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The process by which microorganisms are unintentionally transferred from
one substance or object to another, with harmful effect.
Choose matching term
1 Cross-connection 2 Direct Contamination
3 Cross-contamination 4 Vectoring
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Microbiology The study of microorganisms
The state of being soiled by contact with infectious organisms or
Contamination
other materials.
, The process by which microorganisms are unintentionally
Cross-contamination transferred from one substance or object to another, with
harmful effect.
responsible for ensuring that medical devices are safe and
effective for patient care. It regulates the manufacturing of all
U.S. Food and Drug
medical devices. It regulates sterilant, high-level disinfectants,
Administration (FDA)
packaging materials, sterilizers, and quality monitoring (e.g.,
biological monitoring).
Class 1: Electric Toothbrushes
Medical Device Classification Class 2: Infusion Pumps
Class 3: Pacemakers
Low risk - hand-held instruments, hospital beds, ultrasonic
Class I Devices
cleaners
Potential risk - sterilization equipment, biological indicators,
Class II Devices
chemical indicators
This is the FDA reporting service for adverse effects that occur
MedWatch
from use of approved drugs.
Class I: high risk
Medical Device Recalls Class II: Less serious risk
Class III:Low risk
FDA Enforcement Requirements Requires compliance with FDA 510(k) directives when
for Healthcare Facilities reprocessing SUDs.
Reprocessing Single-Use
Devices (SUD)
Allows the FDA to help strengthen the nation's public health
Emergency Use Authorization
protections against chemical and biological threats, including
(EUA)
infectious diseases, and other threats.
The CDC promotes health and quality of life by preventing and
Center for Disease Control and
controlling disease, injury, and disability and by responding to
Prevention (CDC)
health emergencies.
The EPA is responsible for minimizing greenhouse gases and
toxic emission, regulating the reuse of solid wastes, controlling
U.S. Environmental Protection indoor air pollution, and developing and enforcing chemical
Agency (EPA) regulations. requires an EPA registration number for every
covered disinfectant and sanitizer and requires data relating to
labeling claims, efficacy, and safety
ensures a fast, safe, and efficient transportation system. It
U.S. Department of regulates the transportation of minimally processed
Transportation instrumentation for repair or reprocessing and the transportation
of hazardous and radioactive wastes.
The Occupational Exposure to OSHA guidelines outline employee safety in all areas of the
Bloodborne Pathogens facility as they relate to potential exposure from bloodborne
Standards pathogens.
Requires employers to provide each employee with a place of
General Duty Clause of the
employment that is free from recognized hazards that are
Occupational Safety and Health
causing or are likely to cause death or serious physical harm to
Act
employees.
Health Insurance Portability and established national standards to protect patients' medical
Accountability Act (HIPAA) records and other personal health information