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Patient Safety in Respiratory Therapy: Importance of Human Factors Assessment and Involvement of the Respiratory Therapist in Medical Device Risk Identification, Analysis, and Learning
Respiratory Therapy Student, Dalhousie University, Halifax, NS
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Respiratory therapists play an important role in ensuring quality and safe patient care. The primary objective of patient safety is to minimize events which cause harm to our patients as a result of care. Adverse events remain a pressing issue within the healthcare system, and as such, healthcare organizations seek methods to minimize their occurrence by development of a comprehensive approach to quality and patient safety. These comprehensive programs are designed to assure both prospective risk avoidance and retrospective learning and process improvement. These programs are increasingly being improved upon by the integration of methods commonly used in other industries, such as human factors and human factors engineering. It is important that respiratory therapists familiarize themselves with the measures within their organization to assure safe patient care delivery and take an active role in risk identification and avoidance.
Patient safety is a fundamental concern for all healthcare providers, yet despite all efforts, adverse events are far too common within the healthcare system. Adverse events are most commonly described as unintended injuries or complications that are caused by healthcare management, as opposed to the patient’s underlying disease process [1-4]. Nearly one in ten hospitalized patients will experience an adverse event; approximately seven percent of these events result in the death of the patient . Adverse events are not solely a concern of acute care providers, they also occur within the scope of ambulatory and continuing care . It is important to note that on average, more than forty percent of adverse events are considered preventable . The need for quality patient care demands that healthcare organizations develop strategies to minimize adverse events in a manner that is both comprehensive and effective.
Quality is difficult to define because there are at least seven dimensions. These include: acceptability, appropriateness, accessibility, efficiency, effectiveness, equity, and safety . “In practice, quality is easier to define by its opposite...” (Wrae Hill, September 30, 2012)
A comprehensive approach to quality, patient safety, and overall risk management includes prospective (preventative) elements and retrospective elements such as: reporting, investigation, and organizational learning from adverse events.
Quality and patient safety management utilizes quality control (QC) measures in an effort to control unwanted variation of a process, such as limiting the variation on a standard blood gas values. In this context, doing QC is very important to assure accuracy so that clinicians can have confidence in the data. Quality assurance (QA) is defined as “a program for the systematic monitoring and evaluation of the various aspects of a project, service, or facility to ensure that standards of quality are being met” . QA is a generic term which describes efforts to restrain variation in a process; through development of a policy, a procedure, and then auditing that process. A simple example of QA would be to observe how closely respiratory therapy students actually perform an Allen’s test prior to a radial artery cannulation, thereby providing clinician supervisors assurance that the correct process is uniformly followed.
While QC and QA are important components of a prospective Quality Program, these two older methods are increasingly used as fundamental building blocks. More sophisticated process improvement methods such as Lean methodology, which focuses on elimination of steps and processes which do not add value for the patient  and Human Factors or Human Factors Engineering are now becoming more common. As such, a comprehensive approach to quality and patient safety will include prospective quality assurance of procedures designed both to assure and enhance quality of care, as well as an overall risk management system designed to enable reporting, investigation, and organizational learning from adverse events. Increasingly, both prospective and retrospective elements are supported by human factors and system safety approaches and a just and trusting culture of patient safety .
Human Factors is defined as “designing for human use, a body of information about human abilities, limitations, and other human characteristics that are relevant to design” , whereas Human Factors Engineering is defined as, “The application of human factors information to the design of tools, machines, tasks, jobs and environments for safe, comfortable and effective use” .
In order to provide optimum patient care, it is essential that respiratory therapists familiarize themselves with the processes in place to ensure safe care delivery and what to do if incidents arise; however, we must make efforts to become more resilient. “We are not custodians of already safe systems, the systems we work in are inherently flawed, complex, and we must manage many opposing goals including safety” . It is of equal importance for respiratory therapists to keep a discussion of risk alive even when everything seems safe; anticipating and identifying hazards within their environment and pre-checking all equipment they utilize is key.
LITERATURE REVIEW METHODS
A review of literature relevant to quality assurance in healthcare was conducted through the databases PubMed, CINAHL, and Embase. MeSH terms included “quality assurance,” “health care,” “risk,” “risk management,” and “safety management.” Limits placed on the search query included “humans,” “English,” links to full text, and literature published within the last 10 years. Hazard reports and alerts were reviewed through the Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) and Emergency Care Research Institute (ECRI) event reporting systems.
