SIC 3841 Surgical and Medical Instruments and Apparatus
SIC 3841
This category covers establishments primarily engaged in manufacturing medical, surgical, ophthalmic, and veterinary instruments and apparatus. Establishments primarily engaged in manufacturing surgical and orthopedic appliances are classified in SIC 3842: Orthopedic, Prosthetic, and Surgical Appliances and Supplies; those manufacturing electrotherapeutic and electromedical apparatus are classified in SIC 3845: Electromedical and Electrotherapeutic Apparatus; and those manufacturing X-ray apparatus are classified in SIC 3844: X-ray Apparatus and Tubes and Related Irradiation Apparatus.
339112
Surgical and Medical Instrument Manufacturing
The first medical instruments of precision were used in the seventeenth century. Not until the eighteenth century was surgery recognized as a specific science. Rapid technological advances continued throughout the twentieth century and into the mid-2000s, maintaining the United States' position as the most advanced surgical device industry in the world. In the low-tech segments of the industry, a mature market prohibited robust growth, but the overall outlook was positive for the remainder of the decade with more significant growth expected in the high-tech sectors. Ongoing consolidation within the industry also was expected as larger companies looked to increase revenues through mergers and acquisitions. Total shipment values were $22.9 billion in 2003.
Major consumers of industry output, in order of market size, include foreign consumers, the federal government, medical and health services, doctors and dentists, hospitals, individual consumers, and drug companies.
Like other knowledge-based businesses, the medical and surgical products industry is growing rapidly. However, unlike many technology businesses, barriers to entry are significant. Companies often must incur huge start-up costs to cover research and product development. Furthermore, acute technical expertise typically is needed to develop proprietary knowledge necessary to differentiate products from others in the marketplace and to obtain approvals and patents. Companies that overcome these hurdles, however, can reap large profits if their products succeed.
The industry encompasses a plethora of nonelectric diagnostic and therapeutic surgical devices. Diagnostic equipment is used to identify physical problems based on signs and symptoms. Therapeutic devices treat ailments and illnesses. Some of the largest general categories of equipment are hand instruments, monitoring equipment, intravenous apparatus, syringes, and catheters.
Examples of hand instruments include forceps, knives, saws, retractors, clamps, bone drills, and other products. Forceps are used to grasp, pull, and hold objects during delicate operations. Several monitoring devices also exist. Gastroscopes, for instance, are used to view the interior of the stomach. Cystoscopes provide a view of the interior of the bladder. Likewise, a laryngoscope is used to study the larynx and vocal cords. Ophthalmoscopes permit inspection of the retina, and stethoscopes are used to listen to internal organs, particularly the heart and lungs. Intravenous equipment basically consists of IV transfusion apparatus, which transfer blood or other fluids into the body.
Catheters, an important industry segment, are tubes that are inserted into various body cavities to drain liquids or remove material. Cardiac catheterization involves introducing a small catheter into a vein and then passing it into the heart. This procedure allows doctors to get accurate diagnostic measurements or to clear blocked arteries. A more advanced procedure, angioplasty, incorporates a tiny balloon into the procedure. As an ultra-thin catheter is slipped into an artery, the balloon is inflated, widening clogged arteries. Catheters also are used to drain urine and other bodily fluids.
Other devices produced in the industry include tonometers, speculums, skin grafting equipment, sphygmomanometers, silt lamps, hypodermic rifles, surgical probes, operating tables, needle holders, inhalators, and bone plates and screws.
An important dynamic influencing the industry's production and profitability is Food and Drug Administration (FDA) regulation. The FDA is responsible for insuring that all products sold in the industry comply with federal safety standards. The FDA possesses the authority to recall products, temporarily suspend devices it deems high-risk, and impose monetary penalties for violations.
The 1990 Safe Medical Devices Act (SMDA), which defined procedures for bringing medical products to the market, is one of the most significant pieces of legislation governing producers. Among other stipulations, the SMDA requires certain manufacturers to track patients that should be notified in case of product failure; submit follow-up reviews for certain implants and devices; and, when applying for pre-market clearance, provide a summary of safety and effectiveness data for each device.
One practice presently under FDA review is the reuse of disposable medical instruments approved for one-time use only. Without much federal oversight and against device makers' advice, hospitals often take intrusive medical devices, apply toxic chemicals, and then sterilize at high temperatures. Prompted by the cost-cutting pressures demanded by managed care, this little-known practice has spawned a "reprocessing" industry with revenues in excess of $40 million.
Every year, nearly 2 million patients become sick and 90,000 die from infections contracted while in the hospital. There is no hard data at present linking infection with the reuse of disposable medical equipment, but the savings resulting from recycling are easy to calculate. For example, an argon beam plasma coagulation probe used to stop bleeding in the gastrointestinal tract costs $190. If used ten times it would cost $24 per procedure, even when the cost of cleaning and sterilizing is added. Hospital administrators and the reprocessing companies on whom they increasingly depend say equipment manufacturers are raising false claims to protect sales. But the Association of Disposable Device Manufacturers says patient safety, not corporate profits, is the real issue.
In the early 1600s, an Italian professor named Sanctorious was the first doctor to employ diagnostic instruments of precision in the practice of medicine. Using a pendulum made from a cord and a weight, he was able to measure a pulse rate by adjusting the weight until it swung at an even tempo with the patient's pulse. Sanctorious later implemented a type of thermometer that could measure a patient's weight and temperature. Both inventions were influenced by his friend Galileo.
The seventeenth and eighteenth centuries produced several advancements in surgical and anatomical knowledge. Noted physicians such as Englishmen William Harvey, John Monro, Robert Sibbald, and Archibald Pitcairne contributed to the science and helped establish some of the first formal educational institutions for doctors...
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