TOXICITY/BIOCOMPATIBILITY EVALUATION OF MATERIALS

Dr. PV. Mohanan
(Certified Biological Safety Specialist)
Toxicology Division, Biomedical Technology Wing,
Sree Chitra Tirunal Institute for Medical Sciences and Technology (Govt. of India), Thiruvananthapuram, Kerala

Dr. PV. Mohanan

‘The Institute signifies the convergence of medical sciences and technology and its mission is to enable the indigenous growth of biomedical technology, besides demonstrating high standards of patient care in medical specialties and evolving postgraduate training programs in advanced medical specialties, biomedical engineering and technology, as well as in public health.’

Bubble Oxygenator:

Oxygenator is a bubbler based rigid shell disposable device used during open-heart surgery as the artificial lung.

Cardiotomy reservoir:

is a disposable device used during open-heart surgery for the collection, filtration and recirculation of blood from the surgical site.

Blood Bag:

Sterile disposable unit used for collection, component separation, cryostorage & transfusion of blood.

Mechanical Heart Valve :

Permanent Implant to replace the diseased natural heart valves.

Hydrocephalus Shunt :

Neurosurgical implant used for the controlled drainage of the cerebrospinal fluid.

Products in Technology Transfer

• Large Diameter Vascular Graft

• Fibrin glue

• Wound Dressings

• Field Test kit for detection of bovine mastitis in milk

• BISGMA based Dental Composites

Products in Development

• Hemoconcentrator

• Centrifugal blood pump

• Heparin grafted intraocular lens

• New Chitra Heart valve model

• Disposable ECG electrodes

• Electrical Impedance Tomography

Biomaterials R&D

• Bioceramic products
• HABG composites
• CPC injectable bone cements
• New Dental materials
• Glass ionomer & Dual Cure Resin cements
• Silicone impression material
• PU based composites
• Polymer-ceramic composites
• Oral insulin delivery using nano-particles
• Wound dressings
• Controlled drug delivery

Biological Research

• Endothelial cell culture for vascular applications
• Polymer encapsulation of cells
• Chicken egg derived antibody for Viper Venom
• Monoclonal antibody for b-Tg – platelet aggregation
• TGF-a peptide for accelerated wound healing
• In vitro pyrogen test kit

Medical Device Evaluation

Drug Development Process

• Preclinical research

• Compound synthesis & purification

• Animal testing (ADME)

• Phase I (first time into humans)

• Phase II (first data on effectiveness

• Phase III (large scale effectiveness & safety)

• Phase IV (further efficasy, safety, other indications)

Toxicity testing of medical implants and biomaterials

What is a biomaterial?

Any material of natural or of synthetic origin that comes in contact with tissue, blood or biological fluids, and intended for use in prosthetic, diagnostic, therapeutic or storage applications without adversely affecting the living organism and its components.

Plastics Metals Ceramics

Medical device

Any instrument, apparatus, appliance, material or other article including software, whether used alone or in combination, intended by the manufacturer to be used for human beings solely or principally for the purpose of.....

• Diagnosis

• Prevention

• Monitoring

• Treatment

• Injury or handicap

• Investigation

• Replacement or modification of anatomy or physiological process.

What is Biocompatibility?

Biocompatibility means; a biomaterial, device or construct can be brought into direct contact with living tissue without :

• causing a harmful tissue reaction (pain, swelling or necrosis) that could compromise function;

• causing a systemic toxic reaction; or

• having tumorigenic potential.

The biological evaluation of materials and medical devices is an extremely complex task. No single study will answer all the questions that need to be addressed in the development of medical devices. Each device design is unique and requires a customized series of studies to provide data on the biocompatibility and toxicity of all materials

Biocompatibility is primarily a surface phenomenon

The objective of the toxicity evaluation of materials, intended for the fabrication of medical devices, is to investigate the potential biological hazards by careful observation for unexpected adverse reactions or events in humans during clinical use of the medical device

The ISO 10993 is concerned with the safety in use of medical devices and materials and is intended to assess the biological response of materials or devices, as part of the overall evaluation and development of devices