Production of medicines and medical products in accordance with GMP rules. Registration of medical devices (MPD) in Roszdravnadzor. Obtaining a turnkey registration certificate As part of the service for registration of medical products

The first requirements for cleanliness in the production of medical products were related to contact lenses for the eyes. They then covered a wide range of medical products. In particular, the production of medical needles, syringes, catheters, blood containers, artificial heart valves, etc. requires clean conditions.

The cleanliness of the surfaces of these products is vital for the patient. The condition for surface cleanliness is the cleanliness of the air in the room in which they are finished.

In 1993, the European Union adopted a directive dividing medical devices into the following classes:

Class 1 - low risk - glasses lenses, reusable surgical instruments, hospital furniture, etc.;

Class 2a - medium risk level - eye lenses, blood filtering equipment, surgical gloves, etc.;

Class 2b - increased level of risk - hemodialysis equipment, insulin injection systems, infusion pumps, etc.;

Class 3 - high level of risk - heart valves, artificial veins, implants with biologically active coating.

All medical devices must be manufactured in accordance with EN ISO 9000, ISO 13485 standards. In 1999, the ISO 14969 standard was released, which provides guidance for the application of ISO 13485 and ISO 13488 standards. The manufacture and processing of products of classes 2 and 3 require clean conditions.

General requirements for cleanliness are given in GOST R ISO 13408-1 "Aseptic production of medical products. Part 1. General requirements." . The environmental requirements according to this standard are shown in Table 1.14.

Table 1.14

Requirements for air purity according to GOST R ISO 13408-1

The production of medical devices should be organized in accordance with the general requirements of the GMP Rules.

Critical process parameters need to be investigated using risk analysis techniques.

Neither the European nor the American Guidelines contain specific requirements or recommendations for cleanliness classes of rooms where medical device preparation operations are carried out. However, in practice in Western countries, production is carried out according to the same principle as for the production of sterile medicines. At the same time, there is a clear distinction between approaches to ensuring cleanliness in the manufacture of products that are subject to final sterilization and products for which final sterilization is unacceptable, i.e. for aseptic production (Table 1.15).

The critical zone is the final assembly and processing of surfaces that will come into direct contact with the drugs (blood, tissue).

One can probably draw an analogy between the production of medicines and medical devices of classes 2 and 3 according to the European classification. For example, molding and welding of plastic parts is carried out in ISO zones 5, located in an ISO class 8 room (if subsequent sterilization is provided).

Purity classes used in the production of medical devices

Table 1.15

This analogy with the production of sterile medicines is natural and understandable. Indeed, why produce a drug in clean conditions if it will then be administered to a person through a syringe made without complying with cleanliness requirements?

More on the topic Manufacturing of medical products:

1. APPENDIX 1. Sterilization of medical devices
2. Industry standard. Sterilization and disinfection of medical devices (Extracts)
3. APPENDIX 1. Methodology for quality control of disinfection of medical products
4. Quality control of pre-sterilization cleaning of medical products using the azopyram reagent
5. Guidelines for the use of corrosion inhibitors in the process of pre-sterilization cleaning of medical products made of metal
6. Guidelines for the use of the drug "Gigasept FF" for the disinfection and sterilization of medical devices (Schulke and Mayer GMBH, Germany)
7. Guidelines for the use of the drug "Lisetol AF" for disinfection and pre-sterilization cleaning of medical devices from the company "Schulke and Mayer GMBH" (Germany)

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Russian manufacturer of operating tables and other medical equipment Startechmed.ru. We produce under the STARTECH brand: operating tables, gynecological chairs, functional beds, electrocoagulators, anesthesia and respiratory equipment, patient monitors About the company ⋅ Contacts ⋅ Send a message ⋅ Files ⋅ Market ⋅ Articles ⋅ Advertisements ⋅ Videos ⋅ Photos

Sales and service of medical equipment. JSC "DIAMED" is the exclusive distributor of products from Fazzini (Italy), Emed (Poland) and the official distributor of products from Schmitz (Germany), Melag (Germany), Newtech Inc. (USA) in Russia. The priority areas are: Aria dental units (Slovakia), Fazzini surgical suction units, Melag sterilization equipment, Schmitz gynecological chairs and operating tables, Newtech multi-parameter patient monitors, equipment for equipping operating rooms. About the company ⋅ Contacts ⋅ Send a message ⋅ Files ⋅ Market ⋅ Articles ⋅ Advertisements ⋅ Videos ⋅ Photos

