Accidents related to medical devices are common and impact not only the patient, but also relatives and health care providers. It reduces able workforce and is hence costly for the society at large. Hazards most commonly derive from failure in design, organization and operational system at the Intensive Care Unit (ICU), rather than device failure (1). The large human toll together with the high financial toll puts the medical errors in the top rank of urgent, widespread public problems.
There are 4 hospital beds per 10 000 persons in Bangladesh (2). Further, Bangladesh has a population of 161,083,804 (July 2012), of which 14.251 million live in Dhaka. 31.5 % live on less than 1 US dollar a day (3).
Health care in Low-Income Countries
The subject of patient safety is establishing itself in the research domain. Numerous studies on different aspects of patient safety have been performed in high-income countries but few have been carried out in low-income countries like Bangladesh. In order to address the existing problems the current situation must be documented.
Out of 15 548 patient records reviewed in a group of low-income countries (in Africa and the Middle East), 8.2% showed at least one adverse event1. Of the adverse events, 83% were judged to be preventable
(4). Most of the adverse events were due to medication errors (5).
In low-income countries, health care providers are required to work under increasing workload and with limited resources. In Bangladesh, the admission fee between the public and private hospitals often differs at least tenfold. This is reflected in the facilities of the two categories of hospitals. The large poor population is treated at the public hospitals while a small fraction of citizens can afford private hospital care.
Working Environment at ICUs
Communication between personnel at the ICU is an important factor for improving patient safety (6). Communicating problems such as stress and asking questions about the handling of machines or other health care related issues will have a positive impact on the ICU. In order to prevent adverse events, it is important that not only the physicians but also the nurses and patient’s family are given information about the treatment of the patient (7).
To simplify the work at the ICUs, it is recommended that the patients’ beds are clearly labeled and that it is easy to identify the patients. It is also important to have continuous education for the personnel, enough disposable products, different types of support personnel such as assistants or specialists and developing a reporting system for device malfunction and human errors (6).
Causes of Adverse Events Related to Medical Devices
Often there are mutual root causes to different problems associated with medical devices. Common adverse events are related to medication, unsafe blood, patient care, surgery, anesthesia and obstetric trauma (1). Rather than negligence or poor performance, adverse events are caused by factors such as high workload, inadequate supervision, poor communication, rapid change within organization and deficiencies in system design and operation (1) (8) (9) (10). Health care institutions often respond defensively or secretively, which causes further harm and impairs improvement of the system (1).
Infection risk at ICUs
Since health care-associated infections, or nosocomial infections2, are preventable, this kind of infection control is essential (11). Pittet states that the percentage of patients that acquire nosocomial infections can exceed 25% in low-income countries whereas the corresponding percentage in high-income countries is 5-10%. The rise of such infections in the former is ascribed to shortage of resources and basic facilities, malnutrition, comorbidities, immunosuppression and poor personal hygiene. Nosocomial infections in high-income countries often derive from sophisticated and invasive health care techniques as well as multi-resistant pathogens (11). Maintaining hand hygiene is the most effective method of infection control. The simple measure helps prevent health care-associated infections and the spread of antimicrobial resistance. Still, insufficient maintenance of hand hygiene is a global problem. Other important factors include education for health care workers, an ordered surveillance system of nosocomial infections, relevant legislation as well as consistent implementation of basic infection control measures (11).
Complexity of ICUs
ICUs are reliant on the well-functioning of equipment and are interdependent on different types of personnel. Use of life supporting medical equipment increases the risk of accidents. Thousands of individuals die annually because of insufficient organization of information and control systems (12). This can be improved using Information and Communication Technology (ICT) (12).
Patient safety is increased if the ICU is run by intensivists, physicians with specific education in intensive care. Multidisciplinary teams will increase patient safety and quality of care and will better prepare the ICU in attending patients suffering from different types of medical conditions. The communication within such teams is important. Good communication between the ICU personnel and the administration is also important and can be accomplished through regular meetings (6).
The three factors related to the working environment that are closest correlated to adverse events are the quantity of personnel, exhaustion among the personnel and depersonalization (13). In a study in USA, it was found that a nurse-to-patient ratio change from 1:4 to 1:6 increased patient mortality rate by 14 %. The ratio is strongly correlated with emotional exhaustion among nurses (14).
The World Health Report from 2006 (15) states that Bangladesh, together with 57 other countries in the world, has a critical shortage of physicians, nurses and midwives. WHO considers 2.28 doctors, nurses and midwives per 1000 population to be the limit value. In Bangladesh the figure is 0.56 (15). Further, Bangladesh is one of few countries that have fewer nurses than physicians. Today there are approximately three physicians per one nurse (16).
