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On March 15, 2025, CCTV’s “3·15” evening gala exposed a shocking quality issue in medical and hygiene products that reverberated across the nation. Liang Shan Xi Xi Paper Products Co., Ltd. in Liangshan County, Jining, Shandong Province, was found to be selling large quantities of substandard sanitary napkins and baby diapers. The investigation revealed that defective materials from multiple well-known brands, including Purcotton (a core brand under Steadfast Medical), were being refurbished and resold as “second-hand sales.” This incident not only raised public concerns about the quality of medical and hygiene products but also sounded an alarm for quality control in the medical gauze and other medical supplies industry.
According to CCTV’s “3·15” evening gala report, Liang Shan Xi Xi Paper Products Co., Ltd. in Liangshan County, Jining, Shandong Province, was engaged in the large-scale sale of substandard sanitary napkins and baby diapers. The investigation revealed that the company was refurbishing and reselling defective materials from multiple well-known brands including Purcotton, Sophie, and Libresse.
Following the exposure, Steadfast Medical responded swiftly. On March 16, Purcotton representatives told media outlets that “the involved illegal company has no cooperative relationship with our company.” Meanwhile, the Shenzhen Stock Exchange promptly issued a letter of concern to Steadfast Medical, requiring the company to explain its systems and actual implementation regarding raw material procurement and disposal of defective products.
Steadfast Medical subsequently issued a statement saying it would destroy hygiene product defective materials itself and further strengthen control over defective materials generated during the production process.
After the incident, the Jining Municipal Committee and Municipal Government established a joint investigation team to conduct on-site investigations and had already controlled the company’s responsible persons. Jining City stated it would launch a city-wide special rectification campaign to ensure product quality and safety.
Currently, quality control for medical gauze and other medical supplies in China mainly relies on national standards and industry standards. The National Standards Committee is formulating the national standard “Medical Gauze Dressings,” which is under the jurisdiction of the National Working Group for Standardization of Medical Protective Equipment, with the National Standards Committee as the competent department and Shandong Institute for Medical Device and Pharmaceutical Packaging Testing as the main drafting unit.
Meanwhile, the National Medical Products Administration (NMPA) has issued the “Technical Review Guidelines for Surgical Gauze Dressing Registration,” providing technical guidance for applicants submitting surgical gauze dressing registration applications and technical references for drug regulatory authorities reviewing registration application materials.
On January 15, 2025, the NMPA published a document on its official website, publicly soliciting opinions and suggestions on the “Good Manufacturing Practice for Medical Devices (Revised Draft for Comments).” This revision aims to further improve the medical device production quality management system and strengthen full life-cycle supervision.
Additionally, the NMPA issued the “Announcement on Measures to Optimize Full Life-cycle Supervision and Support Innovation and Development of High-end Medical Devices,” clearly proposing to improve the review and approval mechanism, strengthen full life-cycle supervision, and fully support major innovations in medical devices.
The Steadfast Medical incident exposed management loopholes in the disposal of defective materials by medical supply manufacturers. Although Steadfast Medical claimed it had no cooperative relationship with the illegal company, there were obviously problems with the control of defective material flow. This reminds us that medical supply companies need to establish stricter defective material tracking and disposal systems.
The incident reflects the complexity of medical supply chain management. From raw material procurement to final product sales, strict quality control is needed at every stage. Especially for medical gauze and other medical supplies that directly contact the human body, any quality issues could cause serious harm to patient health.
The fact that Liang Shan Xi Xi Paper Products Co., Ltd. was able to engage in illegal activities for a long time indicates that the existing regulatory system still has weak links in grassroots enforcement. It is necessary to strengthen daily supervision of medical supply manufacturers and establish more effective regulatory mechanisms.
Medical supply manufacturers should establish comprehensive systems for identifying, classifying, disposing of, and tracking defective materials. All defective materials should be harmlessly disposed of according to relevant regulatory requirements, and strictly prohibited from entering the market. Companies should establish defective material disposal records, documenting the disposal process and results to ensure traceability.
Companies should establish supplier access systems, conducting strict audits and regular assessments of raw material suppliers. Establish comprehensive raw material inspection systems to ensure all raw materials meet relevant standard requirements. At the same time, establish product quality traceability systems to ensure each batch of products can be traced to specific raw material sources.
