In order to protect and preserve the health of the patient, specific regulations have been drawn up which dictate the criteria for the design, production, maintenance and use of electromedical devices. Any sanitary product placed on the European market and intended for sale must be designed, produced, maintained and used according to precise standards. This regulation is a diktat to be followed with care and consistency for the end user and therefore valid both at home (when using simple equipment such as blood pressure monitors, aerosol therapy devices, humidifiers for the environment) but also applicable in sanitary facilities and wherever electromedical devices are used.
Inside a health facility or medical clinic where electromedical devices are normally used, it is up to the nursing staff to check the instruments by recording the data on a checklist which can always be consulted in the event of a needed and updated according to set deadlines. Any discrepancies should be reported to the facility manager and the equipment supplier. Compliance with the rules enacted on the control and maintenance of electro-medical devices it contributes to ensure the success of the therapies for which they are applied, to the correct and rapid recovery of the patient as well as to the quality of the processes of design and construction of these and generates ideas for constant future improvement.
The main standards concerning this type of equipment are the CEI62-5 (EN60601) and the precepts relating to it in particular cases, the CEI62-148 (EN62353) standard which regulates the activities of installation, periodic maintenance and control after a technical intervention.
REQUIRED STANDARDS AND OBLIGATIONS
Contrary to popular belief, these regulations do not only concern medical circles, they also always address anyone who uses an electromedical instrument even at home or for personal use. The regulations also extend to patient identification. They describe a patient as a all living things. For this reason, the standards find value and applicability also referring to electromedical equipment intended for animal care and therefore for veterinary clinics.
The fact that there are rules and that therefore the use of electro-medical devices is well defined and regulated does not in any way exclude the responsibility of the doctor, organization or person who arranges and manages them. . Indeed, they assume specific responsibilities in the event of non-compliance or poor application of the regulations with implications, particularly criminal ones.
There are many cases that have populated the news spaces. Precisely because of non-compliance, too often approximate use of instruments or experience and training in the correct use of devices, we come to stories of situations with tragic implications sometimes with consequences irreversible: patients who suffer even profound damage even after one day.
Standard EN 60601 (CEI 62-5) defines what is meant by electro-medical device, ie any device powered by electric current. The intended use is for the diagnosis, treatment, or monitoring of a patient under the supervision and care of a physician, and which makes physical or electrical contact with the patient by transferring energy to or from the patient and /or by detecting a certain transfer of. energy to or from the patient. The device may also include accessories, described by the manufacturer, which are necessary to enable normal use of the device.” (Ref. standard CEI 64-8 and standard CEI 62-5).
The EN 60601-1 standard in its third edition refers to the “Fundamental safety and essential performance” of electromedical equipment. The legislation aims to describe and study the risk deriving from a functional performance outside the specifications established by the manufacturer. “Essential performance” is defined as the performance necessary to eliminate an unacceptable risk. This implies that the only basic electrical safety check is insufficient to guarantee the proper functioning of medical electrical devices. To avoid running risks, a performance check of the equipment must be carried out periodically and constantly over time.
Today, medical treatment can also be carried out comfortably at home (Home Care). This can generate important reflections on the effective guarantee of the safety and proper functioning of medical devices. Measurement aspects relating to basic electrical safety are only an integral part of the inspections to be carried out. While in a medical environment maintained and organized by expert and competent personnel, the risks arising from superficial use of the devices are limited, in a domestic context, these same risks may be underestimated and not taken into account. This is why each tool must be accompanied by clear and simple illustrative information. When even this is not enough to guarantee safety, it is better for the manufacturer himself to minimize the risks.