Alarms in hospitals: The fatigue problems and the improvisations in sociotechnical perspective.

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IN

DEGREE PROJECT MEDICAL ENGINEERING, SECOND CYCLE, 30 CREDITS

STOCKHOLM SWEDEN 2020,

Alarms in hospitals: The fatigue problems and the improvisations in sociotechnical perspective.

SUTHESH KUMAR BALBIR SINGH

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Alarms in hospitals: The fatigue problems and the improvisations in sociotechnical perspective.

Larm på sjukhus: Trötthetsproblem och improvisationer i sociotekniska perspektiv.

SUTHESH KUMAR BALBIR SINGH

Master of Science Thesis in Medical Engineering Advanced level (Second Cycle), 30 credits Supervisors at KTH: Björn-Erik Erlandsson Reviewer & Examiner: Sebastiaan Meijer

School of Engineering Sciences in Chemistry, Biotechnology and Health Department of Biomedical Engineering and Health System KTH, CBH SE- 141 86 Felmingsberg, Sweden http://www.kth.se/cbh

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Abstract

Introduction

Alarms have always been an agent of notification, but it can also be distressing and

annoying. As much as the sounds of alarm effects the patient’s care and their well-being, it also impacts on the well-being of the healthcare workers which often goes unnoticed as the priority is on the patient-care.

Purpose

The purpose of the thesis was to investigate the problems of the alarms fatigue and how the improvisations can be done technically and in the point of management and technical organization.

Methods

The study was conducted through interviews to healthcare staffs and the management of the departments. Four participants from two different hospitals participated in the interview session.

Result and Analysis

The results obtained from the interviews are analysed with the literature reviews that have been studied and the outcome from the interview tallies on the findings from the literature studies. Additional measures have been implemented based on observation and feedback among the healthcare workers.

Conclusion

The interview feedback supports the studies of the literature reviews and the measures that have been practiced and implemented to improve the workflow and fatigue issues based on the feedback of the hospital interviews have shown improvements in some departments. The outcome can be presented as a suggestion on future improvements, with better access to newer technology on making working efficiency better.

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Sammanfattning

Introduktion

Alarm används i varnande syfte, men kan upplevas som irriterande och störande. Så mycket som det kan upplevas som störande för patienterna, så är det personalens välbefinnande som avgör hur alarmen hanteras eller om de passeras obemärkt.

Syfte

Syftet med detta projekt är att undersöka problematiken med alarmutmattning och hur detta hanteras tekniskt utifrån personal- och ledningsnivå.

Metod

Studien genomfördes genom intervjuer med vårdpersonal och förvaltningen av avdelningarna. Fyra deltagare från två olika sjukhus deltog i intervjusessionen.

Resultat och Analys

Resultaten som erhållits från intervjuerna analyseras med litteraturöversikter som har studerats och resultatet från intervjun berättar om resultaten från litteraturstudierna.

Ytterligare åtgärder har genomförts baserat på observationer och feedback hos sjukvårdsarbetarna.

Slutsats

Intervjuåterkopplingen stöder studierna av litteraturgranskningarna och de åtgärder som har praktiserats och genomförts för att förbättra arbetsflödet och trötthetsfrågorna baserade på feedback från sjukhusintervjuerna har visat förbättringar i vissa avdelningar. Resultatet kan presenteras som ett förslag på framtida förbättringar, med bättre tillgång till nyare teknik för att göra arbetseffektiviteten bättre.

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Acknowledgements

I would like to express my greatest appreciation to Björn-Erik Erlandsson for agreeing to supervise me during the whole period during this master thesis. A man full of knowledge of the industry and his sense of lagom-ness if I may add, has been a great inspiration for me and I foresee to be someone like him in the future.

I would also want to thank the following individuals:

- Heikki Teriö for acting as a 2^nd supervisor on assisting on my thesis and also for setting up with the healthcare staffs Karolinska University Hospital Huddinge.

- Kani Zara for assisting me with the healthcare staffs in Karolinska University Solna.

- Mohammed Rashid and Dr Eman Rusydi for assisting with the healthcare staffs in Hudiksvall Hospital.

I would also like to acknowledge Peta Sjölander, Sebastiann Meijer, Annika Szabo, Mats Nilsson and Maksims Kornevs for the support and guidance they have given me throughout the process of writing this thesis.

Finally, to my family and friends. Your support and guidance have been a thriving need in my tenure here in KTH.

Thank you.

Suthesh Kumar

September 2018/May 2019

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Abbreviations

Management and Technology Organisation MTO

Inspektionen för vård och omsorg IVO

Hälso-och sjukvårdens ansvarsnämnd (Medical Responsibility) HSAN Medicinskt ledningsansvarig (Medical Manager) MLL Post-operative Care Unit POC Pre-operative Care Unit PrOC Mobile Intensive Care Group MIG Intensive Care Unit ICU Neonatal Intensive care Unit NI CU Omvårdnads chef OVC Funktionsenhetschef FEC Funktions områdeschef FOC Transplant/cardiac ICU TCICU

Cardiac Intensive Care Unit CICU

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1 Introduction

In a simple dictionary definition, alarm means a signal; deafening noise that is used to warn or to alert, a warning notice that requires attention, and a sudden sharp apprehension which results fear from the perception of an imminent danger [1].

The alarms management system on the medical devices in the hospitals and healthcare facilities, plays the same role as how any alarms would but the effects are on a different scale. Depending on the type of the medical equipment and the departments who is using them, the alarms has different level of sensitivities where the chances of a false alarm to occur is always present. While manufacturers of the medical devices are in the impression that a perfect system is achieved (by designing a true positive or false negative condition variables), the studies show otherwise where at least 80% falls on false-positive variable (active alarms on healthy patients) [2].

An alarm is considered an actionable alarm when it achieves these 2 variable conditions:

true-positive or false-negative. These variables fall under the positive predictive values (PPV), where for alarm systems it represents on the probability that there is a true critical event. In simple terms:

PPV = true alarms/(true alarms + false alarms)

Medical devices are usually designed to have the alarms set on a high sensitivity, and healthcare workers are responsive with all the alarms if the PPV is high. Lower PPV results on delayed action responses and alarm desensitization among the healthcare workers [3]

This leads to another issue: the sound of an alarm. Most clinical alarms come in a loud audible setting though those settings can be adjusted. However, in most medical equipment and devices, the alarms volume is in the loudest at 75dB, which exceeds the standards given by the World Health Organization (WHO) which limits the audibility of the alarms at 35dB [4],[5]. These loud sounds not only create distress among the patients who recuperating, it also effects the healthcare personnel in their routine workflow, as they have to constantly give attention to the patients when all it could have been is a false alarm all the way. In a way, this disrupts the work flow of the healthcare workers while also effecting patients especially those in the critical care units[5].

