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History and Regulation of Medical Devices

Between 2000 and 5000 years ago, many ancient civilizations used tools such as forceps, knives, scalpels, saws, lancets, needles, trocars, cautery instruments, and knives for several medical procedures. Scalpels were used to make large incisions in the abdomen and to make clean and precise incisions in the arms, neck, and legs. Needles were used to puncture various parts of the body. Hooks held blood vessels and skin in place and lifted and moved tissue during medical procedures. Hand drills were used to remove parts of the skull to access the brain, cut out parts of the body during lobotomies, and remove dead tissue from the body. Forceps were extremely versatile tools used in surgery to grasp and position tissue, fix blood flow, and join skin together when adding or removing stitches. The suturing technique used a crude needle and thread. Early surgeries included tracheotomies, amputations, phlebotomies, cataract operations, bone operations, removal of bladder stones, perforations (drilling into the skull), and removal of organs. Early instruments used in these surgeries were made of stone, flint, and obsidian, and later of silver, gold, bronze, and other metals.

From around the 1st century AD to the 17th century, most medical procedures concerned the treatment of injuries sustained by soldiers at war on the battlefield or the ailments of the wealthy. Instruments were used to treat battlefield wounds caused by arrows, knives, sabers, guns, cannons, etc. Once scientific methods were formalized in the 17th century, such instruments became more widespread. Many medical devices were manufactured by physicians or small companies and sold directly to the public without government standards or oversight regarding safety and effectiveness. Hospitals were created as places where soldiers and patients could receive specialized equipment and treatment from doctors. Universities began teaching science, medicine, anatomy, and medical-related topics. Medical knowledge and expertise continued to expand and evolve. Advances were made in the fields of ophthalmology, optometry, artificial organs, catheterization with instruments such as syringes for cataract removal, eyeglasses, metal or wooden prostheses, and metal catheters, respectively.

Illustration from: "Antiseptic Surgery; Its Principles, Practice, History, and Results. By William Watson Shine, 1882.

The 1800s were a landmark period for the invention of medical instruments, treatments, and medicine, and for the development of modern medicine. In 1867, Joseph Lister published his "Antiseptic Principles of Surgical Practice." This was the most important and groundbreaking event in medicine, ultimately leading to cleaner operating rooms, higher success rates in surgery, and better patient survival rates. Louis Pasteur and Robert Koch discovered that "germs" were the cause of many diseases around the world, and by the 19th century instruments such as the stethoscope, hypodermic syringe, ophthalmoscope, electrocardiogram, hearing aid, kymograph, and nitrous oxide as an anesthetic were commercially available. In addition, medicines such as quinine, aspirin, and cholera vaccines were discovered, which brought about major changes in the health status of the population. The design of instruments such as forceps, knives, scalpels, saws, lancets, needles, trocars, cauterizers, and knives continued to evolve along with the use of materials such as steel. in the 20th century, cardiac defibrillators, hip replacement, knee replacement, cardiac surgery, laparoscopy, dialysis machines, infusion pumps, insulin pumps, balloon catheters, disposable catheters, disposables, iron lungs, artificial heart-lung machines, inhalers, artificial joints, cardiovascular devices, ventilators, ventilators, implants such as stents and pacemakers, and an explosion of medical devices and procedures. The growth of medical devices has increased dramatically over the past 100 years. Medical Device Regulation

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During the 19th and early 20th centuries, medical devices and equipment came into use in hospitals and clinics, and large numbers of medical devices were manufactured and sold. However, there was little control or regulation of medical devices. Most regulations concerned pharmaceuticals. It was not until the mid-20th century that several countries began to introduce rules and regulations specific to medical devices to ensure the safety of the general public. These regulations were completely separate from those related to pharmaceuticals. Prior to World War I, several countries attempted to establish their own regional regulations. Most of these regulations were either included in or buried under drug regulations. After World War II, the need arose to establish separate regulations for medical devices to ensure their safety to patients and public health.  By the 1980s, most Western EU countries and the United States had established specific pre-market approval requirements, but requirements varied from country to country and region to region. In the 1990s, efforts were made to harmonize these regulations and requirements by introducing conformity assessment procedures, with cooperation and representation from countries around the world.

Regulations and standards continue to evolve and change with changes in technology, the continuing need for international harmonization, and the changing needs of users and society. The currently applicable and enforceable standards are shown in the figure below.