Medical equipment supplier since 1993. Medical freezers and refrigerators. Equipment for air and water disinfection. Ultraviolet lamps. Fetal monitors, colposcopes. Electrocardiographs and other medical products. About the company ⋅ Contacts ⋅ Send a message ⋅ Files ⋅ Market ⋅ Articles ⋅ Advertisements ⋅ Videos ⋅ Photos

LLC “Medical company “MARIA” began its work in June 2009.
Every year the company’s product list is expanding more and more and currently covers such sections as:

Medical equipment,
- medical instruments,
- medical consumables,
- dentistry,
- medical furniture

We sell medical products from leading Russian and foreign manufacturers.

Some of our largest suppliers are:

JSC "MIZ-Vorsma" - medical instruments (Russia)
JSC "MIZ im. Gorky" - medical instruments (Russia)
JSC "Mozhaisk MIZ" - medical instruments (Russia)
SAMMAR Ltd - medical instruments (Pakistan)
Doschatinsky medical equipment plant - medical instruments and furniture (DZMO) (Russia)
Kazan Medical Instrument Plant (KMIZ) - medical instruments (Russia)
LLC "PP Oka-Medic" (Navashino) - medical furniture and sterilization boxes (Russia)
LLC NPF "Medicon" - trays, stainless steel glasses (Russia)
Elatomsky Instrument Plant - medical equipment (Russia)
CJSC "Kront-Med" - medical equipment (Russia)

You can purchase medical products from our company from any geographical location. We will ship your order by any transport company: “Business Lines”, “Autotrading”, “Attenta”, “ZhelDorExpetition”, “DPD” (Bizpak). About the company ⋅ Contacts ⋅ Send a message ⋅ Files ⋅ Market ⋅ Articles ⋅ Advertisements ⋅ Videos ⋅ Photos

Company "DAR" - Official dealer (partner) SANYO-AWT (JP), Individual Entrepreneur Medindustriya Service-MEDIN (BY), CJSC "Trans-Signal" NN (RUS), PARI (DE), Hospitex (IT), Proteus (AUS) ).
The DAR company is a supplier of laboratory medical equipment, medical equipment, ultrasound scanners HONDA-SONOSITE-GE*LOGIQ*VIVID-MEDISON-FUKUDA-ALOKA-HITACHI-SIUI, tomographs NEOSOFT-PHILIPS-HITACHI-GE-TOSHIBA, imported medical and pharmaceutical refrigerators and domestic production, tools, consumables, technological equipment for the pharmaceutical industry (filling and capping lines for medicinal preparations and solutions), water purification equipment for pharmaceutical production, we provide assistance in the design and comprehensive equipment of medical and sanatorium-resort institutions in Russia and the CIS . About the company ⋅ Contacts ⋅ Send a message ⋅ Files ⋅ Market ⋅ Articles ⋅ Advertisements ⋅ Videos ⋅ Photos

Supplier of medical equipment in Russia. Customers include hospitals and clinics, specialized departments of medical institutions and perinatal centers. We work on the terms of comprehensive support.

We cooperate with German manufacturers:

Dr. Mach GmbH. Creates lighting devices for medical institutions.
- Compart Umwelttechnik. Produces oxygen concentrators.
- Modul Technik GmbH. Manufactures medical consoles and gas supply systems.
- Bitmos GmbH. Manufactures portable and portable oxygen concentrators. About the company ⋅ Contacts ⋅ Send a message ⋅ Files ⋅ Market ⋅ Articles ⋅ Advertisements ⋅ Videos ⋅ Photos

Production and sale of a unique multifunctional barotherapeutic device MKV-01 "IVAVITA" for use in urology, gynecology, sanatorium-resort and medical-prophylactic institutions and physiotherapy. About the company ⋅ Contacts ⋅ Send a message ⋅ Files ⋅ Market ⋅ Articles ⋅ Advertisements ⋅ Videos ⋅ Photos

