Whiz Midstream
We are frequently asked to provide data for the adoption of the Whiz
Midstream by nurses, health specialists, procurement officers, GP's,
financial managers, clinicians etc. With their input we have developed
a pro forma procurement checklist and set out their comments and evaluations
in separate sections. There are certain pre-requisities for the evaluation
and or adoption of any IVD device by health care authorities - that
is:
- Regulatory approval
- Clinical efficacy - does the product do what it is supposed to do
- Patient and clinicians acceptance
- Value for money - although some authorities still cling to the belief
- Patient, staff and clinician safety including medico legal issues
We have divided Patient, staff and clinician safety into the following
categories:
1. Regulatory approval EU: CE Mark; USA: FDA approval:
2. Regulatory and/or Mandatory Compliance Factors
3. Professional regulatory and National Guidelines regarding Professional
Codes of Conduct
4. User (clinician and Patient) Evaluation, Input and Preference:
5. Efficiency
6. Pricing
7. Value and Economic Arguments
8. Risk Assessment
9. Use and methodology of use
Pro-forma documentation available on request.
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