Clinical Engineering: How Biomeds make hospitals safer.

This article was originally written by Michael Brown and was presented at the IHEA Conference 2019.

The city of Christchurch is located on a broad plain, geographically located between the Pacific Ocean and the Southern Alps of New Zealand. Locals sometimes brag that it is one of the few places in the world where you can go skiing and surfing on the same day.  Based on an agricultural economy, it is a city with a growing population, currently at just under 400,000 people.

As many of you may know, Christchurch has been through some significant events in the last few years. 

Possibly the biggest event to occur was a 6.2 Richter scale earthquake that occurred on 22 February 2011. 185 people died as a result of the earthquake, and the face of the city was changed forever.

As part of this article, I was going to post some photos of the earthquake here, but even now, 10 years later, the images are painful for me to look at.

I was personally fortunate not to be harmed as a consequence of the quake and aftershocks that followed. My family were safe and my home sustained very minor damage. However, no one living in Christchurch was left unaffected by the earthquakes.

The thing that probably affected me personally in the greatest way were changes at my place of work, Christchurch Public Hospital. I can recall as clearly as yesterday walking to work several weeks after the main earthquake, and two minutes before arriving at my workshop, receiving a call on my mobile. It was my supervisor, who, in his casual, laid back manner instructed me not to enter our work building. When I enquired as to why not, his jocular but accurate reply was ‘because the roof might fall on you’. We were quickly moved to a new work area, significantly smaller than our original workshop.

Since the quakes, living in Christchurch has been a struggle.

Constant roadworks, building repairs and staff relocations have been frustrating at best. There were times when the traffic routes across the city would change on a daily basis due to roadworks; sometimes when visiting medical centres as part of my work duties, I would not be able to take the same route across the city twice in as many days as routes changed. Hospitals and medical centres have moved, rebuilt or shut, and the staff I work with have been relocated as many as four times, to list just a few frustrations.

And, of course, the city itself was stuffed, or to use the colloquial phrase of the day, Munted.

Fortunately, while the recovery has been long and painful, things are now improving.

The city centre, or CBD, was for many people, a place where you would not normally go unless you had to. Before the earthquakes, I could count on one hand the number of times I visited the city centre in the 10 years I had lived there.

One of my favourite quotes that came out shortly after the quakes was from a well-known New Zealand property developer, Bob Jones, who is claimed to have said that ‘the earthquakes did not kill Christchurch, the city was already dead’.

Whilst I feel that may have been true at the time, I am pleased to say that the city has turned a corner in the last year or two.

New buildings have been rebuilt to replace old structures, and new roads and pathways have been rebuilt throughout the city. New facilities, such as Hoyts EntEX movie theatres and Turanga, the City Library, or the huge Margaret Mahy Playground have reopened in the Central City, and along with other construction currently underway, the city centre is turning into a dynamic, exciting place to visit. I think many would agree with me that the city is now a better place than before the quakes destroyed the city. 

One of my favourite things to do on the weekends nowadays is to walk into the city centre with my girls, taking in the sights and sounds of the inner city, before checking out a new cafe, the gallery, museum or the Margaret Mahy Playground.

I am based at Christchurch Public Hospital, as a Biomedical Services Technician. A tertiary hospital with 550 beds, Christchurch Hospital is the largest teaching and research hospital in the South Island of New Zealand, with over 4000 staff on site. It provides a full range of emergency, acute, elective and outpatient services. In addition, Christchurch Hospital has the busiest Emergency Department in Australasia, treating more than 83,000 patients a year. On average, 300 patients pass through the emergency department every day.

It’s an organisation that I enjoy working for, and I love being able to apply my skills to assist in patient care.

As a Biomedical Services Technician, I am a member of a team that currently consists of 31 members, making it the largest clinical engineering department in New Zealand. Out of the 31 members, our department is broken down into smaller sub-groups, comprising of a dedicated dialysis service, mobility services, school and community dental, theatres, labs and several other hospitals. Our department also manages equipment over more than 50 sites, from private hospitals through to small medical centres.

