What is a medical device? Federal Service for Surveillance in Healthcare

The government of Moscow
MOSCOW HEALTH DEPARTMENT

ORDER

On approval of the List of medical products

Document with changes made:
by order of the Moscow Department of Health dated October 14, 2010 N 1825,
by order of the Moscow Department of Health dated April 6, 2011 N 302;
by order of the Moscow Department of Health dated September 19, 2013 N 911;
by order of the Moscow Department of Health dated March 18, 2014 N 247;
by order of the Moscow Department of Health of April 14, 2014 N 378 (for the procedure for entry into force, see paragraph 1 of the order of the Moscow Department of Health of April 14, 2014 N 378);
by order of the Moscow Department of Health dated April 23, 2015 N 323;
by order of the Moscow Department of Health of December 30, 2016 N 1068;
by order of the Moscow Department of Health dated January 30, 2017 N 37;
by order of the Moscow Department of Health dated June 29, 2017 N 471;
by order of the Moscow Department of Health dated August 1, 2018 N 524.
_______________________________________________________________

Due to the need to adjust a number of items in the nomenclature of medical products intended for ostomy patients, as well as self-monitoring products for patients with diabetes, in accordance with the names in the registration certificates

I order:

1. Approve the List of medical products dispensed free of charge according to doctors’ prescriptions, according to the appendix.

2. Recognize the order of the Moscow Department of Health of December 12, 2005 N 470 “On approval of the list of medical products” (with amendments and additions) as invalid.

3. Control over the implementation of this order is assigned to the First Deputy Head of the Department of Health S.V. Polyakov.

Supervisor
Department of Health
A.P. Seltsovsky

Application. List of medical products dispensed with medical prescriptions free of charge

Application
to the order of the Department
health care of the city of Moscow
dated May 19, 2010 N 787
(As amended as put into effect
by order of the Department
health care of the city of Moscow
dated August 1, 2018 N 524. -
See previous edition)

List of medical products dispensed with medical prescriptions free of charge


	Foley catheters 2-way*
	Nelaton catheters*
	Urine bag kits for self-catheterization: urine bag, lubricated catheter for self-catheterization, container with sodium chloride solution
	Urinals*
	Urinary collection devices*
	Uropondom*
	Straps for attaching leg urine bags
	Syringes for administering insulin
	Syringe pen for administering insulin
	Injection needles for syringe pens
	Self-testing tools (test strips):
	To determine ketone bodies (acetone) in urine
	For glucometers:
	For Accu-Chek glucometers of various modifications
	For OneTouch glucometers of various modifications
	For glucometers "Satellite" of various modifications
	For glucometers "Contour TS" of various modifications
	For glucometers "SENSOKARD" of various modifications
	For glucometers "Glucocard" of various modifications

	Sterile bandage
	Non-sterile bandage
	Elastic bandages:
	Elastic bandage
	Elastic medical tubular bandage
	Surgical cotton wool:
	Surgical sterile cotton wool
	Surgical cotton wool, non-sterile

	Axillary crutches
	Crutches with support
	Medical gauze:
	Packaged medical gauze
	Gauze napkins:
	Sterile gauze wipes
	Non-sterile gauze wipes


	Support cane

	Bed support
	Crawling support
	Seat support
	Lying support
	Standing support

	Two-component undrained colostomy bag included: adhesive plate for attaching the undrained bag with built-in filter*

	Two-component drainable colostomy bag included:
	adhesive plate for attaching the drainage bag supplied with it with a built-in filter*
	Two-component drainable urinal bag included: adhesive plate for attaching the urostomy bag included with it*

	One-piece drainable colostomy bag with built-in filter*
	One-piece undrained colostomy bag with built-in filter*
	One-piece drainable urinal with built-in adhesive plate*
	Sealant paste for protecting and smoothing the skin around the stoma*
	Powder (powder) absorbent for the skin around the stoma*
	Protective cream for the skin around the stoma*
	Stoma Cleanser*
	Odor neutralizer for colo- and urinal bags*
	Belt for additional fixation of colo- and urinal bags*
	Ostomy tampon*
	Irrigation system for bowel movement through a stoma*
	Absorbent gelling bags for colo- and urinal bags*
	Protective ring for the skin around the stoma*
	Protective film for the skin around the stoma*
	Adhesive plate - half ring for additional fixation of colostomy and urinal plates*

________________

* By decision of the Medical Commission of a medical organization, interchangeable (comparable in functional purpose, qualitative and quantitative characteristics) medical products, special means for violations of the excretory function can be prescribed.