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The use of wearable sensors for health monitoring is rapidly growing. Over the past decade, wearable technology has gained much attention from the tech industry for commercial reasons and the interest of researchers and clinicians for reasons related to its potential benefit on patients’ health. Wearable devices use advanced and specialized sensors able to monitor not only activity parameters, such as heart rate or step count, but also physiological parameters, such as heart electrical activity or blood pressure. Electrocardiogram (ECG) monitoring is becoming one of the most attractive health-related features of modern smartwatches, and, because cardiovascular disease (CVD) is one of the leading causes of death globally, the use of a smartwatch to monitor patients could greatly impact the disease outcomes on health care systems. Commercial wearable devices are able to record just single-lead ECG using a couple of metallic contact dry electrodes. This kind of measurement can be used only for arrhythmia diagnosis. For the diagnosis of other cardiac disorders, additional ECG leads are required. In this study, we characterized an electronic interface to be used with multiple contactless capacitive electrodes in order to develop a wearable ECG device able to perform several lead measurements. We verified the ability of the electronic interface to amplify differential biopotentials and to reject common-mode signals produced by electromagnetic interference (EMI). We developed a portable device based on the studied electronic interface that represents a prototype system for further developments. We evaluated the performances of the developed device. The signal-to-noise ratio of the output signal is favorable, and all the features needed for a clinical evaluation (P waves, QRS complexes and T waves) are clearly readable

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Colposcopy is a procedure in which a lighted, magnifying instrument called a colposcope is used to examine the cervix, vagina, and vulva. It is a diagnostic procedure performed to evaluate abnormal cytology results from a screening Pap test. This activity outlines the use of colposcopy and reviews the role of the healthcare team in effectively evaluating and treating patients with an abnormal pap smear.

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Portable Ultrasound Devices-أجهزه سونار محمولة

The use of portable ultrasound (US) devices has increased in recent years and the market has been flourishing. Portable US devices can be subdivided into three groups: laptop-associated devices, hand-carried US, and handheld US devices. Almost all companies we investigated offer at least one portable US device. Portable US can also be associated with the use of different US techniques such as colour Doppler US and pulse wave (PW)-Doppler. Laptop systems will also be available with contrast-enhanced US and high-end cardiac functionality.

Portable US devices are effective in the hands of experienced examiners. Imaging quality is predictably inferior to so-called high-end devices.

The present paper is focused on portable US devices and clinical applications describing their possible use in different organs and clinical settings, keeping in mind that patient safety must never be compromised. Hence, portable devices must undergo the same decontamination assessment and protocols as the standard equipment, especially smartphones and tablets.

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Ultrasound device, essentially, consists of a transducer, transmitter pulse generator, compensating amplifiers, the control unit for focusing, digital processors and systems for display. It is used in cases of: abdominal, cardiac, maternity, gynecological, urological and cerebrovascular examination, breast examination, and small pieces of tissue as well as in pediatric and operational review.

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One of the most common means for diagnosis is through medical laboratory testing, which primarily uses venous blood as a sample. This requires an invasive method by cannulation that needs proper vein selection. The use of a vein finder would help the phlebotomist to easily locate the vein, preventing possible pre-analytical error in the specimen collection and even more discomfort and pain to the patient. This paper is a review of the scientific publications on the different developed low-cost vein finder prototypes utilizing camera assisted near infrared (NIR) light technology. Methods: Electronic databases were searched online, these included PubMed (PMC), MEDLINE, Science Direct, ResearchGate, and Institute of Electrical and Electronics Engineers (IEEE) Xplore digital library. Specifically, publications with the terms vein finder prototype, NIR technology, vein detection, and infrared imaging were screened. In addition, reference lists were used to further review related publications. Results: Cannulation challenges medical practitioners because of the different factors that can be reduced by the utilization of a vein finder. A limited number of publications regarding the assessment of personnel performing cannulation were observed. Moreover, variations in methodology, number of patients, type of patients according to their demographics and materials used in the assessment of the developed prototypes were noted. Some studies were limited with regard to the actual human testing of the prototype. Conclusions: The development of a low-cost effective near infrared (NIR) vein finder remains in the phase of improvement. Since, it is being challenged by different human factors, increasing the number of parameters and participants/human for actual testing of the prototypes must also be taken into consideration for possible commercialization. Finally, it was noted that publications regarding the assessment of the performance of phlebotomists using vein finders were limited.

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Direct laryngoscopy (DL) remains the gold standard technique as an effective means to securing the airway. It is a complicated technical skill with a variable learning curve requiring training, experience, and regular practice to acquire and maintain. DL requires a direct line of sight to align airway axes (oral-pharyngeal-laryngeal) for optimal glottic visualization. Oftentimes, manipulations to align these axes include head extension, neck flexion, laryngeal manipulation, and other stressful movements. Macintosh DL lifting forces can require 35–50 N to expose the glottis. These manipulations of the airway have adverse implications from significant hemodynamic disturbance, cervical instability, injury to oral and pharyngeal tissues, and dental damage.[10]

