Safety requirements for medical devices have been shaped throughout the history of medical devices, gradually becoming more complex and complemented by new items. Medical device manufacturing is a fast-growing industry that offers increasingly sophisticated and innovative solutions based on unique technologies. As devices and equipment become more technologically sophisticated, the evaluation criteria that clinics and centres must meet to select the right equipment are becoming stricter.
Requirements for medical devices must match their type and purpose: the evaluation parameters for surgical and occupational therapy equipment will, of course, be different. However, there are also universal standards that form the basis for the production of any medical equipment.
Safety and operational reliability standards are paramount for therapeutic equipment – the ability of the equipment to work correctly, accurately and without failures thus contributing to the reduction of medical risks depends on them.
The key parameters of functionality and safety are guaranteed by certification, which is required of all medical devices. The medical devices certificate confirms the compliance of the particular equipment with the standards accepted in health care.
Technical and operational reliability is shown in the ability of the equipment to maintain stable operating parameters during the whole period of service: to provide accurate measurements, maintain automatic regulation and perform other functions stipulated by the purpose and engineering design.
The performance characteristics of medical equipment are inextricably linked to safety requirements. Medical equipment and devices must not pose a threat to patients, employees of medical clinics and the environment (if the instructions, rules of use and operation are strictly observed and stable external conditions are maintained).
Although most pieces of modern equipment are protected from the effects of adverse external factors (high humidity, high or low temperature), extreme conditions reduce the period of useful service, so care should be taken to ensure that the operating environment conforms to the manufacturer’s recommendations.
The continuity of operation, fire and radiological safety of the devices are equally important. All medical equipment should be designed to keep patients and doctors as safe as possible from emergency situations – overtemperature protection systems and automatic self-testing contribute to this. The design and ergonomics of medical equipment must be fully consistent with its intended use. Estimated service life is carefully checked by the manufacturer and confirmed by test results.
Of great importance for the medical device safety is the correct choice of materials that must correspond to the intended use of the device. To this end, special studies are conducted: analysis of biocompatibility, toxicity, strength, durability and wear resistance. Careful selection of materials for the manufacture of medical instruments and devices promotes a neutral interaction with skin, tissues, bodily fluids of the human body, eliminates allergies and other forms of incompatibility.
A full set of requirements for medical devices is prescribed in the “Biological evaluation of medical devices“.