Do medical devices equate to medicines?
In this regard, the Association of International Manufacturers of Medical Devices IMEDA expresses concern that the exclusion of most medical devices from treatment standards may entail serious difficulties in providing medical care in both Russian hospitals and outpatients. In particular, vital products for the provision of surgical care, diagnostic procedures, including determination of sugar levels, in-vitro diagnostics, etc., were excluded from some standards. The concern of the IMEDA Association is the fact that, due to the current situation, the question of confirming financing remains open: the lack of medical devices in the treatment standards may prevent the establishment of a specific quality level for each of the standards, since it will be possible to save on technology and quality.
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Another serious consequence of the exclusion of medical devices from treatment standards, according to the Association, may be the need for the patient to purchase vital products on their own. However, as you know, only 1/3 of patients in the country can afford the purchase of truly high-quality products, which can lead to critically serious problems in the fight against diseases that require the daily use of medical devices.
“In many therapeutic areas, medical devices are simply excluded from the new edition of the standards. For example, in the direction of diabetes, the situation is especially depressing, since the new standard of care provides for the exclusion of insulin delivery devices (needles and syringes) from the list of funds purchased from the state budget. As a result, thousands of patients across the country lose the opportunity to receive at least the small amount of medical devices that they received earlier at the expense of the state. According to new standards, patients will be forced to purchase these products at pharmacies at their own expense, and according to statistics, only a small number of Russians can afford to purchase high-quality medical products from their budget, and as a result there is a real risk of serious complications for thousands of diabetes patients associated with the acquisition cheap, but low-quality delivery vehicles, or with the repeated use of disposable needles, “said Alexander Mayorov, MD, head of the department of program training and treatment of the Federal State Budgetary Institution End krinologichesky Research Center “of Ministry of Health of the Russian Federation, member of the Management Board of the European Region of the International Diabetes Federation.
Director of the Diabetes Institute of the Federal State Budgetary Institution Endocrinology Scientific Center of the Ministry of Health of the Russian Federation, corresponding member of RAMS, MD, professor Marina Shestakova commented on this problem: “Only regular self-monitoring helps to avoid complications from diabetes, and, therefore, save money for compulsory medical insurance for hospitalization, including for hypoglycemic cases, and optimize up to 10-12% of the costs of insulin therapy.Test strips for glucometers are currently purchased as drugs for patients with diabetes om within the ONLS / DLO programs on the basis of Orders of the Ministry of Health, where the established annual standards for the provision of test strips for kamboli with insulin-dependent and non-insulin-dependent diabetes mellitus. new orders have not been adopted, therefore, we are concerned that patients may lose the means of self-control, since in 2013 there will be no legal basis for their purchase in certain quantities at the expense of federal and regional budgets. In addition, since the only draft standard of specialized medical care for children with insulin-dependent diabetes mellitus published on the website of the Ministry of Health of the Russian Federation does not contain a blood glucose test using a glucometer, we express concern that the above problem will become relevant for all newly adopted standards for providing medical care for patients with diabetes, including ambulatory standards as the basis for effective treatment of diabetes. ”
Alexandra Tretyakova, executive director of the Association of International Manufacturers of IMEDA Medical Products, noted: “We believe that the issue requires clear explanations and comments from both the Ministry of Health and the FFOMS. The uncertainty of the situation gives rise to nervousness and anxiety for all market participants.