The medical company "Alfa-Medtechnika" offers a wide range of laboratory equipment:
Biochemical and immunoenzyme analyzers from AWARENESS TECHNOLOGY (Stat Fax) (USA), HTI (USA), HOSPITEX DIAGNOSTICS (Italy), HUMAN (Germany), Roshe (Switzerland)
Hematological analyzers ABACUS from DIATRON (Austria), ABX from HORIBA ABX Diagnostics (France), ERMA (Japan), Blood gas and electrolyte analyzers from Medica (USA), Opti Medical (USA), Urine analyzers from BAYER Diagnostics (USA), HTI (USA), Coagulometers from Behnk, Elektronic (Germany), HTI (USA), Microscopes from Micros (Austria), Olympus (Germany) and Unica (USA)
Products of Biohit and Thermo Fisher Scientific (Lenpipet) (Mechanical and electronic dispensers).
Sets of biochemical reagents DiaSys Diagnostic Systems GmbH (DiaSys) Germany and DIAKON-DiaSys (DDS) Russia. Diagnostic equipment from Schiller AG (Switzerland). Endoscopic equipment from Olympus and Pentax (Japan) About the company ⋅ Contacts ⋅ Send a message ⋅ Files ⋅ Market ⋅ Articles ⋅ Advertisements ⋅ Videos ⋅ Photos

The main activities of the enterprise are the development and industrial production of medical equipment for laboratories (State license 99-03-002003 dated May 18, 2010, issued by the Federal Service for Supervision of Healthcare and Social Development of the Russian Federation).

The first GMP rules were adopted in 1963 in the USA, then in Canada, Italy, England and 40 other countries. GMP rules are general guidelines establishing the procedure for organizing the production process and carrying out controls, and also containing minimum practical instructions for the modern correct conduct of production. Based on GMP rules, standards and documents are created in each country that regulate the production of certain types of pharmaceutical products.

In Russia, GMP rules (“Rules for the organization of production and quality control of medicinal products” - RD 64-125-91) were first developed in 1991. In subsequent years, new GMP rules and international standards appeared. They included for the first time or developed new provisions, such as quality management and validation. By order of the Ministry of Health and the Ministry of Economy of the Russian Federation, OST 42-510-98 “Rules for the organization of production and quality control of medicines (GMP)” was introduced in stages, starting on July 1, 2000, and is mandatory for all organizations producing drugs and drugs ( substances). The phased implementation of OST 42-510-98 will be carried out in full until March 31, 2005, and for enterprises producing substances - until December 31, 2008.

The GMP concept is based on the understanding of the limited capabilities of drug quality control after its receipt under laboratory testing conditions. A significant drawback of assessing the quality of the final product is the conditionality of transferring the assessment of test samples to the entire controlled series.

GMP rules are systematic and preventive in nature. They are aimed at preventing errors and deviations by taking into account all factors that can affect the quality of the finished product from the very beginning to the end of the production cycle. The implementation of these rules is impossible without due attention to sanitation and personal hygiene in production, to technological and control documentation, and without modern equipment.

In accordance with the GMP system, the entire production process must be checked, “validated”, equipment “qualified”, control equipment “calibrated”. Moreover, all these operations must be “documented”. GMP rules, promoting the development of products that are homogeneous within batches and between batches, significantly increase the importance of selective analysis of finished products for all types of control, both at the manufacturing enterprise - output, and consumer - state.

Thus, GMP regulations aim to reduce the risk inherent in pharmaceutical production, which cannot be eliminated by controlling the quality of the final product alone.

The GMP standard (“Good Manufacturing Practice”) is a system of norms, rules and guidelines for the production of medicines, medical devices, diagnostic products, food products, food additives and active ingredients. In contrast to the quality control procedure of examining samples of such products, which ensures the suitability of only the samples themselves (and possibly the batches manufactured closest to the given batch), the GMP standard takes a holistic approach and regulates and evaluates the production parameters themselves. and laboratory testing.

"Good Manufacturing Practices (GMP)"

This standard is part of a quality assurance system that ensures that production and control are carried out in the enterprise in accordance with the requirements of the relevant documentation. The rules help minimize the risk of manufacturing errors that cannot be eliminated or prevented by quality control of the finished product alone. The most common types of errors occur:

Cross contamination;

Mixing and/or mixing up finished products.

