Why has disposable infusion set become the most problematic medical device?

Source: Finance Magazine

Original title: Disposable infusion set, why has it become the most problematic medical device?

Is infusion, the most common treatment in China, really safe?

On December 24, 2019, Huizhikang (83235.OC), a new three-board listed company, clarified the "infusion set foreign body" incident.

The incident began at about 0:00 on December 16, 2019. In the Department of Pediatrics, the People's Hospital of Leshan City, Sichuan Province, a child's family found a foreign body in the disposable infusion set. There are reports of foreign bodies suspected insects, but the current investigation has no conclusion, can not be confirmed.

Hui Zhikang admitted that after preliminary verification, the products involved were confirmed to be produced by the company.

A government official in charge of the matter told Caijing that the Leshan Municipal Government has set up a joint investigation team, and the Municipal Public Security Bureau, the Market Supervision Bureau, and the Health Commission all participated in the investigation.

The police intervened to verify whether there was any sabotage in the incident. The hospitals and companies involved are cooperating with the investigation, and there is no preliminary conclusion at present.

Infusions are commonly used in hospitals, and studies have shown that more than 5 billion disposable infusions are used in China each year. This is not the first time a foreign body has been found in a disposable infusion set. Aside from the medical controversy over efficacy, the cleanliness of the infusion set itself used in this treatment is enough to raise public concern.

There is another problem with the infusion set.

At about 00 o'clock on December 16, 2019, in the Department of Pediatrics, Leshan People's Hospital, Sichuan Province, a child's parents found a foreign body in the infusion set 5 minutes after infusion.

According to Leshan people's Hospital, after the parents found the foreign body, the nurse on duty immediately stopped the infusion, and the medical staff immediately carried out a comprehensive examination of the child. After 17 hours of close observation, the child had no discomfort. After obtaining the consent of the family members, he was discharged from the hospital as planned and told to follow up on time.

After the incident, the relevant departments of the hospital immediately sealed the infusion set under the witness of the family members and handed it over to the family members for safekeeping.

The hospital stressed that all medical consumables, including infusion sets, are purchased in accordance with national regulations and in line with national standards. After the incident, the hospital reported to the higher authorities and comprehensively cleaned up the use of all medical consumables in the hospital.

On December 18, Henan Shuguang Jianshi Medical Device Group Co., Ltd. (hereinafter referred to as "Shuguang Group"), the controlling shareholder of Huizhikang, announced on its website that the company appointed quality management personnel and relevant experts to the scene to investigate and deal with it. At the same time, cooperate with the hospital and relevant government departments to do follow-up work.

Six days later, Huizikang admitted that after preliminary verification, the product involved was produced by the company. The product name was "disposable precision filter bag infusion set", the batch number was 191026, and the registration certificate number was 20153660673.

A person from the quality control center of Shuguang Group told Caijing that the government is now leading the investigation.

To this end, the Leshan Municipal Government established a joint investigation team, and the Municipal Public Security Bureau, Market Supervision Bureau, and Health Commission all participated in the investigation. As of press time, no preliminary findings have been released.

This is not the first time that a foreign body has been found in a similar infusion set. In 2019 alone, many similar incidents were exposed by the media.

According to Red Star News, on March 17, 2019, Ms. Sun's child was hospitalized in a tertiary hospital in Jilin City, Jilin Province due to high fever. When she was hospitalized for infusion, Ms. Sun found a hair about 2cm long in the infusion tube. After complaining to the hospital, the Food and Drug Administration and the Health Bureau intervened in handling the incident.

Huashang Daily reported on June 11, 2019 that on June 5, Ms. Li took her 6-year-old daughter to the Pediatrics Department of Xi'an Beihuan Hospital due to asthmatic bronchitis. At about 10:20 a.m. on June 8, when the infusion reached the third bottle, Ms. Li found a foreign body suspected of hair on the inner wall of the infusion dropper.

Infusions are commonly used in hospitals, and studies have shown that more than 5 billion disposable infusions are used in China each year. However, the quality of infusion sets is often controversial. The problems that have occurred in use are not only the discovery of foreign bodies, but also leakage, irregular parts, etc.

Among the medical device adverse event reports reported nationwide in 2017, 43500 adverse events occurred in disposable infusion sets were reported, accounting for 11.57 percent of the total, making it the medical device with the most problems in China.

Reuse, another worry of disposable consumables

In China, in addition to the hemodialyzer can be clearly reused, other disposable consumables are not allowed. However, studies have pointed out that disposable consumables are reused in medical institutions. This is a more worrying issue.

