People always regarded medicine as something sacred inaccessible, incomprehensible to ordinary people. Complex diagnoses, names of active substances in the preparations - all this can easily confuse an uninformed person. Often in pharmacies there is also the inscription “List of“ Medical devices ”, the meaning of which is not always clear. So, what is included in this list and how his knowledge can be useful to the average buyer?
What it is?
Let's start with the fact that the list of medicines and medical devices includes goods made of glass, polymers, rubber, textiles and other materials, this also includes special reagents and control materials for them, as well as other consumables, which used in medicine.
Most often these are disposable items that do not need special maintenance. In the pharmaceutical market, products included in the list of “Medical Devices” account for 20% of the total quantity of goods. Unfortunately, only a fifth of these products are not manufactured abroad.
Reagents, test strips and other means of preliminary diagnostics
Let's move on to specific examples. The approved list begins with all kinds of reagents, among which you can find strips for measuring glucose levels, detecting drugs in the blood and various devices for laboratory tests (some types of acids, alkalis and other reagents). The same group also includes indicators that help to test not only the patient, but also medical equipment (for example, sterilization indicator).
Usually, goods from this group are not very accessible to the general population, since it is very problematic to use them at home. The most popular with "civilians" are test strips that are used in glucometers. You can buy them without a prescription, however, you need to know the model of a particular glucometer.
Identification of dangerous diseases
The next large group, which contains an approved list of medical devices, is the serum that diagnoses some dangerous diseases. This includes medications for determining shigellosis, salmonellosis. There is also a set of basic antibiotics, with which the sensitivity of microorganisms that cause the disease to certain drugs is determined. Such a measure can significantly reduce the likelihood of an inappropriate prescribing error.
Gloves, probes and urinals - a list of consumables
The following is a list of medical devices for 2016, and for previous years, that contains a number of items used as consumables. Here are gloves (from non-sterile, which are often used during examinations, to very thin gloves that are used by neurosurgeons - the list includes a dozen different items used in various fields of medicine).
This also includes different types of probes (gastric, ear, for feeding babies), urinals, oilcloths, used for a variety of manipulations. Simply put, this group of products is probably one of the largest in this list.
Catheters, needles and syringes of all shapes and sizes
This is followed by catheters, needles and syringes - things are very unpleasant, but still necessary. It is worth noting that the list of “Medical Devices” contains several dozen types of catheters that differ not only in diameter, but also in function: there are urological, nourishing, and intramuscular catheters, in other words, for any operation. As for the needles, the variety here is just as great: besides the usual needles that are inserted into syringes for injections, there are needles for puncture, acupuncture, and surgical - the list of products is also extensive. Syringes differ, like catheters, in their functions and sizes: from small insulin syringes to special metal syringes for washing tonsils, in addition to which a whole set of different tubes is provided.
The same group also includes blood transfusion systems, without which it would be impossible to save a huge number of people.
Dressings, various dressings
We must not forget about various devices for dressings, answering the question of what relates to medical devices. The list includes many items, ranging from various types of cotton wool and adhesive plasters to special plaster bandages, which greatly facilitate the life of traumatologists. This also includes various wipes: sterile, impregnated with medications, both anti-inflammatory and analgesics. Of course, do not exclude dressings, which can also be included in this group. The list includes both wound dressings and those that only cover wounds and burns.
For manipulations and inspections
The list of “Medical Devices” would not be complete without the various devices that physicians use during examinations and during various manipulations. These include masks, both surgical and oxygen, with and without analgesics. In the same group are surgical glasses, as well as glasses that protect the eyes from exposure to ultraviolet radiation. The largest group listed in the list under the heading “Other” includes surgical threads, electrocardiogram paper, and medical mirrors, so actively used by dentists and otolaryngologists.
Even such seemingly trifles as gels for ultrasound examination are included in this particular group. Simply put, this includes almost all supplies and medical instruments.
Used in necessary procedures and in-depth studies
The list of vital medical products contains entire sets of tools and consumables used for certain manipulations. This may include procedures such as hemodialysis and peritoneal dialysis, studies using gas chromatogrof and fluoro-immunoanalyzer (during which the presence of drugs and drugs in the patient's body is determined). All the necessary items, from needles to reagents, are in this group of the list.
Specialized tools and supplies
Further, the list of drugs, medical devices begins to be divided into specializations. There are materials for the provision of cardiac surgery (electrodes, vascular prostheses, introducers are all that medical professionals may need in an emergency). Another large group is anesthesiology and resuscitation: there are also sensors for heart rate monitors, and tourniquets to stop bleeding, and artificial nutrition systems. Special attention should be paid to instruments and consumables used by surgeons: suture materials, staplers, clips, clamps - all that is necessary for even the simplest operations.
The latter category is also divided into several subgroups: neurosurgery that works with the brain (drainage systems, systems for fixing fractures, catheters are needed here), thoracic surgery specializing in chest organs (dozens of types of clamping, breathing aids, inhalers, oxygen pads) and some others. Traumatologists and orthopedists may need various pins and screws, metal plates to fix damaged limbs, and plaster casts.
Films and developers, as well as tubes
The list of “Medical Products” includes a variety of tubes, incubation and drainage, gas vents and for mechanical ventilation apparatuses. Consumables can also include flasks for reagents used in radiation therapy. This also includes films used in x-ray and fluorographic images, as well as developers and fixers, fixing the image on these films.
Consumables - inconspicuous, but necessary
The last and most extensive group is consumables. This includes all those tools and items that are used only once, and then either destroyed or undergo serious processing. Such products are spittoon bowls, flasks, test tubes, cuvettes, pipettes, measuring cylinders, laboratory glasses - without them, medical diagnosis and treatment of patients would not have been possible. Such sometimes imperceptible, but still necessary - the last category, which includes a list of medical devices and supplies.
Registration Procedure
At the same time, it is not so easy for new manufacturers to become one of the suppliers of such products as medical devices. The list, registration certificates are approved and issued by the authorized executive body. Such certificates must have all devices, preparations and materials. All requirements for the registration of new products are contained in the Law on the Basics of Health Care. A drug that is being prepared for launch on the market must undergo numerous tests of efficacy and quality, as a result of which a large number of documents are filled.
That is why pharmaceutical companies most often entrust registration to authorized companies that already have experience with executive authorities and will be able to conduct not only the necessary research, but also prepare all the documents. It is also worth noting that all drugs every five years must undergo a recheck, which again confirms their quality and safety. So be sure that the reagents, devices, tools and other medical devices and supplies from the list approved by the highest state bodies are completely safe for health.