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Orthopedic Implants Safety: How to Improve it?

Orthopedic implants’ safety must be taken into account not only in product development. It is extremely important that this process happens from that moment until the end of the process within the operating room.

The advancement in the healthcare technology combined with the increasingly more educated general population in regard to the choices they can make to continuously improve their way of life constitutes two of the main reasons behind surgeries, such as knee and hip implants currently being among the topmost frequently performed surgeries around the world.

Overall, orthopedic implants are safe and highly successful. For example, hip replacement, despite its complexity, has been described in the Lancet as “the operation of the century”. The number of orthopedic implant procedures has increased over the last decades. In trauma care, the use of metal plates and pins has improved the speed and extent of recovery from serious injury enormously.

 

The challenge is: How can we guarantee orthopedic implants’ safety and reduce the risks to the patient?

Quality in the development and manufacturing process

Orthopedic implants are designed to meet the requirements of the intended use, incorporating relevant and necessary features (biological, physical, chemical, physicochemical, mechanical, tribological, etc.) to guarantee orthopedic implants’ safety and efficacy.

In order to minimize potential risks, the controls of production shall be established from a risk analysis, which seeks to list and define qualitative and quantitative limits for the characteristics that could affect orthopedic implants safety, compiling a list of known or foreseeable hazards associated with use both in normal conditions and in failure conditions.

In addition, procedures for quality assurance should be implemented in the company, to ensure continuous improvement of processes associated with both the development of the project and product manufacturing.

 

Evaluation and qualification of orthopedic implants

Orthopedic implants are products with high intrinsic risk since they are invasive surgical products designed to remain inside the human body for the long term. To ensure that the characteristics and performance of the products do not change in any degree which could jeopardize this clinical state, the manufacturing projects must add several requirements, particularly biological and biomechanical. 

In the biological context, must be assured appropriate biological responses to tissue interaction of the materials used in its manufacture, so that all tracks of potential risks, short and long term, may be considered. In the biomechanical context, it must be considered a formal and quantitative analysis of the relationship between structures and functions of living tissues, from the evaluation of forces acting and/or generated by the human body and its effects on products implanted in the body.

Thus, projects should establish appropriate procedures and include the processing of materials to ensure that these biological and biomechanical requirements are met. With regard to materials for surgical implants, although none of them shown to be completely free of adverse reactions in the human body, the clinical trials of prolonged use of standard materials, since correctly processed during the manufacture of products, show that an acceptable level of response can be expected when organic material is used in an appropriate application.

 

Help the surgeon to choose the most suitable implant

Depending on the situation, a patient might only be in need of a temporary implant in which case, biodegradable Magnesium-based alloys are commonly used to support the healing process.

The main biomaterials used in implant surgeries are metals, such as cobalt-chromium, stainless steel, and titanium, but also non-metals, like ceramics, composites and polymers, the uses of each being determined by the surgeon in accordance with the specific circumstances of the patient.

With the support of an orthopedic planning system, the surgeon can easily choose the most appropriate implant. Using a planning system like PeekMed®, a database of orthopedic manufacturers can be filtered to display only the templates for the chosen category, to smooth the search. Upon selection, the template is automatically imported to the planning environment (3D, 2D, or hybrid), added to the image and it is placed based on the real surgical considerations. Besides that, the surgeon may use the software suggestion, to select the best implant for that specific surgery.

Realistic speaking, there will never exist 100% foolproof orthopedic implants that would not fail in some way, but our work is to reduce that risk. Using PeekMed® in the planning process for orthopedic surgeries, there is a bigger chance to be successful in the operating room. The orthopedic implant manufacturers in our database are selected according to quality standards, and the system is able to select the appropriate implant for a specific surgery. According to the patient’s characteristics and the results planned, the system indicates the implant that the surgeon must use on that specific case.

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