Acquisition Of Medical Devices

Question 1

What is NP13?

Answer 1

National procurement 13, all equipment is tested and rigorously evaluated to ensure it meets all relevant guidance documents.

Question 2

What is a medical device?

Answer 2

products specifically intended for the cleaning, disinfection or sterilization of devices as referred to in Article 1(4)

Instrument used for diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease

‘ Medical device regulation -MDR’

Question 3

What are my obligations when acquiring a piece of equipment

Answer 3

Ensure its been through NP13 process on checking it is safe

Ensure operating software for operating these machines are safe and free from malware etc

Ensure company is reputable and is compliant with MDR as well as being CE (UKCA marked)

Question 4

Why is WD first step in decon process?

Answer 4

Consistency
- same process every time

Traceability
- automated and has printable record

Removes gross debris from instruments
- removes proteins / prions
- before sterilisation

Question 5

Loading requirements WD?

Answer 5

Clip trays positioned correctly

No overlapping equipment

Hinged instruments open at hinge

All assemblies disassembled