Selection Of Medical Device Tubing

Selection Of Medical Device Tubing

MedTech Outlook | Monday, September 19, 2022

Here tips include lot traceability, regulatory organization approvals, flexibility, pressure and vacuum conditions, and temperature capabilities.

FREMONT, CA: Deciding what tubing to use in a medical device includes considerable research. Designers must investigate ingredients, performance, documentation needs, sterility, and other qualifying aspects that cannot be disregarded.

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Regulations are an inevitable part of the medical device arena, and for a good reason. The industry involves substances and products that impact our bodies. In the US, the FDA(Food and Drug Administration) verifies that medical devices are safe and do what their manufacturers might say.

Many medical devices incorporate plastic tubing for fluid or gas transfer. In the case of tubing, the FDA’s oversight can involve everything from the individual ingredients that make up a plastic or rubber compound to manufacturing processes to the tubing’s reaction with things with which it may come in contact.

The following tips include lot traceability, regulatory organization approvals, flexibility, pressure and vacuum conditions, and temperature capabilities. The details are designed to help avoid specification errors and, in turn, guarantee the safety of medical devices and, most eminently, the wellbeing of patients.

1. Be aware of what company is manufacturing the tubing. You should know the controls that ensure a high-quality product. Inquire about the manufacturer’s production practices, quality policies, and safeguards. Authenticated work instructions and/or good manufacturing practices should be trailed, and quality control procedures must be in place to guarantee consistent tubing.

Although your particular device may not need tubing manufactured in a clean room, it should still be made with precision and uniformity. If you distrust the manufacturer, consider visiting the facility. It is more logical to have a backup supplier as well.

2. Make certain the tubing is made from raw materials that have full traceability to the resin ingredient manufacturers. For example, some extrusion companies make their compounds, while others purchase them ready to process into the tubing. In any case, full traceability for each ingredient in a formulation should be available to you.

3. Determine what regulatory documentation is necessary for the tubing in your device. Instances are USP (United States Pharmacopeia) Class VI or UL (Underwriters Laboratories) listings and Material Safety Data Sheets. Your tubing supplier should be capable of telling you what documentation they can provide with their product, but don’t assume they will have all the documentation you need for regulatory concerns. Sometimes, it may be necessary to have your testing performed by an independent laboratory.

4. Make sure you have an agreement stating that any time a material ingredient or manufacturing equipment change is scheduled, you are informed in advance. A risk assessment may be necessary to determine how the proposed change may or may not impact your device. The major thing is that you are made aware of the change and have the chance to determine if it will affect your product.

5. Check for ingredient approvals & incompatibilities. You may be required to know whether the tubing is manufactured with the FDA, NSF (National Sanitation Foundation), or other association-compliant ingredients. Check the supplier’s tubing designation for this information.

Additionally, be aware of incompatible or unacceptable ingredients like Di(2-Ethylhexyl) phthalate, better familiar as DEHP. It’s a chemical agent added to the resin to increase workability during processing and to impart flexibility in the finished product. DEHP and other plasticizers like BBP, DBP, DnHP, and DIDP can leach from, or come out of, the tubing and contaminate the gas or fluid flow.

These chemicals are involved in lists of carcinogens from the federal government and the state of California, and their use in medical devices has caused concern. Products comprising these chemicals over a certain concentration must show a warning label. Some tubing materials, polyurethane, for instance, do not contain plasticizers.

6. Learn whether the tubing will convey a taste or odor to the flow. If your device’s application includes foods, beverages, or oral medications, any taste or odor transferred to those products is possibly undesirable. Candidate tubing should be checked to see how the material might impact the stream, the end product, and the patient.

7. Decide whether you want transparent, translucent, or opaque tubing. In case the fluid within the tubing must be seen to check for consistency, progression, or to note measurements, you’ll require tubing that’s transparent (clear) or translucent (allowing light to show through but not a detailed view).

Based on the application and the fluid involved, it may be undesirable to see the flow within the tubing. Certain tubing materials are accessible in transparent, translucent, or opaque styles, while others are available in only one type because of their nature. Tubing construction can also substantially affect its viewing ability. For example, tubing with reinforcement such as wire, braid, or spirals may have restricted sight.

8. Bear in mind pressure and vacuum capabilities. These capabilities are of minimal concern in a medical device application where the tubing acts as a waste fluid drain. But when tubing involves suction, you must use tubing that will not collapse. This type frequently uses reinforcement (braid, wire, or like-material spirals) to support the tubing walls and lessen the risk of failure. Pressure uses may also need reinforced tubing depending on the force involved.

9. Make sure the proposed tubing is so flexible for your device. If the tubing calls for bending around other components, it will have to do so without kinking & cutting off the flow of gas or liquid. Specific tubing materials, silicone, for instance, are highly flexible. In contrast, others are better suited to applications where the tubing remains on a straight path or with only a slight curve.

If the application includes repetitious movement—a pump or robotics— the tubing must be capable of withstanding repeated compression and/or flexing. Resiliency and elasticity are involved here as well. Resilient tubing will rebound to shape after being bent or compressed, while elastic tubing will go back to its shape quickly after being stretched or enlarged.

10. Nearly related to a tube’s flexibility performance is its hardness. The harder the tubing, the more it will be prone to kinking at tight bends if unsupported by reinforcement or external means like a clip or guide to direct the tubing. Softer tubing will be more flexible, and though not kink-free, it will handle turns, twists, and bends more easily.

Tubing hardness is assessed as its durometer, and different scales, namely Shore A, Shore D, and Rockwell R, are generally used for plastic and rubber materials. The lower the scale number, the softer and more flexible the material will be. For example, a typical latex tubing hardness rating is Shore A35.

On the other hand, polyurethane tubing is not as soft and can measure between Shore A70 and A95. Harder materials like nylon and polyethylene are generally measured on the Shore D scale, and others (polypropylene, for example) employ the Rockwell R scale. Learn how various hardnesses of tubing will operate in your particular application.

11. Be aware of all temperatures involved. This implies not only the temperature of the fluid or gas going through the tubing but of the environment in which it will operate. For example, is the room where the device will be kept cool or refrigerated? Is it heated? There may be no adjustments for regulating the temperature, so the device and its tubing may need to withstand a range of fluctuating temperatures. Remember that the higher the temperature, the less pressure the tubing can handle. Humidity levels should also be considered.

12. Discover which sterilization methods the tubing can withstand, e.g., autoclaving, low-pressure steam, gamma irradiation, and ethylene oxide. Sterilization costs vary greatly, so choosing a tube that can be sterilized by one of the lower-cost methods may help minimize the overall cost of your medical device.

In addition, if sterilization for reuse is involved, consider whether the labor and equipment involved with cleaning are worth the expense. Sometimes, it may be more economical—and safer for the patient—to simply replace the tubing.

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