Nurses are securer in their work in the presence of a nurse staff leader (13). The administrative group at the hospital should take into consideration the nurses’ perspective when addressing patient safety. Of all categories of health care personnel, the nurses spend most time with the patients. Including nurses in workshops and other meetings is important in order to learn about the shortcomings in their working environment and involve them in the safety work (17). In order to decrease the work load for nurses, lift teams are suggested. A lift team consists of persons that perform tasks without need of medical skills, such as moving patients and cleaning patient areas (6).
Materials and Method
Field Study at Six Government and Private Hospitals
The study was conducted through field visits where interviews were conducted during two months (June to July 2012) in Dhaka, Bangladesh. The field study aimed to
a) identify problems and accidents due to medical device errors at the ICU,
b) understand the nature and severity of errors and their root causes from a systems perspective,
c) review the current reporting systems of medical device errors and adverse events and
d) evaluate the data obtained from 6 different ICUs covering government and private hospitals in Bangladesh.
The field study was conducted at three government hospitals (BSMMU3, DMCH4, NICVD5) and three private hospitals (BIRDEM6, SQUARE, LAB AID). The study collected information to identify
a) equipment failure,
b) failure to see results of the test,
c) errors in the performance of equipment operation,
d) error in the administrating treatment and
e) delay in treatment due to equipment disorder, malfunction, system failure, inadequate monitoring or follow-up treatment.
In addition, information on the influence of leadership, risk awareness and workplace condition was collected.
Data was collected through interviews with personnel of professions working at or closely to the ICU. This was done at six hospitals. Due to the time frame, only one person per profession and hospital was interviewed. A dictaphone was used to record the interviews and different questionnaires were used for each category of staff. The questions were constructed based on studied literature on patient safety at hospitals in general and ICUs in particular. Open ended questions were used in order to attain as much information as possible. The questionnaires can be found in Appendix I. Physicians and nurses were asked mainly about the use of medical devices at the ICU and education and training on medical devices. The ICU chiefs were asked about procurement and general information about the ICU. Technicians/engineers were primarily asked about installation, management, use, performance and service and repair of medical devices. The questionnaire was divided into four categories: Contact with the Equipment, Procurement, Maintenance of the Equipment and Staff. The interviews with the chiefs of the ICUs, physicians and technicians/engineers were held in English. The interviews with the nurses were held in Bangla. An observation chart was used to document factors such as noise level and cleanliness. See Appendix II for chart.
The visited hospitals are referred to as G1-G3 and P1-P3 for the three government and private hospitals respectively. In order to keep the respondents anonymous and because the study compares government and private hospitals, not specific hospitals, the matching of the actual names of the hospitals with these references will not be disclosed. The numbering is in no particular order.
3 Bangabandhu Sheikh Mujibur Medical University
4 Dhaka Medical College and Hospital
6 Bangladesh Institute of Research and Rehabilitation for Diabetes
A total of 21 interviews were performed. See Table 1 for information on which categories of staff were interviewed at each of the hospitals. One person from each group was interviewed. There were no biomedical engineers at the government hospitals.
The recorded interviews were transcribed. The Bangla interviews were translated before transcription. Information from the transcriptions was compiled in a table. Data analysis resulted in recommendations on methods of increasing the efficiency of medical devices and how to support the collaboration and information exchange, which will be presented through this thesis. These are important for decisions regarding acquisition, inspection, maintenance, reparation and regulations of equipment, as well as the quality of care and patient safety.
Table of contents :
2 Aims and Objectives
3.1 Health care in Low-Income Countries
3.2 Working Environment at ICUs
3.3 Causes of Adverse Events Related to Medical Devices
3.4 Infection risk at ICUs
3.5 Complexity of ICUs
3.6 Human Resources
4 Materials and Method
4.1 Field Study at Six Government and Private Hospitals
4.2 Data collection
4.4 Data Analysis
5.3 Adverse Events
5.4 Reporting System
5.4.1 Reporting System for Failure of Machines
5.4.2 Report System for Human Error
5.5 Working Environment
5.6 Risk Awareness
6.1 Sources of Error in Study
6.2 Biomedical Engineering Department
6.3 Infection Control
6.4 Human Resources
6.5 Organizational Improvements
6.7 Medical Devices
6.8 Further Investigations
Appendix I – Questionnaires
Appendix II – Observation Chart