Medical Device Cold Storage—"An Unusual Cold Storage"

2025-04-16

Medical devices refer to instruments, equipment, appliances, in vitro diagnostic reagents and calibrators, materials, and other similar or related items directly or indirectly used on the human body, including the required computer software.

The state implements classified management of medical devices according to the degree of risk.

Medical Device Cold Storage—

Class I medical devices are those with a low degree of risk, and their safety and effectiveness can be ensured through routine management. For example: surgical instruments for surgery (knives, scissors, forceps, tweezers, hooks), medical X-ray films, surgical gowns and caps, examination gloves, gauze bandages, drainage bags, etc. Class II medical devices are those with a moderate degree of risk and require strict control and management to ensure their safety and effectiveness. For example: medical suture needles, sphygmomanometers, thermometers, electrocardiographs, electroencephalographs, microscopes, acupuncture needles, ultrasonic disinfection equipment, non-absorbable suture threads, etc. Class III medical devices are those with a relatively high degree of risk and require special measures for strict control and management to ensure their safety and effectiveness. For example: implantable cardiac pacemakers, contact lenses, intraocular lenses, ultrasonic tumor-focused knives, hemodialysis devices, implantable devices, vascular stents, comprehensive anesthesia machines, dental implant materials, medical absorbable suture threads, intravascular catheters, etc.

The cold storage used to store medical devices belongs to a type of pharmaceutical cold storage and is generally also called a medical device cold storage. The cold storage for storing Class III medical devices is a very high-level medical device cold storage, and the state has strict requirements for the location selection, construction, renovation, design, and layout of the cold storage. The China Food and Drug Administration has formulated regulations such as the "Guidelines for the Management of Cold Chain (Transportation and Storage) of Medical Devices" and the "Good Practice for the Quality Management of Medical Device Operations". The relevant content about the cold storage is excerpted as follows:

Medical device production enterprises and wholesale enterprises should, according to the variety and scale of production and operation, be equipped with appropriate cold storage (refrigerated storage or frozen storage), refrigerated vehicles, or refrigerated boxes (insulated boxes) and other facilities and equipment. Medical device retail enterprises and using units should, according to the variety and scale of operation and use, be equipped with appropriate cold storage or refrigeration equipment (refrigerated cabinets or refrigerated boxes, etc.).
The cold storage used for storing medical devices should have the function of automatically regulating the temperature, and the refrigeration capacity of the unit should be suitable for the volume of the cold storage. In order to ensure the continuous power supply of the refrigeration system, the cold storage should be equipped with a standby generator set or a dual-circuit power supply system, etc.
The cold storage should be divided into an area for inspection, a storage area, a return area, a pre-cooling area (storage location) for packaging materials, etc., and there should be obvious signs.
The cold storage and refrigerated vehicles used for the storage and transportation of medical devices should be equipped with a temperature automatic monitoring system (hereinafter referred to as the temperature monitoring system) to monitor the temperature. The temperature monitoring system should have the following functions:
(1) The technical parameters such as the measurement range, accuracy, and resolution of the temperature monitoring system can meet the management requirements, and it has the functions of uninterrupted monitoring, continuous recording, data storage, display, and alarm.
(2) During the operation of the cold storage and refrigerated vehicle equipment, the temperature data of the measuring points should be updated at least every 1 minute. During the storage process, the real-time temperature data should be automatically recorded at least every 30 minutes, and during the transportation process, the real-time temperature data should be automatically recorded at least every 5 minutes.
(3) When the monitored temperature reaches the set critical value or exceeds the specified range, the temperature monitoring system can achieve audible and visual alarms, and at the same time, it can send alarm messages immediately to at least 2 designated personnel through communication methods such as text messages.

Each (unit) independent cold storage and refrigerated vehicle should, according to the verification conclusion, set and install at least 2 temperature measuring point terminals. The temperature measuring point terminals and temperature monitoring equipment should be calibrated or verified at least once a year.
The cold storage, refrigerated vehicles, refrigerated boxes, insulated boxes, and the temperature monitoring system should be verified before use, regularly verified, and verified when the downtime exceeds the specified time limit. Facilities and equipment that have not been verified shall not be applied to the transportation and storage process of medical devices under cold chain management.
(1) Establish and form verification management documents, and the content of the documents includes verification plans, standards, reports, evaluations, deviation handling, and preventive measures, etc.

(2) Determine a reasonable continuous verification time according to the verification object to ensure the sufficiency, effectiveness, and continuity of the verification data.
(3) The temperature monitoring equipment used for verification should be calibrated or verified by a qualified metrological institution, and the calibration or verification certificate (copy) should be attached as a necessary appendix to the verification report.
The verification data should be true, complete, effective, and traceable.
(4) Use the relevant facilities and equipment correctly and reasonably according to the parameters and conditions determined by the verification.

Some requirements for the cold storage:

Enterprises with outdoor loading and unloading, handling, receiving, and shipping operations should have corresponding protective facilities. For example, there should be a canopy to prevent rain outside the loading and unloading door, and protective measures and facilities for cold chain products, etc.;
The temperature and humidity in the warehouse should meet the requirements indicated in the instruction manual or label of the medical devices being operated.
For medical devices with special temperature and humidity storage requirements in the warehouse, equipment or instruments for effectively regulating and monitoring the temperature and humidity should be equipped.
Wholesale enterprises of medical devices that need to be stored in cold storage or frozen storage should be equipped with the following facilities and equipment:
(1) An independent cold storage suitable for its business scale and variety, with a buffer area for entering and leaving the cold storage or isolation facilities;
(2) Equipment for monitoring, displaying, recording, regulating, and alarming the temperature of the cold storage;
(3) Facilities that can ensure the normal operation of the refrigeration equipment (such as a standby generator set or a dual-circuit power supply system, a standby refrigeration unit);

The following points should be noted in the design and installation of the medical device cold storage:

The configuration of the cold storage should have the function of automatically regulating the temperature (generally intelligent adjustment, without the need for manual control operation).
The refrigeration capacity of the unit should be suitable for the size of the cold storage volume.
In addition to the corresponding design according to the specified temperature requirements, the medical device cold storage will be equipped with two sets of refrigeration systems to ensure the temperature in the storage. In addition, when the temperature in the cold storage exceeds the set temperature, it will send a text message alarm or an audible and visual alarm, which is convenient for the cold storage operators to quickly find the abnormal situation in the cold storage and deal with it in a timely manner.
The cold storage should be divided into at least four areas, and there should be obvious signs, and the color of the signs should meet the requirements. In addition to setting up the areas for inspection, storage, and return, it is particularly emphasized that a pre-cooling area for packaging materials should be set up, which is used for pre-cooling the packaging materials.
The guidelines also specifically regulate the requirements for the automatic monitoring system of the cold storage and refrigerated vehicles.
The medical device cold storage (constant temperature storage for diagnostic reagents) should complete the verification of the cold storage and have a cold storage verification report.

When using the cold storage, it should be noted that no items should be stacked within 100 centimeters of the air outlet of the refrigeration unit in the medical device cold storage and at the position higher than the air outlet of the air cooler. Medical devices should be in the specific temperature environment indicated in the product label and instruction manual to ensure the management of product quality. Therefore, the temperature of the medical device cold storage is set differently according to the stored materials. Generally, the temperature of the normal temperature storage is 0 - 30°C, the temperature of the refrigerated storage is between 2 - 8°C, the temperature of the frozen storage is below - 20°C, the temperature of the cool storage does not exceed 20°C, and the relative humidity is maintained between 45 - 75%.