Head of Pharmacy Department

Department of Health

Moscow cities

T.V.Sokolova

Revision of the document taking into account
changes and additions prepared
JSC "Kodeks"

Transcript

1 Program of state guarantees for the provision of free medical care to citizens of the Russian Federation in the territory of the Republic of Tatarstan for 2012 List of medical products necessary for the provision of inpatient medical care at the State Autonomous Institution "Central City Clinical Hospital 18" in Kazan Absorbent, adsorbent, sorbent, enterosorbent, hemosorbent , biomaterial Graduated jar Jar for collecting sputum Polymer jar Bed and surgical linen, fabric, clothing, shoes for the patient and staff Bottle for baby food Paper for compresses Cotton wool Ear funnel Electrode gel Anesthetic gel Rubber, thermochemical heating pad, etc. Hemostatic tourniquet Arterial needle and venous Atraumatic surgical needle Laryngeal needle Needle for blood collection 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 of the subclavian vein Needle for puncture intravascular insertion of conductors and catheters Needle for puncture 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 holder Medical absorbent products for patient care Products for immobilization plaster and polymer Products for normalizing blood pressure Products for reconstructive surgery Treatment and prophylactic 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 washing the maxillary sinus Transitional cannula Ear cannula for rinsing the attic Medical dropper illyar for clinical studies Hematology cassette Catheter (probe) for suction and drainage Rectal catheter (probe) Ureteral catheter (stent) Radiopaque catheter (stent) (visceral, spinal, cerebral) Radiopaque ureteral, urological catheter (stent) Silicone catheter (stent), catheter ventricular Intravenous catheter peripheral, 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 Cat ether thoracic Tracheobronchial catheter for mucus suction (set) Female urethral catheter Male urethral catheter Ear catheter Foley catheter for bladder drainage

3 Endobronchial and endotracheal polymer catheter Epidural catheter Catheter, tube, line for anesthesiology Drainage catheter Oilcloth backing Medical glue Terminal for blood vessels Terminal holder for blood vessels Clip-blepharostat Clip holder Laparoscopic clips Fixing clips Massage mat Rubber dielectric mat Konicot (device with needle) Connector for intravenous infusions Cooling container (hypothermic bag) Working container and equipment for working containers Thermal insulating container for infusion solutions Interbody transport container Conchotom Curved forceps Straight forceps Sterilization box (bix) for storing sterile instruments and material Bone holder Crutches Underlay circle Esmarch mug Hook Eye hook Hook decapitation Hook for removing 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 Lamellar hook according to Farabeuf Cystic hook Tracheotomy hook Serrated surgical hook Coagulator hook Dahlgren cutters Cutters for the first rib Curette Curette for obstetrics, gynecology and for removing the fertilized egg 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 removing 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 magnifier Hand magnifier Cuff for measuring blood pressure Medical gauze Protective mask Anesthesia, breathing mask Surgical mask Material for bone tissue regeneration Suture material (catgut) Suture material (surgical threads) Monofilament polypropylene suture material Silk suture material Consumable materials for collection and storage blood samples Packaging materials Bag (container) for collecting urine Microshower for washing the maxillary and maxillary sinuses Urinal bag Urine collector for precise measurement Set for venosection Paracentesis bayonet knife (needle) Amputation knife Laryngeal knife Knife for plaster Knife for operations in the oral and nasal cavity Cutting knife plaster casts Hook-shaped, banana-shaped knife Laryngological knife Ophthalmosurgical knife, capsulotom Resection knife (spear-shaped) Stricture knife Anatomical scissors Ophthalmic, intraocular scissors Horizontal-curved scissors Laparoscopic 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 scissors Ear scissors Surgical scissors Vertical curved surgical scissors Surgical scissors for cutting soft tissues in deep cavities Endoscopic scissors Nose lift Olive for blowing out the nose and auditory tubes Disinfection sprayer X-ray protective diaper Medical gloves X-ray protective gloves Surgical gloves Polyp loop Tweezers anatomical Tweezers gynecological eye tweezers , ophthalmological Tweezers for applying and removing metal staples Toothed tweezers Medical tweezers Plate tweezers for electrocoagulation Vascular tweezers Technical tweezers Urological tweezers Ear tweezers Surgical tweezers Spoon tweezers for dispensing tablets Eye pipette (ophthalmological) Glass hemoglobinometer pipette Capillary pipette (pasteur) ovskaya) 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 wire-electrode Conductor for catheter insertion Conduit for tubes (mandrin) Biliary prosthesis (endoprosthesis) ducts Prosthesis (endoprosthesis) of blood vessels (xenoprostheses, endoprostheses) Prosthesis (endoprosthesis) of the trachea and larynx Rubber ice bladder Reagents and consumables for bacteriological studies Reagents, reagents for biochemical studies Reagents, reagents for the diagnosis of infectious diseases Reagents, reagents for immunological studies Reagents , reagents for the study of hemostasis Reagents, reagents for radioimmunological studies Reagents, reagents for serological studies Reagents, reagents, materials for hematological studies Reagents, reagents, solutions, preparations for clinical laboratory studies Reagents for processing X-ray film Collection of gynecological aspirate Abdominal scalpel Ophthalmic scalpel General surgical (microsurgical) pointed scalpel Surgical scalpel Staples for suturing wounds Saliva ejector Nipple Medical syringe Equipment for calibration and testing of erythrocyte aggregation analyzers Equipment for surgery: dressings, napkins, films Personal protective equipment for medical staff when working with infectious material Movement aids Dressing equipment (gauze, bandages, bags, dressings) Plaster-type dressings Fixing and compression dressings, elastic, rubber bandages Sanitary and hygienic products Disinfectant portable sanitary and hygienic product X-ray contrast agent for the gastrointestinal tract Cup for disinfection of instruments Measuring cup 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 Scratches Hourglass Procedural with sound signal Petri dish Case-bag for a corpse Cotton or gauze balls Voyachek's awl Gynecological spatula Histological spatula Ophthalmic spatula Tongue spatula Laryngological spatula Syringe for intralaryngeal infusions Syringe for intrauterine infusions Syringe for disinfection and sterilization root canals Syringe for washing cavities with accessories Syringe for rectal infusions Single-use insulin syringe Medical syringe and injection devices for multiple use Medical injection syringe for single use 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 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 non-dismountable otolaryngological instrument Forceps for cystoscope Forceps for endoscopes Intestinal forceps Uterine two-pronged forceps Uterine three-pronged forceps Nasal forceps Single-prong forceps for retracting the uterus (bullet) Ophthalmic forceps Polyp fenestrated forceps Urethral forceps Ear polyp forceps Surgical forceps Bone nippers Shield for transporting patients with spinal injuries Evacuator ( catheter) for removing stones Tongue holder

