PeekMed
Orthopedic implants safety is crucial, not only during product development but also throughout their use in the operating room.
Advancements in healthcare technology, coupled with a more informed and educated population, have contributed to the increasing popularity of surgeries such as hip replacement surgery or total knee replacement. These procedures are now among the most commonly performed surgeries worldwide, emphasizing the need for prioritizing patient safety.
The question at hand is: How can we ensure the safety of orthopedic implants and minimize risks to patients?
Orthopedic Implants Safety: Ensuring quality in the Development and Manufacturing Process
Orthopedic implants are meticulously designed to meet the specific requirements of their intended use. They incorporate a range of vital features encompassing biological, physical, chemical, physicochemical, mechanical, and tribological aspects. The goal is to guarantee the utmost safety and efficacy of these implants.
To minimize potential risks, it is imperative to establish robust production controls based on thorough risk analysis. This analysis entails identifying and defining qualitative and quantitative limits for characteristics that may impact the safety of the implants. By compiling a comprehensive list of known or foreseeable threats, both in normal usage conditions and potential failure scenarios, possible risks can be effectively addressed.
Also, it is essential for orthopedic implant manufacturers to implement strict quality assurance procedures. These procedures are designed to ensure continuous improvement of processes associated with project development and product manufacturing. By placing a strong emphasis on quality assurance, companies can consistently deliver orthopedic implants of the highest standards.
Biological and biomechanical requirements of orthopedic implants
Orthopedic implants inherently carry a high level of risk as they are invasive surgical products designed for long-term placement inside the human body. It is crucial to maintain the integrity of these products to safeguard the clinical condition of patients. To achieve this, manufacturing projects must adhere to specific requirements, particularly in the biological and biomechanical domains.
In the realm of biology, it is imperative to ensure that the orthopedic implant materials evoke appropriate biological responses upon interacting with human tissues. A thorough evaluation of potential short-term and long-term risks is essential.
Simultaneously, in the biomechanical context, an analysis of the interplay between the implant structures and the functioning of living tissues is crucial. This involves assessing the forces exerted or generated by the human body and their impact on the implanted products.
Thus, projects should establish appropriate procedures to ensure that the implant materials are biocompatible and the requirements are met.
Although no material used in surgical implants has demonstrated complete freedom from adverse reactions within the human body, clinical trials have shown that properly processed standard materials exhibit an acceptable level of response when used for long-term applications in organic materials.
Assisting Surgeons in Choosing the Right Implant
Choosing the right implant is crucial for orthopedic implant safety, as it directly impacts patient well-being and procedure outcomes.
To facilitate the implant selection process, orthopedic surgeons can rely on an orthopedic preoperative planning system. The surgeon can access a comprehensive database of orthopedic manufacturers and easily filter it to display templates specific to their chosen category. This facilitates the search process significantly.
Once a suitable template is selected, it is seamlessly imported into the planning environment (2D, 3D or hybrid) and aligned with the patient's imaging data, taking into account the details of the surgical procedure.
Additionally, the software can provide suggestions to help the surgeon identify the optimal implant for the specific surgery.
How does PeekMed contribute to orthopedic implants safety?
It is important to acknowledge that achieving absolute perfection in orthopedic implants is an unattainable goal. However, our collective effort within the industry is focused on minimizing implant risks.
By leveraging advanced tools like PeekMed during the planning process for orthopedic surgeries, we can significantly enhance the chances of success in the operating room. The orthopedic implant manufacturers included in our database undergo rigorous selection based on strict quality standards.
Taking into account the patient's unique characteristics and desired outcomes, the system provides valuable guidance to ensure the optimal implant choice for that particular case.
Through all these measures, it is possible to continually improve implant safety and empower surgeons to deliver the best possible outcomes for their patients.
Credits: Peter Dazeley / Getty Images
