Regulatory Compliance and Standards Flashcards
6 cards from real CIS practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 6 Regulatory Compliance and Standards flashcards as text
Which organization provides the CIS (Certified Instrument Specialist) certification for sterile processing professionals in the US?
Answer: International Association of Healthcare Central Service Materiel Management (IAHCSMM)
IAHCSMM offers the CIS certification, which recognizes specialized competency in surgical instrument management, reprocessing, and sterilization.
The FDA classifies most reusable surgical instruments as which device class?
Answer: Class II (general controls and special controls)
Most reusable surgical instruments are FDA Class II devices, regulated under general and special controls, typically cleared through the 510(k) premarket notification process.
What does a Class 5 chemical integrating indicator (CI) measure?
Answer: All critical sterilization parameters: time, temperature, and steam presence
Class 5 chemical integrating indicators respond to all critical sterilization parameters (time, temperature, and steam) and are designed to correlate with BI performance.
Under TJC standards, what must a facility do if a sterilizer biological indicator (BI) test returns a positive result (growth)?
Answer: Immediately take the sterilizer out of service, investigate, recall potentially affected loads, and notify infection control
A positive BI result requires immediate removal of the sterilizer from service, identification and recall of all items processed since the last negative BI, and notification of infection control and risk management.
Which federal regulation requires healthcare employers to offer hepatitis B vaccination to employees at risk for bloodborne pathogen exposure?
Answer: OSHA Bloodborne Pathogens Standard (29 CFR 1910.1030)
OSHA's Bloodborne Pathogens Standard mandates that employers offer free hepatitis B vaccination series to all employees with occupational exposure risk, including SPD decontamination staff.
What is the significance of ANSI/AAMI/ISO 11135 for sterile processing departments using ethylene oxide (EtO) sterilization?
Answer: It provides the international standard for validation and routine control of EtO sterilization processes
ANSI/AAMI/ISO 11135 is the international standard that specifies requirements for developing, validating, and controlling EtO sterilization processes for medical devices.