What applies to medical products? Medical products list
Transcript
1 Program of state guarantees for citizens Russian Federation free medical care on the territory of the Republic of Tatarstan for 2012 List of medical products necessary for the provision of inpatient medical care in the State Autonomous Institution "Central City clinical hospital 18" Kazan Absorbent, adsorbent, sorbent, enterosorbent, hemosorbent, biomaterial Graduated jar Jar for collecting sputum Polymer jar Bed and surgical linen, fabric, clothing, shoes for patients and staff Bottle for baby food Paper for compresses Cotton wool Ear funnel Electrode gel Anesthetic gel Rubber heating pad, thermochemical, etc. Hemostatic tourniquet Arterial and venous needle Atraumatic surgical needle Laryngeal needle Needle for drawing blood Needle for blood transfusion Needle for cardiac puncture Needle for pneumothorax Needle for subcutaneous injections Needle for vaccinations Needle for puncture of the posterior vaginal vault Needle for puncture and drainage of the maxillary (maxillary) cavity Needle for puncture subclavian vein Needle for puncture intravascular introduction of conductors and catheters Needle for needle biopsy Needle for endoscopy and laparoscopy Needle for epidural anesthesia Needle and set for spinal puncture Insulin needle Single-use injection needle Ligature needle Spinal needle (instruments) Dental needle for anesthesia
2 Fistula needle Surgical needle Ligature needle-fork Needle holder for atraumatic needles General surgical needle holder Vascular needle holder Metal needle case Medical absorbent products for patient care Products for immobilization, plaster and polymer Products for normalization blood pressure Products for reconstructive surgery Therapeutic and preventive products for personal hygiene Disposable products for ostomy patients Individual dressing products Polymer connecting products Indicator of the sterilization process Surgical instruments for minimally invasive interventions Oral irrigator Colostomy bag Medical tuning fork Cannula Intravenous and umbilical cannula Suprapubic cannula for urine drainage Cannula for maxillary lavage (maxillary) sinus Transitional cannula Ear cannula for washing the attic Medical dropper Capillary for clinical studies Hematological cassette Catheter (probe) for suction and drainage Catheter (probe) rectal Catheter (stent) ureteral Catheter (stent) radiopaque (visceral, spinal, cerebral) Catheter (stent) radiopaque ureteral, urological Catheter (stent) silicone, ventricular catheter Intravenous peripheral catheter, intravascular single use Catheter for infusion into small veins (butterfly needle) Gastric catheter Metal catheter Nelaton catheter for bladder drainage Nasal (nasopharyngeal) catheter (otolaryngological ) Pezzer catheter self-retaining large-headed latex Subclavian catheter Latex catheter, polymer Thoracic catheter Tracheobronchial catheter for mucus suction (set) Urethral catheter female Catheter urethral male catheter ear Foley catheter for bladder drainage
3 Endobronchial and endotracheal polymer catheter Epidural catheter Catheter, tube, line for anesthesiology Drainage catheter Backing oilcloth Medical glue Terminal for blood vessels Clamp holder for blood vessels Blepharostat clip Clip holder Laparoscopic clips Fixing clips Mat massage mat rubber dielectric Konikotom (device with a needle) Connector for intravenous infusions Cooling container (hypothermic package) Working container and equipment for working containers Thermal insulating container for infusion solutions Interbody transport container Konchotom Curved forceps Straight forceps Sterilization box (biks) for storing sterile instruments and material Bone holder Crutches Underlay circle Esmarch mug Hook Eye hook Decapitation hook Hook for extraction foreign bodies from the ear Hook for isolating nerve trunks Hook for rhinoplasty (for retracting the wings of the nose) Hook for the zygomatic arch Hook for removing foreign bodies and polyps Hook for removing foreign bodies from the nose Sharp hook Farabeuf plate hook Bladder hook Tracheotomy hook Serrated surgical hook Coagulator hook Dahlgren nippers First rib nippers Curette Obstetric, gynecological and removal curette ovum and placental tissue Laryngeal and nasal curette Blade holder Surgical blades (microblades)