EXPERT CONSULTATION METHODS
Subsequent discussion with experts in patient and system safety in other provinces was conducted, as well as additional review of Accreditation Canada - Quality Dimensions and Human Factors approaches to Patient Safety.
Quality improvement and patient safety measures can provide healthcare workers with means to reduce the number of adverse events experienced by patients in our care. The Clinical Engineering Department within the hospital has a significant role to play in ensuring the safety of patients in our care. Clinical engineering staff follow stringent procedures relating to the preventative maintenance and other QC measures of hospital equipment. Increasingly, healthcare teams, including clinical engineering departments are becoming familiar with Human Factors and usability analysis for both (prospective) pre-purchase evaluation and for (retrospective) systems safety investigations of adverse events [12, 13].
Within clinical engineering, from a QC/QA perspective, new devices are assigned a control number. This control number is entered into a work order system which tracks all maintenance, tests, and repairs of the device. Scheduled maintenance occurs for medical devices such as mechanical ventilators according to manufacturer specifications. These scheduled maintenance events include items such as cleaning, sensor calibrations, battery and filter changes, and performance verification tests which utilize automated software. All work order events are tracked through the work order system by the Biomedical Department Manager. The department also contains clinical engineers who monitor Emergency Care Research Institute (ECRI) alerts and forward them to biomedical staff to address. These alerts are logged into the work order system and recorded within the history record for each device (Brian Thibeau, March 14, 2012). The actions taken by the Clinical Engineering Department are the first line of defense to ensure safe operation of medical equipment within the hospital.
Safe operation of medical equipment also depends on the efforts of frontline care providers, such as respiratory therapists. It is essential that equipment be consistently inspected prior to use. There have been several documented cases of patient injury or death resulting from failure to inspect devices prior to use. One such case report involves a patient who received an electrochemical burn from a disposable pulse oximeter sensor. In this particular incident, the insulation over the LED portion of the sensor had been torn, allowing uninsulated electrical connections to come in contact with the patient’s skin. This resulted in a burn at the site caused by “low-voltage, direct-current tissue electrolysis” . Visual inspection of these sensors prior to each application is often overlooked; however, it is necessary to prevent patient injury.
Misconnection of luer lock connections also pose a significant risk to patient safety that respiratory therapists need to be aware of. Several of the items used by respiratory therapists employ this type of connector. Luer fittings are comprised of male and female components, which when threaded together form a secure connection known as a luer lock. These connections are found on a large number of medical devices, ranging from intravascular to respiratory care equipment . Due to the widespread use of these connectors, equipment that should never be connected is compatible. In one such report investigated by the ECRI, a patient death occurred as a result of a connection made between his central intravenous line and his tracheostomy tube cuff inflation port. Initiation of the patient’s intravenous infusion pump resulted in tracheostomy tube occlusion as the cuff filled with fluid . Another report describes a patient death from a massive air embolism sustained when a non-invasive blood pressure (NIBP) monitoring line was inadvertently connected to a needless luer port on the patient’s intravenous catheter. The patient had an intravenous catheter in place due to a pending computed tomography scan, as well as the automatic NIBP cuff. The cuff had been disconnected in order for the patient to go to the bathroom, and upon his return, the tubing was mistakenly reconnected to the luer on the intravenous catheter [17,18]. Examples of other adverse events involving the misconnection of luer connectors include: an enteral feeding set connected to a central venous catheter, an enteral feeding set to a hemodialysis line, and oxygen tubing to a needless intravenous port . Simple QA measures such as educating staff regarding this risk, labelling lines, and tracing all lines from the source prior to connection are methods healthcare workers can use to assist in managing the risks associated with these types of connectors [15,16,19].
