"Four balloons were broken for one operation" Is it really the fault of "collective procurement"?


　　Investigation results announced: related to lesions and surgical operations, not related to balloon quality

　　◎Our reporter Zhang Jiaxing

　　The state has carried out mass procurement with "price for the market", making the prices of stents, balloons and other consumables close to the people, ranging from 10,000 yuan to 1,000 yuan.

However, many people worry that "cheap is not good."

　　"Recently I had a patient, and even after using 4 balloons, they ruptured and caused blood vessel perforation. This didn't exist before."

　　The surgical experience of a cardiologist was previously reported by the media.

　　"Before" refers to the quantity before the centralized procurement. This expert believes that there is no quality problem before the centralized procurement.

We cannot sacrifice product quality in order to save costs.

　　So, why would 4 balloons be broken in one operation? Is it really the fault of "collective procurement"?

In response to this issue, relevant departments organized industry experts to investigate.

A reporter from Science and Technology Daily learned of the investigation results from the National Medical Insurance Bureau on December 29.

　　What happened to the balloon?

　　This is a coronary stent implantation performed at Zhongshan Hospital of Fudan University on August 3, 2021.

　　Why do the implanted coronary stents rupture so many balloons?

　　It is understood that the balloon needs to be "opened" before coronary stent implantation.

Because the patient's coronary arteries are blocked or narrowed, it is difficult to get up and implant a stent.

The balloon needs to be deflated first, and then inflated and expanded to the stenosis of the blood vessel to "squeeze" a certain amount of 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 the balloon rupture during the operation, the National Institute of Medical Security of Capital Medical University organized 10 cardiovascular experts across the country to conduct an independent “double-blind” review of the case back to back. Use to investigate the cause of balloon rupture.

　　Judging from the review of the medical records, 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 the coronary balloon is expanded. The continuous rupture of the balloon has nothing to do with the quality of the balloon, but is related to the disease and surgical operation.

　　Not 4 ruptured balloons, but 5?

　　According to the investigation, a total of 14 coronary balloons were used in this operation, and 5 were ruptured, of which 1 was imported by Medtronic (Shanghai) Management Co., Ltd., and 4 were produced by Guangdong Bomai Medical Technology Co., Ltd.

The above-mentioned two companies are the selected enterprises in the centralized procurement of coronary balloons in Shanghai. The centralized procurement of coronary balloon medical consumables in Shanghai will announce the results of the selection on June 9, 2021, and will be implemented on July 30.

However, the production date of the five ruptured balloons was May 2021, before the start of centralized procurement.

　　The reporter noted that the number of balloons named by the aforementioned surgical experts is only the number of domestic balloons, but imported balloons are not included.

Regarding the quality of balloons, whether imported or domestically produced, relevant departments have conducted random inspections.

　　The results of the investigation showed that the State Food and Drug Administration entrusted Shanghai Municipal Food and Drug Administration and Guangdong Provincial Food and Drug Administration to carry out quality random inspections on related products in accordance with relevant regulations on the quality of medical devices. No problems were found in the quality management of related companies in terms of production records, supplier audits, and incoming inspections.

In addition, after inquiring about the relevant records of medical device adverse event monitoring, no feedback information about the relevant medical device adverse event was received.

　　Is vascular perforation related to balloon?

　　The back-to-back "double-blind" review concluded that the possibility of vascular perforation caused by balloon rupture was ruled out.

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 to provide complete medical records involving cases, and organized a self-examination of relevant medical staff's clinical diagnosis and treatment practices, and expressed that it will strengthen internal management, standardize clinical diagnosis and treatment behavior, and improve medical care. quality.

　　How is the quality?

"Four Strict" Supervision + Evaluation of Grade-A Hospitals

　　So, what is the quality of the centralized procurement of pharmaceutical consumables?

Is it "cheap but no good products" or "cheap and good quality"?

　　"In the centralized procurement work, we always adhere to a'zero tolerance' attitude towards quality issues, and use strict rules and system design to ensure the quality and safety of selected products." The relevant person in charge of the National Medical Insurance Bureau introduced that at present, the national level has organized the development. The centralized procurement of 6 batches of medicines and 2 batches of high-value medical consumables. The drug regulatory department will list all selected products as the focus of supervision, and carry out full-cycle and full-coverage supervision in accordance with the requirements of the relevant department of the National Medical Insurance Bureau to consolidate the main responsibility of the enterprise. Ensure that "price reduction does not degrade quality."

Up to now, the drug regulatory department has conducted full-coverage supervision and inspection and quality random inspections of selected drugs and coronary stents, and no violations of laws and regulations have been found.

　　Recently, a large-scale real-world research evaluation conducted by 20 well-known domestic hospitals on the generic drugs selected in the first batch of nationally organized drug collections showed that the selected generic drugs have the same clinical efficacy and safety as the original drugs.

In the next step, relevant departments will further support medical institutions to continue to carry out clinical efficacy and safety evaluations of the selected products.

　　The person in charge said, “We call on all parties, including medical institutions, medical staff, and pharmaceutical companies, to take a correct view of the reform of centralized procurement and to work together to create a clean and vigorous environment for the purchase and sale of medicines and the practice of medicine.”