Such situations create a sense of mistrust among the healthcare workers on attending the alarms due to the number of the false alarms’ occurrences. In order to reduce the frequency, the healthcare workers will usually do these: reduce the equipment sensitivity so alarms will not be ringing as frequent, switching the alarms off and to a certain extent, ignoring the

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1.1 Aims and research objective

This thesis will take on these approach stances:

• A sociotechnical standpoint.

The main objective will be researching on frequencies on alarms and the alarm fatigues which has been reported and how this has influenced the care and the safety of the patient’s well-being but also on how this effect impacted on the healthcare personnel (which includes doctors, nurses, medical officers etc). Based on the research studies of the literature reviews that I have come upon, most of the literatures only presents on how it effects the patients only but not to those who are working on their care, with most of it only have at least one short paragraph stating on improving the healthcare workers efficiency or training[7] [8][9].

1.2 Research Question

The following research questions were developed for this project:

• Investigating whether the alarm sounds affects the healthcare workers and how it is managed

• To investigate the role of the management on alarm fatigue issues, on how the well- being of the healthcare workers is managed and the measures taken to reduce them

The thesis will also touch on the management’s role on the issues which is stated above: on how they are managing on both fallbacks of the medical equipment’s and the welfare of their healthcare workers and the measures which is being taken to reduce the alarm fatigues as well as the management of the healthcare workers well beings. These two topics will be the main research questions which are used for this thesis.

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1.3 Structure of the thesis project

The thesis is structured to give the readers an overview of the project, with the first chapter being the introduction of the topic and the overall purpose of the project. The second chapter will touch on the literature studies which are performed to support the project and it gives the readers the gist of knowledge of different topics. The third chapter will consist on the methodology on how this study is conducted along with the reasons behind its selection while chapter four will be the presentation of the results, based on the chosen methodology. Chapter five will be the final chapter which covers the discussion based on the results and a conclusion. References and the appendix will be found at the later part of this thesis.

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2 Background

2.1 – Intensive Care Unit

An intensive care unit (ICU) is described as specialist hospital wards that’s provides

treatment and monitoring for very ill patients. Also known as critical care units, these wards are staffed with specialist medical professionals and nurses and is equipped with

sophisticated medical equipment. [10]

The setup in the ICU, however, is different from the general wards. For the comparison sake, some information on a setup of other types of ICU, namely Neonatal Intensive Care Unit (NICU), Paediatric Intensive Care Unit (PICU), Cardiac Intensive care Unit (CICU) will be included as well because all of these high dependency units shares a similar function but with different subspecialties for specific cases. [11],[12]

Figure 1: A schematic diagram of a typical 35-bed ward layout in (a) and schematic of high dependency bays [13].

As depicted in Figure 1(a), normal wards consist a sharing concept where in a single bay, few beds are allocated inside to be shared with several patients. This arrangement of patients only beds cases which are not in emergent cases which needs frequent attention, although equal priority care is still given but not as much as to other emergent zones.

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Figure 2: Schematic of a typical ICU bay layout in hospitals[14].

The schematic on the Figure 1(b) as well as the in Figure 2 shows the layout bay of a typical ICU or any high dependency bays are usually set up. The lines between the rooms are usually divided by glass walls which can be opened but, in some hospitals, it is also separated merely with only curtains. As compared to the normal wards, ICUs uses a different number of monitoring devices per patient as an essential component of a treatment process. [15]

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2.1.1 – ICUs as a source of noisy environment

As noted previously it is common for ICU to use a different number of monitoring devices per patient as the situation needs it to be as such: it is a place where patients who are seriously ill are being treated and monitored. [15]

Christensen [16] noted that ICU is notorious on exposing to unnecessary noise which effects the well-being of patients, the delirium of the ICU and other problems. The noise level which has been recorded exceeds over 80dB, most of it sourcing from mechanical alarms although this level of noise only occurs occasionally. He noted that on average the noise levels in the ICU is around 55dB to 60dB and that 80% of the noise comes from human interactions, it is the mechanical alarms that raises the concern due to the intensity and the physiological effect that is produced. [16]

Konkani noted that it is important to consider the nature of the auditory environment of an ICU; it contains an array of medical equipment along with the usual bombard of buzzers, pagers, telephones, alarms and the interactions of the medical professionals and patients. All of this together creates a bluster that can create a highly unpleasant work environment for the medical professionals [17]. Konkani noted a study done from 17 ICUs at seven hospitals and found that 46% of the nurses agreed that the noisy environment is among the top obstacles on their work performance, with him noting on Padmakumar et al. conclusion that high levels of noises can negatively impact on the communication, intelligibility and stress level of the ICU staffs [18].

2.2 – Alarms Sounds/False Alarms

Alarm sounds is not an uncommon occurrence in ICUs; it is noted the auditory environment where sounds coming from buzzes, pagers, telephones, alarms as well as the level of conversations among medical professionals is common [17], along with the use of multiple monitoring devices on a patient is the norm in such wards and is seen as part of the essential entity in a treatment process [15].

It is also a detriment in those areas. Christensen noted on the concern of mechanical alarms in the ICU due to the intensity of the alarms as well as the psychological effect that is often produced. He noted on the non-uniformity of a standard alarm sound that nurses in ICUs must be able to distinguish the differing alarms and which one they needed to respond to as a matter of urgency. With the additional increase of medical devices in the ICUs the threshold of responding the alarms appropriately diminishes over time [16]. Similarly, Wilken[19] noted that 80% to 95% of the alarms in the ICUs and other care areas are non-actionable or as he defined it as a false alarm and these unnecessary alarms creates more unnecessary extra workload to manage them in the nurses’ working shift. He noted that this phenomena of the

“cry-wolf effect”; managing the high rates of false alarms on non- actionable problems has become something very common.