Respiratory therapists also have an essential role to play in QA by means of preventing adverse events related to hospital-acquired infections. Infections transmitted within hospitals remain a significant factor in patient morbidity and mortality . Environmental transmission of these infections can occur through a variety of equipment utilized by respiratory therapists. In fact, norovirus has been isolated from both non-invasive ventilators and pulse oximeters, even after clinical cleaning . Acinetobacter, which is responsible for diseases such as pneumonia and serious blood infections , has been found on respiratory equipment such as ventilator surfaces, suction equipment, and stethoscopes . This bacteria can cause death in hospitalized patients, with ventilated patients being at significant risk . Respiratory therapists can minimize the risk of such infections by paying rigorous attention to infection control procedures, such as hand washing and equipment disinfection. Items such as pulse oximeters and stethoscopes can easily transmit infections between patients and are often overlooked by healthcare providers. Ensuring consistent disinfection after each use is an important step for respiratory therapists to take in an effort to reduce the occurrence of hospital acquired infections.
It is not only patients that are at risk of adverse events occurring in the healthcare environment. Staff injury can also occur without proper education regarding the hazards associated with equipment and materials in use. For example, alcohol-based hand sanitizers pose a fire risk which can be amplified in environments in which oxygen is in use . A neonatal intensive care nurse experienced burns to her hand when a fire occurred due to failure to allow her hands to completely dry after using a sanitizer. The nurse’s hand was still wet when she walked across the floor and reached to change a setting on an air/oxygen blender. The combination of a static shock, the alcohol-based sanitizer, and oxygenenriched environment resulted in the fire .
MEDICAL DEVICE FAILURE
Medical equipment is often designed to prevent adverse events; however, device damage can render these measures ineffective. For example, medical gas flowmeters and outlets have unique gas-specific connectors in order to prevent delivery of incorrect medical gas to a patient. There have been several documented cases of patient injury and death resulting from damaged flowmeters being forced into inappropriate outlets. For example, two patients undergoing cardiac catheterization died as a result of asphyxiation when an oxygen flowmeter was inadvertently connected to a nitrous oxide wall outlet. The flowmeter had damage to its PIN index safety system, allowing the misconnection to occur [24,25]. Visual inspection of equipment prior to use is a simple QA measure which will assist respiratory therapists to prevent such adverse events from occurring.
An example of medical device failure in the clinical setting involves facilities using the PB 840 mechanical ventilator (Puritan Bennett, 6135 Gunbarrel Avenue, Boulder, CO 80301 USA). User facilities reported failures of the ventilator at their sites . Investigation resulted in determining that cellular phone operation within close range of the ventilator resulted in the device going into Vent-Inop mode, in which the device ceases ventilation and the safety valve opens to ambient air . The ECRI issued a hazard report and the manufacturer took swift corrective action for the potentially life-threatening hazard by improving the shielding of the breath delivery unit and upgrading software to filter the self-check function responsible for the defect .
A single report of an incident involving the VIP Infant Ventilator (Viasys Healthcare Inc., Suite 200, 227 Washington Street, Conshohocken, PA 19428 USA) caused the manufacturer to pledge to modify the device in order to prevent similar incidents. A neonate received a bilateral pneumothorax and possible neurological damage when a clinician inadvertently connected the inspiratory limb of the breathing circuit to the exhaust port on the ventilator while operating in a time-cycled pressure-limited mode. Although the error was quickly corrected, this resulted in pressure greater than 800 cmH2O being delivered to the neonate’s lungs. After report of this adverse event, the manufacturer informed ECRI that modifications would be made to the exhaust port to make misconnection impossible, and thus prevent such errors in the future .
MEDICAL DEVICE USABILITY
It is imperative to note that patient safety issues (such as those described above) resulting from medical device or equipment failure are exceedingly rare, and usually corrected quickly. Far more common, are poorly designed medical devices with inherent error traps which invite human error. “Adverse events can and do occur even with very experienced clinicians if the devices they utilize are not easy to use” .
“Training is the last bastion of poor design” 
An issue of growing importance is human factors, and seeking first to understand “what made sense at the time” when investigating adverse events . For instance, a system safety analysis in British Columbia (2010) using human factors usability analysis demonstrated that infusion pump programming errors initially attributed to nurses were found to be design faults , and that the infusion pump had seven severe usability violations. This triggered a wholesale change toward more intuitive and user friendly infusion pump technology for an entire health authority in Canada . As reported in this Journal in 2006,  the legislated, designed in protections against medical gas misconnections such as diameter index safety systems (DISS) and pin index systems (PIN) end at the wall outlet. The similar Thorpe tube design of both medical air and oxygen flowmeters with a common threading for oxygen tubing easily facilitated misconnections for years. A reported death in 2005 triggered a large-scale change in a large regional health authority toward the use of medical [air] valves as opposed to Thorpe tube [air] flowmeters (see figure 1). This approach also used a human factors forced function and did not rely solely on education, policies, and procedure, which (by themselves) are very weak measures to improve safety .
