5.2 Regulatory Agencies Flashcards
5 Federal Regulatory Agencies
- FDA - Food and Drug Administration
- CDC - Centers for Disease Control
- DOT - Department of Transportation
- EPA - Environmental Protection Agency
- OSHA - Occupational Safety and Health Administration
FDA – food and drug administration
Regulates Sterilants, high-level disinfectants, medical device manufacturers, requires pre-market clearance of new medical devices. Works alongside the public health service in the US Department of health and human services.
Medwatch program
Provides voluntary reporting of device related problems, provides a vehicle for healthcare professionals to notify the FDA of problems.
Medical device recalls
An action taken if there is a medical device that violates FDA regulations. Enforced when device is defective and/or poses a risk to health. Can be voluntary when instituted by the manufacturer, distributor, or other interested party.
Class I FDA recall
High risk – there is a chance the product will cause serious health problems or Deas
Class II FDA recall
Less serious risk – there is a chance the product will cost temporary or reversible health problems. There is a remote chance the device will cause serious health problems.
Class III FDA recall
Low risk – there is little chance that using or being exposed to the product will cause health problems
FDA labeling document
Requires manufacturers to comply with the seven criteria, mostly involving reprocessing instructions, when they submit medical device applications to the FDA for evaluation
Manufacturer responsibilities according to the FDA labeling document
Provide sufficient instructions on how to prepare the device for the next patient. Provide documentation of test that show the instructions are adequate and can be reasonably executed by users.
User responsibility according to FDA labeling document
Confirm that they have the facilities and equipment to execute the manufacturers instructions. Ensure that the instructions are followed.
SUD - single used devices
Labeled as single use or one time use. If an SUD is being reused an institution must demonstrate that the item can be adequately cleaned and sterilized, the quality of the device will not be adversely affected, the device for main safe and effective for its intended use.
FDA enforcement requirements for repossing SUDs
All hospitals and third-party rep-processors who reprocess SUDs are required to be in compliance with pre-market and post market requirements outlined in “enforcement priorities for single used devices reprocessed by third parties and hospitals”, FDA 2000
CDC - centers for disease control and prevention
Collects and analyzes data about infectious diseases, issues infection control guidelines, guidelines and recommendations are often incorporated into healthcare facility policies and procedures and other agencies rely heavily on them.
DOT – Department of Transportation
Dedicated to ensuring a fast safe and efficient transportation system. The DOT regulates labeling and containment of hazardous waste biohazard items and minimally processed items for transport. They also regulate labeling and containment of radioactive materials for transport.
State or local DOT?
State or local DOT regulations may be more restrictive than federal DOT regulations. When this happens, the most stringent regulations apply.
EPA – environmental protection agency
Responsible for minimizing greenhouse gases and toxic omissions. Regulates the reuse of solid wastes. Controls indoor air pollution and develops and enforces pesticide regulations. Responsible for regulating all products with anti-microbial claims such as sterilants disinfectants and sanitizers according to the “federal insecticide fungicide and rodenticide act” (FIFRA)
FIFRA requirements
Manufactures must obtain an EPA registration number for every chemical sterilant, disinfectant, and sanitizer. Each products label must contain product ingredients, directions for use, product precautions and warnings, directions for storage and disposal, the EPA registration number.
Clean air act amendments
Industrial ethylene oxide sterilization facilities follow emission standards set by the national emission standards for hazardous air pollutants (NESHAP). Medical waste incinerators are regulated
OSHA – occupational safety and health administration
Primary role is to protect workers from occupational caused illnesses and industries. May conduct announced an unannounced inspections of any workplace to investigate employee exposure to hazardous or toxic chemicals, blood-borne pathogens, and other potential hazards.
Willful OSHA violation
A violation intentionally intentionally and knowingly committed by the employer, can carry fines and penalties of $5000-$70,000
Serious OSHA violation
A violation in which there is substantial probability that death or serious injury could result on the employer new or should have known of the hazard. These violations carry fines up to $7000
Repeat OSHA violation
A violation of any standard regulation or rule where, upon reinspection, a substantial similar violation is found. These carry penalties of up to $70,000
Failure to abate OSHA violation
Failure to correct a prior violation may result in penalties of up to $7000 per day
Professional associations
Develop and promote voluntary standards that set the foundations for good work practices
AAMI – association for the advancement of medical instrumentation
Technical advisory groups comprised of practitioners, industry experts, and manufactures help develop recommended practices and standards. Although it is a voluntary organization, the standards are used by regulatory organizations that inspect healthcare organizations
ANS I – American National standards Institute
Standards are submitted to ANSI for approval, from other organizations such as AAMI
AORN – association of Perry operative registered nurses
Professional organization dedicated to providing optimal care to the surgical patient. Regulatory officials look for compliance with AORN standards, recommended practices, and guidelines
AP I C – association for professionals in infection control and epidemiology
Voluntary international organization dedicated to the prevention and control of infections and related outcomes. Works with the CDC and other related agencies to adopt standards for infection and disease prevention.
ISO Dash international standards organization
Globally based nongovernmental standards organization representing approximately 165 countries. Standards groups such as AAMI submit standards which are granted ISO status based on it consensus of the membership
The joint commission
An independent not-for-profit organization which sets healthcare quality standards and is used as a measurement of organizational quality. They survey approximately 15,000 healthcare facilities in the US. Loss of joint commission accreditation may result in forfeiture of Medicare and Medicaid reimbursement payments.
NF PA – national fire protection organization
International organization that works to reduce the burden of fire and other hazards, made up of representatives from nearly 100 nations and organizations. The NFPA sets fire safety standards
USP – NF – United States pharmacopia national formuly
Creates and revises standards for medicines, dosages, forms, drug substances, and dietary supplements. Set standards for packaging, labeling, bacterial logical purity, pH, and mineral content of purified water or water stairize for irrigation.
WHO – world health organization
United Nations agency established to further international cooperation in improving health conditions. Agencies such as the CDC may base their policies on WHO guidelines and research
SGNA – society of Gastro intestinal nurses and associates
Nonprofit organization that collects information and establishes standards and guidelines related to the reprocessing of flexible endoscopes.
CSA - Canadian standards association
Develop standards for Canadian provinces
ECHN - European commission for standardization
Sets healthcare standards for Europe in much the same way that AAMI set standards in the United States
CS technicians can ensure compliance by
Becoming familiar with standards and regulations that impact their jobs, correctly following procedures, calling attention to poor practices, staying updated on changes in standards and regulations, and putting ourselves in the patient’s place.