Min Cho et al. mentioned that the number of alarms on medical devices in the ICUs has also increased, noting that there were only 6 different type of alarms in 1983 on one critically ill

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patient to at least 40 types in 2011 [20]. In addition to that, he noted that nurses may have difficulty on differentiating the different types of alarms for urgent intervention as different device manufacturers uses different types of alarms, where they have difficulty in differentiating more than 6 different type of alarms. Min Cho also added that most medical staffs are exposed to an average of 771 alarm notification per patient in a day and with such overexposure they may experience to decreased in concertation and also to them becoming more desensitize to the alarm, adding to the cry-wolf effect as well [20].

Johnson et al. noted on a study conducted on nurses responses on the medical alarm in the NICU, where the cardiorespiratory alarms alerted about 16.7 times per hours, most of it stemmed from the oxygen saturation alarms and the study has noted that this alarm does not include the ones coming from other monitoring devices, as an estimate was done on how frequent the nurses are exposed to the alarms from the oxygen saturation monitoring device [3].

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2.2.1 – Alarm Fatigue

The definition of alarm fatigue and the studies which conducted on that matter varies on what that is seen as a cause of that fatigue. The Emergency Care Research Institute (ECRI) defined alarm fatigue as the emotional pressure that the care-providers experience when one is exposed to too many alarms sounds [21]. Johnson et al structed the key sources of alarm fatigue in the diagram below [3].

Figure 3: Diagram of key sources on alarm fatigues in the critical care units [3]

Christensen refers alarm fatigue as failing to response to the alarms due to overwhelming frequency of alarms and noted that the major cause of it is the number of false alarms, which leads to the desensitisation of the alarms [16]. Torabizadeh et al. has a different view on this:

their study noted that alarm fatigue is considered as a kind of human error due to the desensitisation that is caused by the alarm sounds where the fatigue causes the nurses to not only becoming dilatory on responding the clinical alarms but also readjust the alarms, adopt to a setting which might be harmful to patients and turn the alarms silent or switching them off completely [22].

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Wilken et al noted on a general term of alarm fatigue: effect on the caregivers from a high number of alarms and notes the workload from managing a number of non- actionable alarms per shift, along with the mental stress from prioritizing the number of alarm conditions as the main contributing factor. His study also argued that alarm fatigue should not be seen as a condition on a healthcare worker but more of a state of the sociotechnical system where the healthcare workers are exposed to a number of unnecessary alarms till a point where they react inadequately to them. He notes that his study concentrates on the ICU but added that similar problems exist in every different CCUs [19]. Deb and Claudio added on the other influencing factors which includes the mentioned number of false alarms, the workload, difficulty with the alarm settings of the equipment, types of alarms, emotional and psychological factors and the working shift periods [23].

2.2.2 – Alarm fatigue case studies in Critical Care environments 2.2.2.1 - Case study 1 -Linköping Hospital Dialysis Incident

The dialysis incident which happened in 1983 is one of the cases which highlights how an error caused by an introduction of a new system of equipment that could lead to one of the most high-profile news, both on the hospital management and the personnel which was involved.

The hospital has introduced a new dialysis system in 1983, notably a modern system which eventually turned into a failing one. On the day of the accident, 15 patients were getting their treatment and at a point of time, the nurse on duty accidently switched off the equipment alarm which was signalling an error: the percentage of salt in the dialysis liquid dropped to an extent that it only consisted clean water, which in turns to be fatal for the patient. This resulted the death of 3 patients while the remaining was in great danger[24] [25].

The highlight of this case is that only the nurse was regarded as the only responsible and charged with involuntary manslaughter while the hospital management, technicians and the doctors was not, when they are the first in line when comes on being responsible for both the patient care and also on managing the equipment. Along with that, the introduction of the new equipment without the proper knowledge transfer to the end user and its technical errors have also contributed to the incident. The law for hospital responsibilities on better protection to the healthcare workers have changed ever since but this does not change the fact on how dangerous the situation in the healthcare facility can ever be.

In this incident, one can conclude that the incident could have been avoided in entirety should

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2.2.2.2 – Case study 2 - The Libby Zion Law

The implication of the Libby Zion law may not be relevant to Sweden as this law origin from the state of New York based on an incident on a medicinal misdiagnosis from an overwork resident as one of the contributing factors. While this may not be related to the fatigue caused by the alarms of a medical equipment, the impact of the fatigue is something to be pondered on cases with alarms mismanagement and that can be learnt upon [26][27].

18-year-old Libby Zion was admitted in New York Hospital when her health status was not showing any signs of improvement but prior to that earlier, she was prescribed some antibiotics as given by her family physician who told her mother to continue the prescription when her fever was not subsiding. She eventually became slightly better, only to have worsen later that night and was hospitalized after a call to her physician who advised her family to do so.

Her admission to the emergency department was close to midnight, and she was only to be admitted in a couple of hours later where she was examined by a medical intern and a medical resident, who both have worked long hours and have several patients under their care. When Libby’s condition worsens, the medical intern instructed physical restrains as she was severely agitated and gave her a shot of sedation, on addition to the opiate drugs administrated earlier. Eventually, the medical intern left to attend her other patients while her medical intern has gone out across the street to get a couple of hours of sleep, where he is to be notified only by a pager. As Libby was finally calmed, her fever spiked to an alarming level a couple of hours later after a nurse was checking her vital signs, where they tried to cool her down but eventually, Libby suffered a cardiac arrest and died after attempts to resuscitate her failed.

While Libby’s cause of death is unknown, her post mortem revealed that a possible cause was due to a several mix up of several medications which was administered along with antidepressants she was taking due on her depression. It was also noted that Libby was taking some other medications as well, with a recent addition of a painkiller for a dental procedure.

When Libby’s father found out that Libby was restrained and left unattended by the orders of the medical intern who was attending a number of patients besides Libby, with training residents being the only doctors who attended her (all whom clocked for more than 36 hours with little to no sleep) without any supervision from a senior doctor, he decided to take legal action against the hospital, which lead to what is known now as the Libby Zion Law [28], [29], [30].

While this regulation took time to come in force with all the investigation and trials of the case, this brought up a very important outlook on how a patient care is affected by healthcare personnel who is lacking a proper rest but are still working on a longer shifts just to cover in longer clinical hours. This regulation eventually made an impact in United States, where issues like proper patient care and the working hours of interns and residents are being under investigation, with several changes are observed from time to time. To note in Europe, resident doctors are required about 48 working hours per week with 20 minutes of break

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every 6 hours and they may choose to work more if they want to. The given rest times are mandatory, but it can also be rescheduled under certain circumstances [31].

