Quality

Sree Chitra Tirunal Institute For Medical Sciences And Technology (SCTIMST)-Your Partner

For Testing And Bilogical Evaluation Of Medical Devices & Biomaterials

 

Sandhya C G, Scientist F, SCTIMST Email: csc@sctimst.ac.in

Testing and Biological evaluation of the medical devices based on international standards is gaining importance for meeting regulatory requirements in the country. In the selection of materials to be used in device manufacture, the initial consideration is the fitness for purpose with regard to characteristics and properties of the material, which include chemical, toxicological, physical, electrical, morphological and mechanical properties. This is followed with a comprehensive biological evaluation including the biocompatibility evaluation to assess the possible biological hazards and the functional performance. The Biomedical Technology Wing (BMT) of Sree Chitra Tirunal Institute for Medical Sciences & Technology, Trivandrum, which is an Institute of National Importance under the Department of Science & Technology, Government of India, has established a strong testing and evaluation capability for not only its own R&D activities but also has been a pioneer in offering an accredited testing service to the medical device industry and academia since 2003. Medical device industry across the country have availed the testing services of the Institute and it has facilitated many of them obtain regulatory approvals from Central Drugs Standard Control Organization (CDSCO) in India.

Quality Management System

The Quality Management System (QMS) for testing services confirms to the international standard ISO/IEC 17025: “General requirements for the competence of testing and calibration laboratories”. The expertise and infrastructure for testing of medical devices and biomaterial conforming to the QMS has been operational for more than two decades. Some of the highlights of the testing and calibration services offered by SCTIMST includes the following :

 

	Certified medical device testing laboratory under CDSCO
	About twenty biological tests which includes biocompatibility testing also are accredited by Le ComiteFrancaisd’Acreditation (COFRAC) of France. The test reports of all accredited tests are issued with the COFRAC logo.
	Calibration services (mechanical and thermal calibration) are accredited by National Accreditation Board for Testing & Calibration Laboratories (NABL)
	Physico-chemical testing (Residual EO, Compositional Analysis of materials using TGA, Determination of Transition Temperature & Enthalpies of fusion and crystallization of materials using DSC) is accredited by National Accreditation Board for Testing & Calibration Laboratories (NABL).

Physicochemical Characterization

Material characterization is a critical initial step in the biological evaluation process. The following is generally taken into account for their relevance to the overall biological evaluation of the device:

a) the material(s) of manufacture;
b) intended additives, process contaminants and residues;
c) leachable substances;
d) degradation products;
e) other components and their interactions in the final product;
f) the performance and characteristics of the final product;
g) physical characteristics of the final product, including but not limited to, porosity, particle size, shape and surface morphology.

Identification of material chemical constituents and consideration of chemical characterization shall precede any biological testing. Physical effects of the device shall be considered if they impact the biocompatibility and also for the functional efficacy.

Services Offered for Physicochemical Characterisation at SCTIMST

• Imaging

• Scanning electron microscopy

• Transmission electron microscopy

• Micro CT

• Fluorescence microscopy

• Stereo microscopy

• Confocal Raman

• Atomic Force microscopy

• Live animal imaging

• Chromatography

• Gas chromatography – Qualitative, Quantitative, Residual

• Ethylene Oxide

• Gel Permeation chromatography

• High Performance Liquid chromatography

• Spectroscopy

• FTIR spectroscopy

• UV visible spectroscopy

• Micro Raman Spectroscopy

• X- ray diffraction spectroscopy

• Trace element analysis (ICP-OES)

• Thermal analysis

• Differential Scanning Calorimetery (DSC)

• Differential Thermal Analysis(DTA)

• Thermogravimetric Analysis (TGA)

• Mechanical testing – tensile, compressive, shear, 3 point bending, Dynamic Mechanical analysis

• Profilometry – line/surface scanning

• Tests for PPE and fabrics

• Tensile strength and elongation at break, tear strength, synthetic blood penetration test, water vapour transmission rate

Biocompatibility Testing

Devices are made of a diverse range of materials and have various intended uses, with body contact ranging from transient skin contact to contact with blood to permanent implantation. The properties and safety of these materials must be carefully assessed with respect to the specific application in question and its degree of patient contact. An important principle in the safety assessment of medical devices is that a material that was found to be safe for one intended use in a device might not be safe in a device intended for a different use. Accurate characterization is an essential step in selecting a material for a medical device, but ultimately the final assessment must be performed on the finished product, under actual use conditions. The specific methods used to characterize materials depend in part on the criticality of the medical device for which they are intended.

Biocompatibility testing and evaluation of medical devices is performed to determine the potential toxicity resulting from contact of the device with the body. The device materials should not—either directly or through the release of their material constituents—produce adverse local or systemic effects, be carcinogenic, or produce adverse reproductive and developmental effects. Therefore, evaluation of any new device intended for human use requires data from systematic testing to ensure that the benefits provided by the final product will exceed any potential risks posed by device materials. The intended clinical use of a medical device needs to be understood in order to determine the extent of biocompatibility testing required.