In order to ensure sterility, knowledge of the levels and types of contamination in used surgical instruments is a primary requirement. Sterility is determined by
Product Recall; It is a voluntary withdrawal or recall from the market by the manufacturer of the device for technical and medical reasons, depending on
Stress (tension) is one of two measurable engineering quantities important in understanding the durability or fatigue life of a product. Surgical power tool systems are
Errors resulting from the cleaning process of surgical power tool systems not only pose risks to the patient. Users also have losses. In this article,
Surgical Power Tool Systems are devices that complete their preparation for use by sterilising at 135 degrees due to their area of use and design.
Today, the raw materials for surgical power tools handpiece body are aluminum or hard plastic. In some product designs, only certain parts are made of
In this article; By examining what happened in the field of production and marketing in the medical device industry in 2023; We will explore what
The World Health Organization defines health as “a state of complete physical, mental and social well-being and not merely the absence of disease or infirmity.”
When we wash the surgical engine, are we destroying the bacteria or the device? The handpiece and attachments of the surgical motor, which is a
How to develop a goal-oriented perspective in the job search process? If the path to the goal is not clear during the job search process,
How to achieve an ideal integration of indications, performance and safety in hand tool products such as surgical power tools and surgical saw blades? Surgical
How is the number of medical device test samples determined? The reliability and effectiveness of medical devices are verified by various tests. However,it is important
What are the 2017/745 MDR Harmonized Standards? In this article, we are going to give you the list of 2017/745 MDR Harmonized Standards and their
The European Medical Device Regulation (MDR) has brought harmonization for many medical device manufacturers. However, the transition period for legacy devices and the MDR harmonization
The correct, safe and efficient use ( cutting technique ) of a power bone saw has become a fundamental task in modern orthopedic surgery. Using
Introduction to Usability in Medical Devices Usability research looks at the interactions between human operators and the medical device. Testing (usability in medical devices) should
In all bone cutting processes, there are two factors that affect the cutting area on a product basis. 1) Saw blade oscillation angle 2) Saw
The force applied by the surgeon in the use of surgical power tools in knee and hip surgeries directly affects the amount of heat generated
Surgical saw blades are medical devices used for bone shaping. They differ in size and usage according to their usage areas. Since the implant will
We know that electronic medical devices are sensitive to water, temperature and pressure. For example, when using our mobile phones, we protect them so that
Literature is all of the writings and works written in any branch of science. (Google’s Turkish Dictionary/ Oxford Languages ) For medical device manufacturers, PSUR
Surgical saw blades are medical devices that are used with surgical power tool systems and that enable the bones to be shaped by cutting (osteotomy).
Orthopedic surgical power tools were produced as separate handpieces for all functions when they first appeared on the market. For example, there were 3 different
There are reamer adapters in the surgical power tool system set used in orthopedic surgeries can perform the reaming process. These adapters allow the surgical
What is emotional intelligence? Emotional intelligence; it is the capacity of the individual to be aware of his own and others’ emotions and to use
Surgical saw blade is used in the shaping of bone with hard surfaces in the surgical field. These medical instruments, which are made of stainless
What are the 2017/745 MDR Harmonized Standards? In this article, we are going to give you the list of 2017/745 MDR Harmonized Standards and their
In this article, we will look for an answer to the question of whether quality or quantity is important in surgical power tools, which is
How can we do OEM – OBL under MDR? In this article, we are going to describe what can we do about OEM – PLM
Cemented and cementless (uncemented) implants preference is very important in knee and hip arthroplasty surgeries. Cemented implants have been available for many years, but complications
This “Trend Reporting” shall be procedured and planned immediately for transitional substances covered by the MDR. In addition, in order to prepare this report, it
Noise-Induced Hearing Loss (NIHL) in the workplace is called occupational hearing loss. Exposure develops slowly over the years and varies according to sensitivity. According to
Updated in April 2023 MDR – UDI Requirements What is UDI? Unique Device Identifier (UDI) is a series of numeric or alphanumeric characters that is
Repair and maintenance are two very important terms in the asset management field. The terms we mentioned are valid not only for medical devices (Orthopedic
One of the biggest challenges during MDR transition is to understand what brings new regulation to post market surveillance requirements. Click here for the full
In order to provide uninterrupted and effective health services in hospitals, a wide variety of materials, devices (such as orthopedic surgical power tools) and services
With MDR, the reprocessing of single-use devices (MDR Article 17) have also entered our lives. This issue was not previously regulated by the law. Click
Surgical power tool systems, which are used in surgeries and come into contact with the body, are devices that frequently come into contact with liquids.
Cast Saw Injuries While Removing Cast Cast saw injuries occur during the removal of the cast after the cast has fulfilled its function on the
Oscillating surgical saw blades are used for bone shaping in total knee arthroplasty. In order to facilitate these cutting procedures, cutting guides have been designed
Post operative medical device disinfection process is a crucial step to eliminate the microorganisms after the medical device is used on a patient, therefore, if
Aseptic loosening, periprosthetic joint infection are two major complications of hip and knee arthroplasty. In this article, we will try to show you how saw
Whereas old Medical Device Directive has these obligations but new Medical Device Regulation has new ones that are more detailed. Here are the manufacturer’s basic
Oscillating surgical saw blades are used for bone shaping in total knee arthroplasty. In order to facilitate these cutting procedures, cutting guides have been designed
Nobody wants a medical device that they manufacture to harm a person or result in death. The important thing is to be able to take
Surgical power tool systems used in orthopedics and traumatology surgeries are produced with pneumatic, electrical or battery options. With the development of lithium-ion battery technology,
If you are not a small company, you might ask yourself: “Shouldn’t we have already a responsible person for regulatory compliance?” Answer is “no”. All
All “non-EU” medical device manufacturers should have an authorised representative, if they want to sell their products within EU countries. This representative plays a role
The forward & reverse (F&R) modes (Kirschner Wire Driving Modes) of the power tool are used while drilling with surgical power tools in orthopedic operations.
Blood-borne diseases pose a significant risk for healthcare workers, especially in operating rooms. There are several ways these diseases can be infected to the surgeon.
