dr. M R Murali, Dr. S S Murugan, Dr. T S Kumaravel - GLR Laboratories Pvt. Ltd.

The biological evaluation ( BEP ) of medical devices is crucial for ensuring patient safety and regulatory compliance, guided by standards like ISO 10993-1. The BEP outlines the evaluation strategy, including test selection and risk assessment, to address potential biological risks and ensure compliance.

By integrating post-market surveillance data and new scientific findings, the biological evaluation process remains relevant and accurate, safeguarding patient health and maintaining high standards of medical device safety...

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Regulations

Navigating Regulatory Landscapes: Drug-Device Combination Products In The EU And USA?

Anil Chaudhari, Founder, Operon Strategist

The article discusses what are challenges manufacturers of combination product may face when seeking regulatory approval for their integral combination product and what are requirements for EU and US markets...

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Book Review

1. Applications of Polyurethanes in Medical Devices
2. Plastics in Medical Devices for Cardiovascular Applications

Author: Dr Ajay Padsalgikar has worked for different companies including Huntsman Polyurethanes in Belgium, Tech Biomaterials in Australia and Abbott in Minnesota, DSM Biomedical, Pennsylvania. He has more than 30 published scientific papers and 10 patents...

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Global Trends

Drug Device Combination Products Market Worth Over $180 Billion by 2029

This sector, valued at USD 110.15 billion in 2023, is a testament to the synergy between drugs, biologics, and medical devices, providing targeted therapeutic effects...

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Global Market : Medical Devices

Colombia Medical Devices Market

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

Colombia Highlights : A fairly large and stable market, A decent and growing economy, More than 80% of devices requirements are imported, Regulatory mechanism very clear and clean, Very competitive pricing dynamics...

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AiMeD & REGULATORY UPDATES

• Government Working On A Scheme To Strengthen Indian Medical Device Sector: Pharma Secretary
• CDSCO Mandates GMP Compliance For Sterile Equipment Manufacturers
• DoP To Launch Scheme For Common Facilities In State-Suported Medical Device Parks: DoP Secretary

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Industry News

• FDI Inflow Into Hospitals & Diagnostic Centres Grows 89 Per Cent in 2023-24
• Medical Device Import Grows In Last One Year In India

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Product Gallery

Ensuring Safe and Healthy Medical Plastics with Bry-Air Dryers

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Press Release

Qosina Welcomes New Representative in Germany and Benelux Region

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Did You Know?

Medical Devices That Use Breathing Gas Pathways, Like Oxygen Masks, Can Pose Risks To Patients?

Air from the device and its parts can enter the patient's breathing passageways, exposing internal tissues to chemical emissions and condensates. Patients receiving supplemental oxygen can expose others to exhaled air, especially if they cough. Patients with respiratory infections or COVID-19 who require oxygen therapy can spread viral particles through the air. If the gas pathway of a medical device can reach 100 percent saturation with water causing condensation to form, and that condensate can then reach the patient, there could be a considerable risk to patient safety. This is typically associated with medical devices which deliver humidified gas to patients.

Traditionally, toxicologists and biocompatibility experts considered the materials in breathing gas pathways as external communicating devices and evaluated these materials according to the ISO 10993 series of international standards.

In March 2017, ISO 18562 (Biocompatibility Evaluation of Breathing Gas Pathways in Healthcare Applications ) was published which is a four-part standard aimed at providing the general framework required to adequately determine the acceptability of medical devices that contain breathing gas pathways.

ISO 18562 is comprised of four parts:

1. Evaluation and testing within a risk management process,
2. Tests for emissions of particulate matter,
3. Tests for emissions of volatile organic compounds (VOCs), and
4. Tests for leachables in condensate.

The scope of ISO 18562 covers the gas pathways of every medical device, device parts, or device accessories that are intended to provide respiratory care or supply substances via the respiratory tract to patients. Therefore, not only does the facemask of a breathing device need to be tested, but also any connectors, filters, and tubing that may come into contact with the gas being delivered to the patient.

Medical devices, parts or accessories containing gas pathways that are addressed by this document include, but are not limited to, ventilators, anaesthesia workstations (including gas mixers), breathing systems, oxygen conserving equipment, oxygen concentrators, nebulizers, low-pressure hose assemblies, humidifiers, heat and moisture exchangers, respiratory gas monitors, respiration monitors, masks, medical respiratory personal protective equipment, mouth pieces, resuscitators, breathing tubes, breathing system filters and Y-pieces as well as any breathing accessories intended to be used with such medical devices. The enclosed chamber of an incubator, including the mattress, and the inner surface of an oxygen hood are considered to be gas pathways and are also addressed by this document.

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