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Quality Control Of Surgical Suture Needle And Suture

date:[2021-06-04 17:10:04]

Oct 12, 2020

Surgical suture is generally implanted into the human body, belonging to three types of sterile medical devices, but it is not implanted medical devices.

At present, the commonly used sutures are as follows:

1. Silk

Silk suture is widely used, cheap, strong, easy to use, and occupies most of the surgical suture market. The silk braided yarn is made of natural silk and coated on the outside, which can reduce the wear of tissue and capillary phenomenon and reduce postoperative infection. The tissue reaction of high quality natural silk is smaller than that of common silk. Moreover, the natural silk without sericin is woven by protein fiber, which increases its tensile strength and is not easy to break.

The common specifications are 8-0, 7-0, 6-0, 5-0, 4-0, 3-0, 2-0 / T, 2-0, 0, 2, 3, 4#

2. Nylon

Nylon suture is a monofilament suture with soft body and high temperature resistance. It is widely used in micro anastomosis of nerves, blood vessels and lymphatic vessels, replantation of severed fingers (limbs), plastic reconstruction of maxillofacial and burn, repair of limbs, deformity correction and other microsurgical operations, and clinical use of Dentistry, hand surgery and plastic surgery. The commonly used models are 11-0, 10-0, 9-0, 8-0, 7-0, 6-0, 5-0, 4-0, 3-0, 2-0 / T, 2-0, 0, 1, 2#

 3. Absorbable suture

PGA, PGLA: The most commonly used absorbable sutures are PGA and PGLA. Most areas at home and abroad recommend the use of absorbable sutures, which do not need to be removed and reduce the pain of patients. However, due to the relatively high price, some remote areas have not yet been popularized. The commonly used models are 8-0, 7-0, 6-0, 5-0, 4-0, 3-0, 2-0, 0, 2, 3, 4#

The size of suture is marked by numbers from 12-0 to 10, from left to right. With the increase of number, the diameter of suture is thicker and the tensile strength is greater. The type of suture is decided by the suture tissue, which should consider the tensile strength of the suture tissue. Generally, the tensile strength of suture does not need to exceed the tensile strength of tissue, but it should be equal to that of normal tissue. Choose the thinnest thread to minimize the wound. 

The suture needle is made of 420 or 304 imported high-quality stainless steel wire. The needle types are divided into 1 / 2 arc, 3 / 8 arc, 1 / 4 arc, 5 / 8 arc, half curved needle and straight needle. The needle tip is divided into round needle, angle needle, short blade triangular needle, shovel type needle, etc. At the end of the needle, there are pressure groove needle, drilling needle and conventional needle double elastic machine hole suture needle, and the drill hole needle is the main suture needle of haidike suture needle.

Quality control of suture needle and suture

1. Raw materials

The selection of raw materials for needle and thread should not be confused. Raw materials of different batches should be classified and stored separately. The purchasing information shall clearly indicate the information of purchased products, manage the quality supervision system and inspection criteria, and select qualified suppliers.

2. Material storage

The storage environment of suture needle and suture raw materials is very high, indoor temperature and humidity, ventilation and light conditions will affect the function of materials. Wrong storage will lead to deterioration and decomposition of materials, shorten the validity period, and even lead to scrap. Materials should be stored within the service life.

3. Release of finished products

Before the release of finished products, the quality management department shall review the relevant records, and the auditor shall sign for release if the audit meets the requirements.

Production environment control

The control of environmental pollution to products should start with air, water, surface and people.

Production enterprises must not have tall trees, produce pollen, fluff, cotton wadding and other plants that have an impact on the air. The land should be afforested and no soil should be exposed.

Process water shall be verified, daily maintenance records shall be kept, and process water management system shall be established.

Employees entering the purification workshop should wear purification clothes, masks and gloves, which should effectively cover underwear and hair. People who directly contact the products with hands should be disinfected once for a period of time.

Contact Us

Tel: +86-530-4660062
Mobile: +86-13105409308
Tianfu Roud, Dongcheng District,Shan County, Heze City, Shandong, China 274300


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