In contrast to DL, VL utilizes indirect laryngoscopy via its camera; thereby eliminating the need for a direct line of sight to visualize airway structures. In fact, this helps improve glottic visualization.[3,6,12] VL requires the application of less force (5–14 N) to the base of the tongue, therefore is less likely to stimulate stress response and induce local tissue injury.[2,13] Certain videolaryngoscopes (Airtraq®, Pentax® AWS [Figures ​[Figures11 and ​and2])2]) have been shown to produce less cervical movement when compared to DL.[14] Furthermore, there is a faster learning curve relative to DL independent of status as a novice or experienced laryngoscopist.[3,6,15] Some data suggests prolonged intubation times with VL as compared to Macintosh DL,[7,9] but there is also evidence on the contrary demonstrating equal and possibly faster ETI times.[2,6]

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Infant carrying likely emerged early in human evolution as the emergence of bipedalism would have necessitated some means of carrying babies who could no longer cling to their mothers and/or simply sit on top of their mother’s back.[1] On-the-body carriers are designed in various forms such as baby sling, backpack carriers, and soft front or hip carriers, with varying materials and degrees of rigidity, decoration, support and confinement of the child. Slings, soft front carriers, and “baby carriages” are typically used for infants who lack the ability to sit or to hold their head up. Frame backpack carriers (a modification of the frame backpack), hip carriers, slings, mei tais and a variety of other soft carriers are used for older children.

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A ventilator is a device that supports or recreates the process of breathing by pumping air into the lungs. Sometimes, people refer to it as a vent or breathing machine.

Doctors use ventilators if a person cannot breathe adequately on their own. This may be because they are undergoing general anesthesia or have an illness that affects their breathing.

There are different types of ventilator, and each provides varying levels of support. The type a doctor uses will depend on a person’s condition.

Ventilators play an important role in saving lives, in both hospitals and ambulances. People who require long-term ventilation can also use them at home.

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Suction devices for clearing the surgical field are among the most commonly used tools of every surgeon because a better view of the surgical field is essential. Forced suction may produce disturbingly loud noise, which acts as a nonnegligible stressor. Especially, in emergency situations with heavy bleeding, this loud noise has been described as an impeding factor in the medical decision-making process. In addition, there are reports of inner ear damage in patients due to suction noises during operations in the head area. These problems have not been solved yet. The purpose of this study was to analyze flow-dependent suction noise effects of different surgical suction tips. Furthermore, we developed design improvements to these devices.

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Syringe pumps were traditionally the instrument most frequently used in microfluidics (Agarwal et al., 2013; Loskill et al., 2015, 2017; Li and Tian, 2018; Misun et al., 2016; Rennert et al., 2015). They are also used in the biomedical field and in hospitals, for drug dosing and calibrated injections. A wide range of syringe pumps is available on the market, delivering flow rates of 0.012–300 mL/min. Most syringe pumps are standardized instruments since they are designed to be compatible with a variety of syringes. Their flow stability and intuitive user experience make them the preferred choice of biologists, but their volume capacity is limited by the volume of the syringe. Their footprint and compatibility with incubators are other restrictive factors, as most syringe pumps are not designed to work in a humid environment

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https://elfagr-med.com/nicu/patient-monitors-nicu.html

Patient monitoring system allows continuous monitoring of patient vital signs, support decision making among medical personnel and help enhance patient care. This system can consist of devices that measure, display and record human’s vital signs, including body temperature, heart rate, blood pressure and other health-related criteria. This paper proposes a system to monitor the patient’s conditions by monitoring the body temperature and pulse rate. The system consists of a pulse rate monitoring software and a wearable device that can measure a subject’s temperature and pulse rate only by using a fingertip. The device is able to record the measurement data and interface to PC via Arduino microcontroller. The recorded data can be viewed as a historical file or can be archived for further analysis. This work also describes the preliminary experimental results of the selected sensors to show the usefulness of the sensors for the proposed patient monitoring system.

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neonate incubator-حاضنة حديثي الولادة

Infant incubators provide thermal support for the neonate (Perlstein and Atherton, 1988). Most incubators also incorporate means for controlling oxygen levels and relative humidity of the air the infant breathes. Microprocessors incorporated in most modern incubators assist in the accurate control of temperature, humidity, and oxygen levels while enabling such features as graphical data trending of the critical parameters controlled by the incubator. An incubator PM program should take into account the manufacturer’s recommendations and should include measurement of sound levels, operating temperatures of humidifiers, and oxygen sensors. Servo-controlled oxygen and humidity delivery systems typically require unique calibrations to be preformed during PM. In addition to calibration, humidifiers require periodic replacement of the air-intake filter.

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https://elfagr-med.com/intensive-care-equipment/video-otoscope.html

Otoscopy is a simple, yet fundamental tool for medical practitioners of all levels to diagnose common otologic conditions. Otoscopy is traditionally performed by a handheld light with a lens. This technique has several disadvantages, especially during teaching sessions since only a first-person view is available. Video otoscopy has the ability to project the view of the scope onto a screen that can be displayed for medical or patient education. Recently, handheld video otoscopy has advanced to display compatibility with personal devices such as cell phones or tablets. In this technical report, we demonstrate components, setup, and use of video otoscopy for otologic examination that can be easily used on a personal electronic device.