There is no original in your own country – Newspaper Kommersant No. 26 (7471) dated 02/13/2023

As follows from the draft order of Roszdravnadzor, from September 1, 2023, Russian medical institutions will be able to repair medical equipment using non-original spare parts and components. The department fears the imposition of Western sanctions against the Russian healthcare industry – one of the last not yet affected by restrictions. At the same time, most of the high-tech medical equipment in Russian hospitals and clinics is produced abroad and must be regularly exported for repairs abroad.

From September 1 this year, Russian hospitals and clinics will be able to use non-original spare parts for the repair of foreign medical equipment. This, as follows from regulation.gov.ru published on the portal draft order Roszdravnadzor, will reduce the risks of “further sanctions pressure” on Russia. Now, as follows from the analysis of the medical equipment market, conducted by the analytical company MEDITEX, the share of domestic manufacturers is no more than 20-30%. Most of the medical equipment market, as before declared the association of international manufacturers of medical devices IMEDA, especially when it comes to high-tech equipment such as CT, MRI and ultrasound devices, is represented by manufacturers from Europe, the USA and Asian countries. It is repaired or serviced under warranty at an authorized service center, usually in the same country where it was manufactured.

Recall that in April last year, the government imposed restrictions on the export of a number of goods from the country, including medical equipment, which caused dissatisfaction with the industry (more see “Kommersant” dated July 21, 2022) — and, as follows from the Roszdravnadzor document, fears that legal or transport difficulties may arise with her return to the country remain. According to the consolidated report published by Roszdravnadzor along with the draft order, the department also fears that in the future, due to “increasing risks of further sanctions pressure” on the Russian Federation, Russian medical institutions may encounter difficulties in supplying original components or accessories to them. This, in turn, will make it impossible to operate the already delivered medical equipment and worsen the quality of treatment for Russians.

To avoid the risks of non-return, Roszdravnadzor proposes to allow the use of components not provided by the manufacturer for the repair and maintenance of medical equipment in the Russian Federation.

For example, X-ray tubes for CT scanners often need to be changed every year and a half, but their main manufacturers are companies from the Netherlands, Germany, the United States and Japan, and in the event of new sanctions, cooperation with them may not be possible.

In addition, many components are not medical devices themselves, which makes it impossible to register them in the Russian Federation as a separate product and import them for repair through intermediaries.

To obtain permission to use non-original components, the owner of the medical equipment will have to collect a package of documents, including permission to use components from their manufacturer, as well as his letter of consent confirming liability for possible harm to patients. After that, the safety of sharing, as follows from government decree No. 2525, must be confirmed by technical tests and toxicological studies on the basis of the All-Russian Research and Testing Institute of Medical Equipment (VNIIIMT) subordinate to Roszdravnadzor.

As Kommersant was told in the IMEDA association, since the fall of 2022, a number of its member companies have been exporting various types of medical equipment and components for repair abroad, and “the association is not aware of cases of refusal to provide maintenance or refusal to return repaired equipment to the territory of the Russian Federation.” At the same time, as a source in the private medicine market told Kommersant, back in the summer of 2022, one of the Swiss manufacturers of lung ventilation devices refused to service the ventilators already supplied in the Russian Federation in one of the large Moscow clinics.

The return of medical equipment to the Russian Federation can also be complicated if the repair requires components that fall into the category of dual-use goods, such as chips, the import of which into the Russian Federation is currently prohibited by a number of Western countries.

So far, however, as IMEDA told Kommersant, medical equipment service centers abroad have not had problems obtaining the appropriate permits, but “this delays the repair process for another two to three weeks.”

However, even if the fears of the Russian authorities are confirmed and foreign service centers will not be able to service medical equipment from the Russian Federation, says Alexei Vanin, head of the consulting company MDPro, it will not be easy to replace original components with analogues. “A significant part of medical equipment in the Russian Federation is still serviced by non-certified service centers, but they can provide standard parts. High-tech medical equipment, on the contrary, often consists of unique elements, the technology of which is known only to the manufacturing company,” he notes. In fact, they will have to be recreated practically from scratch, and it will take several years.

Note that now most Russian hospitals and clinics are working with relatively new equipment – it was purchased during the coronavirus pandemic in 2020-2021 as part of the reform of primary healthcare in the regions – therefore, the need for its repair is still relatively small.

On the other hand, developing your own components or even models of medical equipment will inevitably cost more than buying them abroad.

A similar problem, we note, was identified at the United Aircraft Corporation, which will have to replace French-made engines on Russian Sukhoi Superjet 100 (SSJ 100) aircraft with its own design – it can almost double the cost of each aircraft (more see “Kommersant” dated November 23, 2022).

Anastasia Manuylova