Best practice for medical device storage
Regulation on medical devices and in vitro diagnostic (2017/745 and 2017/746) will fully come in to force on May 2022. These two Regulations will replace the current European Directives for medical devices, and requirements for distribution of devices are essentially the same in both Regulations.
Here, we gather the best practice to store medical devices under the new EU law.
According to the new Regulations, distributors must ensure that storage and transport comply with the conditions set by the manufacturer. These specifications are normally explained on the containers, for example, ‘Store between 2 and 8°C’, ‘Store at -20°C’ or ‘Do not store above 25°C’.
Medical devices must also be stored in accordance with the labelled conditions, including potential relative humidity conditions.
The temperature always needs to be monitored to make sure that the appropriate conditions are maintained. This applies to all areas where medical devices are stored (e.g. bulk storage, pick-face, quarantine and returns areas). At a minimum, a calibrated max/min type thermometer should be used.
When monitoring the temperature, you should:
- Keep records reviewed and approved regularly to ensure compliance with the required conditions.
- Investigate temperature variations and keep these documented.
If multiple temperature variations are registered across a time period, you should consider the impact of this fluctuation on the devices. If unsure, get in touch with the manufacturer of the medical device to confirm any possible issues. The protocol to follow when these variations take place should be described in a procedure.
Checking calibration certificates
The distributor should review calibration certificates for temperature monitoring devices to ensure that the accuracy of the devices is acceptable.
You are responsible for keeping any documentation to demonstrate that the reviews have happened.
Auxiliary temperature measuring
Temperatures should also be monitored during periods when temperature measuring devices used are being recalibrated. This may mean that auxiliary temperature measuring devices are required. These devices should also be calibrated.