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This section is for patients and their families and friends who already have or may soon receive an Orthopaedic Implant or Device as part of their treatment.



What is an orthopaedic implant?
An orthopaedic implant is a device (generally metallic, although non-metallic devices are also used for some applications) that is implanted into the body. Implants such as bone plates, bone screws or nails used in cases where a bone has fractured, are generally known as trauma implants.

Why are implants needed to fix fractures? Why can an old-fashioned plaster not do the job?
The science of fracture healing has undergone significant changes in the last few decades. It is now well understood that a fracture needs ‘stability’ (broken bones held together in a stable position) in order to heal with predictable results. Implants which hold the injured bones together during the healing phase, provide the ‘stability’ that is necessary to promote healing in the correct position. A limb which is stabilised with an implant can also be mobilised early, thus preventing possible negative consequences of prolonged immobilisation. It is well understood today that conventional ‘plaster’ is not adequate to achieve the desired ‘stability’. Plaster treatment also has other limitations as it cannot always prevent fractures from healing in an incorrect (or mal-aligned) position.

Will a fracture heal faster with the use of an implant?
An implant cannot influence the time it takes for the fracture to heal. Fractures heal by a biological process where the broken ends of the bone come together and re-unite. An implant (or implants) provides the stable environment that makes it conducive for healing to occur.

What materials are implants made out of?
Metallic implants are generally made out of three types of materials viz. Stainless Steels, Titanium and its alloys and Chrome-Cobalt alloy. Implants used for stabilization of fractures are most commonly made out of special grades of stainless steel.

What is special about implant materials?
As implants are placed within the body, it is critically important that the materials used are safe and do not degenerate or corrode in the presence of body fluids. This means that the materials used should not only be of specially approved grades but should also have extremely high purity. Commercially used metals (even Stainless Steels used for commercial applications) are generally not suitable for implantation in the human body. International standards (like the ISO 5832 series of standards) provide guidelines to approved grades of materials. The standard for implantable stainless steel, for example, specifies the use of a grade known as 316LVM. The letters LVM stand for Low Carbon, Vacuum Melted. Vacuum remelting is the process by which the steel is remelted under vacuum, a process that eliminates impurities. The ISO 5832 series of standards also specifies the properties of other materials used for implants such as titanium and titanium alloys, Chrome-Cobalt alloys and plastics used for implants.

Are there any quality regulations for orthopaedic implants? 
As these are critical care products used within the human body, most developed nations have some form of quality regulation in place for these products. The USFDA regulates various medical devices including orthopaedic implants sold in the U.S.A through an independent division of the US FDA office called the Center for Devices and Radiological Health. In Europe, all medical devices including orthopaedic implants are regulated under the Medical Device Directive of the EU and a CE certification issued by a recognised European notified body is mandatory for any medical device manufacturer to be present in the market. Being a more modern and contemporary regulation with a risk-based regulatory approach, the EU regulation has found takers in many countries who now insist on a CE certification to allow medical device manufacturers to sell their products. In India, the Indian FDA has recently initiated a process to regulate both importers and manufacturers of certain medical devices including orthopaedic implants. 

How do I know if the materials used in the implant I buy are appropriate?
Standard implant manufacturers who believe in providing high product quality generally disclose the grade of material used as well as identify themselves by means of a company name or logo which are laser marked on the implant. Verification for the presence of such markings can be a good guide to implant quality. The marking also makes the manufacturer legally liable for compliance to the material indicated by the marking. Additionally, verification of the quality certifications and regulatory compliances followed by the manufacturer would additionally assure safety and correctness of the products. 

Are implants safe? Are there any side effects associated with the use of implants?
Implants have been used for stabilization of fractures for over a hundred years. The use of implants has been particularly widespread over the last forty years. Implants are widely accepted to be safe assuming that the implant used meets necessary standards of material quality and workmanship.

What aspects of implant quality are regulated?
Any good regulatory process takes into account the important aspect of ‘safety in use’. An implicit assumption in any regulation is that all devices pose some form of risk and the emphasis of a robust regulatory process is on ‘minimization’ of risk by bringing down risk to levels considered acceptable.

For example, European guidelines under the Medical Device Directive classify orthopaedic implants under the risk class II-B which means that a high degree of care needs to be exercised in the manufacturing and quality control of such devices.

Generally, the important aspects of safety that are regulated under a process like the CE certification include the rationale used and safety aspects built-in to the design of the implant, the clinical experience with the implant,  ascertainment of controls related to raw material procurement and safety aspects related to storage, handling and issue of incoming raw materials and semi-finished products, ascertainment of controls related to manufacturing processes and equipment used to ensure that devices are manufactured in a consistent fault-free manner in accordance with design specifications, processes related to quality control including maintenance and calibration of quality control equipment, instruments and tooling etc. 

Overall, the certification process generally seeks to verify if all necessary measures to minimize ‘risk in use’ have been followed by the manufacturer in the process of designing, producing and marketing the product.

Where can I obtain more information related to implant quality and manufacturing?
To obtain more information, you may send an email to info@sushrut.com  with your specific query. Your queries would generally be answered within seven working days. Also, if your query is likely to have widespread interest or raises an issue of interest to the general community, the same may be posted/included in this FAQ section for the benefit of other visitors.