Similarly, something can be observed here. One of the main causes on why patient care can fail comes from doctors who are tired, overworked residents and improper supervisions.

Adding that, and the medical equipment which can be an irritant with the sounds and the alarms which goes off from time to time, this adds to the unnecessary fatigue that the healthcare personnel have to face, especially on emergent cases although one can never rule out that it can happen anywhere and in the case of Libby Zion, in an emergency room where most patients are attended to only after a couple of hours of being admitted.

This case also points outs the importance on how the management can do to protect their healthcare employees, should similar cases arise. The start comparison can be seen with Libby’s incident to the one which happened in Linkoping, where the nurse was the only one who was charged with the malpractice suit while her superiors walked away free, although it is noted that that is not the only contributing factor. In the Libby’s incident, the residents, the supervising doctor and the emergency department doctor are all charged being responsible for her death, although the latter was eventually released from the charges as one of the doctors who contributed to her death [28].

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2.3 – The Role of Medical Product Agency

The Swedish Medical Product Agency (MPA) or Läkemedelsverket is a national agency which plays an important role on all medical related reporting and standards, namely from drugs, pharmaceutical products and also medical devices, both in manufacturing and distribution.

The agency is a government body housed under the umbrella of the Ministry of Health and Social Affairs, with the employees working there are mostly pharmacist and medical doctors.

MPA also ensures that both the users (patients and healthcare professionals) have the proper access to the safe and effective medicinal product and making sure that the users always gets the best of them where they enjoy the benefits more that the risk that always come along.

Besides overlooking medicinal products, MPA is also responsible on the medical technology, be it on implantable devices and medical equipment, while IVO overlook on the supervision on both the manufacturers which produces them as well as getting close within the products as well [32], [33]. However, MPA does not work alone on the supervisions: The National Board of Health and Welfare (SoS) is the responsible body on developing regulations based on the legislation and the collected information and as stated in SOSFS 2008:1, the regulation details on the usage of the medical devices in healthcare [34].

On the subject matter of medical equipment, MPA plays an important role on matters like accidents and near accidents related with the usage of medical devices as well as any vigilant occurrences that might happen during the use of the medical devices, which includes standalone devices, home care equipment and IVD, to name some. This is also stated in SOSFS 2008:1.

The reporting of the accidents can be done by both the users (which is not limited to home- bound and care facility patients, nurses, doctors) and the manufacturers of the medical devices, where the users are to report their incidents to the distributors of the manufacturers and to IVO. The manufacturers have to make sure their equipment’s which is marked with the CE as accordance to the standards according to where the devices category falls upon, are to report all serious incidents to the MPA.

According to the European Commission, the manufacturer has to oblige the necessary steps as stated in the MEDDEV 2.12/1 rev8, which is a guideline for medical vigilance system. The incident reporting should be submitted to MPA (which can be initial reporting, the follow up or the final report) along with the separate report called the Field Service Corrective Action.

Several things which can be highlighted from this guideline[35]:

• Section 3.1.2 (devices that are not intended to act directly on the individual) notes that the devices can still be considered to cause hurt on the users, even if it is used as it was intended to. For instance, diagnostic devices may harm indirectly when the result of an action is either taken or not taken on the grounds of an obtained incorrect result.

• Software of a device which is qualified as a medical device will also be listed as an indirect harm to the users

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• This section mentions in general that the term users meant the patients who are using the devices and also the medical personnel who manages the equipment, and both are obliged to report if the devices they are using, or handling goes faulty.

• The term indirect harm includes misdiagnosis, delayed diagnosis and treatment, absence of treatment, with some of the causes which lead to that includes false positive and false negative results, inadequate calibration and quality controls, to name a few.

• This also coincided with how the user error is defined, which describes this action as an act or an omission of an act which yields a different result that intended by the manufacturer of the medical device, or also by the person in charge who operators the device, which could include any of the medical personnel.

While the users have the key responsibilities on reporting incidents, it’s the manufacturer who plays the most important role on the incident reporting and the next course of action which will be taken as a pre-cautionary measure. Some notes include:

• All initial reports should be sent to the National Competent Authority, with a final report as a follow-up unless the initial report sent has the final report attached along with. The authority will also take in consideration of a pre-deposition report before reporting in a case, should there I be any doubt in of the reported event.

• Not all incident reports will be entitled to a corrective action

• Manufacturers have to oblige on the basic reporting as stated on section 5.1.1, where they have to comply 3 criteria in order for the report to be considered an incident:

o The occurrence of the event (not limited to device malfunction, degradation/destruction of the device, inaccuracy or mislabelling in instruction and promotional materials etc.

o When the device is suspected to be the main contributor cause of the incident (incident reporting here will be taken account from the evidence of the healthcare professional and any evidences of similar incidents which might have occurred)

o Events which leads or might have led to death or serious health deterioration to the patient, healthcare personnel or anyone who is handling the device.

• Section 5.1.3.6 highlights on the negligible likelihood of the incident reporting on situations where deaths or near death/serious deterioration of health. In cases where the incidents have the risk of death or any health deterioration is quantified to be low, the need of reporting the incident is not needed as the risk is documented as acceptable within a full risk assessment. Otherwise, if the incident has led to death or serious health deterioration, the reporting has to be performed along with the risk reassessment.

• Section 5.1.5 notes on 2 issues which can be actually used against the healthcare personnel: reporting of the use error and abnormal use of the devices

o The use error is defined as an act or omission of the act which yields to a

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o The reporting will not be necessary if death or serious health deterioration does not happen, however it will be handled by the manufacturer’s quality and risk management system, along with the documentation on choosing not to report.

o Abnormal use is defined by the act or the omission of the act by the users of the medical devices which results on a conduct which beyond the risk controls of the manufacturer. It is noted that manufacturers are not obliged to report this to the National Competent Authority, but it has to be handled by the healthcare facility within the schemes which is not covered by this section.

o However, the manufacturers are obliged to alert other healthcare facilities on abnormal use incident.

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3 Methodology

The basis of this thesis will be further explored in these 2 methods; by reviewing the literature studies which touches on the alarm fatigue and conducting interviews within the healthcare premises with the healthcare personnel’s and what measures that have been taken to manage the issues, as seen on how the steps are being done with a flowchart in figure 6.

