Quality

Safety Assessment of Medical Devices and GLP Complaint Studies

 

Plant Protection Products (Pesticides) – pure and formulations Chemical - generics Botanical Microbial/Biopesticides Devices – pheromone traps, impregnated mosquito net, mosquito mats.. GMOs – Genetically modified plants – B.t. cotton, B.t. Brinjal Industrial chemicals, Intermediates, Dyes Medical Devices – IUDs, Intra-ocular lenses,… Safety Assessment of Medical Devices and GLP Compliant Studies How medical devices can create safety hazards? Determinants of safety hazards Descriptive / Regulatory Toxicology Bicompatability (Toxicity) Test Methods Principles of Good Laboratory Practice (GLP) GLP Certified Test Facility - INTOX How a medical device can create safety hazards? Physical damage during its application or/and use Functional / Physical failure during its use Release of ingredients which incite undesirable local / systemic reactions in the body Local Reactions toxicity to cells stimulation of immune system Surface : skin, mucous membranes, eyes… irritation, corrosion Tissue Contact : intradermal, subcutaneous, intramuscular, intravascular… Degeneration, necrosis (cell death), inflammation, fibrosis (replacement with connective tissue) Secondary infections, abscess, systemic spread Sensitization / Allergenicity Effects Loss of function of the tissue; Physical obstructions of passages; Systemic spread /reaction; Hypersensitivity (Allergic) reaction… Systemic Reactions Organ Toxicity Entero-hepatic system - liver, stomach, intestines… Respiratory system – lungs Cardiovascular system – heart, blood vessels Urinary system – kidneys Nervous system – brain, nervous tissue Endocrine system Hemopoietic System – blood, bone marrow Reproductive system – testes, ovaries, uterus, accessory genital organs Other – bones, muscles, skin etc. Mutagenicity / Carcinogenicity Sensitization / Allergenicity

Determinants of safety hazards:   Adverse effects of medical devices depend upon, Intrinsic toxicity – chemical / physical nature of its component materials Type of tissue that will be exposed to the device The duration of that exposure Science of Toxicology “All substances are poisonous. There is none which is not a poison. The right dose differentiates a poison from a remedy” Paracelsus (1493-1541)   Biocompatability Assessment – A risk assessment exercise..   There is no risk-free device or material; The goal of device designers is to minimize risk while maximizing benefit to patients. Objective of safety assessment for medical devices: For designer – risk / benefit assessment For manufacturer – qualify the supplies and the product Mechanistic toxicologist is concerned with identifying and understanding the cellular, biochemical, and molecular mechanisms by which chemicals exert toxic effects on living organisms. Descriptive toxicologist is concerned directly with toxicity testing, which provides information for safety evaluation and regulatory requirements. Regulatory toxicologist has the responsibility for deciding, on the basis of data provided by descriptive and mechanistic toxicologists, whether a drug /chemical or a medical device poses a sufficiently low risk to be marketed for a stated purpose. RECAP.. Medical devices – one of the many essential hazards; How they pose a hazard; Local / systemic toxicity; its determinants Science of Toxicology Descriptive / Regulatory Toxicology Objective of safety assessment for medical devices: For designer – risk / benefit For manufacturer – qualify the supplies and the product Bicompatability (Toxicity) Test Methods Principles of Good Laboratory Practice (GLP) GLP Certified Test Facility - INTOX

.Page 1 :  2 :  3 :  4