User error and poor practice putting lives at risk, medical device watchdog warns

The Medicines and Healthcare products Regulatory Agency has issued a warning after an increasing number of incidents that have resulted in injury or death because of products being used incorrectly or poor practices. The One Liners bulletin states: “All medical devices can fail, but an increasing number of incidents that result in significant morbidity or mortality arise out of user/device problems or because of poor practices. The aim of this news sheet is to detail briefly some of these problems in an attempt to make users more aware of what can go wrong. It is all too easy to take equipment for granted.”

The examples provided are:

• Reports have been received where interference was observed on an ECG monitor during the operation of a heart-lung bypass circuit. This was initially assumed to be mains interference, but was later discovered to be the result of mechanical movement of the bypass tubing directly over the ECG electrodes. ADVICE: Ensure electrodes are not placed directly under the bypass circuit
• Reports continue of difficulty and delay in administrating emergency drugs because of incompatibility of pre-filled syringes and needle-free connectors. ADVICE: Determine the compatibility of such connectors in routine use with the pre-filled syringes in emergency drip boxes. In an emergency, if such incompatibility is found, consider removing the connector to access the IV catheter directly
• Luer slip syringes have been found to become disconnected from needle-free connectors. ADVICE: Maintain pressure/hold between connector and Luer slip syringe. Luer connections should not be left unattended. Consider using a Luer lock syringe to minimise the risk of disconnection
• Personal computers and large monitor displays have been found to be connected to medical devices within the patient environment. Although devices and IT equipment may conform to relevant standards, the combination of such equipment may result in touch voltages and leakage currents being exceeded, putting the patient at risk. ADVICE: Check the user manual before use or consult technical staff for advice. Check compatibility and electric safety when connecting IT equipment to medical devices
• There have been reports that the metric/imperial equivalent of the French size may differ between vascular devices. ADVICE: Ensure the metric/imperial equivalent is noted to ensure compatibility, particularly with the use of introducers