Figure 4 – Flowchart of the methods

Conclusion Discussion Results (Analysis)

Interviews

Hospital Management Healthcare Professionals

Literature Reviews

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3.1 – Literature Reviews

The outcome from the literature reviews are presented in the previous chapter, where the studies and the approaches that are conducted from the reviewers served as the guideline of the thesis.

It also served as a guide on the questions of the interview that is to be conducted for the result outcome.

3.2 – Conducting Interviews Studies

The interview studies were taken on this method of approach. Here a qualitative approach will be taken in instead due to the nature that the interview will be more on the open ended approached instead on a survey-base kind of questions. As qualitative method touches on how the parties which being interviewed give their output on the subject matter, and it may vary differently as their point of views on their roles will differ from one individual to another [36].

Previous literature studies use the quantitative method, where most of the authors conducted their data collection using online questionnaires and surveys, where this can be hampered with surveys which is not complete or explanations which is not well elaborated [37]. Open ended surveys and questionnaires will be harder to interpret and tabulated as compared to interviews [38].

There will be two different target audience here which will be interviewed: the management of the hospital departments and the healthcare personnel, the latter will consist of doctor(s)/specialist(s) and nurse(s).

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3.2.1 – Interview for the hospital department management

As the management role reflects the whole hospital organisation, the interview will overlook on how the management has developed with the system that is adapted in the department, the approaches that is taken to make sure that the system is well functioning and how the well-being of the healthcare workers is managed and monitored from the effects of overworking and burnouts, with alarm fatigues as one of the causes.

The questions on this interview outlines on the role of the interviewee and the department they are attached to, as this gives the readers an idea on what their job scope is like and it is followed with how the departments works in general and whether it comes certain protocol which is practiced within the department.

The following questions covers on what the department does whenever a new system or equipment is introduced and what kind of preparation they do to the healthcare and the non- healthcare personnel. This gives an overview on how the department manages with the new system, and how they are preparing the personnel to familiarise with the system in general along with the know-hows if the system fails and how it is managed.

The follow up with that question is on how the management keeps up with the well-being of the personnel who works in the department. this is to find out on how the personnel’s fatigue is managed and whether the department is taking any initiatives to make sure that the personnel are working in conditions that is well managed, be it in personal or open interactions. A question on the management of the alarm fatigue is noted, where this checks on whether alarms have impacted the workflow of the personnel in the department as well as their personal well beings as well.

The following questions looks at the system that is used in the department: on how it is managed if the has any technical hiccups, whether the system that is used is the best employed to date etc. This is to check out on the management personnel who might have worked in different areas previously and for them to share on their opinions on whether any improvements can be achieved in order to make their current department work better.

Since this is done on a managerial level, the questions will be designed in a way that it will not breach any protocols which is limited to the hospital management and not to the public but will be more on a general context for the public to get a better overview and understanding.

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3.2.2 – Interview with the healthcare personnel

As compared to the management, the healthcare personnel’s have a closer approach on the hands on of the equipment and also the effects which will be inflicted towards them. For this group, the questions will be in a direct approach on how they manage and use the system, which is implicated to their job roles, on how the fatigue affected them in a personal and professional level and the coordination of the job flow should problems arises, to name a few.

The questions highlight on the department that they are attached and their roles there along with how their daily routine is and who do they report to: this is to give an overview on their daily job scope is like, as the healthcare personnel will vary from doctors, nurses etc and the scope of their roles might have similarities and differences.

The follow up of questions highlights on the kind of stresses they face in the workplace: this is to take note that critical care departments are an environment of urgency and time is a factor when attending patients on time. A question on alarm frequency is asked along with how the alarm fatigue is managed and how it affects their workflow as well: this gives a better understanding on whether the sounds of alarms affects them and what is being done if it does and also how they manage it. this is also a way of finding out whether the personnel have a way of managing it if the department does not have any alarm management systems. On top of that, they were asked on how the systems can be improved in a long term: this is to capture on how they personal views on how it can be managed and have their ideas shared to the management or to their superiors.

Comparing to the management, the interview within this group will be longer and also will be done with different healthcare professionals as the workload on them varies differently.

3.3 Ethics Consideration

Before the interviews were conducted, the participants were given an information letter and a consent form, both which can be seen in the Appendix. As an author, it was an obligation to explain a brief introduction of myself and the project, on how the study would benefit and the contents of the consent form so that they will know what they will be subjected to. The participants are also informed that the interviews and the data will be anonymized and that the study is voluntary, and they could deny it if they want to do so anytime.

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4 Results

4.1 - Hospital A

4.1.1 – Healthcare Personnel 1 (HP1)

HP1 is a physician who works as an ICU specialist in a hospital at the east cost of Sweden and has been working in this department for two years. The arrangement of the ICU unit in the hospital consist five beds and two post-operative beds, along with a team of two residents and one medical intern or student. Her daily routine in the department consists on the normal rounds and discussions with the physicians responsible for the admitted patients to the ICU.

Along with that, the team also goes on MIG missions in the different wards of the hospital and check on the vital details of the patients along with the responsible doctor in that ward and usually direct the patients to the ICU if the vital signs are bad.

When asked on who authorise the calls and leads the ICU department, HP1 says that on the daily basis she will be the lead physician in the department while a department director (Verksamhetschef) who are responsible for all the activities in the ICU. The departments also houses a physician (medicinskt ledningsansvarig -MLL), where his responsibilities is more on the quality of care of the patients. On the subject of reporting on any incurring problems, HP1 mentions that it is not don’t on a daily basis, but should anything arise, the MLL will be informed otherwise it will be the Verksamhetschef.

The interview proceeds on questions which tackles the technical aspects of the equipment’s used in the department, along with the fatigues which would have on the equipment and the effects on herself and her colleagues. As critical care units are an emergent department, it can be a very stressful environment. When asked on that subject on what kind of stress she is subjected to, it is mostly on patient-care related (failing vital functions, ethical care on care level priority on certain patients, end of life-care patients) although she mentioned on lacking of bed space as one of the issues.

Eventually, the subjected on alarms is touched. HP1 gives an overview of the alarms and its function:

• The origin of the alarms in the ICU department mostly comes from the equipment which is used there, which mostly are monitors, syringe pumps, dialysis equipment.

She mentions the alarms are mostly coming from the patient’s vital signs are going down and some from the electrodes or sensors, which comes off loose and blares off the notification. She adds that everyone who works in the department are equipped with pagers, which also sets off loud sounds on emergent cases such as trauma, cardiac arrest to name a few.