Strictly implement the “Good Manufacturing Practice for Medical Devices” and establish comprehensive production process control systems. Focus on monitoring key processes to ensure stable product quality. Regularly maintain and calibrate production equipment to ensure equipment performance meets requirements.
Companies should establish ISO 13485 medical device quality management systems and continuously improve them. Conduct regular internal audits to promptly identify and correct quality management issues. Establish quality risk management mechanisms to identify, assess, and control risks that may affect product quality.
Regulatory authorities should accelerate the improvement of national and industry standards for medical gauze and other medical supplies, enhancing the scientific nature and operability of standards. At the same time, strengthen standard publicity and training to ensure companies can correctly understand and implement standard requirements.
Establish and improve regulatory enforcement mechanisms, strengthening daily inspections and unannounced inspections of medical supply manufacturers. For discovered illegal activities, strictly handle them according to laws and regulations to create a deterrent effect. Meanwhile, strengthen inter-departmental collaboration to form regulatory synergy.
Establish information-based regulatory platforms for medical supply manufacturers to achieve real-time monitoring of corporate production and business activities. Establish product quality traceability systems to ensure full-process traceability from raw materials to end users.
Establish comprehensive reporting and reward systems to encourage public participation in supervision. Strengthen cooperation with media to promptly expose illegal activities. At the same time, strengthen consumer education to improve consumers’ quality awareness and rights protection consciousness.
Although the Steadfast Medical incident exposed problems, it also provided opportunities for industry technological innovation. Companies can improve product quality and production efficiency through technological innovation. For example, adopting new materials and processes to improve the absorbency, breathability, and comfort of medical gauze.
Medical supply companies should actively embrace digital transformation, using Internet of Things, big data, artificial intelligence, and other technologies to improve quality management levels. Establish digital quality management systems to achieve precise control of production processes and real-time analysis of quality data.
With increasing environmental awareness, medical supply companies should focus on green and sustainable development. Adopt environmentally friendly materials, optimize production processes, and reduce environmental pollution. At the same time, establish circular economy models to improve resource utilization efficiency.
The Steadfast Medical incident sounded an alarm for the medical gauze and other medical supplies industry but also provided new opportunities for industry development. Only by establishing comprehensive quality control systems, strengthening regulatory enforcement, and promoting technological innovation can we ensure the quality and safety of medical supplies and protect people’s health rights.
In the new historical period, the medical supplies industry must regulate its own development with higher standards and stricter requirements. While ensuring product quality, it should promote high-quality industry development. Only in this way can we regain consumer trust and promote the healthy and sustainable development of the entire industry.
Main Sources:
CCTV “3·15” Evening Gala Report, March 15, 2025
NetEase News: “Core Brand Named by CCTV 3·15 Evening Gala, Performance Declining, Steadfast Medical Struggles to Stay ‘Steadfast'”, March 16, 2025
Tencent News: “Purcotton ‘Named’ by 315, Affecting Steadfast Medical”, March 17, 2025
21 Finance: “After CCTV 315 Evening Gala Exposure, Refurbished Sanitary Napkin Executive Controlled, Purcotton and Libresse Parent Companies Receive Letters of Concern”
Securities Times: “CCTV 315 Evening Gala Exposes Substandard Sanitary Napkins, Local Market Supervision Bureau Responds: Enforcement Team Has Gone to the Enterprise Site, Measures Have Been Taken”
Blue Whale Finance: “After CCTV 315 Evening Gala Exposure, Refurbished Sanitary Napkin Executive Controlled, Purcotton and Libresse Parent Companies Receive Letters of Concern”
National Medical Products Administration: “Good Manufacturing Practice for Medical Devices (Revised Draft for Comments)”, January 15, 2025
National Medical Products Administration: “Guidelines for On-site Inspection of Good Distribution Practice for Medical Devices”, July 30, 2024
OFweek: “In the ‘Garbage Refurbished Sanitary Napkin’ Incident, Is Purcotton’s Involvement in Defective Material Sales Forgivable?”
China Association for Pharmaceutical Regulatory Studies: Medical Device Regulations and Standards Information
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