Marketing authorization of Medical Devices for aviation in Russia
Marketing authorization of Medical Devices (MD) for aviation and the registration procedure for “conventional” medical devices are different. The main difference is the special aspects of the technical tests.
First of all, the types of medical devices should be determined that can be used on aircraft. The list of medical devices and medicinal products that can be provided to civil aircraft is described in the “Methodological Recommendations “Provision of Civil Aviation Aircraft with Medicinal Products and Medical Devices” (approved by the Federal Air Transport Agency on 9 December 2013)”
For example, the following MD can be available on board: Respiratory bag for artificial respiration (disposable) for newborns, children, adults, a set of disposable intravenous cannulas (catheters), etc.
In addition, medical units can be used on the aircraft, or the aircraft itself can serve as a mobile medical unit.
The difference in such products’ registration lies in the technical acceptance tests for the purpose of registration, namely:
- Special aspects of the operation of medical devices on board aircraft provide for the mandatory conditions of the medical equipment’s electromagnetic compatibility with the airplane’s electrical systems in all operating modes of the airplane’s systems and medical equipment.
- The electrical interface of the aircraft and medical module (medical equipment) should ensure their safety and performance.
- The impact of operational, shock and vibration loads (especially low-frequency vibrations, multiple rotations of a helicopter’s main rotor) in some cases causes a change in the medical device’s characteristics.
- Changes in temperature, external pressure, humidity in the helicopter cabin are more significant and violent as compared to other transport facilities.
- Materials used that have long-term contact with an injured person should be resistant to biological fluids and have no negative effect on the patient.
The structure of technical tests to register an aviation medical unit involves additional tests not conducted for conventional MD.
The technical test report for the aviation medical unit should include:
- Assessment of aviation requirements (laboratories accredited to conduct this assessment: the Aviation Register of the Interstate Aviation Committee (ARMAK), the State Research and Development Institute of Civil Aviation (GosNIIGA), OJSC “Flight Research Institute named after M.M. Gromov”)
- EMC rating. In this case, the tests are carried out in two types of EMC laboratories: Aviation laboratory and medical device laboratory.
In addition, for conducting technical tests of such MD it is necessary to involve special civil service equipment for which this MD is being registered. Since loads and emergency landing conditions modelling is a mandatory test requirement, where the placement and proper securing of medical equipment should not increase the risk of additional damage to patients and medical staff.
In addition, the participation of all involved governmental agencies in technical tests allow a significant reduction in the financial and time commitments associated with the high cost and complexity in the manufacture and introduction of changes in the design of mobile medical units. Since it is most difficult to find a compromise between the requirements for equipment installed on board aircraft and the requirements that medical devices must meet to safely provide effective assistance to injured persons. The contradictions between aviation safety requirements and the ability to provide effective medical care on board aircraft is a similar issue in the ambulance service.
Therefore, in recent years, technical acceptance tests have been carried out, as a rule, in collaboration with specialists from the State Research Institute of Military Medicine, as a medical and technical institute of the Ministry of Defence, specialists from the State-owned Federal State Institution “State Central Airmobile Rescue Team (Centrospas)” and Federal State Budgetary Institution “Russian National Center for Emergency Medicine (Zashchita)”, as organizations with extensive experience in operating aviation medical units. This made it possible, despite all the difficulties, to carry out complete work cycles and obtain marketing authorisations from Roszdravnadzor for medical helicopter modules for Mi-8, Ka-32 and medical airplane modules for Il-76 and An-148.
In recent decades, the experience of using aviation for medical purposes on the territory of the Russian Federation shows that the use of specialised rapidly-mounted onboard medical modules in multi-purpose helicopters and airplanes can significantly increase the economic efficiency of using helicopters and airplanes in comparison with highly specialised medical types of “flying hospital” with medical equipment permanently installed in a specially modified cabin. In this regard, attention should be paid to the aviation medical modules of well-known world manufacturers that are not certified for use on national aircraft, but which are being actively promoted to the national market “as they are”. This provides for the need to refine these modules in terms of pneumatic and electrical connectors, the main mounting units. As a rule, the additional mounting hardware needs to be installed on board to exclude resonant vibrations in a “non-native” helicopter or plane module. In turn, this requires additional tests and developing new documentation, the costs of which, as well as the subsequent registration procedure, fall on the shoulders of the national buyer of this module. In the event of any technical or medical emergency, where the medical devices used have no documents confirming the compliance of these products with the operating conditions on board aircraft (in terms of resistance to mechanical stress, electromagnetic compatibility, etc.), as well as the marketing authorisation that is unavailable for these medical devices issued by Roszdravnadzor providing the right to be used in medical practice on the territory of the Russian Federation, a liability arises in accordance with the legislation of the Russian Federation.
Unfortunately, the acquisition of foreign-made planes and helicopters by regional state and private entities remains a serious issue within medical aviation. The vast majority of these aircrafts are equipped either in accordance with the standards of the country where the aircraft was manufactured or refitted, or it has a medical cabin from one manufacturer and a separately purchased set of medical equipment, often with no documents, confirming the possibility of its use on board. Such aircraft, unchecked in terms of the safety, quality and effectiveness of the medical equipment unit, in accordance with clause 4 Article 38 of Federal Law 323 “On fundamental healthcare principles in the Russian Federation”, cannot be in operation on the territory of the Russian Federation.
Examples of national medical aviation modules and systems:
- FSR 2009/05427 Medical helicopter ММВ module for helicopters type MI-8, MI-17
- FSR 2009/05426 Medical aircraft MMS module as a component of Il-76 aircraft
- FSR 2012/13780 Medical MM module as a component of An-148 aircraft
- FSR 2012/13522 Medical helicopter unit as a component of Ka-32A11BC helicopter medical helicopter MM module Ka-226T medical aviation MMA1 module