Seminar Report

Medical Plastics : Materials, Applications And Processing

For Medical Devices And Pharmaceuticals Industries

Host Response

• Short term

• Acute toxicity 
• Irritation (to the eye, skin, mucosal surfaces) 
• Sensitization 
• Hemolysis 
• Thrombogenicity 

• Long term 

• Subchronic and chronic toxicity 
• Genotoxicity 
• Carcinogenicity 
• Effects on reproduction, including teratogenicity

Cytotoxicity

• With the use of cell culture techniques, these tests determine 

• lysis of cells (cell death), 

• inhibition of cell growth, 

• other effects on cells 
  

• caused by the device, material or its extracts.

• In vitro method 
• Mandatory for all biomaterials

Sensitization

• These tests estimate the potential for contact sensitization of medical devices, materials and / or their extracts using suitable animal models 
• These tests are appropriate because exposure or contact to even minute quantities of potential leachables can result in allergic or sensitization reactions 
• Mandatory for all biomaterials

Irritation

• These tests estimate the irritation potential of medical devices, materials or their extracts, using appropriate sites for implant tissue such as

• Skin 
• Eye 
• Mucous membrane 
  in a suitable animal model.

• These tests are performed using appropriate route (skin, eye or mucosa) and duration of exposure or contact to determine irritant effects of materials or potential leachables

Intrcutaneous Reactivity

• Assesses the localized reaction of tissue to medical device / material extracts. 

• These tests are carried out in such devices, where determination of irritation by dermal or mucosal tests are not appropriate

          Eg : Devices having access to the blood path OR where material extractables are hydrophobic

Systemic Toxicity (Acute Toxicity)

• Estimates the potential harmful effects of either single or multiple exposures, during the period of less than 24 hours, to medical devices, materials or their extracts in suitable animal model 

• Pyrogenicity tests carried out to detect material mediated pyrogenic reactions of extracts of medical devices or materials 

Note : Pyrogenicity tests are also conducted to ensure the safe level of endotoxins in the finished / sterlized product

Subchronic Toxicity (Subacute Toxicity)

• Estimates the potential harmful effects of either single or multiple exposures, during the period of NOT less than 24 hours to a period not greater than 10% of the life span of the animal model, to medical devices, materials or their extracts in suitable animal model 

• Note : These tests may be waived for materials which has chronic toxicity data