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Biocompatibility Evaluation and Pre-Clinical Testing of Medical Devices

This document discusses biocompatibility evaluation and pre-clinical testing of medical devices. It describes how materials are characterized physically and chemically and evaluated biologically for cytotoxicity, haemocompatibility and toxicology. Animal trials are conducted to evaluate devices pre-clinically. Standards from organizations like ISO, FDA, EU are followed. Histopathological analysis is done at implant sites like muscle, bone, to study tissue response over time and ensure safety and integration. Examples discussed are coronary stents, heart valves, vascular grafts.

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Mythri
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53 views

Biocompatibility Evaluation and Pre-Clinical Testing of Medical Devices

This document discusses biocompatibility evaluation and pre-clinical testing of medical devices. It describes how materials are characterized physically and chemically and evaluated biologically for cytotoxicity, haemocompatibility and toxicology. Animal trials are conducted to evaluate devices pre-clinically. Standards from organizations like ISO, FDA, EU are followed. Histopathological analysis is done at implant sites like muscle, bone, to study tissue response over time and ensure safety and integration. Examples discussed are coronary stents, heart valves, vascular grafts.

Uploaded by

Mythri
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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Biocompatibility Evaluation and Pre-

clinical Testing of medical devices

A.Sabareeswaran,MVSc(Path), PhD
Histopathology laboratory,
Bio Medical Technology Wing,
Sree Chitra Tirunal Institute for Medical
Sciences and Technology.
Design- medical
Materials
device
Metal,
Engineering,
polymer,ceramic
Technology

MEDICAL
DEVICE
Evaluation
Physicochemical Clinical use

Biological- Specialities – cardio,


biocompatibility neuro, ortho, etc.,
evaluation
STANDARDS: MEDICAL DEVICES
 International Organization for Standardization: ISO

 The United States Pharmacopoeia, The National Formulary: USP

 American Standard for Testing Material: ASTM

 Food and Drug Administration : FDA

 Center for Devices and Radiological Health : CDRH

 European Union Directives : EU

 Association for the Advancement of Medical Instrumentation : AAMI

 Organization for Economic Co-Operation and Development : OECD

Central Drug Standards Control Organization (CDSCO)


India's main regulatory body for pharmaceuticals and medical
devices
INTERNATIONAL ORGANIZATION FOR
STANDARDIZATION (ISO)

Risk based
classification
Class I, IIa,b, III

 CDSCO
classification
 Class A,B,C,D
Role of Pathology in medical device
evaluation
Application Physico-
(material Chemical
identification) Characterisation

Biocompatibility
Device Evaluation Evaluation
(Animal Trials- (cytotoxicity,
Preclinical) haemocompatibility,
toxicology)

Clinical trials Clinical Use


BIOCOMPATIBILITY is the ability
of a material to perform with an
appropriate host response in a
specific application.
By Prof. David Williams
Biomaterials in living tissue can

Change over a period of time


surface chemistry, physical character

Cause biological reactions


Initiate different tissue responses in relation
to material, host
Application
 Cardio Vascular  Etc.,
 Orthopedic
 Muscular
 Neural
 Dental
 Eye
 Ear
Stents, vascular grafts
Artificial Heart valves
fabric sewing ring

Chitra-TTK

Highly polished, metal cage

Highly polished polymer disc


Orthopedic application

What is the best combination?


Dental application
 Biocompatibility evaluation– Biomaterials
 Metals,
 Polymers and
 Ceramics

 Pre clinical evaluation – Medical devices


 Single or Combination of biomaterials
 Design
BIOLOGICAL RESPONSE
• Injury
• Protein adsorption
Early
phase • Provisional matrix

• Acute inflammation
Inflamma • Chronic inflammation
tory • Foreign body tissue reaction
phase

• Fibrosis/fibrous tissue(soft) new bone


Healing • Scar tissue
phase
 Biological safety

 History and evolution


of the tissue response

 Final
integration/resorption
/degradation
Local effects after implantation
ISO10993-6
 Intramuscular implantation
 Subcutaneous implantation
 Bone implantation
 Neural implantation

(Rat, Guinea pig, Rabbit, Dog, sheep, goat,


Pig)
Intramuscular implant

Paravertebral
muscle

1 week, 4 weeks, 12
weeks

> 12 weeks- long


term

Color Atlas of Tissue Response to Biomaterials


by Mira Mohanty, A Sabareeswaran, Sulekha Baby, Joseph Sebastian, Caroline S Diana
Implant site
muscle

Color Atlas of Tissue Response to Biomaterials


by Mira Mohanty, A Sabareeswaran, Sulekha Baby, Joseph Sebastian, Caroline S Diana
Biocompatible-Nonbiocompatible

ONE WEEK

TWELVE WEEKS TWELVE WEEKS


Bone implantation

Rabbit – femur bone (cortical bone)

1 week, 4 weeks, 12 weeks

> 12 weeks- long term

Color Atlas of Tissue Response to Biomaterials


by Mira Mohanty, A Sabareeswaran, Sulekha Baby, Joseph Sebastian, Caroline S Diana
Histology – bone- implant interface- osseointegration
Coronary stent
evaluation
 ISO25539-
2:2012(en)Cardio
vascular
implants —
Endovascular
devices — Part 2:
Vascular stents
CORONARY STENTS
7 days- sub acute thrombosis (SAT)

4 weeks- Neointimal hyperplasia(NIT)

 26 weeks- long term effect, remodelling


Histology - Coronary
blood vessel with stent
struts

Color Atlas of Tissue Response to Biomaterials


by Mira Mohanty, A Sabareeswaran, Sulekha Baby, Joseph Sebastian, Caroline S Diana
Chitra –TTK
mechanical
heart valve
ISO 5840-1:2015
Vascular graft
ISO 7198:2016
Vascular graft- anastomoses, mid region

Color Atlas of Tissue Response to Biomaterials


by Mira Mohanty, A Sabareeswaran, Sulekha Baby, Joseph Sebastian, Caroline S Diana
Steps in soft tissue processing- Paraffin
embedding
Grossing Tissue processing Embedding-paraffin

Sectioning –rotary Staining


microtome 29
Steps in hard tissue processing- Resin
embedding

Bone Embedding Cutting- linear precision saw


processing

Staining
Microscopy Grinding &
Polishing
SCTIMST

Thank you

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