Medical Device Cold Chain (Transport, Storage) Management Guide

(draft for comments)

Chapter I General Provisions

Article 1 (Purpose) According to the requirements of the "Regulations on the Supervision and Administration of Medical Devices" and Other relevant laws and regulations, to strengthen the quality management of transportation and storage processes requiring refrigerated and frozen medical devices (hereinafter referred to as "cold chain management medical devices"), Medical devices are always in compliance with the medical device specifications and labeling temperature requirements in all aspects of production, operation and use.

Article 2 (Scope of Application) The medical device production and operation enterprises and the use of units to transport and store cold chain management medical devices shall follow this guide.

Chapter II Personnel and Facilities

Article 3 (Training of key personnel) The staff of the cold chain management medical equipment receiving, accepting, storing, inspecting, leaving the warehouse, transporting, etc. shall accept relevant laws and regulations, professional knowledge, working systems and standard operating procedures. Training, after passing the examination, can only be employed.

Article 4 (Refrigerated Refrigeration Equipment) Medical device manufacturers and wholesale enterprises shall be equipped with suitable cold storage (refrigerator or freezer), refrigerated truck, refrigerator or incubator according to the variety and scale of production and operation.

Medical device retail enterprises and users should be equipped with suitable cold storage or refrigeration equipment (refrigerators/tanks, etc.) according to the type and scale of operation and use.

Article 5 (cold storage) cold storage shall have the function of automatically regulating the temperature, and shall be equipped with an auxiliary refrigeration unit. The refrigeration capacity of the unit shall be compatible with the volume of the cold storage. In order to ensure continuous Power Supply to the refrigeration system, the cold storage should be equipped with a standby generator set or a dual-loop power supply system.

The cold storage should be divided into the area to be inspected, the storage area, the return area, the pre-cooling area (package) of the packaging materials, etc., and clearly marked.

Article 6 (Refrigerated vehicles) Refrigerated vehicles shall have automatic temperature regulation function. The compartments shall be waterproof and sealed, and there shall be room for ensuring sufficient circulation of airflow in the compartments.

Article 7 (refrigerator, incubator) refrigerators and incubators should have good insulation function. The refrigerator should be able to automatically adjust the temperature inside the cabinet; the incubator should be equipped with a coolant and a temperature isolation device, and meet the storage and transportation requirements marked in the product labeling instructions.

Article 8 (Temperature Control System) The cold storage and refrigerated trucks shall be equipped with an automatic temperature monitoring system (hereinafter referred to as “temperature control system”) to monitor the ambient temperature and establish equipment operation, inspection, maintenance and maintenance files. The system should have the following features:

(1) The technical parameters such as measurement range, accuracy and resolution of the temperature control system can meet the management needs, and have the functions of continuous monitoring, continuous recording, data storage, display and alarm.

(2) The temperature data of the measuring point is updated at least every 1 minute during the operation of the equipment. The real-time temperature data is automatically recorded at least every 30 minutes during the storage process, and the real-time temperature data is automatically recorded at least every 5 minutes during the transportation process. When the monitored temperature value is outside the specified range, the system should record the real-time temperature data at least every 2 minutes.

(3) When the monitoring temperature reaches the set threshold or exceeds the specified range, the temperature control system can realize the sound and light alarm, and at the same time realize the short message and other communication methods to immediately send alarm information to at least two designated personnel.

The temperature measurement points of cold storage and refrigerated trucks should be set and installed according to the verification conclusion. Each (stand-alone) independent cold storage and refrigerated truck should have at least two temperature measuring point terminals installed. The temperature measuring point terminal and the temperature monitoring device should be calibrated at least once a year.

Refrigerators, incubators or other refrigeration equipment should be equipped with equipment that automatically records and stores the temperature.

Chapter III Verification Management

Article 9 (Device Verification) Cold storage, refrigerated trucks, refrigerators, incubators, and temperature control systems shall be verified under pre-use verification, periodic verification, and deactivation for longer than the specified time limit. Unverified facilities and equipment shall not be used for the transportation and storage of cold chain management medical devices.

(1) Establish and form verification control documents, including verification schemes, standards, reports, evaluations, deviation handling and preventive measures.

(2) Determine the appropriate continuous verification time according to the verification object to ensure the sufficient, effective and continuous verification data.

(3) The temperature sensor and temperature monitoring equipment used for verification shall be calibrated by a qualified metrology institution. The calibration certificate (copy) shall be used as an essential annex to the verification report, and the verification data shall be true, complete, valid and traceable.

(4) Properly and reasonably use the relevant facilities and equipment according to the parameters and conditions determined by the verification.

Chapter IV Receiving and Acceptance

Article 10 (Receipt Management) When receiving the medical equipment for cold chain management, the transportation method, arrival and in-transit temperature, departure time and arrival time shall be verified and recorded; the products returned after the sale shall also be verified. Temperature record during the sale period. If it meets the requirements, it shall be moved into the waiting area of ​​the cold storage in time; if it does not meet the temperature requirements, it shall be rejected.

Article 11 (Acceptance Management) If the cold storage is used, the inspection and acceptance of the medical equipment for cold chain management shall be carried out in the cold storage.

