BTC Safety & Regulatory Compliance 2 — Questions and Answers
Question 1: Which federal agency enforces the Safe Medical Devices Act (SMDA) and requires hospitals to report device-related deaths and serious injuries?
- OSHA
- FDA (Correct answer)
- CMS
- EPA
Correct answer: FDA
The FDA enforces the SMDA, which mandates that hospitals and manufacturers report device-related deaths, serious injuries, or malfunctions.
Question 2: What is the maximum safe leakage current limit for chassis/enclosure current in a patient-care–related electrical appliance under NFPA 99?
- 100 µA
- 500 µA
- 300 µA (Correct answer)
- 10 µA
Correct answer: 300 µA
NFPA 99 specifies a chassis leakage current limit of 300 µA for patient-care–related electrical equipment.
Question 3: A biomedical technician discovers that a ventilator's manufacturer has issued a Class I recall. What is the correct immediate action?
- Document it and schedule repair at next PM cycle
- Remove the device from service and notify clinical staff immediately (Correct answer)
- Increase PM frequency and continue use
- Notify the FDA directly before telling clinical staff
Correct answer: Remove the device from service and notify clinical staff immediately
A Class I recall indicates a serious risk of harm; the device must be immediately taken out of service and clinical staff notified.
Question 4: Under OSHA's Bloodborne Pathogens Standard (29 CFR 1910.1030), what must be used when cleaning blood spills on biomedical equipment?
- 70% isopropyl alcohol only
- An EPA-registered disinfectant appropriate for bloodborne pathogens (Correct answer)
- Sterile saline solution
- Diluted bleach mixed at any concentration
Correct answer: An EPA-registered disinfectant appropriate for bloodborne pathogens
OSHA requires use of an EPA-registered disinfectant effective against bloodborne pathogens for decontaminating blood spills.
Question 5: Which document must accompany a medical device returned to the manufacturer for repair to protect shipping personnel from biohazard exposure?
- PM completion certificate
- Decontamination/cleaning certificate (Correct answer)
- FDA 510(k) clearance letter
- Joint Commission inspection report
Correct answer: Decontamination/cleaning certificate
A decontamination certificate confirms the device has been cleaned and is safe to handle, protecting shipping and repair personnel.
Question 6: What does the term 'macroshock' refer to in electrical safety?
- Current applied directly to the heart via a catheter
- Large current passing through the body surface causing burns or cardiac fibrillation (Correct answer)
- Static electricity discharge from equipment
- Low-level current detectable only by instruments
Correct answer: Large current passing through the body surface causing burns or cardiac fibrillation
Macroshock refers to relatively large electrical current entering the body through intact skin that can cause ventricular fibrillation or burns.
Question 7: According to The Joint Commission standards, how often must high-risk biomedical equipment undergo preventive maintenance at minimum?
- Every 6 months
- Annually
- Per manufacturer's recommended schedule or a risk-based alternative (Correct answer)
- Every 3 months regardless of device type
Correct answer: Per manufacturer's recommended schedule or a risk-based alternative
TJC allows facilities to follow manufacturer-recommended intervals or use an evidence-based, risk-stratified PM schedule as an alternative.
BTC Safety & Regulatory Compliance 2
Which federal agency enforces the Safe Medical Devices Act (SMDA) and requires hospitals to report device-related deaths and serious injuries?