CBET Public Safety and Regulations 2 — Questions and Answers
Question 1: What is the primary role of The Joint Commission (TJC) in healthcare?
- Manufacturing medical devices
- Accrediting healthcare organizations by evaluating compliance with patient safety and quality standards (Correct answer)
- Providing health insurance
- Training biomedical technicians
Correct answer: Accrediting healthcare organizations by evaluating compliance with patient safety and quality standards
The Joint Commission accredits healthcare organizations by evaluating compliance with standards for patient safety and quality of care.
Key standards for biomedical engineering include EC.02.04.01 (medical equipment management) and EC.02.04.03 (clinical alarm management). Technicians may be directly questioned during surveys.
Question 2: What does OSHA require regarding bloodborne pathogen exposure protection for biomedical technicians?
- No specific requirements exist
- Employers must provide an exposure control plan, training, PPE, hepatitis B vaccination, and post-exposure procedures (Correct answer)
- Only hand washing is required
- Technicians must purchase own PPE
Correct answer: Employers must provide an exposure control plan, training, PPE, hepatitis B vaccination, and post-exposure procedures
OSHA's Bloodborne Pathogens Standard requires comprehensive employer-provided protection for workers with occupational exposure.
Technicians should always request equipment decontamination before servicing and refuse to work on visibly contaminated equipment until properly cleaned.
Question 3: What is the purpose of an equipment management plan in a healthcare facility?
- To track equipment purchase prices
- To establish a systematic program for managing medical equipment throughout its lifecycle (Correct answer)
- To schedule equipment cleaning only
- To manage cafeteria equipment
Correct answer: To establish a systematic program for managing medical equipment throughout its lifecycle
An equipment management plan provides a comprehensive approach to managing medical equipment from selection through retirement.
The plan must include inventory, risk-based PM schedules, PM completion rates (typically >95%), safety testing records, and must be reviewed annually.
Question 4: What is the FDA's role regarding medical devices and what is the 510(k) clearance process?
- The FDA manufactures medical devices
- The FDA regulates safety and effectiveness; 510(k) demonstrates substantial equivalence to a predicate device (Correct answer)
- The FDA only regulates drugs
- 510(k) is a hospital quality process
Correct answer: The FDA regulates safety and effectiveness; 510(k) demonstrates substantial equivalence to a predicate device
The FDA regulates medical devices; 510(k) requires demonstrating substantial equivalence to a legally marketed device.
Class I (low risk), Class II (moderate risk, 510(k)), Class III (high risk, PMA with clinical trials). Higher class means more stringent maintenance requirements.
Question 5: What are the reporting requirements under the Safe Medical Devices Act when a device causes patient death or serious injury?
- No reporting is required
- Facilities must report deaths to both FDA and manufacturer, and serious injuries to the manufacturer, within 10 working days (Correct answer)
- Only manufacturers report
- Reports only required for recalled devices
Correct answer: Facilities must report deaths to both FDA and manufacturer, and serious injuries to the manufacturer, within 10 working days
Healthcare facilities must report device-related deaths to FDA and manufacturer, and serious injuries to manufacturer, within 10 working days.
Biomedical technicians must sequester the involved device, document its condition and settings, preserve disposables, and support the investigation.
Question 6: What does NFPA 99 cover and why is it important for biomedical technicians?
- Fire extinguisher schedules only
- Healthcare facility requirements for electrical systems, medical gas systems, vacuum systems, and other building systems (Correct answer)
- Pharmaceutical manufacturing standards
- Food preparation safety in hospitals
Correct answer: Healthcare facility requirements for electrical systems, medical gas systems, vacuum systems, and other building systems
NFPA 99 establishes criteria for safeguarding patients from fire, explosion, electrical hazards, and medical gas hazards.
NFPA 99 defines electrical safety testing requirements, medical gas outlet testing procedures, and emergency power system testing. TJC references NFPA 99 in its standards.
CBET Public Safety and Regulations 2
What is the primary role of The Joint Commission (TJC) in healthcare?