The health sector is one of those industries which require the utmost caution and care in all aspects. Whether it is medical uniforms or devices used for investigating various issues; whether it is products used in procedures or the setup itself; you can’t overlook any part of it. In this blog, we have discussed 7 tips for selecting the right medical device seals. Before we begin with the tips, let’s first take a look at the need for a medical device.
It is important to ensure the optimum quality of all medical tools. When we talk about medical devices, picking the right seal is also of paramount importance because small negligence in any aspect can result in disaster. Considering the significance of medical devices quality seals should be ensured so that the quality, safety, and effectiveness of devices are not affected. Besides the quality of equipment, quality seals are critical for patient safety as well.
Medical Device Need
A medical device is used in the health industry for diagnosing or treating a disease without having to perform any chemical procedure on the body or any part of it. There are three classes of medical devices identified by the US FDA.
The class 1 devices are low-risk devices. These could be handheld surgical instruments, wheelchairs, etc. class II devices are intermediate-risk devices such as CT scanners, MRI scanners, infusion pumps for intravenous medications, and so on.
Class III devices are critical situation devices such as pacemakers and deep-brain stimulators.
The importance of medical device seals
Seals and gaskets are an important component of many medical devices. These devices could belong to any class, but seals are an integral component of theirs because they help keep a device safe for use. These device seals protect a gadget from coming in contact with a pollutant. They also help prevent the device from leakage which ensures optimum device performance.
Seals are a critical component of many medical devices. If a seal breaks down, it can lead to disastrous consequences. For example, if the seal of an electric wheelchair fails, the chair cannot be controlled as electromagnetic interference (EMI) from a nearby cell phone cannot be blocked. Likewise, if the infusion pump seal fails you cannot control the dose flow. If an under-dose doesn’t result in desired results, an overdose of the drug can be highly disastrous for health. Hence, it is critically important to choose high-quality and reliable seals.
Now, let’s begin with our tips for picking the right medical device seal.
Tips for selecting medical device seals
1. Understand the requirements
To pick the right seal it is important to first understand the application requirements. There are many materials available for seal manufacturing. Once you know the physical requirements of the material, you can pick the right material seal.
A piece of complete knowledge about the device such as its hardware specifications, conditions in which it will be working, chemicals it can come in contact with, motion, pressure, temperature, and other such traits can help you determine the right material media device that is reliable and durable.
2. Consider regulatory compliance
Some sealing materials may require compliance with a particular regulation or certification. USP Class VI certification is often a requirement for regulatory compliance. Before you select a seal or sealing material, you might want to check if it has the same requirements for compliance. If yes, you need a seal supplier with USP certification to assure quality and compliance with regulations.
3. Evaluate biocompatibility
Many devices come in contact with the body, internally as well as externally. Some devices come in contact with the body as well as drugs. You need to consider this aspect while picking the device seal. Of course, the seal material has to be completely safe for the human body and it should not affect or harm in any way. If it has to come in contact with the internal body. Then you cannot risk the well-being of people with cheap quality seals.
4. Consider the need for sterilization
Some materials are great sealing materials but they cannot endure high temperature or contact with moisture. In the medical industry, sterilization is often a requirement of medical devices because this is to ensure that a device is germ-free and safe to bring in contact with the human body. Expose sterilized seals to radiation or high temperatures, as per the sterilization method. Make sure to choose a seal that can endure high temperature, moisture, and radiation.
5. Consider the need to shield against EMI
Just like sterilization, EMI can also cause damages to medical devices seals. To protect devices against EMI, the performance and quality of devices can deteriorate. Cables, tubes, and other connectors pass through an opening in the outer enclosure of a medical device. It is important to protect these openings with a seal so that EMI cannot make its way to the device.
6. Keep in mind the material grade required to support the application.
Some material grades are highly popular in other industries but they cannot be used for medical devices because doing so can be a major health hazard. For example, nitrile rubber is used to make industrial O-rings. These o-rings are highly popular in other industries are used widely, but they are banned for use in medical devices. Or-ring can collapse when exposed to ozone. When compounded with dioctyl or disononyl phthalates o-ring can be extremely harmful to human health. For medical device seals, it will be good if the manufacturer uses only medical-grade rubbers.
7. Have an Alternative material
You can reduce the risk of material shortage or discontinuance by having a backup option. Considering only one material for a medical device seal is not a good idea because you never know when suppliers will discontinue a material or change its compound. Having an alternative material will help you in the rainy days of uncertainty and material shortage.
SW Seals
At SW Seals, our objective is to manufacture high-quality medical devices seals. Whether you need standardized seals or custom cuts, SW Seals can help you in both scenarios. With our industry knowledge and experience, we can make seals of a wide range of materials, including EPDM, silicone rubber, PTFE, fluoroelastomer, conductive and non-conductive rubbers for EMI shielding, and others. Medical devices of all sorts can rely on our seals when it comes to quality and performance. To know more about medical device seals in Albuquerque visit our website.
Also Read: 10 Things You Should Know About Center for Health and Healing
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