4 Blades for scalpels Adhesive plasters Measuring tape (ruler) Ligature Gynecological spoon Spoon for micro-operations on the larynx Spoon for paranasal sinuses Spoon for removal gallstones Bone spoon Curettage spoon Medical spoon Medical spoon for taking scrapings from the rectal mucosa Medical spoon for curettage of fistulas Ear spoon Kidney-shaped tray Medical magnifying glass Hand-held magnifier Cuff for measurement blood pressure Medical gauze Protective mask Anesthesia, breathing mask Surgical mask Material for regeneration bone tissue Suture material (catgut) Suture material (surgical threads) Monofilament polypropylene suture material Silk suture material Consumable materials for taking and storing blood samples Packaging materials Bag (container) for collecting urine Microshower for washing the maxillary and maxillary sinuses Urine bag Urine collector for precise measurement Set for venosection Paracentesis knife (needle) bayonet-shaped Amputation knife Laryngeal knife Knife for plaster Knife for operations in the mouth and nose Knife for cutting plaster bandages Hook-shaped, banana-shaped knife Laryngological knife Ophthalmosurgical knife, capsulotome Resection knife (spear-shaped) Knife stricture Anatomical scissors Ophthalmic, intraocular scissors Horizontal curved scissors Laparoscopy scissors Metal scissors
5 Nail scissors Scissors for otorhinolaryngology Scissors for dressings Scissors for resection and coagulation Scissors for sinusotomy Curved scissors Scissors for a proctoscope for rectal biopsy Medical scissors Microsurgical scissors Pointed scissors Flat-curved scissors Straight scissors Rhinoscopic scissors Straight scissors with one sharp end Sanitary scissors Vascular scissors Blunt-pointed scissors Ear scissors Surgical scissors Vertical curved surgical scissors Surgical scissors for cutting soft tissues in deep cavities Endoscopic scissors Nose lift Oliva for blowing the nose and auditory tubes Disinfection sprayer X-ray protective diaper Medical gloves X-ray protective gloves Surgical gloves Polyp loop Anatomical tweezers Gynecological tweezers Ophthalmic tweezers Tweezers for applying and removing metal staples Toothed tweezers Medical tweezers Plate tweezers for electrocoagulation Vascular tweezers Technical tweezers Urological tweezers ear surgical tweezers spoon tweezers for dispensing tablets Eye pipette (ophthalmological) Glass pipette for hemoglobinometer Capillary pipette (Pasteur) Plasma filter Film for surgical operations Film for surgical treatment of hernias X-ray medical film
6 Headrest X-ray protective diaper-panties Sippy cup Wound cover Strip, indicator plate for rapid urine analysis Condom Test tube and microtube Stopper for catheters Sampler for determining bacterial air pollution Cardiac electrode wire Conductor for catheter insertion Conductor for tubes (mandrel) Prosthesis (endoprosthesis) bile ducts Prosthesis (endoprosthesis) of blood vessels (xenoprostheses, endoprostheses) Prosthesis (endoprosthesis) of the trachea and larynx Rubber ice pack Reagents and consumables for bacteriological research Reagents, reagents for biochemical research Reagents, diagnostic reagents infectious diseases Reagents, reagents for immunological studies Reagents, reagents for studying hemostasis Reagents, reagents for radioimmunological studies Reagents, reagents for serological studies Reagents, reagents, materials for hematological studies Reagents, reagents, solutions, preparations for clinical laboratory research Reagents for processing X-ray film Gynecological aspirate collection Abdominal scalpel Ophthalmic, ophthalmological scalpel Pointed general surgical (microsurgical) scalpel Surgical scalpel Staples for stitching wounds Saliva ejector Nipple Medical syringe Equipment for checking and testing erythrocyte aggregation analyzers Surgical equipment: bandages, napkins, film ki Personal protective equipment medical staff when working with infectious material Means for ensuring movement Dressings (gauze, bandages, bags, bandages) Bandage-type dressings Fixing and compression dressings, elastic bandages, rubber Sanitary and hygienic means Disinfectant portable sanitary and hygienic means X-ray contrast agent for the gastrointestinal tract Glass for disinfection of instruments Measuring glass Cup for biopsy material Cover glass and slide glass
7 Blanket Serum for CDL Kidney-shaped basin Disinfecting swabs Packaging containers Test strips for urine analysis Test system, kit, strips Test system, strips, plates for biochemical studies Test system, strips for determining blood glucose Titrator Tube for washing purulent cavities Drainage tube Intubation tube Medical rubber tube, PVC Optical tube for endoscopes Rectal, vaginal tube X-ray tube Tracheal, endotracheal, tracheostomy, tracheotomy tube, set of tubes and accessories Device for intravenous infusions Device for enteral nutrition Clamp Air filter Filter for drugs blood, hemofilter Medical film Tsapki Watches hourglass procedural with sound signal The cup of Petri Caps for the corpse balls are cotton or gauze awl of the voyage spatula gynecological spatula of the eye spatula for the tongue laryngological syringe for intra-regional infusions of the syringe for disinfecting and sterilization of the root canals of the cavities with accessories with the belongings of the syringe ny syringe single-use insulin Medical syringe and multiple-use injection devices Single-use medical injection syringe Brush (brush) for endoscopes Obstetric forceps Biopsy forceps
