Release date: 2009-08-26
By Zhujiang Ma Junyao, Jiangsu Dantu Food and Drug Administration In the production, operation, use, and supervision of medical devices, batch numbers serve as a crucial identification code for tracking and managing product quality. Despite their importance, there is currently no clear regulation on which types of medical devices should be labeled with batch numbers or how to implement effective lot number management. This lack of guidance has led to inconsistencies and challenges in implementing proper batch control. Below, the author explores the significance of medical device batch number management and proposes strategies for improvement from several perspectives. **Current Status and Causes** First, the concept of "batch number" is not clearly defined in existing regulations such as the *Regulations on the Supervision and Administration of Medical Devices*, *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 standardized definition of what constitutes a batch number for medical devices. Second, some non-disposable, small medical devices do not have a batch number at all. For example, sphygmomanometers and glass thermometers are often not required to bear a batch number by law, nor do their product standards mandate it. Some companies may choose to include a batch number in their internal standards, while others do not, leading to inconsistency across manufacturers. Third, some manufacturers manipulate batch numbers to cut costs. They may produce large quantities of the same device and later assign different batch numbers based on customer demand. In some cases, expired devices are repackaged and relabeled with new batch numbers, raising serious safety concerns. However, the legal framework does not clearly address this issue. Fourth, sales documentation often lacks batch numbers. There are no strict rules requiring medical device sellers to include batch numbers on invoices or delivery notes. As a result, many documents simply omit this critical information, making traceability difficult. Fifth, purchase and use records frequently fail to document batch numbers. While certain regulations require medical institutions to record sterilization batch numbers for sterile or implantable devices, there is no penalty for non-compliance. Additionally, other medical devices are not subject to similar requirements, leading to incomplete records. **Challenges and Consequences** First, identifying unqualified devices becomes challenging when batch numbers are missing. For instance, if a thermometer is found non-conforming during testing, it is hard to determine the full scope of affected products without a batch number. Second, tracing illegal devices is complicated when batch numbers are not recorded. If a device lacks a registration certificate and its batch number is missing from purchase records, it becomes nearly impossible to track its origin and usage. Third, product traceability is compromised when batch numbers are not consistently used. Without proper tracking, recalling defective devices or controlling their distribution becomes extremely difficult. Fourth, altering batch numbers can endanger patient safety. Some companies may re-label expired medical devices with new batch numbers, potentially compromising the integrity of the product, especially for rubber-based or drug-containing devices that degrade over time. **Regulatory Recommendations** First, it is essential to clarify the definition of "batch." According to GB/T 2828, a "batch" refers to a group of products produced under the same conditions. For medical devices, a batch should include devices manufactured in the same cycle using the same materials, process, and equipment. The batch number should allow for tracking the production history of each batch. Second, the scope of devices requiring batch numbers should be clearly defined. Small, mass-produced devices should be subject to batch management, and regulatory authorities should specify this in product standards. Third, regulations must be updated to require batch numbers on purchase and sales records, as well as on sales vouchers. Sterilized and implantable devices must include both production and sterilization batch numbers. Non-compliance should result in penalties like warnings or fines. Fourth, regulatory inspections should focus on ensuring batch number compliance. Even if current laws don't impose strict penalties, enforcement agencies should conduct regular checks and encourage compliance through incentives like "qualified pharmacy" certifications or corporate credit evaluations. Fifth, training and education are key. Regulatory bodies should provide ongoing training on medical device regulations to ensure all stakeholders understand the importance of batch number management. Sixth, manufacturers should improve internal controls to ensure consistency within each batch. Using the same raw materials, assembly lines, and workers helps maintain product homogeneity. Future systems could even include detailed production data like line numbers and worker IDs in batch numbers for better traceability. Shanghai Medical Device Industry Association
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