Minimising electrical risks in Group 2 locations

A system that prevents electrical accidents in hospitals and other healthcare facilities is vital to electrical safety, protecting patients, personnel, and medical equipment, preventing electrical fires and burns, and ensuring that unnecessary downtime is avoided and the service life of surgical equipment is extended. It is essential, in our view, to stimulate discussion about vital hazard prevention. In this article, I will share our team’s point of view on the most comprehensive and safest way to implement medical IT systems with insulation monitoring, and what should be considered in the future. I will also share comments from our Indian, Malaysian, and UK partners to give a more global picture. It is worth noting that protective solutions have yet to be universally adopted, but promising developments in legislation and knowledge are steering a path towards international adoption.

Variable practices globally

At the global level, practices are variable, due — for example — to a low level of expertise, lack of regulation, and a reluctance to invest and change established ways. Although Group 2 healthcare facilities are generally isolated from the national power grid and equipped with medical protection isolation transformers at an international level, monitoring and hazard alerts often need to be more adequately addressed. Some healthcare premises may rely solely on rudimentary residual current devices that offer limited protection. Such devices only provide notification after damage has already occurred, and cut off electricity to all connected devices within the fuse group.

Crucially, an insulation monitoring system’s effectiveness hinges on its weakest link. For instance, the absence of continuity monitoring for the PE wire means that a fractured PE wire may go undetected, rendering the insulation monitoring system ineffective. We must address such vulnerabilities comprehensively to strengthen electrical safety in healthcare settings.

PPO-Elektroniikka Oy is a Finnish company focused on electrical safety technology. In the beginning, in 1981, we had the vision to develop electrical safety for Finnish hospitals’ Group 2 premises, such as operating rooms and intensive care units. After noticing a significant need for development, the vision turned into a mission: we wanted to develop a system capable of monitoring and predicting potentially dangerous scenarios from leakage currents.

During our 42 years in business, we have developed five generations of such equipment. The first analogue insulation monitoring equipment was built in 1981, and a digital version followed two years later, in 1983, the same year that the authorities in Finland ensured electrical safety in these critical environments through legislation. The legislation required use of both a medical isolation transformer and equipment that monitors its insulation level. Consequently, no surgical procedure within Finnish hospitals is conducted without the assurance of comprehensive electrical safety monitoring equipment.

Electrical hazards in Group 2 medical locations

Group 2 locations are the most critical facilities, where medical devices are used for heart-related functions, and where failure of the medical device may mean immediate danger to the patient’s life (such as operating rooms and ICUs). The stakes are incredibly high, as even momentary interruptions in electricity supply or electronic device malfunction 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 arrhythmia, 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. Due to the effects 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 employ many different electronic medical devices and electronic equipment, the safe operation of which must be ensured. While the standards in place regulate the equipment requirements, 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 it is vital to pay particular attention to how each unit is supplied with power.

Electrical leakage currents stemming from malfunction, ageing, and sub-optimal design, can manifest in older and newer electrical devices. Common insulation faults include problematic connections, damaged cable insulation, defective components, or faulty installations. The 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.

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 so that it can be continuously monitored by medical and technical personnel, 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. Consequently, hospitals might continue using outdated and inadequate safety measures to reduce costs, highlighting the urgent need for increased awareness and education in this regard.

The degree to which standards are complied with varies from country to country across Europe. While Finland boasts a commendable 100% 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 the imperative to prioritise 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 legislation. However, this not only requires a lot of work, training, and introducing new ways of working, but equally a willingness follow the good practice set out.

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 partners has played a pioneering role in their respective country, paving the way for the adoption of cutting-edge monitoring systems that were previously less advanced.

• The Asia-Pacific regional market

We are proud to say that our partnership with our first export partner has spanned more than five years. BEC Engineering Sdn Bhd, led by Mr Mohd Farez, has managed the entire Asian Pacific Regional Market, fostering a 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 initiative to prioritise high-quality healthcare and enhance the accessibility of health services.

2024 marks a significant milestone as BEC Engineering Sdn Bhd gains entry to the public sector with an extra view of the Central Monitoring IPS System via cloud feature. Initially, only private hospitals procured medical IPS systems with particular functions for monitoring. This shift towards their inclusion in public healthcare facilities signifies a huge step forward in ensuring regional comprehensive electrical safety.

•  The UK and Ireland

In the UK and Ireland, electrical safety in operating theatres continues to improve, but there are still hospitals with old, non-compliant infrastructure. New-build private and NHS hospitals, and refurbishments, will likely always strive to be compliant and will invest in monitoring.

We received an overview from Gary Mcilvain from KVA Power Installations, which specialises in uninterruptible power supply standby generators, and has over 20 years’ experience of working in UK hospitals. Remarkably, our experiences with partners across different regions have mirrored this pattern. Upon installing advanced medical IT systems in hospitals, stakeholders invariably appreciate the profound significance of these solutions. They begin to grasp the importance of receiving early warnings before potentially hazardous situations arise.

• An example from India

We received the Indian overview from our partner, Ranjit D Deshmukh, from M/s HonorAi Pvt., an experienced system integrator in Pune, Maharashtra. The COVID-19 pandemic put significant pressure on the Indian healthcare system, particularly in Group 2 locations. Infrastructure faced severe strain, and many facilities failed, resulting in casualties due to hazards such as equipment failures and fires, mainly caused by short circuits. These occur because old cables have lost their insulating ability and are overloaded due to the increasing number of devices.