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depending on the conditions of the patients, in a way that the alarms does not sets off unnecessarily.

• The pager notifications, are seldom false and that is mostly cause by accidental button trigger.

We proceeded on the possible alarm fatigue issues. When asked on that matter, HP1 mentions that there is possible moments where they ignore a patient when a lot of alarms sets off on them but due to the nature that the ICU department is small, it is one of the risk that her team is willing to take as all of them who works there are trained enough to know which of the alarms are real and otherwise. She noted that the alarm fatigue is not a big problem, to her department at least.

On lieu to that, when asked whether any improvisations that can be added on the current system which is being practiced there, HP1 noted that the system that the department has been using has been good in default and should changes needs to be done in the future, it can be tailored easily with the current system they are using now.

Key insights obtained from the interview:

• Good communication contact with the superiors of the department

• Alarms are well managed, but noted that most of its origin comes from loose sensors of the patients and accidental pagers triggers from the personnel

• Alarm fatigue is managed well due to personnel trained on the distinguishing false and real alarms.

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HP2 is a healthcare personnel at a hospital located in the east coast of Sweden and she works as a senior medical resident. Being a resident, her role is not fixed to any department and she can be posted to the emergency department or any of the intensive care units depending on the medical consultant she is assigned to. At the time of the interview, HP2 is assigned in the cardiac intensive care unit (CICU).

HP2 works on a shift schedule, where she could be assigned to either a morning or a night shift. Her role as a medical resident mirrors the medical consultant in charge where she will be assisting them with the usual routines and assisting with the patient’s admission into the department. She reports to the consultant on the normal schedule and if assigned to the night shift, she leads the department with the on-call consultant.

When questioned on the what aggravates the stress levels, HP2 noted that being a CICU, it manifests with different kind of alarming sounds and she pointed out that alarm is not the only one which stresses her and her other collogues in the department: while most of the alarms originates from the monitoring devices plagues the department, sounds from the telephone calls and pager alerts on critical patient dropping vitals happens frequently as well.

HP2 noted that the alarms alerts usually comes in the form of ischemic or telemetry alarms when the patients strokes out, and alarms from the vital signal monitors and most of the alarms are functional actionable alarms, although she mentions that false alarms happens as well but not in a frequent manner which might danger the patients. In most cases, HP2 and her staffs attends to all the alarms notifications and documents all occurrences of the alarms, including the false alarms as well.

When the subject on how the alarm fatigue affects the working staffs, HP2 noted that the frequent alarm sounds in the department usually makes them nervous, agitation and sometimes angry as the department move in a fast pace due to the condition of cardiac patients which can be unpredictable. The multiple alarm sounds also leads to loss of concertation, as HP2 and her team has to attend towards it while examining other patients.

She noted that this often disrupts the work efficiency and also increase the possibility on making mistakes as everything has to be done fast in order to resolve the alarms.

Concluding the interview, HP2 noted that the improvisation that can be done in the department includes additional courses on all the medical devices, rather than a quick basic run-through of the devices to all the healthcare personnel in a way that the staffs could integrate with the devices better in their future rotations of different departments. HP2 also noted that the alarm sounds could have different harmonics for different matters, be it in both patient vitals and technical indicators as a way to maximize efficiency in fast pace

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• Works on different departments as part of rotation based on the assigned medical consultant. Notes that different departments have different way of handling things

• Alarms origins from the equipment connected to the patient while miscellaneous sounds from telephones and pagers

• False alarms does not happen frequently but are attended to as well

• Alarm fatigue is apparent in this department and notes on affecting the work flow

• Noted on better integration with other department on training of medical devices usage, along with different harmonisation of alarms

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4.2 - Hospital B

HP3 is a healthcare personnel in one of the leading hospitals in Stockholm and he works as one of the senior nurses in the post-operative care (POC) department. HP3 works together with MP1, who works as a nurse care manager (MP1’s interview follows in the next section) and also a supervisor to HP3.

HP3 role as a nurse covers the basis on what it is called advanced nursing: the role consist on stabilizing the vital of the patient after a major surgery, which is not limited to respiratory, circulatory and the kidney functions, along with the assessments of the patients pain level, acid/base, electrolytes and the fluid intake. HP3 also noted that checking and using medical devices which is used on monitoring and the treatment of the patients. HP3 reports to the OVC during the shift, which is MP1 and to the head nurse on the later working shift.

When questioned on what aggravates the stress levels, HP3 noted that the level of stress that they face mostly comes from the patients that arrives to the operating theater which has complications that cannot be evaluated initially and also on those who pre-operative assessment that is not done correctly. HP3 quickly noted that as much as it is part of their jobs to not put in such emotions that might affect them personally, it cannot be helped as it is part of being human. HP3 added that the medical devices also contributed to the stress levels in working environment, where they faced some malfunctioning equipment although it has been a very uncommon issue in the POC department. Along with that, newer medical equipment adds into that course as well; HP3 added the complexity of the new equipment can be stressing to use without having proper training on using those devices.

HP3 noted that alarm sounds in the POC department happens frequently, with most of it originating from the infusion pumps and those from the monitoring devices where the sound blares on monitoring vitals (low blood pressure, arrhythmia, low saturation etc). HP3 added that these devices have different alarm tunes depending on the severity of the situation.

Along with that, HP3 highlights that most of the alarms are real functional alarms but they added that false alarms do come as well although not frequent, mostly comes from the false readings of the patients’ saturation.

HP3 added that the faults of the false alarms are due on the limitation of the apparatus used.

HP3 shares a routine which is practiced in the department:

• The patient will be assed first when the alarms comes into action.

• If the patient is the cause of the alarm to be sounding, then the treatment will be

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• If the alarm sounds are originated on the device malfunction, it will be removed and mark as out of use and will be reported to the technical staff.

• If patients are at risk due to the faulty devices, a report will be made for further investigation.

The interview proceeds to the alarm fatigue and HP3 noted the alarm fatigue as annoying.

HP3 notes that with all the alarms that happens in the POC, they have to take it as serious as they would not know the severity of the alarms and adds that all of them working on the shift are responsible to responding on all the alarms properly. To avoid a mismanagement of the alarms, HP2 mention the routine has helped on keeping the alarms well managed in such a way that it became a system that is practiced among all the nurses in different shifts as well.