When people ask me what I do as a Biomed, I tell them that I service and repair anything that plugs into a patient and a wall. A colleague once described it this way; if all the clinicians moved to a new building, we would go with the doctors and nurses, whereas Facilities Maintenance would stay with the building.

The main part of my job is maintaining and repairing medical devices however, the position is much broader than this.

All medical centres and hospitals in New Zealand must comply with the AS/NZS3551 standard for managing medical equipment. In Australia, I understand that this standard is considered best practice whereas, in New Zealand, compliance with the standard is mandated by legislation; New Zealand law dictates that we must comply with this standard.

AS/NZS3551 is my bible, and most of what I do is prescribed in the document. 

It’s important to recognise that the Clinical Engineering department is not just about repairing broken things, which is how many staff appear to see us.

These images are recognisable to most biomeds. 

Clinicians and hospital managers tend to relegate biomeds to lower ground floors, external buildings and out of the way places. Even in my own hospital facility where I work, we are on the lower ground floor, just down the hallway from the mortuary. We sometimes joke in-house about how handy it is given the age of many of my colleagues. And without getting sidetracked, the ageing workforce in Clinical Engineering is something I feel our organizations, the IHEA and NZIHE, need to address.

Medical equipment is essential in running a hospital. I was recently in a conversation with some nurses, and while I repaired their ECG monitoring system, the tired nurses coming to the end of their night shift joked about how wonderful it would be to work in a technology-free hospital. Where there was no equipment that could break down, and they would just guess at what a patient’s vital signs were. Obviously, this is never going to happen, and hospitals need clinical equipment to operate.

Although we repair and maintain medical equipment, our job is much more than walking around with analysers on a cart, making sure that equipment ‘works’. We are the hidden force within the hospital, working behind the scenes of surgical and emergency departments. Not only do we provide a safety analysis on equipment, we calibrate and inspect equipment to see if a component is wearing out. Then we replace it, preventing the need for emergency repairs that always seem to occur outside of normal working hours.

I read recently that the space shuttle Challenger that exploded in 1986, resulting in the loss of seven lives and a billion-dollar space shuttle, was caused by a faulty $2.00 O-ring. It reminded me of a piece of advice that an old colleague and NZIHE board member, Nigel Cross, gave to me. He told me that whenever I worked on a piece of equipment, I should remember that the next person to be attached to that equipment could be me, my wife, or one of my children.

A recent article on the AAMI website was titled ‘When Disaster Strikes, How HTM rises to the occasion’, and I thought to myself, when disaster strikes, it should be business as usual as the biomeds should have already been prepared.

After the main Christchurch earthquake, I can recall sitting at my bench testing intravenous fluid pumps, which is the bread and butter of what we do, and thinking that there must be something better that I could be doing to help out at the hospital during the time of crisis. In hindsight, this is probably how things should work in Clinical Engineering. It’s an indication that our equipment held up well during a period of extraordinarily high use.

As the clinical engineer in my hospital responsible for the maintenance of the equipment located in our emergency department, it is a source of honour to me that my work supports and enables the clinicians who are doing the real lifesaving work. This is particularly fitting, given the mass casualty incidents that we have experienced over the last ten years, such as the previously mentioned earthquakes, or more recently, the mosque shooting that occurred earlier this year in Christchurch, resulting in 49 gunshot victims arriving at our Hospitals Emergency Department with the space of an hour.

In today’s throw away society, biomeds work to keep equipment working like new in hospitals, clinics and laboratories, saving our organisations millions of dollars every year.

Biomeds have an extremely important role to play regarding not only the repair and testing medical equipment, but other important aspects also.

Here are some examples of other activities biomeds are involved in:

Managing equipment from install to disposal:

Pre-purchase planning.

I suspect that every Biomed has had a crate turn up in their workshop that they were not expecting, and that have known nothing about it. Upon excitedly unpacking it, they have found a piece of equipment that they have never seen before, minus manuals and statutory paperwork, and in the odd case, with power cables fitted with the wrong country plug. As a consequence, the Biomed has had to go back to the supplier, requesting such standard information as WAND, which is New Zealand’s medical equipment database operated by the New Zealand government, and  ARTG inclusion documentation, service manuals and the like. To this, the response from the supplier is sometimes ‘no one has ever asked for that before’, despite the requirements being a statutory one.

