Metal tubing plays an essential role in delivering fluids, gases, and other medical substances throughout the healthcare industry. From small-bore tubing used in catheters and cannulas to large-bore tubing transporting gases in hospitals, metal proves to be a durable and reliable material for medical tubing applications. This article will explore the various types of medical metal tubing used today along with their key benefits and applications in patient care.
Types of Medical Metal Tubing
There are several common types of metal used for medical tubing based on the specific application requirements. Some of the most prevalent include:
Stainless Steel Tubing
Stainless steel offers corrosion resistance, strength, and biocompatibility ideal for many medical tubing needs. Grade 304 stainless is a popular choice due to its balance of properties and value. Applications include respiratory equipment, dialysis machines, surgical tools, implants and more. The non-magnetic properties of 304 stainless also make it suitable for MRI environments. Higher-grade 316L stainless provides enhanced corrosion resistance for long-term implants.
Copper-Nickel Tubing
Copper-nickel alloys such as 70/30 and 90/10 compositions provide excellent anti-microbial capabilities important in healthcare applications. The alloy is self-sanitizing and kills bacteria, viruses, fungi and molds on contact. As such, it is commonly used for tubing in hemodialysis machines, respiratory equipment, IV sets and related medical devices where infection control is critical.
Nickel-Titanium Tubing
The shape memory and superelastic properties of nickel-titanium (nitinol) make it well-suited for medical devices requiring flexibility, kink resistance and precision. Nitinol tubing is used in minimally-invasive surgical tools, catheter guidewires, stents and orthodontic/dental applications. The non-magnetic properties also facilitate use in MRI proximity.
Plastic-Coated Stainless Steel Tubing
For applications requiring electrolytic passivation or fluid compatibility with plastic components, stainless steel tubing can be coated internally or externally with PTFE, FEP or other medical-grade polymers. This hybrid construction combines the strength, durability and corrosion resistance of stainless with the non-reactivity and lubricity advantages of plastics. Common uses include biopsy devices, dental tools and components in surgical equipment.
Tubing for Specific Medical Applications
Beyond generic material types, tubing is also engineered to very specific dimensional, mechanical and fluidic requirements depending on the target Medical Metal Tubing. Some key examples:
Catheter Tubing
Very small tubing diameters ranging from 0.25 mm to 2 mm are common for catheters used in cardiovascular, urology and other minimally invasive procedures. Materials include stainless steel, nitinol and polymer-coated varieties for flexibility and pushability. Tubing design also considers kink resistance, torqueability and other performance factors.
Dialysis Tubing
Larger 4-6 mm diameter stainless steel and copper-nickel tubing transports blood in hemodialysis machines. The tubing must demonstrate high flow rates and durability under pulsatile blood flow over many thousands of treatment hours. Enhanced finishes provide optimized biocompatibility for direct blood contact.
Respiratory Tubing
Finding application in ventilators, nebulizers and other respiratory equipment, tubing diameters vary from 3 mm to 22 mm depending on the specific device. Materials include plastic, silicone, stainless steel and aluminum. Key properties include flexibility, kink/buckle resistance and compatibility with flows up to 80 L/min in positive pressure ventilation.
IV/Infusion Tubing
Generally 1/16” to 1/8” I.D. sizes, IV tubing transports fluids and medications into patients. Materials are typically flexible PVC or silicone polymer tubing suitable for low pressure fluid delivery. Sterilizability and resistance to medication leachability are important material characteristics.
Quality and Regulatory Considerations
Due to the critical nature of medical devices, metal tubing and tubing components must meet stringent quality, cleanliness and certification requirements:
Materials Certification
Raw materials like stainless steel, nitinol, copper alloys etc. require certification to medical device material standards such as ASTM F138, ASTM F136 and others stipulating chemical composition and mechanical property limits.
Cleanliness Testing
Tubing undergoes particle testing using USP <788> or ISO 11607 methods to ensure cleanliness levels below 25 microns, protecting against contamination in medical use. Endotoxin and bioburden testing may also apply depending on the device application.
Sterilization Validation
EtO, gamma irradiation and other sterilization methods are validated for tubing to demonstrate sterility assurance levels of 10-6 or better prior to patient use. Sterilization can impact material properties, so validation ensures no adverse effects.
Regulatory Registration
Medical tubing component manufacturers maintain ISO 13485 registration and register with the FDA as a tube, pipe or profile extruder. Additional regulatory approvals like 510(k) clearance may be required at the finished device level depending on risk classification.
Overall, metal tubing continues advancing to meet the growing needs of modern healthcare. Driving factors like miniaturization, enhanced performance requirements and demand for single-use products will surely lead to new applications and innovative tubing solutions in the future. Medical OEMs rely on tubing experts to develop customized solutions while ensuring the highest quality, regulatory compliance and patient safety.
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