In order to support healthcare applications, implements such as medical ball bearings must be of the highest quality and carefully constrained purity. This is critical in making sure that both the short-term and long-term patient outcomes are maximized. Because of this, healthcare practitioners must rely on a manufacturer that is able to meet the strict and demanding requirements of the medical and laboratory industries. There are a few important factors to consider, including the below.
Effects of Irradiation
Medical devices comprised of plastic polymers can either be enhanced or compromised through radiation effects. Irradiation interacts with polymers in one of two ways:
- Chain Scission: compromises or reduces tensile strength and elongation
- Crosslinking: actually increases tensile strength, but decreases elongation
Meeting Legal Standards
All medical grade equipment introduced to the body must meet uncompromising standards. Proper polymer sterilization is essential in the healthcare industry to prevent disease and minimize the risk of infection during surgery.
In order to ensure safe, effective surgical implants and implements, there are two strict quality standards that manufacturers must comply to in the United States:
- S. Code of Federal Regulations CFR Title 21, Part 820
- ISO 13485:2003
These standards address quality management for manufacturing medical-grade equipment and ensure that production, design, storage, packaging, labeling and maintenance of all devices used in the human medical intervention are up to code.
Maximizing Material Evaluation
The antioxidants and stabilizers often added to surgical grade polymers can often have negative effects on a given polymer’s physical appearance or even its mechanical properties. Because of this, radiation stability of particular polymers must be thoroughly understood and properly utilized by surgeons and technicians who work with such surgical polymers.
In order to do this, proper record-keeping and a thorough history of the component’s parts and processes must be strictly monitored to ensure that patients are not improperly matched with polymers or surgical components that are unsafe or improperly treated.
For more information about the importance of choosing proper medical devices, and what factors to consider when doing so, download our free eBook, “Precision Polymer Radiation“.