A Key Step | Domestically Produced Disposable Robotic Bronchoscope from Prilichuan Receives NMPA Registration Certificate, Strengthening the Foundation for "International Innovation, Chinese Intelligent Manufacturing"

Recently, Pulibaichuan's disposable robotic bronchoscope and accessories successfully obtained the NMPA registration certificate. This is a key breakthrough in the field of domestically produced disposable robotic bronchoscopes, marking a solid and powerful step forward for "international innovation and Chinese intelligent manufacturing" in the respiratory interventional device field.

As a core component of the Pulibaichuan system, this disposable robotic bronchoscope and its accompanying consumables together constitute the current intelligent platform equipped with disposable robotic bronchoscopes and their accompanying consumables, providing innovative solutions for the entire process from diagnosis to treatment in clinical settings.

01 Why has the single-use bronchoscope become a strategic choice for global healthcare systems?

Healthcare constantly faces the challenge of balancing operational efficiency, cost savings, and patient safety and improved outcomes. Disposable bronchoscopes offer a practical and forward-thinking solution that can simultaneously meet all of these goals.

Today, the breakthrough in the localization of Puli Ark, coupled with the support of Puli Baichuan system robot control, has given this solution a more independent, controllable, and accessible path to realization in China.

02 Reduce infection risk and alleviate liability burden

The long-standing contamination risk of reusable bronchoscopes poses a significant risk to patient safety and the reputation of medical institutions. Studies have shown that even with strict cleaning procedures, the cross-contamination rate of reusable bronchoscopes can still exceed 8% [1]. A systematic review and meta-analysis included 8 studies and 2169 bronchoscope samples, and found that the total cross-contamination rate was 8.69% ± 1.86 (95% confidence interval: 5.06%–12.33%) [1].

Disposable bronchoscopes completely eliminate risks, providing sterile, ready-to-use equipment for each procedure. For hospitals, this translates to a significant reduction in liability risks and a continuous improvement in infection control compliance. Pulibaichuan's disposable robotic bronchoscopes truly make "one new bronchoscope for every case" a standard clinical practice.

03 Optimize operational processes: Free up manpower and improve efficiency

The reprocessing of reusable bronchoscopes is a resource-intensive task that requires professional personnel, specialized equipment, and strict quality control. It is prone to process bottlenecks and increases operating costs.

Disposable bronchoscopes eliminate these challenges, streamline workflows, and free up staff to focus on other critical tasks. This efficiency is especially valuable in high-intensity work environments where time is of the essence. The certification of domestically produced consumables means that Chinese hospitals can upgrade their processes more efficiently and with lower barriers to entry.

04 Economic Efficiency Solutions

While the initial purchase cost of disposable bronchoscopes may seem higher, their long-term economic benefits are significant. Eliminating the reprocessing step reduces costs associated with labor, water, energy, and chemical reagents. Furthermore, avoiding expensive repairs and reducing infection-related expenses contributes to overall cost savings.

Studies have shown that, after taking these factors into account, the cost per operation of a single bronchoscope may be more advantageous[2]. After the localization of Puli Ark, the supply chain and cost structure have been further optimized, benefiting more medical institutions.

05 International trends keep pace with China

For hospital administrators seeking sustainable and financially sound solutions, disposable bronchoscopy is a strategic option. Since January 1, 2024, the Centers for Medicare & Medicaid Services (CMS) has established a new Transitional Direct Payment (TPT) category and a new HCPCS code (C1601) for disposable bronchoscopy. [3]

The approval by China's NMPA signifies that the "Made in China" disposable robotic bronchoscope has entered a new stage of standardized and large-scale application.

06 Improve equipment availability and ensure uninterrupted medical services

Ensuring that bronchoscopes are in good working order and readily available can be a significant logistical challenge. Delays in reprocessing, equipment downtime, and sudden surges in demand can all disrupt workflows.

Disposable bronchoscopes are readily available, eliminating delays and ensuring continuity of medical services. This reliability improves both patient satisfaction and staff productivity. The continuous supply of domestically produced consumables from Puli Ark provides hospitals with truly uninterrupted service.

07. Advance medical standards and respond to emergencies.

Disposable endoscopes also offer key advantages in emergency situations. For example, when personal protective equipment is scarce, disposable bronchoscopes are a viable alternative because they greatly reduce the need for reprocessing. Furthermore, in situations where no one is available to clean the bronchoscope—such as when performing a bronchoscopy during "off-duty hours" or when surgery is performed outside of a dedicated endoscopy unit—disposable equipment ensures continuity of care.

The Pulibaichuan system, combined with the Pulibaichuan disposable robotic bronchoscope, is designed for such complex, urgent, and demanding scenarios.

08. Pulibaichuan System: Currently the intelligent platform equipped with disposable robotic bronchoscopes.

As healthcare systems seek innovative solutions to deliver on their promise of improved patient care, disposable bronchoscopes have become an easy option for achieving efficiency, cost savings, and enhanced safety standards. The PriBio system takes this concept to new heights.

As an intelligent platform equipped with a disposable robotic bronchoscope and related consumables, the Pulibaichuan system achieves:

• Zero cross-infection: Each patient uses a brand new sterile endoscope, eliminating the risk of reprocessing and contamination.

• Fully robot-assisted operation: high precision, stability, and ease of operation, reducing the learning curve for operators.

• Complete set of consumables: All necessary accessories for biopsy, irrigation, and treatment are provided, ensuring seamless integration.

The NMPA certification of PriBaiChuan's disposable robotic bronchoscope and accessories provides a new and highly accessible option for a wide range of interventional respiratory physicians and patients in China.

A crucial step: solidifying the foundation.

From addressing infection risks to optimizing operating costs, from improving equipment accessibility to responding to sudden public health emergencies, disposable robotic bronchoscopes are leading a paradigm shift in the field of endoscopy. The certification of Puli Ark's domestically produced disposable bronchoscope marks a new stage in China's transformation, characterized by independent control and large-scale application.

A crucial step has been taken, and the foundation for "Made in China 2025" is being continuously strengthened.

Let us congratulate Puli Ark and Puli Baichuan System—safeguarding respiratory health.

References

[1] Travis HS, Russell RV, Kovaleva J. A systematic review and meta-analysis of cross-contamination rates of reusable flexible bronchoscopes. Journal of Infection Prevention. 2023;24(3):115-122. (The study showed a cross-contamination rate of 8.69% ± 1.86%, exceeding 8%)

[2] Comprehensive cost analysis shows that, considering reprocessing, maintenance, and infection-related expenses, the cost per operation of a single disposable bronchoscope is advantageous. (Related health economics research)

[3] Centers for Medicare & Medicaid Services (CMS). Notice of Establishment of Transitional Direct Payment (TPT) Category and HCPCS Code C1601 for Single Bronchoscopes in 2024. Effective January 1, 2024.

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