According to 3551, the equipment must also have the correct markings, such as the Manufacturers name, supply voltage and ratings, and other markings. Biomeds are responsible for ensuring that equipment complies with these basic standards.

Pre-purchase planning is not just about ensuring that the equipment to be purchased is of high quality and fulfils statutory requirements. It also requires ensuring that there is adequate service backup and that the cost of ownership has been considered.

I once had to tell a client that their $2000 defibrillator required a $700 battery. Needless to say, my client now wishes they had purchased a different brand of defibrillator. If they had asked a Biomed like me what I thought prior to purchase, I would have been happy to point them in the right direction. This is just one small example where a customer was not aware of the true cost of ownership; I have been involved in far more expensive and serious issues where our advice was ignored and consequently our healthcare system has suffered.

Involving biomeds in equipment purchasing also leads to hospitals standardising on equipment. Multiple monitoring systems result in the need for additional training to be given to clinicians, and of course, a greater range of consumables must be stocked to suit each brand.

Ultimately, clinical engineering involvement can prevent the hospital from purchasing junk.

The costs involved with servicing healthcare equipment is massive, and Biomeds have the potential to make or break a hospital’s budget. 

Interconnectivity with IS

In most hospitals, computer networking services are separated from clinical engineering, however the demarcation lines are starting to get fuzzier. We are now in a situation where we have increased software support versus hardware support. Consequently, my hospital has been upskilling biomeds in the area of computing networking.

Biomeds are more frequently required to work with a hospital’s IT staff as an increasing amount of equipment is becoming interconnected to the hospital’s data network. This is huge growth in this area at the moment, and we are seeing more and more equipment that requires networking or that can enhance patient care by being connected to the hospital’s network. Here are just three examples of where Biomed’s are working closely with Information Services, as they are known in our hospital:

  1. We have intravenous fluid pumps at our hospital that have wifi built-in or wifi tags attached to them, and thus, we can use software to track the pumps whereabouts within the hospital. In my hospital, pumps that are used in our emergency department travel all over our main campus, and sometimes even to other hospitals. Using wifi, we can find these pumps wherever they are within our hospital wifi system, and this has resulted in huge savings in man-hours looking for pumps when our ED has run out of them. This has been a huge help to those involved in running ED. The same system also enables us to remotely monitor drug fridge temperatures using the same tags. If a remote temperature gauge located inside a fridge goes out of range, an alert is raised in our telephone office, and the telephone operators will call the department involved to inform them. This has resulted in the prevention of thousands of dollars worth of drugs being damaged.
  2. Our newest AEDs, The Lifepak CR2, is a wifi-connected device that is capable of not only sending email alerts when it is not in a ready state, but it is also capable of providing first responders with real-time ECG data remotely. For example, our ED staff can be observing a patient’s arrhythmia tracing while the patient is receiving CPR at a remote location, such as a rural hospital or medical centre. And as a Biomed, I regularly receive notifications when a defibrillator has been used, and not immediately returned to a state of readiness.
  3. ECG’s taken on mobile ECG carts are now being automatically uploaded to the patient’s electronic medical records. Our newest monitors, such as the Welch Allyn CSM and CVSM, are capable of transmitting basic patient vital signs, such as heart rate, blood pressure and temperature directly to the medical network and the patient’s electronic medical records. This removes the need for the nurse to manually enter data into a PC or Notebook PC, and hence, removes the opportunity of errors while freeing up the nurses time. 

Ongoing in-service improvements and education.

Alarm fatigue has been a hot topic for some time and has been highlighted for several years as one of ECRI’s top ten healthcare hazards. In my own hospital, with clinical consultation, I have been involved in helping to make the ED a quieter place to work, by altering alarm protocols. This is just one example of where I, as a Biomed have been able to make ongoing improvements to the equipment that we manage. 