HP3 added an occasion when he started working in the POC department, where the alarms has overwhelmed the workflow due to the number of alarms in the department and had a hard time differentiating the alarms which needs the urgent care and the alarms which just needs an overlook on the settings and added that as a fast learner, he managed to highlight the urgent ones and the ones that are not. With that personal experience, HP3 noted that now he subconsciously registers the sounds of the alarms and respond to them automatically when the alarm is urgent as it is ‘locked’ in the mind and that the patient needs the urgent care. On the alarms which is not urgent, HP3 usually directs the assistant nurses to check the parameters but only does so when HP3 is busy on urgent matters. All that and the systemized routine, which is practiced in the department, HP3 confides that the care of the patients in the department will not be affected as well as it has reduced them to the effects of the alarm fatigue.

Concluding the interview, HP3 added that improvisations can be done by using a universal standard for all the alarms on the medical devices, as different alarms tones takes time to learn and to be understood. HP3 gave an example that the alarm sounds of a low battery on a device sounds more severe than the one of the patients on distress. HP3 also noted that the technical education of the device use could be done in the e-learning format along with a practical training on the medical devices, noting that the latter would be important for the nurses and the staff to get a better understanding of the devices and its usage to its full potential.

Key insights obtained of the interview:

• Cause of stress from equipment alarms is not a major issue but still seen as one

• Complexity of using newer equipment takes time to understand without proper training

• Both false and functional alarms are attended with same level of severity, and is well managed with a routine practices among other colleagues

• Personnel learnt a personalised way to track alarms that needs urgent care

• Alarm on malfunctioning devices has more distressing sound than from one of the patients vitals.

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4.2.2 – Management Personnel 1 (MP1)

MP1 works as nurse care manager (Omvårdnadschef – OVC) in the post-operative care (POC) unit at a major hospital in Stockholm, and has been in that job role for 9 years. Prior to that, he was working as one of the lead nurses in the ICU department of the same hospital. In the duration he was being interviewed, most of the content he provided will be based on his time with his current department, and some small part from his previous department.

The interview began with general description of the department and how the workflow is being performed here. MP1 states that the POC unit houses about 82 working staffs and their main role is to take care of the patients who just comes out form the operation theatre. The unit houses about 70 patients per day and admits patients from all ages and conditions.

Patients who comes in to the POC usually leaves to their respective wards after three hours but in some cases, some patients will be in this recovery wing to a maximum of 48 hours. MP1 points out that POC unit is as emergent as all the critical care units in the hospital. When asked on the comparison of POC and ICU, MP1 states that ICU only takes in patients which needs the most severe care and the occupancy is small, with only nine beds and the patients usually stay for longer periods as opposed to POC.

When asked on how the process of the patients being admitted to this department, MP1 explained in detail:

• The POC unit also includes a pre-operative care unit (PrOC). Before the surgery begins, the patient will be prepped in the PrOC where an anaesthesiologist and anaesthesia nurse will begin to prepare the necessities before wheeling in the patient to the operation theatre. This unit only holds a maximum of 9 patients and most of it will not be fully used as the hospital does not take in a lot of patients at one time for surgeries.

• After the operation is completed, the patient will be wheeled in to the POC unit. There is two different areas: one which only keeps in the patients for a maximum of three hours ( smaller area with the children and adults separated) while another holds in patients for a maximum of 48 hours. This particular area is larger (holds about maximum of 18 patients)

• Most of the patients usually undergo their surgeries in the mornings, so usually the morning shift team will manage the patients from the PrOC and back to POC after their operations. A team usually consist of nurses and nurse care assistants.

• The unit will be only be packed with nurses and nurse care assistants on the afternoon and evening shifts as that is the time where most patients will be out from their surgeries. On those shifts, there will be six nurses and four nurse care assistant each shifts. There number will be lesser on the night shift as the patients who are staying in will be only around 7-10 patients.

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• MP1 clarifies that his job scope only handles the nurses, not the doctors. The nurses and nurse-care assistants will report directly to him.

• When a new system or equipment is being introduced in his department, MP1 will request the companies to give the training to the nurses and the nurse-care assistants.

He will choose on what kind of training package is necessary, usually as advised by the representatives if the company, as a whole complete package will be expensive hence he picks on the ones which is crucial and beneficial for his department.

• The trainings is done in a way that it does not disturb the working hours of the nurses.

For example, MP1 mentioned on one of the new equipment which his department purchased recently and the company provided a series of training for the duration of 3 weeks, 3 hour per day in the morning for 3 days in a week. The nurses will then resume to their normal routine after the training is done.

• MP1 also noted that not all the staff will be able to attend the training due to valid reasons (holidays, maternity leave etc) so in each of the training, he picks a few lead nurses ( the ones with longer working experiences) to get extra trainings from the companies or manufacturers, where they will learn everything including the technical aspects as well. These lead nurses are called super-users and thy will be in charge to train the nurses who misses the direct training sessions from the companies. Doctors will not be trained as a super-user as they main priority will be only at the patient care.

• Since super-users are well versed on all the equipment, they will be the first in-line personnel to be called should any major issues arises on the equipment. They will be one working in each shift and will only take over if the lead shift nurses are on the dead end when comes to managing the issues of the equipment.

.

In the midst of the interview, MP1 clarified some things on the new organization levels in Hospital A. While he manages the nurses in his department, he reports to another lead nurse manager who reports in to a senior doctor who works with the hospitals top line of the managements. The senior doctors also over seas the same hierarchy of doctors; in MP1’s words, the doctors will not be the boss for the nurses and vice versa but both groups are managed by the senior doctor. MP1 mentions that if he makes any authority calls, it will only be for his department. The chart below gives a rough idea of the organisation of the department.

Figure 5: The organisation chart at the POC department

Head Management

(Doctor FOC)

Head Chief Nurse

OVC 1 OVC 2 OVC 3 OVC 4

Head Chief Doctor

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The interview proceeded on how the department manages on the staff’s well-beings and the system which is being used to managed on the working hours of the staffs.

• MP1 takes an interesting approach on handling his well-being of his nurses: he approaches his staffs on a regular basis rather than keeping track on them via e-mail.

He mentions that he prefers to do this as this is one way he gets to know his staffs better in a personal manner and he has practiced this method since the time he started to work in this department.

• The nurse job schedule is mostly monitored by one of the non-medical staff. the nurses will usually choose they working shifts of their choice but they will have to comply with the maximum amount of hours which is fixed. Should they go more hours, the system will alert the nurses that they are not allowed to go beyond the hours.

