18 January 2021
Brief History of Medical Devices and Regulations
As early as 2000 to 5000 years ago, many of the ancient civilizations used tools such as forceps, knives, scalpels, saws, lancets, needles, trocars, cauteries and knives for several medical procedures. Scalpels were used to make big incisions across the abdomen, and clean, precise incisions on the arms, neck, and legs. Punctures in various parts of the body were made using needles. Hooks held up blood vessels and skin, and, lifted and moved tissue during a medical procedure. Hand drills were used to remove parts of the skull to access the brain, to either cut out portions in a lobotomy, or to remove dead tissue from the body. Forceps, an extremely versatile tool during surgery, were used to grasp or position tissues, immobilize blood flow, and hold skin together while adding or removing stitches. Suturing techniques used crude forms of needle and thread. Early procedures included tracheotomy, amputations, bloodletting, cataract surgery, bone surgeries, removal of bladder stones, trepanation (making a hole in the skull), organ removal etc.The earliest instruments used in these procedures were made of stone, flint or obsidian, and later on from metals like silver, gold and bronze.
From about the 1st century CE to the 17th century, most medical procedures involved treatment of injuries of soldiers at war on the battlefields, or the ailments of the very rich. Devices were used to treat battleground wounds received from arrows, knives, sabers, guns and cannons. With the formalization of the scientific method in the 17th century such devices became more prevalent. Many medical devices were manufactured by doctors or small companies and sold directly to the public with no government standards or oversight for safety or effectiveness. Hospitals were created as a place where soldiers and patients could be treated by doctors with access to specialized equipment and care. Universities began teaching science, medicine, anatomy and medical-related topics. Medical knowledge and know-how continued to expand and evolve. Advances were made in the areas like ophthalmology, optometry, prostheses, catheterization with devices like syringes for removal of cataracts, eyeglasses, metallic or wooden artificial limbs and metallic catheters respectively.
The 1800s was a groundbreaking era for medical devices, therapeutic and medical inventions and the development of modern medicine. In 1867, Joseph Lister published his “Antiseptic Principle of the Practice of Surgery“. This was one of the most seminal and pivotal moments in medical science that would ultimately lead to cleaner operating theatres, more successful outcomes and higher survival rates of patients. Louis Pasteur and Robert Koch identified “germs” as the cause of many diseases around the world. In the 19th century, devices such as the stethoscope, the hypodermic syringe, the ophthalmoscope, the electrocardiogram, hearing aids, the kymograph and nitrous oxide as an anesthetic were brought to market. In addition, drugs such as quinine, aspirin and cholera vaccines were also discovered, significantly changing health outcomes of the public. The design of devices such as forceps, knives, scalpels, saws, lancets, needles, trocars, cauteries and knives continued to evolve with the use of materials like steel. The 20th century saw an explosion of medical devices and procedures that included the cardio defibrillator, hip and knee replacements, heart surgeries, laparoscopes, dialysis machines, infusion pumps, insulin pumps, balloon catheters, disposable catheters, disposables, the iron lung, heart lung machines, inhalers, prostheses, cardiovascular devices, respirators, ventilators, and implants such as stents and pacemakers. The growth of medical devices has been exponential in the last 100 years.
Medical Device Regulations
As the use of medical devices and medical equipment grew in the 19th and early 20th centuries in hospitals and doctor’s offices, larger volumes of devices were being produced and sold. However, there was a paucity of any control or regulations of medical devices. Most regulations were drug related. It was not until the mid-20th century that several countries started implementing medical device-specific rules and regulations to ensure the safety of the general public. These regulations were completely separate from the drug-related regulations. Before World War I, several countries attempted to establish their individual, regional regulations. Most of these regulations were either included in or buried under drug regulations. Post-World War II, there was a need to establish a separate regulation for medical devices to ensure safety for patients and public health. By the 1980s, there were specific pre-marketing approval requirements in most Western EU countries and the United States, but requirements varied from country to country and region to region. In the 1990s, an initiative was undertaken to harmonize these regulations and requirements by introducing conformity assessment procedures, with collaboration and representation from countries around the world.
Regulations and standards continue to evolve and change with the changes in technologies, continued need for global harmonization, and changing user and societal needs. The current applicable and enforceable standards are shown in the figure below.