Ongoing improvement requires good relations with clinical staff. Biomeds are typically siloed from clinical staff. One of my previous roles involved paying regular visits to a local but somewhat unloved hospital, just for a routine walk-around. During my visits, it was not uncommon to hear the old ‘oh wait, Michael, while you are here…’ Likewise if I see a nurse struggling with a piece of equipment, it’s an opportunity to help. One of the most crucial relationships that exist in a hospital is that which exists between the nursing staff, who work on the front lines, and Clinical Engineering, who are responsible for the reliability and safety of the equipment upon which they rely. When that relationship is strong and the needs of nursing, and by extension, the needs of patients are quickly addressed everyone benefits. 

Almost everything nurses do depends on the information that they get from medical devices, and Clinical Engineering staff are responsible for these devices. A colleague once told me that a misreading tympanic thermometer, a very common issue due to dirt build-up on the ear probe, could result in a patient having an unnecessary overnight stay in a hospital. I discussed this with some clinicians, who assured me that a temperature reading on its own was not enough to admit a patient, however, it was something to think about.

Managing Device Incidents

There are many reasons why a device may fail, potentially resulting in patient harm. A defibrillator could fail to deliver a shock, an infusion pump could overdeliver or underdeliver a drug to a patient.

Fully understanding a root cause for a device-related incident requires full knowledge about the device, patient, building, infrastructure, clinical procedures and numerous other factors. Good communication with clinical staff is vital to getting to the cause of an incident. 

There are several steps involved in understanding a device incident, and without going too deeply into it, here are the basic steps:

  1. Clinical staff should ensure that the patient is safe.
  2. Clinical staff should notify the clinical engineering of a device incident.
  3. The device should be removed from service, and clearly marked as being faulty. 
  4. And the one thing that clinical staff most often forget, all accessories, disposables and packaging should be preserved.

Clinical Engineering then work with the clinical staff and whoever else is required to establish the cause of the fault, and how to prevent it from happening again.

Swiss Cheese

A commonly used metaphor for understanding safety incidents is ‘Reason’s Swiss Cheese Model’. To summarise, in a complex system such as healthcare, hazards are prevented by a series of barriers. Each barrier has unintended weakness or holes, hence the Swiss Cheese analogy. However, in reality, unlike swiss cheese, the holes are ever-changing size and moving. This adaptation of Reason’s model specifically for the management of medical equipment encourages a focus on three main factors that we should pay attention to:

  1. Identifying and eliminating or minimizing potential threats
  2. Improving the effectiveness of processes, procedures, people or equipment, represented by the slices of cheese. Effectively making the holes smaller
  3. Proactively seeking and plugging holes or weaknesses in barriers.

Clinical Engineering literature is full of examples, case histories and horror stories involving device-related injuries and deaths. Many devices apply energy to the patient, be it pneumatic, mechanical or electrical. While continuing improvements in device design can and has reduced the incidence of such injuries, these devices, by their very nature, remain intrinsically dangerous. As such, users need to rely upon the development and use of appropriate and pragmatic barriers to ensure patient safety.

Recalls

During the life of a product, the manufacturer may issue device upgrade notifications, advising of changes that may be necessary to keep a medical device running optimally. ECRI Institute regularly sends out notifications of recalls and upgrades to equipment, as do equipment manufacturers and vendors. It is absolutely vital that the recommendations are carried out, as failure to do so can result in patient harm. I was once involved in an incident in a remote hospital, where I was required to test an AED. The AED had two battery bars showing, so I felt confident that I could test it and leave it with sufficient battery capacity after I had completed my tests, should it be required for therapeutic use. However, one 360 Joule shock was sufficient to flatten the battery. To compound the issue, I did not have a spare battery on me. In some ways, it was fortunate that the unit stopped working while I was testing it, and not while on a patient, however, I had left the hospitals only AED useless while we sourced a replacement battery. A few months later, the agent for the defibrillator announced a software upgrade, as I was not the first person to encounter this issue.

So this has just been a bit of an insight into how biomeds like me help make hospitals safer places for patients and staff alike. I love what I do, and the fact that I am able to use my technical and engineering skills to assist in patient care.