المملكة: Manager and monitored refrigerators.. New controls for transporting and storing medical devices

The Saudi Food and Drug Authority issued new strict controls to regulate the transportation and storage of medical devices and supplies in the Kingdom, with the aim of ensuring their safety, quality and efficiency.
The controls included general requirements, the most important of which is the appointment of a full-time technical manager for the storage area, who is required to have an engineering or technical qualification in the field of medical devices or any related specialty, and that all medical devices and supplies to be stored or transported must have a marketing permit or a valid import permit. Effect.

Storage area requirements

As for the requirements for the storage area, the Authority required that the area be appropriately designed and prepared to store medical devices and supplies, while providing sufficient spaces to allow cleaning and examination operations.
It also stipulated the provision of sufficient lighting to enable the data of medical devices, supplies, and information signs to be clearly seen, with sufficient ventilation equipped with filters to prevent the entry of dust and pollutants.
The authority stressed the necessity of providing personal protection supplies, transportation and handling equipment, and the necessary safety tools, and that storage surfaces and shelves should be high above the floor level and low above the ceiling level.

Clear sign

It was obligated to provide a designated place to isolate medical devices and supplies that have been disposed of, returned, returned, recalled, damaged, or expired, provided that they are clearly marked and monitored, in addition to high-quality electronic means to measure temperature and humidity, while adjusting them in accordance with the manufacturer’s instructions.
The controls stipulate the necessity of having an emergency plan or a backup electric generator in the event of a power outage, especially for devices and supplies that need refrigeration and air conditioning, with the necessity of notifying the Authority when any modification is made to the design or size of the storage area.

Environmental conditions

With regard to transportation, the Authority emphasized the use of clean and equipped means of transportation to protect medical devices and supplies from environmental and climatic conditions, while prohibiting the use of open vehicles to transport them.
It also required that means of transport be equipped with the necessary safety tools and means, and the presence of electronic means to measure temperature and humidity levels, capable of being linked and read electronically, and installed in different places and heights according to an effective heat map, and activated throughout the transport period, with it being calibrated and monitored periodically. Finally, the controls stressed the importance of qualifying and equipping workers involved in transportation and storage.