Many questions have been raised by the public and media in India about the failure of critical infrastructure in hospitals. The Indian government set out to implement improvements to the level of healthcare, introducing various healthcare-related legislation and regulations. A regulatory update in September 2021 (IS 17512:2021) provided for adopting insulation monitoring systems (IMS) according to IEC 61557-8 in Indian hospitals in the private and public sectors. However, despite these reforms, it remains key to educate hospital building consultants, contractors, and the hospital engineering sector in general in India. A few hospitals use a conventional insulation monitoring system with a medical isolation transformer.

• Critical issues in India

Training staff is critical in preventing hazards. Safety training programmes are primarily organised by large corporations, major government hospitals, and Trusts, often in collaboration with external consultants. Unfortunately, many others do not show the same level of commitment to safety measures. Other important issues include a lack of both preventative and scheduled maintenance, and interest from management. In addition, many other critical factors are slowing the introduction of new advanced safety solutions: a diversity of attitudes, cultural factors, lack of compliance with safety norms, laxity in surveillance and control, the apathy of top management, and a reliance on unskilled and short-term workers. Insulation monitoring would help to transmit the alarms to permanent skilled staff who could react immediately to the problem.

• Small steps forward

Healthcare technology is constantly evolving, and large-scale hospitals are often eager to adopt new technologies that enhance patient care and safety. The critical issues are efficiency, ease of implementation, and cost-effectiveness. The private sector in India has generally been quicker to adopt new technologies due to more significant financial resources and autonomy. They want to benefit from safety, reliability, and operational efficiency. In contrast, public sector hospitals often have budget constraints, and may require more time to allocate resources for new technologies.

India is a popular destination for medical tourism, with hospitals offering high-quality healthcare services at competitive prices. Healthcare tourists greatly value hospitals that follow European safety norms where insulation monitoring is mandatory. India is an excellent example of what kind of situation many other countries are currently in. Development is happening slowly.

Enhancing staff’s understanding

Proper guidance and investment in training are beneficial for the usability and efficiency of the new technology equipment. The optimal results are achieved when staff have a proper understanding of, and familiarity with, the operation of the equipment. Regular training provides the necessary skills and knowledge, and ensures the safe use of electronic medical devices. The existing hazards should be discussed using real examples.

A medical isolation transformer separates the operating theatre’s electrical network from the national grid. There needs to be sufficient insulation monitoring with alarms within the network so that:

• The insulation level monitoring device monitors the insulation of the floating IT network (leakage current), transformer load (current A), and temperature (°C).
• The system monitoring panel indicates any insulation level alarms, line controller alarms, test lead faults, transformer overloading, and temperature alarms.
• The line controller monitors the continuity of the floating IT network’s protective earth (P/E wire).
• The fault locator unit locates any insulation faults in the floating IT network.

It is also worth investing in usability, facilitating staff workflows, and speeding up operations, with a cloud service that enables remote operation, alarm transfer, and storage with statistics. A remote monitoring station might typically be located at the nurses’ counter or break room.

Electronic devices should be used only in sockets intended for them, with the sockets clearly marked. Electric cabling should be arranged safely, and no unnecessary wires or other items be on the floor.

At PPO-Elektroniikka we have noticed a current trend for the entire medical IT system to be installed within the operating theatre itself. However, it would be wise to consider both the consequences of malfunctions and access to maintenance, and whether perhaps it would be make sense to keep some of the medical IT equipment elsewhere, so that a malfunction/maintenance doesn’t interrupt surgery when engineering staff have to attend the operating room to resolve any issues. A technical cabinet in the hallway could be a good solution to facilitate access for electrical maintenance and help to minimise downtime for maintenance, or repairs. In the event of a problem, the healthcare engineering or biomedical engineering team can then be informed immediately, and the faulty device quickly replaced, and sent off for repair.

Summary

We are now at the point where global safety measures are being developed due to constantly increasing awareness and prioritisation of patient safety, with international legislation being implemented in different countries to meet the current requirements. Implementation and use of electrical equipment in healthcare facilities needs to be sufficiently well controlled, and sanctions for negligent practice determined. In addition to saving human lives, this will help minimise operating theatre outages, resulting in greater efficiency and cost reductions. Before these critical premises are used, the relevant bodies should, during their commissioning inspections, pay special attention to ensuring that all electrical installations are in accordance with laws, regulations, and standards, and that Group 2 medical facilities have undertaken power and equipotential measurements. In Finland, the commissioning inspection is always carried out before a new installation is implemented, or any additions or changes are made to an existing building.

Maintenance is a topic that needs far more attention and detailed discussion. If this single issue is handled correctly, it will resolve many problems in healthcare applications.

Electricity can be an invisible killer that may not even leave a trace, but with properly installed and maintained advanced safety equipment and adequate training, it is possible to counter these hazards. The cost is minimal in comparison to the benefit; the lifecycle of an insulation monitoring system can be over 30 years.

• The author would like to thank Ranjit D Deshmukh (India), Mohd Farez (Malaysia), and Gary Mcilvain (UK) for their country-specific reviews.

Acknowledgment

• This article first appeared in the IFHE Digest 2024, titled ‘Raising safety standards in healthcare facilities’. HEJ thanks the article’s author, the IFHE, and the Digest’s editor, Matt Seex, for allowing its re-publication here.