The acceptance personnel shall check the status of the product and make a record in accordance with the requirements of Article 38 of the “Quality Management Specifications for Medical Device Management”.

Article 12 (in the library maintenance) cold chain management medical equipment should be stored and inspected according to the requirements of the medical device manual or label during the storage period, and should focus on the packaging, label, appearance and temperature of the stored cold chain management medical equipment. The condition, etc. are checked and recorded.

Items within 100 cm of the air outlet of the refrigeration unit in the cold storage and above the outlet of the air cooler are not allowed to be placed.

Chapter V Outbound and Transportation

Article 13 (Outbound Management) When a cold chain management medical device is shipped out of the warehouse, it shall be handled by a special person for the review of the warehouse, packing and sealing, and loading and unloading.

If the cold chain management medical equipment is transported using a refrigerator or incubator, the packaging standard operating procedures shall be formulated according to the parameters and conditions determined by the verification. The packing and sealing operations shall meet the following requirements:

(1) Pre-cool or preheat the refrigerator and incubator to the temperature range indicated by the medical device manual or label before packing.

(2) According to the conclusions confirmed by the verification, the cold storage agent suitable for temperature control and transportation time limit is reasonably equipped in the incubator.

(3) The chiller starts the cooling (heat) function and the temperature monitoring equipment (the incubator start temperature monitoring equipment), checks the equipment for normal operation, and after the specified temperature is reached, the product is boxed.

(4) When installing the box, the product should be isolated from the refrigerant such as the coolant by using a temperature isolator.

(5) The packaging, packing and sealing of the product shall be completed in a refrigerated environment.

Article 14 (Transportation Management) Transportation of cold chain management medical equipment shall be based on the number of transportation, transportation distance, transportation time, temperature requirements, external environmental temperature, etc., and select appropriate transportation tools and temperature control methods to ensure the transportation process. Temperature control meets the requirements.

Article 15 (Transportation of Refrigerated Cars) The use of refrigerated trucks to transport cold chain management medical devices shall meet the following requirements:

(1) Open the temperature control and monitoring equipment in advance to preheat or pre-cool the cabin to the specified temperature.

(2) The stacking of the products in the refrigerated compartment shall be no less than 10 cm from the front panel of the compartment, and the distance between the rear panel, the side panel and the bottom panel shall not be less than 5 cm, and the height of the stacking shall not exceed the lower edge of the outlet of the refrigeration unit to ensure normal circulation of the airflow. And the temperature is evenly distributed.

(3) After the cold chain management medical equipment is loaded, close the compartment door in time, check the sealing condition of the door and lock it.

(4) Check the temperature control and monitoring equipment operation status, and the operation can only be started.

(5) Cold chain management Medical equipment During the loading and unloading process, insulation measures should be taken to ensure that the temperature meets the requirements for packaging and labeling of medical devices.

Article 16 (Loading and Unloading Management) When cold chain management medical equipment is shipped, the temperature of the refrigerated truck, the refrigerated box and the incubator shall be checked and recorded. When the goods arrive, the receiving unit shall be provided with the full temperature record during the transportation period.

Article 17 (Entrusted Transportation) If other units are entrusted to transport cold chain management medical equipment, the qualifications and capabilities of the carrier shall be reviewed and the entrusted transportation agreement shall be signed, which shall meet at least the following requirements:

(1) Requesting the carrier's transportation qualification documents, transportation facility equipment and monitoring system certification and verification documents, carrier qualification certificates, transportation process temperature control and monitoring and other relevant information.

(2) Entrusting the pre-contracting and periodic auditing of the carrier's transportation facilities, personnel qualifications, quality assurance capabilities, safe transportation capabilities, and risk control capabilities, and reviewing the audit reports for future reference.

(3) The contents of the entrusted transportation agreement shall include: the carrier shall formulate and implement the transport standard operating procedures that meet the requirements, the requirements for temperature control and real-time monitoring during the transportation process, the requirements of the transit time limit, and the quality and safety responsibility during the transportation process.

(4) Review and evaluate the relevant personnel of the carrier according to the qualifications and conditions of the carrier when necessary.

Article 18 (Entrusted Storage) If other units are entrusted to store cold chain management medical equipment, the entrusted enterprise shall meet the requirements of Article 31 of the "Quality Management Regulations for Medical Device Management".

Chapter VI Emergency Management

Article 19 (Emergency Management) Production and operation enterprises and users shall formulate emergency plans for temperature control of cold chain management medical devices during storage and transportation, and for power outages, abnormal weather, equipment failures during storage and transportation, In case of accidents or emergencies such as traffic accidents, effective measures can be taken in time to prevent temperature loss due to abnormal situations.

Chapter VII Supplementary Provisions

Article 20 Cold chain management Medical equipment refers to the transportation and storage process of medical equipment in the production, operation and use links, and its various links are always in the specific temperature environment indicated by the product labeling instructions to ensure the management of product quality. In general, the refrigerating temperature is between 2 and 8 degrees Celsius and the freezing temperature is below -20 degrees Celsius.

Article 21 This guide is interpreted by the State Food and Drug Administration.

Article 22 This Guide shall be implemented as of the date of promulgation.

This document is the draft for comments issued by CFDA in May 2016 and will be uploaded by Shenzhen Yuanda Innovation Technology Co., Ltd.

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