Seals and o-rings are vital components in many medical products, including medication pumps, respiratory equipment, artificial heart valves and kidney-dialysis machines, to name a few. They allow for the smooth operation of medical devices and equipment while eliminating contaminants. The failure of a seal can cause a medical device to malfunction, leading to injury or death.
For example, a leak in a medication pump due to seal failure can result in a patient getting the wrong dose of a medication. To prevent failures, devices that come into contact with the human body, body fluids and drugs must meet rigorous standards. These standards are unique to the medical industry and can cause design, manufacturing and delivery challenges.
Seals and o-rings must operate in environments that place them into contact with the human body yet must be resilient and free from contaminants. This means that they face strict manufacturing and distribution standards to maintain a high-quality level. From biocompatibility and operating environment to FDA regulations and supply chain interruptions, let’s take a closer look at the unique challenges seals face in the medical industry.
Seals must be compatible with and able to interact with human tissues and fluids without being affected by them. A medical device placed within a human body must not break down into toxic substances that can cause harm.
Medical seals, if designed improperly, can become or brittle or break down when exposed to changes in temperature or humidity. Specific materials that are not adversely affected by temperature changes must be used.
Seals and o-rings are often exposed to chemicals, water and body fluids. Determining their typical working environment is important, but extremes that may stress them to their limits must be taken into account.
Changes in pressure
Seals must be able to withstand changes in pressure without any alteration in their size. This could lead to leakage, which is unacceptable in medical systems.
Medical seals must not contain impurities such as bacteria, viruses or manufacturing debris that can be transferred to a patient. This usually calls for specialized cleaning procedures and quality control at many stages in the manufacturing and packaging processes.
Packaging of seals often involves the use of clean rooms, specialized washing and vacuum sealing. These procedures must not cause damage to their contents in any way. Package designers have to take this into account.
Getting approval by regulatory agencies
For medical applications, high-grade materials must be used. Their ubiquitous use and critical importance mean that they must meet standards set forth by:
- ISO 10993
- FDA standards
- USP Class VI
Keeping the industry moving forward
When considering the use of seals in the medical industry, the supply chain is just as important as the type of material used. Without the correct raw materials, crucial devices cannot be produced in a timely manner. Dual sourcing raw materials and flexible shipping options can help to keep a chain from breaking down. Anticipating problems before they arise is crucial to keep critical medical devices and equipment flowing to where they are needed most.