Module 5-Regulation and Standards PDF

Regulation and standards Introduction The healthcare organizations are obligated to follow regulations, national and international guidelines and voluntary standers in order to maintain the minimum level of safety and quality assurance. This has a major impact on the healthcare professionals, CSSD a...

Regulation and standards Introduction The healthcare organizations are obligated to follow regulations, national and international guidelines and voluntary standers in order to maintain the minimum level of safety and quality assurance. This has a major impact on the healthcare professionals, CSSD as service and on the CSSD workers. If these guidelines are not followed the outcome may vary from legal consequences to poor patient outcomes. This online module layout the regulations and standards related to the CSSD and their influence on the CSSD process. Moreover, definitions related to the topic will be given. Learning Objectives: • Explain the difference between regulations, voluntary and regulatory standards • Explain the Saudi Food and Drug Administration SFDA/ U.S Food and Drug Administration role and regulations in teams of: § Medical device classification and medical device reporting requirements § Medical device recalls • Explain the roles and responsibilities of other governmental agencies such as: § Centers for Disease Control (CDC) § Environmental Protection Agency (EPA) § Occupational Safety and Health Administration (OSHA) • Discuss professional agencies and associations that develop regulations and standards affecting Central Service: § Association for the Advancement of Medical Instrumentation (AAMI) § American National Standards Institute (ANSI) § International Standards Organization (ISO) § Association of Operating Room Nurses (AORN) § Association for Professionals in Infection Central and Epidemiology (APIC) § Society of Gastroenterology Nurses and Associates (SGNA) Learning Outcomes By the end of this module the student should be able to: 1. Understand the role of the Saudi Food and Drug Administration in the CSSD 2. Understand the difference between regulations, voluntary and regulatory standards 3. Outline an important professional agencies and associations that have an affect in the CSSD. Regulation and standards Regulation and Standards In the field of CSSD, officers and healthcare professionals are mandated to adhere to the national and international standards and the regulations. In order to translate standards and the regulations into practice once must understand their meanings and differences. Standards are divided into: § Regulatory Standards: defined as standards mandated by the government and noncompliance with this type of regulations may subject the healthcare facilities to citations and legal penalties. § Voluntary Standards: defined as a benchmark that is highly recommended by a governing agency or professional organization that provides recommendations and guidelines to provide evidence based patient care. 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. The main aims for the SFDA is to regulate the following: I. The safety of food and drugs for human and animal. II. The safety of biological and chemical substance. III. The safety of electronic devices that related to human health. IV. The accuracy and safety of medical and diagnostic devices. V. The Control and supervise licenses procedures for food, drugs and medical devices factories. VI. The Disseminate and exchange information with local and international scientific and legal agencies, and setting up a database for food and drug. Medical device classification The regulations placed on the Medical Devices depends on their classification as per the FDA which are: Regulation and standards Class I Devices Low Risk •Subject to the FDA’s general controls such as device registerations. no effect on patient's health •Suf_icient to provide reasonable assurance of the safety and effectiveness of the device •Examples: stethoscopes, Ultrasonic cleaners and hand-held surgical instruments Class II Devices Intermediate Risk •Subjected to FDA's general and special controls •May cause potential risks •it requires special guidelines and special labeling •Examples are : Sterilization machines, Biological Indicators and Chemical Indicators Class II Devices High Risk • Subjected to the FDs's highest regulations due to ability to cause potential risk •New products will require a Premarketing Approval (PMA) from the FDA to assure product safety and ef_icay •Examples: Heart Valve, Pacemakers and life sustaining devicess Medical device reporting requirements Healthcare facilities and medical device manufacturers are required to report to the FDA any kind of medical device malfunction as per the Safe Medical Device Act of 1990. Prior to this act, device manufacturers were only required to report medical device with malefactions that led to patient illness or death to the FDA. MedWatch is defined as a voluntary reporting program that was developed by the FDA in