The rules provide:

Clear regulation of all production processes and process control to confirm its suitability for the production of finished medicinal products of the required quality;

Conducting validation of all stages of production that may affect the quality of products and all significant changes in it;

Providing production with properly trained and qualified personnel, the necessary premises, appropriate equipment and services, raw materials, auxiliary, packaging and labeling materials of the required quality, as well as storage of raw materials and materials in appropriate conditions and proper transportation;

Availability of clearly and unambiguously written technological regulations and instructions for each specific production;

Training of personnel in the proper performance of technological operations;

Registration of all stages of production, confirming that all operations required by regulations have been completed, and the resulting products meet the established requirements in terms of quantity and quality. All deviations must be carefully recorded and investigated;

Storage of current production documentation (batch reports, route maps, etc.), including documentation on the sale of the finished product, which makes it possible to track the progress of each batch of products over a certain period of time, in an accessible form in a certain place;

Storage and sale of the finished product in such a way as to minimize the risk of quality degradation;

The procedure for returning, if necessary, any batch of a finished medicinal product at the stage of sale or delivery, followed by an analysis of the reasons for the violation of its quality and to prevent the recurrence of identified deficiencies.

Quality control is part of the GMP Rules, including sampling, testing and issuing relevant documents to ensure that all necessary tests have been carried out, the production process complied with the requirements of the regulations, and the finished product was sold only if its quality met ND requirements.

The quality control system (objects of control, operations, technical equipment, methods, etc.) is an integral part of the production process. The structure of each pharmaceutical enterprise must have a quality control department (QCD).

Production process

The main purpose of pharmaceutical production is the production of drugs and drugs. In this case, raw materials, auxiliary, packaging and labeling materials are used. The most important part of the quality assurance system for finished products is properly compiled documentation. It must be related to all sections of the GMP rules and reflect their basic requirements. The production process must be carried out in strict accordance with technological regulations, which reflect the requirements of GMP rules, which ensures the proper quality of the finished product.

Great importance is attached to the quality of raw materials. Pharmaceutical enterprises must have an approved RD for raw materials, as well as an enterprise standard for it. The latter includes: description of raw materials, link to RD, indication of possible suppliers, volumes and delivery times, instructions for sampling and incoming control, quality requirements, proper storage conditions and precautions, expiration date or date of additional quality control. All specified requirements are strictly observed and controlled.

The resulting raw materials are subjected to incoming control according to ND, for which average samples are taken from each batch. Only raw materials that comply with RD are released into production with permission from the Quality Control Committee. Samples are left from each batch of raw materials in case of repeated analytical tests. Much attention is paid to preventing secondary contamination during the delivery of raw materials. All components included in non-sterile drugs are tested for microbial contamination, and those included in sterile drugs are also tested for sterility, and, if necessary, for pyrogenicity and the absence of mechanical inclusions.

The production process must strictly comply with technological regulations and guarantee the release of drugs or pharmaceutical drugs, the quality of which meets the requirements of the RD. The conditions for carrying out the technological process must ensure its flow, consistency, safety and trouble-free operation of technological equipment, and optimal loading. It is necessary to exclude or minimize contact of personnel with raw materials, packaging material, and finished product during its receipt. Strict documentation of all stages of the technological process is ensured, and generated waste is processed. It is necessary to ensure maximum automation and computerization of technological processes, mechanization of loading and unloading operations. Particular attention is paid to the process of production of sterile drugs, which requires a special set of measures.

During the production process, stage-by-stage control is carried out. Is it carried out by employees of the workshop laboratory? regularly) and OKC (periodically). The purpose of stage-by-stage control is to prevent the release of a finished product that does not meet the requirements of the RD. Control is carried out with periodic checks in relation to a given product and production conditions in strict accordance with current industry documents, technological regulations and written instructions.

During stage-by-stage control, the following is checked: compliance with the requirements of the RD of the raw materials, semi-finished products, packaging and other materials used; sanitary condition of workshops, workplaces and equipment; performing technological operations and observing technological operating conditions. The results of stage-by-stage control are reflected in the appropriate journals. If deviations from the modes and norms of the technological process are detected, it is necessary to identify the causes and take measures to eliminate them, which are also documented and entered into the dossier.

