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Specifying systems
Selecting methods, devices, equipment, etc.
There are some simple rules to follow when selecting a method, piece of equipment or a device. 1. Evidence-based considerations (a) Has the method, device or instrument been used by other IVF Labs? (b) Are there established performance Indicators for the method, device or instrument? (c) How do the established performance Indicators for the method, device or instrument compare to your internal benchmarks? 2. Regulatory approvals (a) Does the method, device or instrument have necessary regulatory approval(s) from the authorities that govern your operations? (b) Does the method, device or instrument have any other regulatory approval(s) from other authorities, as indication of its quality and fitness-for-use? Possible regulatory approvals include those from authorities such as the US Food and Drugs Administration, e.g. a 510(k) pre-market clearance, or CE marking within the European Union. 3. Follow the manufacturer’s instructions (a) If the manufacturer has provided instructions on how to use the method (e.g. reagents or kits), device or instrument, ensure that everyone is aware of them and follows them. (b) If the manufacturer has provided instructions on how to store reagents, a kit, or a device, ensure that everyone is aware of them and follows them. (c) If you have modified any of the manufacturer’s instructions then ensure that your SOP describes the change(s) in detail. Maintain records of the development and validation studies that were performed to establish such changes in your lab.