8 Hemorrhoidal forceps Gynecological forceps Laryngeal forceps Dissector forceps Forceps for operations on the nasal septum and paranasal sinuses nose Forceps for packing the ear, throat and nose Forceps for removing papilloma Forceps for removing the fertilized egg Forceps for installing an artificial stapes Clamping forceps Grasping forceps Forceps for a non-dismountable otolaryngological instrument Forceps for a cystoscope Forceps for endoscopes Intestinal forceps Uterine two-pronged forceps Uterine three-pronged forceps Nasal forceps Single-tooth forceps for retracting the uterus (bullet) Ophthalmic forceps Polyp fenestrated forceps Urethral forceps Ear polyp forceps Surgical forceps Bone forceps Shield for transporting patients with spinal injuries Evacuator (catheter) for removing stones Tongue holder
List of medical products necessary for the provision of inpatient medical care Absorbent, adsorbent, sorbent, enterosorbent, hemosorbent, biomaterial Apparatus for cataract removal,
List of medical products necessary for the provision of inpatient medical care List of medical devices necessary for the provision of inpatient medical care, and
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People have always treated medicine as something sacredly inaccessible and incomprehensible. ordinary people. Complex diagnoses, names active ingredients in medications - all this can easily confuse an ignorant person. Often in pharmacies you will also find the inscription “List of Medical Products,” the meaning of which is not always clear. So, what is included in this list and how can knowledge of it be useful to the average buyer?
What is it?
Let's start with the fact that medical products include goods made from glass, polymers, rubber, textiles and other materials, this also includes special reagents and control materials for them, as well as others consumables which are used in medicine.
Most often these are single-use items that do not require special maintenance. In the medicine market, products included in the list of “Medical Products” account for 20% of total number goods. Unfortunately, only a fifth of these products are not manufactured abroad.
Reagents, test strips and other preliminary diagnostic tools
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 research (certain types of acids, alkalis and other reagents). This group also includes indicators that help test not only the patient, but also medical equipment (for example, a sterilization indicator).
Typically, products from this group are not very accessible to the general population, since using them at home is very problematic. The most popular among civilians are the test strips used in glucometers. You can buy them without a prescription, however, you need to know the model of the specific glucometer.
Identification of dangerous diseases
The next large group, which contains the approved list of medical devices, is sera that diagnose certain dangerous diseases. This includes medications for the detection of shigellosis and salmonellosis. There is also a set of basic antibiotics used to determine the sensitivity of microorganisms, causing disease, to certain medications. This measure can significantly reduce the likelihood of an error in prescribing the wrong medicine.
Gloves, probes and urine bags - list of consumables
Further, the list of medical products for 2016, and previous years, contains a whole series items used as consumables. Here are gloves (from non-sterile ones, which are often used during examinations, to especially thin gloves that are used by neurosurgeons - the list includes a dozen different items used in different fields of medicine).
Also included here different types ear, for feeding babies), urinals, oilcloths used for a wide variety of manipulations. It's easier to say this group products are probably one of the largest on this list.
Catheters, needles and syringes of all shapes and sizes
Next come catheters, needles and syringes - things that are very unpleasant, but still necessary. It is worth noting that the list of “Medical Products” contains several dozen types of catheters, differing not only in diameter, but also in their functions: here you can find urological, nutritional, and intramuscular catheters, in other words, for any operation. As for needles, the variety here is just as great: in addition to the usual needles that are inserted into syringes for injections, there are needles for puncture, acupuncture, and surgical needles - the list of products here is also extensive. Syringes, like catheters, vary in their functions and sizes: from small insulin ones to special metal ones, in addition to which a whole set of different tubes is provided.
This group also includes blood transfusion systems, without which salvation would be impossible. huge amount people.