Great importance is attached to maintaining documentation during the production process. It must meet all production requirements, be carefully designed, compiled, tested and approved.

The main documents used in the production process: technological regulations, instructions, production registration records, analytical methods, quality specifications and other enterprise standards. The production process of each drug is described according to the requirements of special instructions, which must contain the following data: name, type of drug and dosage of the drug; the authenticity, quantity and quality of each type of raw material for all stages of production; description of operations for the production and storage of intermediate products and pharmaceutical drugs; theoretical yield and acceptable limits of actual yield of the finished product at different stages; description of methods of packaging and labeling of drugs; description of the necessary control analyzes at each stage of production and the name of the departments performing control.

Thus, the drug production process at each stage is accompanied by quality control of raw materials, packaging, auxiliary and other materials, intermediates and the final product.

Validation and implementation of GMP rules

According to the new GMP rules, the main elements of validation are: assessment of the installation and performance of all technological equipment (including computer systems); assessment of the conditions and parameters of the technological process and the permissible limit of possible deviation in its implementation; assessment of analysis methods, preparation of protocols and reports certifying the technological process.

Validation must be carried out for each new technological process before its introduction into production, as well as for existing processes for the production of sterile drugs (validation of the technological process and equipment).

Repeated validation (revalidation) is carried out in the following cases: changes in RD for pharmaceutical products, raw materials, auxiliary, packaging and other materials; changes in technological documentation; replacement or repair of equipment; re-equipment of production premises, heating, ventilation and other auxiliary systems; identifying unregulated deviations in the technological process; planned validation in accordance with approved schedules.

The implementation of GMP rules is a means of achieving sustainable high quality products, a measure of proof of the reliability of the quality system. The concept in GMP is flexible and takes into account local conditions, as well as the characteristics of a particular enterprise. The GMP system includes a number of independent rules: rules and regulations for production design, rules for drug registration, rules for licensing and validation of production, rules for self-inspection and state inspection of production.

Compliance with GMP rules is, first of all, a transition from quality control of finished products to quality assurance at all stages of production. This is precisely what the issues of reconstruction of production premises and equipment renewal should be subordinated to. Validation is of great importance in relation not only to technological and control processes, but also to equipment, premises, systems, and production products.

According to GMP, there are the following types of sterile products: drugs subject to sterilization and drugs produced under aseptic conditions. This gradation is the basis for the approach to the design of production facilities, the validation of technological processes, and the selection of appropriate cleanliness classes for various operations and process stages.

General GMP requirements for the production of sterile products require clean areas, personnel access and/or the flow of materials that must be equipped through airlocks. Clean areas are classified according to the required environmental characteristics. Each process operation requires a certain class of operational cleanliness to minimize the risk of contamination by particles or microorganisms, including the risk of cross-contamination. These areas or premises are designed in such a way as to ensure a certain class of cleanliness when equipped and functioning. Equipped state - a condition in which the cleanroom system is fully prepared, the production equipment is fully installed and ready to operate, but the process and personnel are absent. Operating state (in the new GMP requirements - operational) is a condition under which the premises and equipment operate in the established mode with a certain number of working personnel.

For the production of sterile drugs, the following purity classes are distinguished, for each of which there is a maximum permissible number of particles in the air:

class A: local area of ​​high-risk operations for product quality (packing, capping, preparation and mixing of components under aseptic conditions) with laminar (unidirectional) flow, the air speed of which is 0.45 m/s±20%;

Class B: Class A environment when prepared and filled under aseptic conditions;

Classes C and D: designed for less critical stages in the production of sterile products.

People have always treated medicine as something sacredly inaccessible, incomprehensible to ordinary people. Complex diagnoses, names of active ingredients in drugs - all this can easily confuse an uninformed 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 it is?

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 other consumables that 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 the total number of 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 products, is sera that diagnose some dangerous diseases. This includes medications for the detection of shigellosis and salmonellosis. There is also a set of basic antibiotics, which is used to determine the sensitivity of microorganisms that cause the disease to certain drugs. 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 number of 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).