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Definition of medical devices

Medical products are all kinds of auxiliary devices, equipment, care items, reagents, consumables and other items used in the process of providing medical care.

Medical products have a number of characteristic features:

they are used independently or in combination with other products;
some products can only be used together with other objects necessary for preventive measures, diagnosis, therapy and recovery from illness, as well as monitoring the condition of the patient’s body, research, replacement, rehabilitation, modification of physiological properties or human anatomy;
Medical devices are subject to important requirements for efficiency and safety. They should help achieve a positive effect after their use, but these products are not allowed to cause harm to the patient;

Medical products are divided into classes depending on the potential risk of their use and into types in accordance with the nomenclature classification.

Order of the Ministry of Health of the Russian Federation dated June 6, 2012 N 4n approved the Nomenclature Classification of Medical Devices by Type and the Nomenclature Classification of Medical Devices by Class depending on the potential risk of their use.
The list of medical products related to measuring instruments in the field of state regulation of ensuring the uniformity of measurements, in respect of which tests are carried out in order to approve the type of measuring instruments, was approved by Order of the Ministry of Health of Russia dated August 15, 2012 N 89n.
The list of measurements related to the sphere of state regulation of ensuring the uniformity of measurements performed when carrying out activities in the field of healthcare, and mandatory metrological requirements for them, including indicators of measurement accuracy, was approved by Order of the Ministry of Health of Russia dated February 21, 2014 N 81n.

Medical Device Safety Monitoring: SOP for Internal Control

Let us give an approximate assortment of medical products for patient care, as well as those intended for treatment and prophylactic, sanitary and hygienic tasks:

individual pharmacy kits;
blood suction cups;
bandages;
eye baths;
ankles;
sponges;
heating pads;
tourniquets to stop bleeding;
injection needles;
catheters;
uterine rings;
medical, polyvinyl chloride, compress oilcloth;
teething rings for children;
different types of crutches;
backing circles;
forceps;
knee pads;
various prostheses;
surgical scissors;
finger pads;
eye blades;
breast pumps;
disposable diapers;
gloves;
pads and tampons;
eye droppers;
oxygen pillows;
individual rubber belts;
masks and respirators;
syringes;
baby pacifiers;
reagents;
reagents;
means for protection;
glasses for medicines;
test system;
medical thermometers;
jockstraps;
tubes;
support clothing (stockings and knee socks);
medical syringes.