Dressing materials, various dressings
We must not forget about various devices for dressings when answering the question of what constitutes medical products. The list includes many items, ranging from various types cotton wool and adhesive plasters to special plaster bandages, which make life much easier for traumatologists. This also includes various napkins: sterile, impregnated medicines, both anti-inflammatory and analgesics. Of course, we should not exclude bandages, which can also be included in this group. The list includes both wound-healing dressings and those that only cover wounds and burns.
For manipulations and examinations
The list of “Medical Products” would not be complete without a variety of devices that doctors use during examinations and during various manipulations. This includes 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 ultraviolet radiation. The huge group that appears in the list under the title “Other” includes paper for taking electrocardiograms and medical mirrors, so actively used by dentists and otolaryngologists.
Even such seemingly trifles as gels for ultrasound examination are included in this group. Simply put, this includes almost all consumables and medical instruments.
Used for 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 a gas chromatograph and fluoro-immunoanalyzer (during which the presence of drugs and narcotic substances). All necessary items, from needles to reagents, are located in this group of the list.
Specialized tools and consumables
Next, the list of medicines and medical products begins to be divided into specializations. There are materials for providing cardiac surgical care (this includes electrodes, vascular prostheses, introducers - everything that doctors may need in an emergency). Another large group is anesthesiology and resuscitation: here you can find sensors for heart rate monitors, tourniquets to stop bleeding, and artificial nutrition systems. The instruments and consumables used by surgeons deserve special attention: staplers, clips, clamps - everything that is necessary when performing even the simplest operations.
The last category is also divided into several subgroups: neurosurgery working with the brain (drainage systems, systems for fixing fractures, catheters are needed here), thoracic surgery, specializing in the chest organs (dozens of types of clamps, drugs to support breathing, inhalers, oxygen pillows) and some others. Traumatologists and orthopedists may need various pins and screws, metal plates to fix damaged limbs, as well as plaster casts.
Films and developers, as well as tubes
The list of “Medical Products” includes a variety of tubes, incubation and drainage, gas outlet and for consumables. Consumables can also include flasks for reagents used in radiation therapy. This also includes films used for x-ray studies and fluorographic photographs, as well as developers and fixers that fix the image on these films.
Consumables - nondescript, 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 the most serious processing. Such products are spittoons, flasks, test tubes, cuvettes, pipettes, graduated cylinders, laboratory glasses - without them, carrying out medical diagnostics, and treatment of patients would be impossible. These are sometimes unnoticeable, but still necessary - the last category, which includes a list of medical products and consumables.
Registration procedure
At the same time, it is not so easy for new manufacturers to become suppliers of such products as medical devices. The list and registration certificates are approved and issued by the authorized executive body. All devices, preparations and materials are required to have such certificates. All requirements for registration of new products are contained in the Law on Fundamentals of Health Protection. A drug that is being prepared for release onto the market must undergo numerous efficacy and quality tests, based on the results of which a form is filled out. large number documents.
That is why registration is most often entrusted to authorized enterprises that already have experience in communicating with executive bodies 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 must be retested every five years, which again confirms their quality and safety. So rest assured that the reagents, devices, instruments and other medical products and consumables from the list approved by the highest government bodies are completely safe for health.
Antonov Vladimir Stanislavovich
Assistant general director FSBI "TsMIKEE" Roszdravnadzor, Ph.D.
What are the criteria for classifying a product as medical?
— Legally meaningful definition medical product is formulated in Federal Law No. 323-FZ “On the fundamentals of protecting the health of citizens in the Russian Federation”, Art. 38, paragraph 1 "Medical products".
“Medical products are any instruments, devices, instruments, equipment, materials and other products used for medical purposes, separately or in combination with each other, as well as together with other accessories necessary for the use of these products for their intended purpose, including special software, and intended by the manufacturer for the prevention, diagnosis, treatment and medical rehabilitation of diseases, monitoring the condition of the human body, conducting medical research, restoration, replacement, changes in the anatomical structure or physiological functions of the body, prevention or termination of pregnancy, the functional purpose of which is not realized through pharmacological, immunological, genetic or metabolic effects on the human body. Medical products can be considered interchangeable if they are comparable in functional purpose, quality and technical characteristics and can replace each other."
So, the product can be intended for use together or separately (not always, if the product is not independent, it is not medical). It may not be independent in use, but it may be considered medical.
