to patient safety

Personnel and training

Policies and procedures

Medical management

Patient harm

Swiss cheese monitor.

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 exists 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: l Clinical staff should ensure that the patient is safe.

l Clinical staff should notify clinical engineering of a device incident.

l The device should be removed from service, and clearly marked as being faulty.

l And the one thing that clinical staff most often forget, all accessories, disposables and packaging should be preserved.

The clinical engineering team 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 model A commonly used metaphor for understanding safety incidents is ‘Reason’s Swiss Cheese Model’ (see image above). To summarise, in a complex system such as healthcare, hazards are prevented by a series of barriers. Each barrier has unintended weakness

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.


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 send 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. This has been a bit of 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.


Equipment management

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: l Identifying and eliminating or minimising potential threats

l Improving the effectiveness of processes, procedures, people or equipment, represented by the slices of cheese. Effectively making the holes smaller

l Proactively seeking and plugging holes or weaknesses in barriers.


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