Patient care facilities consist of:

compression paper;
tips;
spittoons;
lining oilcloth;
urinals and colostomy bags;
drinking bowls and backing circles;
ducks and vessels;
canes and crutches.

Dressings consist of:

napkins;
cotton and gauze products;
adhesive-based dressing materials;
tampons for surgery;
gypsum;
bandages.

Medical products, checking according to Roszdravnadzor checklists

Roszdravnadzor began checking how the system for handling medical devices is organized in clinics, using checklists. How to prepare for such an inspection and what to pay attention to, read the recommendations of the Chief Nurse System.

The expert told how to follow eight steps to avoid getting fined by the department. Download the package of necessary documents - current SOPs and checklists for working with medical devices.

Medical instruments are varied in their functionality and scope, however, the main groups can be distinguished:

tweezers;
probes and inhalation masks for anesthesia;
gynecological, surgical, microsurgical, laparoscopic and endoscopic instruments;
anesthesia kits;
endoscopic trocars;
spinal needle;
incubation tubes;
cosmopores;
furrier's needles;
cuvettes;
stilettos;
trocars;
tracheostomy sets;
Farabeuf hooks;
various pins;
spatulas;
bacteriological loops;
clamps;
tourniquets;
mirrors;
needle holders;
cuvettes for equipment;
sterilization bags and box;
bactericidal irradiator;
tripods;
tazomer;
frontal reflector;
manual ophthalmoscope;
fork;
pressure measuring instruments;
expander;
dynamometer;
tables for examining color sensation and visual acuity;
blood count readers.

Let us recall that the Code of the Russian Federation on Administrative Offenses provides for administrative punishment for the sale of medical devices that do not comply with the established rules.

Medical products, circulation

All types of goods classified as medical devices go through a number of successive stages from the moment of their creation, the totality of which constitutes the process of circulation of medical devices.

On the territory of Russia, the circulation of medical devices that are registered in accordance with the legislation of the country is not prohibited.

Those products of medical equipment and devices that are made according to the individual order of the patient and are intended only for personal use are not subject to state registration.

Ready collection for a nurse

How can the chief nurse control work with medical devices in order to pass inspection by Roszdravnadzor?

Roszdravnadzor began using sheets with control questions during scheduled inspections of medical organizations. The Federal Supervisory Service approved them by order No. 10449 dated December 20, 2017. The document came into force on February 6, 2018.

To organize internal control over work with medical devices, use the new checklists of Roszdravnadzor.

Ildar Bulatovich Minulin, chief specialist of the Federal State Budgetary Institution “Center for Monitoring and Clinical-Economic Expertise” of Roszdravnadzor, Ph.D. n. explained how to control the quality and safety of medical devices in a hospital:

Define Responsibility
Check maintenance documents and control deadlines
Carry out technical condition monitoring in a timely manner
Eliminate low-quality, unregistered and falsified medical products from circulation

The expert provided a complete algorithm for quality control and safety when working with medical devices in the form of a memo-presentation to the manager. The instructions are available in the journal "Chief Nurse".

Procedure for importing medical devices

Federal authorities determine the procedure by which medical devices must be imported into the country for their further official registration.

The Government of the Russian Federation establishes the grounds and rules for organizing doping control, during which a test system or special materials are used.

This measure is necessary precisely at the stage of import into the territory of the Russian Federation.

Registration

Before registration, it is determined how high quality and effective the product is, for which it must pass a series of serious tests, both technical and clinical.

Toxicology tests and other tests may also be performed. The set of preliminary measures for checking a medical device depends on its type and operational features.

The procedure for conducting such events is established by the authorized state body.

After successful testing, the organization that owns the rights to the medical device must receive an official document confirming this registration certificate. For its registration it is necessary to pay a state duty, the amount of which is specified in the Tax Code of the Russian Federation.

names of registered objects (for example, syringes, surgical scissors, needles, etc.);
registration date and number, validity period of the certificate;
purpose;
class of potential operational risk;
OKP code;
name and location of the organization;
manufacturer's address;
information about interchangeability.

What is a medical device? Federal Service for Surveillance in Healthcare

Application. List of medical products dispensed with medical prescriptions free of charge

Transcript

INSTRUCTION A-18/06 for the use of Alaminol (FSUE State Scientific Center "NIOPIK, Russia) for disinfection and pre-sterilization cleaning.

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