Disposable Delivery Packs: What Class of Medical Device Are They?

Disposable delivery packs are commonly used in the obstetrics and gynecology departments of medical institutions during the clinical delivery process. Utilizing disposable delivery packs can effectively reduce the risk of surgical infections for both clinical medical personnel and patients, thereby enhancing the quality of medical services.

The Importance of Hygiene in Delivery Processes

During the delivery process, the risk of infection is heightened due to factors such as the detachment of the placenta creating fresh wounds, blood loss, and perineal lacerations. Thus, the hygiene and safety of surgical instruments are of utmost importance. Traditional surgical instruments carry the risk of cross-infection in their repeated use, not only increasing the workload of medical personnel but also affecting the outcome of surgeries. Consequently, an increasing number of medical institutions and healthcare workers are seeking a safer and more hygienic solution.

The Advantages of Disposable Delivery Packs

Disposable delivery packs are favored for their safe and hygienic features. Their single-use design effectively prevents cross-infection and the spread of viruses, ensuring the safety of pregnant women, newborns, and medical personnel. Additionally, the reasonable configuration of components also reduces the cleaning and disinfection costs for medical institutions.

Classification of Disposable Delivery Packs as Medical Devices

Typically, based on the composition of the pack, disposable delivery packs are classified as Class II medical devices, with the industry standard being YY/T0720-2009. Manufacturers categorize different models based on the composition of the pack, such as those commonly used for childbirth, abortion, etc.

Contents of Disposable Delivery Packs

A typical disposable delivery pack may include: disposable caps, medical masks, surgical gowns, medical underpads, treatment towels, surgical drapes, medical sheets, sterile protective covers, leg covers, medical wrapping cloth, surgical gloves, rubber examination gloves, medical degreased gauze pieces, cotton pads, cotton swabs, gauze bandages, umbilical cords, fixing clips, abdominal bands, medical suturing needles, non-absorbable surgical sutures, degreased cotton balls, polyethylene examination gloves, umbilical caps, toilet paper, sterile medical dressings, sleeve covers, umbilical cord protection packages, maternal blood loss measuring pads, trays, respiratory suction catheters, shoe covers, and more.

Market Demand for Disposable Delivery Packs

According to relevant data, China welcomes approximately 10 million newborns annually, meaning a significant number of mothers require disposable delivery packs each year. If every hospital utilizes disposable delivery packs, the annual market size could reach several billion yuan. Furthermore, with the continuous improvement of China’s healthcare system and the enhancement of medical service levels, the demand for disposable delivery packs is expected to increase further.