SAFETY
Electrical hazards in Group 2 medical locations Group 2 are the most critical facilities where medical devices are used for heart- related functions and where the failure of the medical device may cause immediate danger to the patient’s life (operating rooms/intensive care). The stakes are incredibly high, as even momentary interruptions in electricity supply or electronic device malfunctions can potentially lead to fatal electric shocks, jeopardising the safety of both patients and healthcare staff.
Using electrical equipment potentially
exposes patients and staff to the risk of electrical shock, burns, internal organ damage, and cardiac arrhythmias due to leakage current resulting from improper earthing and electrical isolation. The patient is entirely dependent on equipment that ensures their vital functions and, therefore, is more susceptible to complications. Because of anaesthesia or strong medication, the patient may be unable to react to dangerous situations caused by electric currents. The electrical conductivity of body fluids and various conductive solutions and gels in the patient care system make the patient even more vulnerable in this environment. Even relatively small voltages can pose significant dangers when current traverses the heart directly. Currents as low as 10 mA passing through the human body can induce muscular paralysis, which can swiftly progress to respiratory paralysis. Ventricular fibrillation, a potentially fatal cardiac arrhythmia, can manifest with currents slightly exceeding 20 mA. Remarkably, even minute currents in the order of 10 µA have a probability of triggering ventricular fibrillation or causing pump failure when applied to a specific heart region.
Preventing electrical hazards beforehand These critical and complex environments use many different electronic medical devices and electronic equipment, the operation of which must be ensured. The standards regulate the equipment requirements, but the equipment’s safety mechanisms might need to be improved. A piece of equipment that causes a
short circuit or residual current can trigger a protective system upstream and, in doing so, shut down other, possibly life- sustaining, equipment. Thus, paying particular attention to how each unit is supplied with power is necessary. Electrical leakage currents stemming
from malfunction, ageing, and suboptimal design can manifest in older and newer electrical devices. Common insulation faults include problematic connections, damaged cable insulation, defective components, or faulty installations. The
IFHE DIGEST 2024
PE line monitoring unit.
rapid pace of technological advancement and the urgency to introduce new medical equipment present an additional layer of complexity. These devices may inadvertently introduce disturbances into power networks and other electrical apparatuses.
Electrical safety standards in Europe In Europe, utilising unearthed systems, commonly known as IT systems, is not just a choice but a regulatory requirement. This legislation came into force in 2015, with a two-year transition period for implementation. A medical IT system must be used for final circuits supplying medical electrical equipment and plans for life support, surgical applications and other electrical equipment in these premises. Installing at least one dedicated medical IT system is mandatory for each group of rooms serving a similar purpose. These systems must incorporate an insulation monitoring device (IMD) compliant with EN 61557-8:2007 standards. Furthermore, every medical IT system must feature an acoustic and visual alarm system strategically positioned for continuous medical and technical personnel monitoring, ensuring real-time awareness through audible and visual signals. Strict adherence to standards is
paramount during electrical installations and commissioning inspections within healthcare facilities. However, a significant challenge arises from insufficient official oversight, often due to limited resources.
It is essential to stimulate discussion about vital hazard prevention
Consequently, hospitals might continue using outdated and inadequate safety measures to reduce expenses. This highlights the urgent need for increased awareness and education in this regard. The degree of standard compliance
varies from country to country within Europe. While Finland boasts a commendable 100 per cent adherence to these regulations, not all Nordic countries have reached this level of compliance. Nevertheless, the region as a whole is progressing towards a common goal.
Enhancing global awareness Due to prioritising patient safety, the issue has begun attracting attention in many countries. The European standard has started to
be followed in other parts of the world, and there is a clear desire to implement it in their legislation. However, It requires a lot of work, training and introducing new ways of working. It also requires a willingness to use them. In 2019, we embarked on our journey of
global export, introducing our advanced fifth-generation insulation monitoring system. Today, we are collaborating with 11 distributors in 24 countries across different continents. Each of our esteemed partners has played a pioneering role in their respective countries, paving the way for adopting cutting-edge monitoring systems that were previously less advanced.
Asian Pacific regional market We are proud to say that our partnership with our first export partner has spanned over five years. BEC Engineering Sdn Bhd, led by Mr Mohd Farez, has managed the entire Asian Pacific Regional Market, fostering our relationship that includes collaborative development efforts and acquiring valuable insights into the healthcare landscape in the Asia region. At the onset of our collaboration, the Malaysian government launched a robust
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