Week 6 Flashcards
1
Q
Prime Functions for Effective Packaging Systems are to (4):
A
- permit sterilization of the package contents
- maintain sterility of the contents until the package is opened
- permit aseptic presentation of the package contents
- protect the contents from damage during shipping
1
Q
Essential Performance Characteristics of Packaging includes (7):
A
- ability to withstand physical conditions of the specific sterilization process
- adequate air removal; sterilant penetration and contact with the contents and evacuation of sterilant
- free of toxic materials or dyes and low-linting
- adequate barrier to microorganisms and environment
- durability to resist tears and punctures
- removal of contents without contamination
- easy to use and cost-effective
2
Q
Acceptance Testing
A
accept results to be positive if it meets the criteria/expectations
3
Q
___________ is as important to the device itself.
A
packaging
4
Q
Importance of Packaging (3):
A
- key role in safely delivering specialized treatment to patients
- sterilized devices can be opened with a degree of confidence that is has remained sterile throughout storage, handling, and transportation.
- reduces the risk of healthcare acquired infections by protecting the sterile components from contamination until they are used.
5
Q
Top 10 Mistakes of Medical Device Packaging:
A
- losing sterile integrity
- cutting too many corners
- not prequalifying package and product for compatibility
- ignoring the worse-case scenario
- not developing protocols
- having the wrong sample size
- using the wrong package type/material
- squeezing oversized pouches into cartons
- not recognizing Tyvek separation as false-positive
- performing accelerated aging at high test temperatures
6
Q
Protocol
A
provides a blueprint for how testing will be done, including:
1. purpose
2. scope
3. responsibilities
4. parameters
5. product equipment settings
6. acceptance test criteria