An important point is the criterion of purpose: for diagnosis, treatment, prevention, medical rehabilitation, monitoring the condition of the human body, conducting medical research.
What is the sequence of criteria used to decide whether a device is medical?
— First- mechanism of action. This point immediately distinguishes between the product and the medicinal product. The main purpose of the medical device (hereinafter referred to as the medical device) should not be achieved through pharmacological, genetic, immunological and metabolic actions, however, such methods can support the main purpose of the medical device. It is important what is the main mechanism of action.
Second- purpose, which relates to this concept. The applicant does not simply have to declare that he intends the product for medical purposes. The product must objectively have those properties and characteristics that affect its ability to act as intended for the stated medical purposes. In addition to the objective presence of such properties, it is necessary that these properties be documented and reflected in technical specifications, operational documentation, instructions for use. If the properties are objectively present, but they are not identified, not standardized, not specified, this casts doubt on whether the product is medical.
Since the purpose of the product as given to it by its manufacturer is important, the applicant must take such a claim in the technical documentation very seriously. The description of the medical device must reflect that it is intended for medical purposes; those technical aspects and properties that actually support its medical purpose must be indicated.
DON'T FOLLOW THE SIMPLE PATH
The Roszdravnadzor website contains the “Nomenclature Classification of Medical Devices by Type,” the database of which contains more than 20 thousand types. Often, an applicant finds it convenient to use this classifier to determine whether a product is medical: he finds a similar definition and decides that his product is medical. Let me emphasize that this approach is wrong. If you carefully read the norm of the law, it states that MIs are divided into types. First you need to determine whether this is a medical product, and then classify it, and not vice versa, because the types are not formulated in the form and in that comprehensive form that would allow the product to be classified as medical. For example, we find the type “hematology analyzer” in the nomenclature classifier. Let's look technical details, and there is an indication “for veterinary use.”
Although it seems that the name MI is quite exhaustive, there is detailed description and medical purposes are defined, questions still arise.
THIN EDGES
There are many edge cases where applying the criteria causes difficulties.
Let's consider an example of distinctions between groups of similar concepts, when the nuances allow or do not allow the product to be classified as medical.
Medical products and medicines. What are the differences? "A patch containing a drug." Is he medical device?
In this case, we must turn to the definition, which addresses us to the mechanism of action. What is the purpose? If the purpose of the patch is to close the wound and protect it from external influences, and the product may contain a bactericidal agent, then such a product is classified as medical.
Its main effect is not pharmacological, but the bactericide present in the composition supports the main purpose.
But there are patches whose purpose is to deliver medicine to the human body. Despite the fact that this product looks like it, its purpose is realized pharmacologically, which means it is a medicine.
Another area of distinction is between medical and non-medical devices.
The name of the product does not always indicate the only criterion for classification as a medical device. What is more important is its purpose. For example, a simulator may be designed to restore body functions, then it is a medical product.
But there are a large number of exercise equipment that are not intended for medical purposes, which are mentioned in the definition.
A special case is software. It also raises problems when classifying a product as medical. Here we are talking about so-called stand-alone software. This area is new from a regulatory point of view. A special group is working to restore order in this area and develop uniform approaches and criteria. There are many rules and standards governing software, incl. They are also used for those software products that are intended for medical purposes.
Let me remind you that the documents must not simply state that the operating system is intended for medical devices, it must actually have properties and characteristics that justify the purpose. If not, then the product cannot be classified as MI.
CONTROVERSIAL POINTS
In cases of MI for diagnosis invitro Questions also arise. One of the most critical is the distinction between whether a set of test systems for determining specific analytes is a medical device. The difficulty arises from the fact that often the product itself looks like a medical product: packaging, instructions for use. But at the same time, you can notice that in the manufacturer’s primary documentation there is an indication “only for scientific research"This means that the device is not intended for medical purposes, and the information obtained from it is not scientifically and clinically valid enough to be applied to the patient. Often, when such a device is submitted for registration, it is discovered that The product is not intended for diagnostic purposes invitro, but only for scientific research.
There are situations when it is really difficult to determine whether a particular product is medical, either due to the vagueness of the purpose, or (most often) due to the uncertainty of the mechanism of action. In such cases, the issue is considered at a meeting of a special commission in Roszdravnadzor with the involvement of qualified specialists to make the most objective decision possible.
Based on materials from the Roszdravnadzor seminar “On the procedure for preparing and processing documents for state registration medical products"
