Regulations & Standards
A uniform method of defining basic parameters for processes, products, services and measurements
What is a Standard?
This organization monitors all mandated recalls, Medical device classification and is responsible for the safe medical device act of 1990.
Who is the FDA?
Humidity in the sterile storage area should not exceed this percentage.
What is 70%?
This is the sealed area where items are placed for sterilization.
What is the chamber?
This is the first phase in a steam sterilization cycle, where air is removed.
What is conditioning (or pre-conditioning)?
Rules issued by administrative agencies that have the force of law
What is a regulation?
This agency surveys and accredits hospitals, often using CMS guidelines.
What is The Joint Commission?
This environmental factor is used to help prevent cross-contamination between SPD work zones.
What is traffic control?
This component surrounds the chamber in a steam sterilizer and helps maintain consistent heat.
What is the jacket?
This low-temperature method uses hydrogen peroxide vapor and plasma.
What is a gas plasma sterilizer?
The US Food and drug Administration's safety information and adverse event reporting system designed for voluntary reporting of device related problems associated with the drugs and medical devices they use, dispense or prescribe
What is MedWatch?
This non-profit voluntary consensus organization whose membership is comprised of healthcare technology professionals. Although their standards are voluntary (i.e. standards like ST79 for steam sterilization), they are a key resource for healthcare guidelines and used by organizations that inspect healthcare facilities.
Who is AAMI?
The decontamination area should have this many air exchanges per hour and what type of air pressure.
What is no less than 10 and negative air pressure
This part forms an airtight seal around the sterilizer door during operation.
What is the door gasket?
Why is proper drying critical before sterile storage?
What is to prevent microbial contamination and wet packs?
A medical device that has a labeling error but poses no health risk would likely be placed in this recall class.
What is Class III?
This agency is responsible for regulating the reuse of solid wastes, controlling indoor air pollution, and developing and enforcing chemical regulations.
Who is the EPA
The HVAC system in SPD should be monitored and documented at what frequency to ensure compliance with standards?
What is daily
This system removes air and allows steam to enter and exit the sterilizer during cycles.
What is the air removal and exhaust system?
During this phase, steam is maintained at the required temperature and pressure.
What is exposure (or sterilization phase)?
True or False: A Class I recall means the product can continue to be used under certain conditions.
What is False?
This organization is a nonprofit who oversees endoscope reprocessing standards and guidelines
Who is the Society of Gastroenterology Nurses and Associates (SGNA)
The sterile storage area must maintain this air pressure and minimum number of air exchanges per hour.
What is positive pressure and 4 air exchanges per hour?
This mechanical component regulates and displays cycle data such as time, temperature, and pressure.
What is the control panel
A load comes out wet after steam sterilization. What is the most likely issue?
What is a clogged or malfunctioning drain line, or faulty drying phase, Overloaded Loads, etc.?