Medical Classification and Agencies PDF

gg Medical Classification and Agencies what is mean of FDA and what type of agency it is FDA is food And Drug administration and its federal agency What is FDA responsible for FDA is responsible for ensuring that food cosmetic human and veterinary drugs biological product that emit radiation are sa...

gg Medical Classification and Agencies what is mean of FDA and what type of agency it is FDA is food And Drug administration and its federal agency What is FDA responsible for FDA is responsible for ensuring that food cosmetic human and veterinary drugs biological product that emit radiation are safe and effective for public use FDA is classified Medical device to what ? FDA is classified Medical device to 3 Class Class 1 these include low risk device Class 2 these devices are considered to pose potential risk great enough warrant a higher level of regulation Class 3 these are the most stringently regulated device and include heart valves PHOTO#$#$ gg 1 Recall Medical device recall is the process of recollecting products due to malfunction or patient harm and the manufacturers; distributors or the end-users can carry it. The FDA monitors all the products that are mandated for recall in order to protect the public. FDA classifies product recall into three categories: gg 2 what is SFDA Saudi Food and Drug Administration SFDA/ U.S Food and Drug Administration The Saudi Food and Drug Administration is a governmental regulatory body it was established in 2003 and it directly reports to the President of Council of Ministers. what is the aims for SFDA is to regulate 1. The safety of food and drugs for human and animal. 2. The safety of biological and chemical substance. 3. The safety of electronic devices that related to human health. 4. The accuracy and safety of medical and diagnostic devices. 5. The control and supervise licenses procedures for food, drugs and medical devices factories. 6. The disseminate and exchange information with local and international scientific and legal agencies, and setting up a database for food and drug. gg 3 What it the meaning of DOT DOT is US department of transportation what is DOT Its Federal government agency dedicated to ensuring A fast safe and efficient transportation system laws relating to health care including those concetning the transportation of minimally processed instrumentation for repair or reprocessing and the transportation of hazardous and radioactive waste The DOT inspects and cites organization for statute violation CDC Centers for Disease Control It is a federal agency within the department of Health and Human Services in USA. The aim of the agency is to promote the wellbeing and prevent injuries, diseases and disabilities. CSSD professionals are in charge of developing infection control and prevention guidelines and isolation techniques. Although CDC is not a regulatory body, majority of healthcare organizations incorporate the CDC recommendations in their policy and procedures. what is US environmental protection agency Regulatory agency the purpose of protecting human health and the environment by writing and enforcing EPA Responsible for Minimizing greenhouse gases and toxic details The USA congress developed the EPA department in 1970 as a regulating agency that protects human health and the environment. The aim of the agency is to reduce the greenhouse gases and toxic emissions, control indoor air pollution, create, and reinforce pesticide regulations. In the Kingdome of Saudi Arabia, the Ministry of Environment, Water and Agriculture is the national agency that provides the environmental and water regulations for healthcare organization. gg 4 The goal is to maintain optimum human health and to reduce the greenhouse gasses for the environment protection. Moreover, the ministry cooperates with other ministers and authorities to create and implement national guidelines that aims to protect and minimizes environmental, water pollution and response to environmental emergencies. Greenhouse gasses are defined as gasses that absorb solar radiation such as carbon dioxide, methane, ozone and fluorocarbons. What is Occupational safety and health Administration its primary role and responsibilty is to protcet worker from occupational caused illnesses and injuries Details The OSHA organization was developed in 1971 under the U.S. Department of Labor. Its main objective is to protect all kind of workers from occupation associated injuries and illnesses. Many of the OSHA regulations and guidelines are incorporated into the Saudi Labor Law. CSSD professionals must be aware of the OSHA regulations that pertaining to their practices. Guidelines and standards of OSHA related to the CSSD are: • The Occupational Exposure to Blood-borne Pathogens standards • Guidelines for the use of Ethylene Oxide Sterilization • The General Duty Clause of the Occupational Safety and Health Act gg 5