This also includes different types of earplugs, for feeding babies), urinals, oilcloths, used for a wide variety of manipulations. Simply put, this group of products is 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 it would be impossible to save a huge number of 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 of cotton wool and adhesive plasters to special plaster bandages, which make life much easier for traumatologists. This also includes various napkins: sterile, impregnated with medications, 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 to 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 in the patient’s body is determined). 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 in 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, medical diagnostics, as well as patient treatment, 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, which result in the completion of a large number of 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.

The assortment of pharmacies must necessarily include goods for sanitary and hygienic purposes and patient care items, since in case of serious illnesses, after surgical interventions, for non-ambulatory patients and in other cases, they are necessary to ensure human life. They belong to medical products, the range of which includes hygiene and dressing products, medical clothing, etc.

Medical products (IMD) are medical products made of glass, polymer, rubber, textile and other materials, sets of reagents and control materials for them, other consumables and products, mostly single-use, that do not require maintenance during use (order of the Ministry of Health RF No. 444 dated December 13, 2001 “On the validity period of registration certificates for medical products and medical equipment”).

This group of products accounts for about 20% of the total medical device market, which emphasizes its importance for the medical industry. Currently, only a fifth (20%) of products in this area are domestic.

Order of the Ministry of Health and Medical Industry No. 161 dated June 9, 1995 regulates the assortment list of medical products, patient care, prevention, sanitation and hygiene items that should be in pharmacies.

Assortment list of medical products, patient care items, prevention, sanitation and hygiene for pharmacies (Order No. 161 of the Ministry of Health and Medical Industry of the Russian Federation dated June 9, 1995)

First aid kits (sets) individual, first aid, universal, mother and child

Bandages

Blood suction cups

Compress paper

Eye baths

Ankles

Hemostatic tourniquets

Injection needles

Colostomy bags and collection bags

Catheters

Oilcloth lining, compress, polyvinyl chloride, medical

Children's dental rings

Uterine rings

Crutches for adults, children, teenagers and tips for them

Backing circles

Esmarch mugs (irrigator)

Ophthalmic scapulas

Breast pumps

Urinals

Knee pads

Fingertips

Medical scissors

Disposable diapers

Women's hygiene bags (pads), tampons

Medical gloves

Eye pipettes

Spittoons

Sippy cups

Oxygen pillows

Hygienic rubber belts

Ice bubbles

Respirators, medical masks

Baby pacifiers

Syringes

Means of contraception (caps, condoms, intrauterine devices)

Cups for taking medicines

Bedpans

Suspensions - Medical thermometers

Medical tubes

Stockings, half-stockings (knee socks) medical

Medical syringes

Certain products (catheters, scissors, thermometers, syringes, etc.) are discussed in other topics. This topic discusses groups of other products.

According to their functional purpose, sanitation, hygiene and patient care items can be systematized into groups presented on

Classification of sanitary and hygiene products, patient care items by functional purpose

Patient care items for taking medications, mainly liquids and water, include cups, sippy cups, eye pipettes, etc.

To perform some medical procedures, blood suction cups, Esmarch cups, hemostatic tourniquets, gloves, syringes, thermometers, etc. are used.

If the patient is in bed rest, sanitation and hygiene products for the toilet are needed: bedpans, urinals, colostomy bags, oilcloth.

Certain products are intended for the personal hygiene of patients, in particular, bandages, catheters, uterine rings, spittoons, jockstraps, etc.

At the same time, the assortment also includes sanitary and hygiene products that are needed by healthy people, children, women, including pregnant women, for example, first aid kits, children’s dental rings, breast pumps, finger pads, pacifiers, feminine bags, masks, medical respirators and etc.

In recent years, groups or series of products designed to solve certain problems of healthy or sick people have appeared on the Russian pharmaceutical market. For example, the company Artsana (Italy) offers a group of products - care products

for newborns and young children, as well as accessories for nursing women, including:

Physiological project KiKKO:

Physiological nipples have original design features, namely: an anti-hiccup valve in combination with unloading channels-grooves that regulate the flow of air into the bottle;

Physiological “drop” pacifiers have a teardrop shape;

Physiological bottles consist of a cup cap, a physiological nipple, a hygienic plug, a bottle, a valve that prevents colic in children, and a removable bottom;

The adjustable breast pump is designed for expressing breast milk in nursing women.