• MP1 has the power to bypass the system to make the changes but he only does that on cases where the nurses are to take emergency leave, in which he will change their working hours with another nurse in waiting so they can replace them.

• When asked whether the nurses have deliberately worked more than the time they are supposed to, MP1 mentioned that they had such cases but it happened very seldom and that was not in a recent years of him working in the current department.

He did mentioned, that it happened quite frequently during his time working in ICU due to shortage of staffs.

• However, if a nurse wants to work on extra hours they have 2 compensating options:

extra day of leave or extra pay. MP1 usually asks this option on the nurses as he does not have the right to deny the nurse if they want to work extra hours. MP1 makes it smart; he talks to the nurses who has not clocked on longer hours instead.

Eventually, the interview proceeded on the subject on how the equipment are being managed in the department.

• Most of the equipment last about 5-10 years and its usually the companies contacts them and notifies about a product update or a new equipment. MP1 usually will discuss with his superior before taking on the next course of action.

• On equipment’s which repeated plagued with issues, the superuser will inform the matter to MP1, in which he will contact the companies directly. The companies has a 3-time policy where they will be sending the technicians to the hospital to resolve the

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When asked on the alarms fatigues in the POC department, MP1 states on how the department is managed.

• MP1 trained his nurses and nurse-care assistants to both hear and see the alarms when it is being set off. The department floor arrangement is unique: each patients spaces are actually open amongst each and are only barricaded with a foldable shutter walls if the patient wants some privacy.

Figure 6: The open space area of a patient bay. Note the foldable shutter walls tucked at the corner

• The central desk where all the nurses usually sits also plays as an area where they can actually see what alarm is being set off on each of the patients around there. The distance from the central desk is not far from all the patients, hence the nurses would still need to attend the alarms by going to the patients and check if the alarms are real or false.

• The volume of the alarms are set low for two reasons: for the patients to recuperate mainly as some of them are sensitive to the noises due on the medication from the operations and that he wants to keep the working environment as quiet as possible for his staffs to not be affected with the loud sounds.

• He highlighted two rooms in the POC where the alarm sound are the loudest: these isolation rooms only houses patients who needs to be barricaded on bacterial and viral infections. The room has its own thick sliding door along and toilet, along with a monitor outside of the room where the nurses can monitor the vitals without the need to going to the room frequently. The reason given on why the alarm are the loudest in that rooms is mainly that MP1 prioritises the patient safety more than the patient comfort and that he will not take any risk of losing the patient.

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Figure 7: The isolation room (green walls with bay area A7 as noted)

• Due to the low level of the alarm sounds , the staffs are not affected at all.

• MP1 recalls on his own alarm fatigue when he was working in the ICU, where he could not reduce the alarms on his own and that the small number of patients would mean he has to be there in their bedside almost all the time, hence he could not walk always from the alarms as he wish as majority of the time the alarms are false.

• The only way MP1 did to reduce the fatigue then was nothing: he took it as part of the job working in an emergent area and issues as such was not talked openly with his bosses. This is one of the reason on he taking a personal approach with his staffs in his current department when comes to talking about issues which affects them.

• MP1 also mentioned that in his first year working in POC, he still prioritised his patient care first, only to realised it later that the setup has evidently affected his staffs. With that, he took the approach of reducing the alarm volumes, along with adding sound absorbing materials in the desk and the walls to reduce the annoying echoes.

The interview concluded on the following questions I asked on how the overall system can be further improved. MP1 gave his following personal insights:

• When asked whether the current measures which is practiced in his department are the best, he mentioned that he sees what he has been practicing has no issues and is good, based on his observations.

• He added that he does not know how up to date it is as he has not keep himself updated with the latest research and does not know on how far the development has

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his working staffs if a centralised unit where everything, namely the patients vitals and alarms which is being set off will be pushed to the nurses cell phones as a measure of saving time as much as possible instead of only relying by visual and hearing as what they are currently practicing. When asked whether the idea was something he read off on articles or just an idea which he was thinking, MP1 says that he has been thinking about this idea for several years and has no idea that such system is available in the market.

MP1 added that with such system, the nurses efficiency will be much improved. MP1 highlights a common scenario: when the nurses are in the medicine room, they have to key in the vitals before releasing the medicine from a secure cabinet. By having a centralised system, the nurse would not have to rush out from the medicine room and attend the patient based on the urgency that it could not have been. MP1 pointed out that this is one issue where he hoped to eliminate as every minute counts and that he wants what is efficient now with the current measure to be even efficient, should the technology be implemented in his department. MP1 added as well that this could also work the best in the 2 isolation rooms where the patient comfort can be prioritised. MP1 added that despite all that, they would still want the nurses close to the patients instead of hiding behind the table and checking the vitals from the monitor.

MP1 noted that should they want any new technologies, such like the one suggested above, they would need to make a request to a department in Stockholm which decides on what new technologies and equipment the hospital should and will get. MP1 noted that to make an application to get such access is time consuming and that he does not have the resources to request it as well. MP1 concluded that it is also difficult to get an agreement from that body on suggestion that could actually make an improvement in a longer run.

Figure 8: The floorplan of the department of POC.

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• New equipment trainings is conducted without interrupting the time of the nurses

• Senior nurses aka superusers will attend all the training and will train nurses who could not attend the initial training.

• Training packages are selected based on the importance, as part of managing within the allocated funds

• Well-being of the healthcare personnel is well managed via a personal approach and the working hours is registered and monitored via a computerised system

• Good communication contact between the superior and with all the personnel in the department

• Alarm management system is well approached with a structured system practiced in the department for a duration of time

• Well managed alarm auditory volume as part of managing the well-being of the nurses on the department floor

Alarms in hospitals: The fatigue problems and the improvisations in sociotechnical perspective.

Alarms in hospitals: The fatigue problems and the improvisations in sociotechnical perspective.

SUTHESH KUMAR BALBIR SINGH

Alarms in hospitals: The fatigue problems and the improvisations in sociotechnical perspective.

Larm på sjukhus: Trötthetsproblem och improvisationer i sociotekniska perspektiv.

SUTHESH KUMAR BALBIR SINGH

Abstract

Sammanfattning

Acknowledgements

Table of Contents

Abbreviations

1 Introduction

2 Background

3 Methodology

4 Results