Acquisition of Medical Devices Flashcards
1
Q
What is the role of a USER?
A
- Manage decontamination
- Train operators
- Ensure testing carried out
- Keep records
2
Q
What is the role of an OPERATOR?
A
To be trained in operating of ALL equipment and practices
3
Q
What is the role of a MANAGER?
A
- Takes ultimate responsibility for operation of LDU
- Practice owner
4
Q
What is the role of an AUTHORISING ENGINEER (DECONTAMINATION)- AED?
A
- Provide expert advice
- Independently audit Quarterly and Annual test results
5
Q
What is the role of a TEST PERSON/ VALIDATION ENGINEER?
A
- Carry out Quarterly and Annual testing -> provide report
requires training and qualification
6
Q
What is the role of a MAINTENANCE ENGINEER?
A
- Maintenance and repairs
- 2 yrs exp –> qualify to become test person
7
Q
What is the role of a COMPETENT PERSON?
A
- Appointed by insurer to inspect sterilisers and compressors for safety
- Pressure System Safety Regulations 2000
8
Q
What factors should be considered when acquiring medical devices?
A
- Single use V reusable
- CE mark
- Appropriate?
- Can it be decontaminated with equipment you have?
9
Q
What is meant by the term ‘STANDARD’?
A
- Document created by consensus and approved by recognised body
- Serves as basis to which practice should conform
10
Q
What is meant by the term ‘LEGISLATION’?
A
- Process of enacting statutory law
- A statute or regulation
11
Q
What is meant by the term ‘GUIDANCE’?
A
- Recommendations by HCP based on best available evidence