In the case that the regulatory authorities have not liberalized the reuse of consumables, the similar practice of medical institutions is not an isolated case. This is already worrying about the safety and quality of disposable supplies, but also bring some controversy.

For example, on July 16, 2019, "Dahe Daily" reported that a special inspection action in Zhengzhou City found that some local dental clinics had illegal and illegal use of disposable oral equipment.

A medical device practitioner told Caijing that the management of some small hospitals is not standardized enough, not only disposable consumables are reused, but also disinfection is not thorough enough.

A research report entitled "Reprocessing and Reuse of Disposable Medical Devices in China: Pilot Survey" shows that from July 26 to August 4, 2015, researchers conducted a survey on 544 respondents from 31 different regions and 9 different fields through an online questionnaire survey platform and found that although China prohibits the reuse of disposable medical devices, but there is still a lot of repeated use in hospitals. The report was published in the British journal BMC Public Health.

The national survey report stated that if the safety of medical devices can be guaranteed while reducing prices, most people tend to accept the reuse of single-use medical devices.

In addition, many respondents expressed doubts about the hygiene and functional safety of reused disposable consumables. Although most people believe that reliable cleaning and sterilization technology can ensure the hygiene and safety of single-use medical equipment reuse, 66% of people still hold a negative attitude towards the reliability of the reuse of disposable consumables.

This research report also pointed out that the contradiction in concepts and the lack of related research make China's drug regulatory authorities face many challenges in building and improving the medical device use system to meet the growing needs of all walks of life.

As far as the existing regulatory policies are concerned, 90% of the respondents believe that a special management system should be established.

In China, other disposable consumables are not allowed except for hemodialyzers that are clearly reusable. The "Regulations on the Supervision and Administration of Medical Devices (2017 Revised Edition)" shows that disposable medical devices must not be reused, and those that have been used should be destroyed and recorded in accordance with relevant national regulations.

Reusing disposable consumables, an important driving factor is to reduce the cost of medical institutions. If appropriate rules and regulations are established and strictly enforced, it is not impossible to reuse consumables.

In foreign countries, there are precedents for reuse. For example, more than 25% of hospitals in the United States reuse at least one type of disposable consumables. At present, the reprocessing of disposable consumables is regulated by the US Food and Drug Administration (FDA). The FDA allows the 100 of many different disposable consumables for legal reprocessing. Most European countries are also reusing disposable supplies.

China is trying to establish norms for the reuse of disposable consumables, and the pace is very cautious. On August 12, 2019, the official website of the National Medical Insurance Administration released the ''Response to Recommendation No. 6395 of the Second Session of the Thirteenth National People's Congress, ''which mentioned that the State Food and Drug Administration had commissioned relevant units to carry out subject research, and the survey showed that At this stage, various stakeholders still have major differences in the formulation of the one-time use medical device catalog.

The National Medical Insurance Bureau replied that the recycling and reuse of disposable medical consumables involves laws and regulations such as the the People's Republic of China Law on the Prevention and Control of Infectious Diseases and the regulations on the Supervision and Administration of Medical Devices, as well as technical guarantees such as the safety and effectiveness of reused products, and the economic feasibility of reuse. Social ethics and doctor-patient relationship and other issues require joint research and promotion by multiple departments.

In the next step, the State Food and Drug Administration will cooperate with relevant departments to carry out the reuse of high-value medical consumables, and provide technical support in the functional verification and safety and effectiveness guarantee of reused products.

This reply is in response to the suggestion of Liang Yijian, deputy to the National People's Congress and director of the Department of Orthopedics of the Third People's Hospital of Chengdu, Sichuan Province.

Liang Yijian found through research that a large number of disposable consumables, including ultrasonic cutter heads, can be reused after strict disinfection, which can not only reduce the economic burden of patients, but also save a lot of medical insurance funds.

However, after in-depth research, Liang Yijian also found that the one-time use of consumables is well regulated, but the risk prevention and control of reuse after strict disinfection is more complicated, which means that the regulatory authorities must strengthen and improve supervision.

"Reusing devices is balanced against social benefits over personal benefits, and medical personnel have an obligation to protect patients from harm." Baotou Central Hospital Hospital infection management department Zhao Jing and others wrote in a discussion.

People frequently use consumables in hospitals, which has a direct impact on the health of patients. Safe clean without foreign body is the bottom line, which should be the consensus of enterprises, hospitals and regulatory agencies.