4 balloons for one operation after collection?

In August of this year, some media released the title "Four Balloons for One Surgery!" The industry calls for the "low-price bidding concept to be evaluated objectively" in the report, which mentioned a cardiology expert who said: "After the centralized procurement bidding, the quality of the balloon still needs to be evaluated
.

Recently, I have a patient and used it for four consecutive times.

Investigation results: The continuous rupture of the balloon has nothing to do with the quality of the balloon, but is related to the pathology and surgical operation

Investigation results: The continuous rupture of the balloon has nothing to do with the quality of the balloon, but is related to the pathology and surgical operation

In response to media reports that "four balloons were broken in one operation," relevant departments quickly investigated and verified the issues mentioned in the report
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According to the National Medical Insurance Administration, the first is that the medical insurance department verified the relevant information about the cases reported by the media, and consulted the relevant medical records with the medical institutions where they were located to understand the basic information of the brand, model, batch and other rupture balloon products
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Second, the National Medical Security Research Institute of Capital Medical University organized 10 cardiovascular experts across the country to conduct an independent "double-blind" review of the case back to back to investigate the cause of balloon rupture from the use of intraoperative medical devices

The National Medical Insurance Administration stated that after verification, the multiple balloon rupture operations mentioned in media reports were a coronary stent implantation performed by Zhongshan Hospital affiliated to Fudan University on August 3, 2021.
The surgeon was performed by the Department of Cardiology.
The person in charge
.

The surgery using a total of 14 cases of coronary balloon burst five, including one for Medtronic (Shanghai) Management Co.

The production date of the 5 ruptured balloons is May 2021, before the start of the collection

The product quality survey results showed that the relevant batch of coronary balloon sampling inspections met the quality standards, and no related companies were found to have problems in quality management such as 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 relevant medical device adverse events was received

No problems were found in the quality management of related companies in production records, supplier audits, and incoming inspections

The hospital involved: In response to issues such as inaccurate comments made by individual medical staff, internal management will be strengthened

The hospital involved: In response to issues such as inaccurate comments made by individual medical staff, internal management will be strengthened

During the investigation, what did the hospital where the case was doing in terms of incident handling and standardized diagnosis and treatment? In this regard, the National Medical Insurance Bureau introduced that during the investigation of incidents reported by the media, Zhongshan Hospital affiliated to Fudan University actively cooperated, provided complete medical records involving cases, and organized a self-examination of relevant medical staff's clinical diagnosis and treatment practices
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Recently, the Shanghai Municipal Medical Insurance Bureau and other relevant departments performed the duties of medical procurement and medical device supervision, conducted interviews with the hospital, and notified the results of the investigation on the quality of coronary balloons
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The hospital stated that it recognizes the investigation conclusions of relevant departments and expert groups, and will strengthen internal management, standardize clinical diagnosis and treatment behavior, and improve the quality of medical care in response to inaccurate comments made by individual medical personnel
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The hospital will conscientiously implement the deployment requirements of the Party Central Committee and the State Council on centralized procurement reform, maintain the order of medical device supervision, strengthen the ideological and political work of medical staff, and actively eliminate adverse effects

National Medical Insurance Administration: Take a correct view of the reform of centralized and volume procurement, and jointly create a clean and vigorous pharmaceutical purchase and sales and practice environment

National Medical Insurance Administration: Take a correct view of the reform of centralized and volume procurement, and jointly create a clean and vigorous pharmaceutical purchase and sales and practice environment

After the centralized procurement reduced the falsely high prices of pharmaceuticals and consumables, the general public paid great attention to the quality of the selected products
.

In this regard

In the centralized procurement work, we always adhere to the "zero tolerance" attitude towards quality issues, and use strict rules and system design to ensure the quality and safety of selected products

The National Medical Insurance Administration stated that in the next step, relevant departments will further strengthen policy coordination and work cooperation, and support medical institutions to continue to carry out clinical efficacy and safety evaluations of selected products, to ensure the quality and safety of selected products in centralized procurement, and to ensure that the people receive high-quality, high-quality products.
Efficient and affordable medical and health services
.

In addition, the National Medical Insurance Bureau also expressed that it welcomes all sectors of the society to uphold an objective, rigorous, and pragmatic work attitude and professional ethics to supervise, and jointly maintain the order of centralized medical procurement and medical device supervision
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At the same time, it also calls on all parties, including medical institutions, medical staff, and pharmaceutical companies, to take a correct view of the reform of centralized and mass procurement, and jointly create a clean and vigorous pharmaceutical purchase and sales and practice environment to truly benefit the general public