The Tena series of products - for the care of patients with urinary incontinence, includes adult diapers and absorbent sheets. The use of these products simplifies patient care and provides the patient with a feeling of comfort.

Types of goods:

“Lady” diaper pads for women have an anatomical shape, are suitable for use both night and day, invisible under clothing; Normal, extra, super types are available, in packages of 7-12 pcs.;

“Slip” pads are available in two sizes: M - medium, L - large, 10 pcs. packaged;

“Comfort” pads are supplied complete with fixing panties;

“Bed” sheet pads, size 60x60 or 60x90, 20-30 pcs. packaged.

These goods are of domestic production: the company "SCA Hygiene Products" (Russia).

A certain group of products consists of personal hygiene products for women during the menstrual cycle and for every day. These include pads, tampons, bags that perform one function - absorption (absorption) of body secretions and ensuring women's comfort.

Hygienic intravaginal products for use on “critical” days - Tampax tampons are made from specially bleached cotton fiber, viscose or a mixture thereof, and have a return cord. Available in three types: mini, normal and super-super plus; 8 pcs per pack

They are compact and allow a woman to lead an active lifestyle. Researchers from the Russian Association of Obstetricians and Gynecologists have proven that they do not cause changes in the vaginal microflora and are safe for women’s health. Tampons should be changed every 4-8 hours. At the same time, you need to know the precautions, because if an unexpected deterioration in your health occurs when using tampons (fever, vomiting, diarrhea, muscle pain, dizziness, etc.), you should immediately consult a doctor. The cause may be toxins produced by staphylococcus. These health changes are called toxic shock syndrome. There are no reported cases of TSS in Russia yet. The use of tampons during the postpartum period, especially during surgical interventions, is undesirable and is possible only after consultation with a doctor. Issued by branches of Procter and Gamble (USA).

Procter and Gamble (USA) also produces a series of hygiene products for women, in particular:

“Olways Ultra” - hygiene products for use on “critical” days, and are available in four types depending on the characteristics of these days for women: 1) light - pad length 240 mm; 2) normal - 284 mm; 3) super - 284 mm; 4) night - 302 mm.

These pads absorb moisture well, as they have a unique “Driven” top layer, consisting of extremely fine three-dimensional funnel-shaped pores. It allows moisture to enter the gasket and prevents it from coming to the surface under pressure. The pads have elongated elastic “wings” for reliable fixation to the laundry. The materials from which the pads are made do not support the growth and reproduction of bacteria, do not irritate the skin and do not cause allergies. Pads are changed 4-6 times a day. Shelf life: 2 years. Produced by company branches in Germany, Hungary, and Turkey.

A series of "Oldaze" pads is available for daily use. They have a softer surface, control the appearance of unpleasant odors, create comfortable conditions for the female body, and prevent skin irritation and the feeling of diaper rash.

The pads available are "Oldaze Black" in black, "Oldaze Black Tanga" - black, "Oldaze Tanga" - regular color, with a shape modified for underwear, "Oldaze Ladge" - large, normal - medium, resin - small, in packs of 16-22 pieces, shelf life 2 years. Made in Germany.

Series O.BI. (o.b.) - tampons are made of viscose, cotton, have a non-woven surface and a return cord. Available in different sizes to suit different discharge volumes. Requires changes every 3-6 hours. Tampons O.BI. Comfort have a special silky surface. In packs of 8 and 16 pcs. Produced by Johnson & Johnson (Austria).

A series of sanitary napkins (pads) for daily use “Care Free” are made of cotton, the surface is soft, impregnated with a special solution containing various substances that maintain the natural acid-base balance of the intimate area, chamomile extract prevents the possibility of inflammation and irritation. Thin, flexible, shape follows the lines of the body, securely fixed on underwear. In packages from 16 to 30 pcs., may be black,

Various types are available: “Care Free”, “Care Free Black”, “Care Free Flexiform” (breathable), “Care Free Fresh” (with the aroma of freshness), “Care Free Ultra” (for use on menstrual days), etc. Produced by Johnson & Johnson (Italy).