Release date: 2009-08-26
By Zhujiang Ma Junyao, Jiangsu Dantu Food and Drug Administration In the production, distribution, use, and supervision of medical devices, batch numbers serve as essential identifiers that enable quality control, traceability, and efficient management. However, there is a lack of clear regulations regarding which medical devices should be labeled with batch numbers and how to implement such management effectively. This ambiguity has created challenges in maintaining proper oversight and accountability throughout the supply chain. The concept of "batch number" for medical devices is not clearly defined in existing regulations such as the "Regulations on the Supervision and Administration of Medical Devices," the "Measures for the Supervision and Administration of Medical Device Production," or the "Regulations on the Management of Medical Device Instructions, Labels, and Packaging Labels." As a result, there is no unified standard across the industry. Some non-disposable and miniaturized medical devices, such as sphygmomanometers and glass thermometers, do not have batch numbers at all. These products are not required by law to include them, and their internal standards may vary between manufacturers. This leads to inconsistencies, where similar products from different companies might have different batch numbering systems or none at all. Additionally, some manufacturers manipulate batch numbers to reduce costs. For example, they may produce large quantities of the same device and label them with different batch numbers based on customer demand. In some cases, expired devices are repackaged and relabeled, making it difficult to track their true origin and condition. Sales documents often fail to include batch numbers, and purchase records from medical institutions frequently omit this critical information. While some regulations require tracking of sterile and implantable devices, there are no strict penalties for non-compliance. This lack of enforcement weakens the overall effectiveness of batch number management. As a result, identifying unqualified devices becomes challenging. Without batch numbers, it's hard to determine the full scope of defective products or trace their origins. Similarly, when illegal devices are discovered, the absence of batch numbers makes it difficult to trace their source and usage. To address these issues, it is crucial to define the term "batch" more clearly. A batch of medical devices should refer to a group of units produced under identical conditions—same process, materials, and equipment. The batch number serves as a unique identifier that allows for full traceability. It is recommended that regulatory bodies establish clear guidelines on which devices must have batch numbers and incorporate these requirements into product standards. Additionally, all purchase and sales records should include batch and sterilization numbers, especially for high-risk devices like implants or sterilized equipment. Regulatory improvements should also include stricter enforcement, with penalties for non-compliance. Inspections should focus on ensuring that batch numbers are properly recorded and maintained. Integration with pharmacy certification programs and corporate credit systems could further incentivize compliance. Training and education for both regulators and industry professionals are essential to ensure that batch number management is taken seriously. Manufacturers must also strengthen internal controls to ensure consistency within each batch, using the same raw materials, equipment, and workers. By improving batch number management, the medical device industry can enhance safety, improve traceability, and better protect public health. Shanghai Medical Device Industry Association
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