The Announcement of the State Administration on Issuing the Classification Catalogue of Medical Devices (2017 No. 104), issued and implemented on August 1, 2018, has included reusable surgical gowns and surgical orders in the management of Class II medical devices, which is applicable to the relevant provisions of the Regulations on the Supervision and Administration of Medical Devices.
Why does the country include surgical gowns, surgical orders, and other products that were not originally medical devices in the new medical device classification catalog implemented in 2018?
The country implements classified management of medical devices according to their degree of risk. The first category is low risk medical devices, and implementing routine management can ensure their safety and effectiveness. The second category is a medical device with moderate risk that requires strict control and management to ensure its safety and effectiveness. The third category is medical devices that have high risks and require special measures to strictly control and manage them to ensure their safety and effectiveness. From this, it can be seen that in order to ensure the safety and effectiveness of surgical gowns, surgical sheets, and other instruments in use, it is necessary to strictly control and manage them.
Surgical gowns and surgical sheets are necessary protective equipment during the surgical process to reduce the risk of contact between medical personnel and patients with pathogenic microorganisms, reduce the infection rate of the surgical site, improve medical quality, and shorten hospital stay. At the same time, it indirectly reduces doctor-patient disputes by improving medical quality. This shows the importance of surgical gowns and surgical sheets. In recent years, many studies at home and abroad have fully demonstrated that there is a risk of infection of blood borne disease pathogens such as HIV (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV) during surgery, and these viruses can be transmitted through damaged skin or mucous membrane contact. A large number of studies both domestically and internationally have compared the differences in reducing surgical site infections between cotton surgical gowns with non bacterial and non water blocking functions and long fiber polyester fibers with bacterial and water blocking functions. The research results consistently demonstrate the importance of surgical gowns with bacterial and water blocking functions in reducing surgical site infections.
Standard performance surgical gowns
For operations with high risk of liquid splashing, such as hip Joint replacement, caesarean section, heart bypass, etc., high-performance surgical clothes are required to provide higher protection for medical personnel. For high-performance surgical gowns, three-layer composite materials are generally used in key areas such as the chest and sleeves.
Other parts of high-performance surgical gowns, such as sleeve seams, generally need to be fitted to ensure the integrity of protection. The back of the surgical gown is made of breathable material, which can improve wearing comfort while ensuring protection.
High performance surgical gowns
When purchasing soft equipment, it is also necessary to consider environmental protection, which is an important means of sustainable development. The use of disposable surgical supplies can lead to issues with storage, transportation, and disposal of medical waste, increasing the risk of infection and medical expenses.
When using surgical gowns and sheets that belong to Class II medical device management, the following issues should be noted:
Surgical gowns or sheets with damage, holes, or tears should not be used; Unsterilized surgical gowns and sheets should not be used; Do not use surgical gowns or sheets that have obvious fading or aging; Surgical gowns and sheets should not be used beyond their expiration date (frequency); Strictly follow the product's cleaning, disinfection, and sterilization procedures for reprocessing. Before 2018, products such as surgical gowns and surgical orders were not included in the management of medical devices, so the supervision of their production, sales, procurement, and use was far inferior to the management of medical devices.
Two high-quality research topics in China have consistently shown that using long fiber polyester surgical sheets can significantly reduce the infection rate at the surgical site compared to traditional cotton surgical sheets.
Since the country has issued corresponding management requirements for surgical gowns and surgical orders, manufacturers and users of such products should strictly comply with the country's management requirements for Class II medical devices to produce, sell, purchase, and use such products in accordance with the law.
In order to improve the quality of medical treatment, enhance the two-way safety between doctors and patients in medical behavior, and improve the quality of humanistic care in hospitals, let's build a safer and more reliable surgical environment together, under the premise of having laws to follow and having laws to follow.