order to receive any malefaction related to the medical devices by the public, healthcare professionals, consumers or patients. Medical device recalls 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: Regulation and standards Class I Class II Less Seriouse Risk High Risk Class III Low Risk Can cause temporary or medically reversible adverse health problem Not likly to cause harm Details of recalled product Must notify the custamers Due to violation of the FDA guidlines action must be taken Press release for the Public No Press Relase needed No Press Relase needed Can cause patient harm or death Governmental agencies Centers for Disease Control (CDC) 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. Environmental Protection Agency (EPA) 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. The goal is to maintain optimum human health and to reduce the greenhouse gasses for the environment protection. Moreover, they ministry cooperates with other Regulation and standards 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. Occupational Safety and Health Administration (OSHA) 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: I. The Occupational Exposure to Blood-borne Pathogens standards II. Guidelines for the use of Ethylene Oxide Sterilization III. The General Duty Clause of the Occupational Safety and Health Act Healthcare Agencies and Associations Healthcare agencies and associations create and promote voluntary guidelines and standers that can be provide the fundamental process and practices of the CSSD professionals. CSSD professionals are required to be aware of theses agencies and their standards. Association for the Advancement of Medical Instrumentation (AAMI) The AAMI was established in 1967, its nonprofit organization that comprised of multidisciplinary healthcare professional from technicians, engineers, scientists and members of other organizations such as FDA. The aims is to develop a Technical Information Reports (TIR) that are address the following: • To develop, manage and the utilization of safe and effected reusable medical devices • To address the proper care and reprocessing of reusable medical devices. • To develop standards related to medical products labeling and performance requirement. Although the standards from the AAMI are voluntary and not mandatory they are considered critical elements in the CSSD practices, therefore CSSD personal must be familiar with the AAMI guidelines and the new updates. American National Standards Institute (ANSI) The ANSI institution was established in 1918 with a mission “To enhance both the global competitiveness of U.S. business and the U.S. quality of life by promoting and facilitating voluntary consensus standards and conformity assessment systems, and Regulation and standards safeguarding their integrity”. American National Standards Institute is the only U.S.A representative to the International Standards Organization (ISO). International Standards Organization (ISO) The ISO is considered as non-governmental organization with national standards representing more than 163 countries. The standards from the ISO give specifications related to products, service or practice. Although that ISO provides a voluntary standers most of these standards are adopted and enforced by many countries. Moreover, the ISO standers in regards to the CSSD are submitted by the AAMI organization therefore it’s a trend by the healthcare organizations internationally to become ISO- Certified in the field of CSSD. Association of Operating Room Nurses (AORN) Association of Operating Room Nurses (AORN) is a professional organization that consists of Registered Nurses in the specialty of the Perioperative Care and other professionals with an aim to enhance patient care related to surgery. The AORN standards are reprinted annually and reviewed every five years. Association for Professionals in Infection Central and Epidemiology (APIC) It’s an international organization that voluntarily provides guidelines related to infection prevention and control in order to prevent Hospital Acquired Infection (HAI) in the healthcare organizations. The Infection Prevention and Control Department can conduct CSSD departmental surveys annually depending on the organization’s policy. Examples of the APIC guidelines are: • Bioterrorist Readiness Plan. • Guidelines for Infection Prevention. • Control in Flexible Endoscope Society of Gastroenterology Nurses and Associates (SGNA) Society of Gastroenterology Nurses and Associates is non-profit organization that develops voluntarily guidelines to assure safe and effective practice of the gastroenterology and the endoscopy nursing services. Moreover, the organization develops and reviews guidelines related to reprocessing flexible endoscopes. Examples of the SGNA guidelines are: • Guidelines for the Use of High Level Disinfectants and Sterilization for Reprocessing of Flexible Gastrointestinal Endoscope • Standard of infection Control in Reprocessing of Flexible Gastrointestinal Endoscope. Key points: