Regulatory News Flash | A Class III product guideline released!

Recently, the Center for Medical Device Evaluation of the National Medical Products Administration has organized the formulation of the “Guidance Principles for Registration Review of Disposable Anesthesia Needles” and is now releasing it.

Scope of application

The anesthetic needles to which these guidelines apply are used for puncturing the human body and injecting drugs, including epidural puncture needles, lumbar puncture needles, combined anesthesia set needles, and nerve block puncture needles. The products are supplied sterile and for single use.

Epidural puncture needles, lumbar puncture needles, and combined anesthesia set needles generally consist of a stylet hub, needle hub, needle tube, protective sheath, and stylet. The needle tube is typically made of stainless steel; the stylet is usually made of stainless steel or polymer materials. Epidural puncture needles, lumbar puncture needles, and combined anesthesia set needles are commonly used with anesthetic catheters to inject anesthetic drugs into the epidural space or subarachnoid space, playing a role in intraspinal anesthesia. The puncture sites can be the lumbar spine and sacral canal.

Nerve block puncture needles generally consist of a needle tube, needle hub, protective sheath and/or stylet (if applicable), stylet hub (if applicable), and cursor (if applicable), and may have length markings. Nerve block puncture needles are typically used for puncturing and injecting drugs during peripheral nerve block and local regional block anesthesia. They often require ultrasound-guided puncture positioning, and some have echo-enhancing points for precise ultrasound positioning. The puncture sites can be peripheral nerve plexuses (such as cervical plexus C1-4, brachial plexus C5-T11, lumbar plexus T12-S4, sacral plexus S4-5) or the surgical area.

These guidelines do not apply to anesthetic puncture needles used in conjunction with active devices, those using electrical stimulation for positioning, or those for continuous nerve analgesia.