The Canadian Patient Safety Institute’s Root Cause Analysis Framework (2006) describe the human factors hierarchy of effectiveness, where forcing functions are most effective and education and training is less effective  (see figure 2).
FIGURE 2. Human Factors Hierarchy of Effectiveness 
Hierarchy of Effectiveness
REPORTING AND USING ADVERSE EVENTS TRENDS TO IMPROVE SYSTEM SAFETY
In order to facilitate investigation and effect change, it is essential to report any incidents that compromise safe healthcare delivery. Even near-miss events warrant reporting . These are described as mishaps that have the potential to cause harm but are prevented from doing so due to chance or interception . Although there may be variances between facilities, virtually all healthcare organizations provide systems with which to report incidents. These may be either paper-based or electronic forms which contain pertinent information such as the time and location of occurrence, as well as a description of the incident or near-miss . Healthcare workers should familiarize themselves with the adverse event reporting system (AES) available to them.
Reporting systems within healthcare facilities are an integral component to patient safety efforts as they provide organizations with a means to learn from experience [4,33]. Incidents experienced within an organization should be analysed for trends in their AES and can then be shared by means of an external reporting system, such as the Global Patient Safety Alerts (CPSI Canada), ECRI or Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) databases. External reporting enables other facilities to become aware of an issue or hazard, which serves to prevent and identify similar adverse events at a system-wide level. “Although each event is unique, there are likely to be similarities and patterns in sources of risk which may otherwise go unnoticed if incidents are not reported and analyzed” .
Consultation with a Risk Management and Patient Safety Consultant with the Capital District Health Authority (CDHA) in Halifax, Nova Scotia, revealed that events originally recorded into the district’s Patient Safety Reporting System had resulted in three international recalls and/or advisories of medical devices. In one of these cases, the CDHA was the only facility to report the issue internationally, resulting in a recall, redesign, and an improved quality inspection process of the product (Beth Kiley, July 18, 2012). This reinforces the concept that a small piece of information, when properly reported, can effect big changes which improve the safety of our patients.
Despite the importance of event reporting, many adverse events are not reported through hospital or organization reporting systems. In fact, a study revealed that only 3.6% of adverse events found in retrospective hospital record review were found in one or more of four available reporting systems . Literature suggests that there are several barriers to event reporting by healthcare workers, such as time constraints, peer disapproval, and lack of perceived benefit [3,33]. It is important that healthcare professionals realize the impact of adverse event reporting in order to encourage the utilization of such systems when incidents or near-misses arise.
Respiratory therapists can play an integral role in patient safety by educating themselves to hazards which may impede safe patient care delivery, correcting these where possible, and promoting measures to prevent incidents such as consistent inspection and disinfection of respiratory equipment, and cautious bedside care. Through talking with patient safety experts locally and in other jurisdictions, staff can remain informed of hazards and assist in adverse event prevention. Respiratory therapists should familiarize themselves with local procedures in place to maintain safe patient care delivery, including the QC measures of biomedical engineers and the importance of risk management by means of event reporting. A comprehensive approach to quality and patient safety which includes both prospective components such as QC/ QA procedures as well as retrospective components serves to ensure safe patient care by outlining processes to prevent deficiencies, identify problems, and initiate corrective action.
The author would like to gratefully acknowledge the contribution and expertise provided by Wrae Hill, Director of Patient and System Safety for Interior Health, in Kelowna, British Columbia. As well, sincere thanks for clinical engineering information provided by Brian Thibeau, Biomedical Professional at the Halifax Infirmary Site, QEII Health Sciences Center, in Halifax, Nova Scotia and to Beth Kiley, Risk Management and Patient Safety Consultant with the Capital District Health Authority (CDHA) in Halifax, Nova Scotia, for information provided on local adverse event reporting.
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