Table 15.

Operational risks, and measures to mitigate risk.

Hazard	Potential cause	Mitigation
Injury from spring decompression	Uncontrolled release of compressed spring and plunger during loading.	Follow assembly instructions, ensure the escapement and one-way bearing lock the screw, and ensure the grub screws are installed securely in the plunger.
Injury from needle	Contact with the exposed needle of the infusion set.	Follow manufacturer’s instructions for handling infusion sets and cover exposed needle with a sheath when the pump is not in use.
Injury from sharp edges on manufactured components	Burrs or rough surfaces on pump housings could cause injury when loading and handling the pump.	De-burr all components after manufacture and ensure there are no exposed sharp edges.