"1 surgical break 4 balloons" is not collected? Surveys showed no association with balloon quality

◎ Science and Technology Daily reporter Zhang Jiaxing

The state carries out volume procurement with "price for market", so that the price of consumables such as brackets and balloons has become close to the people, from ten thousand yuan to thousands of yuan, but many people are worried about "cheap and no good goods".

"I recently had a patient who ruptured even 4 balloons, causing perforation of blood vessels, which did not exist before." The surgical experience of a cardiologist was previously reported by the media.

"Before" refers to the amount of centralized procurement before, the expert believes that there is no quality problem before the collection. Product quality cannot be sacrificed in order to save costs.

So, why does 1 operation use 4 balloons, is it really a "collection" to cause trouble? In response to this problem, the relevant departments organized industry experts to carry out investigations. A reporter from Science and Technology Daily learned of the results of the investigation from the National Medical Insurance Bureau on December 29.

Image source: Visual China

What happened to the balloon?

This is a coronary stent implant surgery performed at Zhongshan Hospital affiliated to Fudan University on August 3, 2021.

Why do implanted coronary stents rupture so many balloons?

It is understood that the balloon "open circuit" is required before coronary stent implantation. Because the patient's coronary arteries are blocked or narrowed, it is difficult to implant a stent when they come up. The balloon needs to be entered first, inflated to the narrowing of the blood vessels, and "squeezed" a certain space for the stent to be placed. The balloon is then deflated and retracted, and the stent is implanted in the same position.

In order to find out the cause of balloon rupture during surgery, the National Medical Security Institute of Capital Medical University organized 10 experts in the cardiovascular field nationwide to conduct an independent "double-blind" review of the case back-to-back, and investigated the cause of balloon rupture from the use of intraoperative medical devices.

Judging from the case review, experts believe that due to the severe diffuse calcification of the patient's blood vessels, the coronary balloon is easily punctured by the calcification site when it is expanded, and the continuous rupture of the balloon has nothing to do with the quality of the balloon, but is related to the lesion and surgical operation.

Ruptured balloons are not 4, but 5

The investigation learned that a total of 14 coronary balloons were used for the operation, and 5 ruptures were made, of which 1 was imported by Medtronic (Shanghai) Management Co., Ltd. and 4 were products produced by Guangdong Bomai Medical Technology Co., Ltd. The above two enterprises are the selected enterprises in Shanghai coronary balloon collection, and the centralized procurement of shanghai coronary balloon medical consumables was announced on June 9, 2021, and the implementation was implemented on July 30. However, the five ruptured balloons were all produced in May 2021, before the start of the collection.

For the quality of balloons, whether imported or domestically produced, the relevant departments have carried out spot checks and inspections.

The results of the investigation show that the State Food and Drug Administration entrusted the Shanghai Municipal Food and Drug Administration and the Guangdong Provincial Food and Drug Administration to carry out quality spot checks and inspections of relevant products in accordance with the relevant provisions of the quality spot check and inspection of medical devices, and the sampling of relevant batches of coronary balloons met the quality standards, and no problems were found in the quality management of relevant enterprises in production records, supplier audits, and incoming material inspections. In addition, after querying the relevant records of medical device adverse event monitoring, no feedback information on relevant medical device adverse events was received.

Are vascular perforations related to balloons?

The results of the back-to-back "double-blind" review concluded that balloon rupture led to the exclusion of the possibility of vascular perforation. Experts generally believe that vascular injury has a certain relationship with intraoperative operations.

In addition, the investigation also found that the operation also had problems such as insufficient preoperative evaluation and imperfect medical record.

In response to the above problems, Zhongshan Hospital affiliated to Fudan University actively cooperated, provided a complete case involving the case, and organized self-examination of the clinical diagnosis and treatment specifications of relevant medical personnel, and said that it would strengthen internal management, standardize clinical diagnosis and treatment behavior, and improve medical quality.

What is the quality of the collection product?

So, what is the quality of the pharmaceutical consumables that are centrally purchased? Is it "cheap and no good goods" or "cheap and good"?

"In the centralized procurement work, we always adhere to the 'zero tolerance' attitude towards quality issues, and ensure the quality and safety of the selected products with strict rules and system design." According to the relevant person in charge of the National Medical Insurance Bureau, at present, the national level has organized the collection of 6 batches of drugs and 2 batches of high-value medical consumables, and the drug regulatory department has included all selected products in the regulatory focus, and carried out full-cycle, full-coverage supervision in accordance with the requirements of the relevant department heads of the National Medical Insurance Bureau, compacting the main responsibilities of enterprises, and ensuring that "price reduction does not degrade quality". Up to now, the drug regulatory department has fully supervised and inspected the selected drugs and coronary stents, and no violations of laws and regulations have been found.

Recently, the large-scale real-world research evaluation conducted by 20 well-known tertiary hospitals in China for the first batch of selected generic drugs in the drug collection and procurement of the first batch of national organizations shows that the clinical efficacy and safety of the selected generic drugs are consistent with the original research drugs. In the next step, the relevant departments will further support medical institutions to continue to carry out clinical efficacy and safety evaluation of selected products.

The person in charge said, "We call on all parties, including medical institutions, medical personnel, and pharmaceutical enterprises, to correctly view the reform of centralized procurement, and jointly create a clean and healthy environment for the purchase and sale of medicines and the practice of medicine." ”

Source: Science and Technology Daily

Editor: Zhang Qiqi

Review: Julie

Final Judge: Liu Haiying