Permanent Harm Research Articles

Malpractice litigation, quality improvement, and the University Hospitals Obstetric Quality Network

Objective A healthcare organization’s medical malpractice data can help identify patient safety risks and drive improvement. In most organizations, obstetric malpractice losses are assumed to be part of the risk of delivering obstetric care. We describe a systematic approach to mitigating risks for obstetric patients and their newborns while simultaneously improving patient outcomes and reducing obstetric litigation costs at University Hospitals, a northeast Ohio-based health system of 18 hospitals, including seven hospitals providing obstetric services and delivering approximately 8000 women per year. Methods From multiple data sources, including malpractice claims data, the team identified four key drivers of risk on the obstetric service: hypoxic ischemic encephalopathy, obstetric hemorrhage, hypertensive disorders of pregnancy, and shoulder dystocia. Collectively, these contributed to multiple adverse maternal and neonatal outcomes and accounted for 71% of obstetric litigation costs from 2009 to 2015. In response, the team built a regional obstetric quality network and implemented interventions to mitigate the four major risk areas. Results We achieved a substantial reduction in serious safety events from 2010 to 2018, defined as any event where the standard of care was not met and the level of harm to mother or baby was one (death) or two (severe permanent or temporary harm). We also achieved a reduction in obstetric litigation costs between 2009–2012 and 2015–2018. Discussion This multifaceted intervention was associated with decreased patient harm and reduced obstetric litigation costs. Application of this approach to other hospitals could result in improvements in obstetric patient safety and reduced obstetric litigation costs.

The Relationship Between Populism and Democracy: Cases From Latin America

Latin Amerika, popülizm çalışan araştırmacılar açısından önemli bir araştırma alanı olarak ortayaçıkıyor. Dünyanın bu bölgesinde, popülizmin farklı türlerine rasgelmek mümkün. Üstelik LatinAmerika’da, tarih boyunca, popülist liderlerin siyasal gücü ele geçirmeyi başardıkları söylenebilir.Elinizdeki çalışma, popülizm ve demokrasi arasındaki çatışmalı ilişkiyi incelemek niyetindedir.Bunu yaparken popülizm bir siyasal tarz olarak ve liderin merkezi rolüne referansla tanımlanacaktır.Bu doğrultuda, Arjantin’de Peron dönemi klasik popülizmi, Peru’da Fujimori’nin sağ popülizmi venihayetinde Venezüella’da Chavez’in sol popülizminin analizinin göstereceği üzere demokrasi vepopülizm ilişkisi farklı popülizmlerin varlığına rağmen büyük ölçüde aynı kalmıştır. Bu doğrultudadenilebilir ki popülizm, demokrasinin içerici kapasitesini artırmış, buna karşın, anayasal denetimmekanizmalarına, demokratik kurumlara ve genel anlamda liberal demokrasiye zarar vermiştir.

Airway management in the critically ill patient - How can we improve?

Introduction The NAP4 demonstrated adverse airway outcomes are associated with poor airway assessment and poor planning. 25% of major airway events occur in the Intensive Care Unit (ICU) or emergency department (ED), and the outcome of these events are more likely to lead to permanent harm or death compared with the operating theatre. This study set out to review documentation of intubations in ICU patients, including the pre-procedure planning taking place to identify areas for improvement. Methods Single institution retrospective review of documentation of endotracheal intubations performed by ICU staff (on either ICU or a ward/ED) over a six week period in an English district general teaching hospital. Criteria assessed were: use of a pre-intubation checklist, documentation of name and grade of intubator, airway assessment, time of intubation, drugs and doses given, number of attempts at intubation, use of cricoid pressure, laryngoscopy grade, ETT size + length at teeth, type of laryngoscope used, monitoring used (including etCO2), ventilator settings and any complications. Results In the 6 week study period, there were 15 intubation episodes identified and reviewed (12 on ICU, 3 in ED). See attached table for full results. Discussion The lowest performing domain was airway assessment (0%). The explanation for this is likely in part due to the acutely unwell nature of ICU patients making airway assessment more challenging than in an elective setting. Another particularly low scoring domain was the use of a pre-procedure checklist (33%). Considering the NAP findings associating adverse airway events with poor airway assessment and planning, these are concerning findings, and unlikely to be isolated to this hospital. We suggested education to promote the routine use of a pre-intubation checklist that incorporates an airway assessment and procedural plan.

Understanding the Nature, Contributing Factors, and Corrective Actions of Medication Administration Errors: Insights from Saudi Arabia

Abstract Background: Medication errors continue to be a global patient safety concern as they are associated with a negative impact on morbidity and mortality and health-care costs. Research in Middle Eastern countries has been limited and focused on reporting on the incidence, type, and contributing factors with limited knowledge on the preventability and severity of medication errors and the corrective action taken from the reported medication errors. Materials and Methods: A retrospective, descriptive study design was used with selected clinical units in one hospital in the Middle East to gain insight into the incidence, type, location, level of severity, and causes of medication administration errors (MAEs) and the corrective actions taken. Data collected between February 17, 2014 and August 30, 2015, in the organization's reporting system were analyzed using descriptive statistics. Results: The most frequent types of MAEs reported were delayed administration (23%) and wrong dose (15%), occurring in the clinical units (65%), ambulatory settings (18%), the pediatric children cancer center (11%), and the surgery division (3%). The majority of MAEs were rated as no harm (184 errors, 69%) followed by temporary harm (80 errors, 30%), with two incidents with pediatric patients resulting in permanent functional harm and one incident with a pediatric patient resulting in death. The majority of factors contributing to the MAEs involved staff factors including failure to follow policies and procedures (86%) followed by inadequate communication (17%). The most common corrective action was no action (30%) followed by counseling the staff involved in the MAE (29%), sharing at a unit or departmental meeting (25%), and training and educating the staff (15%) as a result of the error. Conclusion: Our study results delineated the nature, contributing factors, and corrective actions taken associated with reported MAEs. Future research is required to examine and explore the nature of MAEs, contributing factors, corrective actions taken, and exploration and examination of the impact of efforts to enhance MAE reporting and learning systems in hospitals.

Duration of second victim symptoms in the aftermath of a patient safety incident and association with the level of patient harm: a cross-sectional study in the Netherlands

ObjectivesTo describe healthcare providers’ symptoms evoked by patient safety incidents (PSIs), the duration of these symptoms and the association with the degree of patient harm caused by the incident.DesignCross-sectional survey.Setting32...

MON-503 Difficult Decisions in Endocrinology: Unexpected Pregnancy during Diagnosis of TIO

Introduction Fibroblast Growth Factor 23 (FGF23) is a hormone which controls phosphate homeostasis by increasing renal excretion of phosphate and preventing hydroxylation of 25-OH vitamin D. Tumor Induced Osteomalacia (TIO) is a rare condition in which there is exogenous production of FGF23 from tumor cells which leads to hypophosphatemia, progressive muscle weakness and bone fractures. In our case, we present a young pregnant female who presents an ethical dilemma in TIO workup. Case Presentation A 29-year-old Hispanic female with history of anemia, Chiari I Malformation was referred to Endocrine clinic for workup of fractures in the setting of low vitamin D. She initially presented to an outside hospital after fall and was noted to have “bruised bones.” She came to our ED multiple times for hip and back pain. Imaging showed stress fracture of the femur and lytic lesions in the hips. Bone biopsies were negative. Labs showed decreased alkaline phosphatase, 25-OH vitamin D and phosphate. DEXA scan showed decreased bone density and skeletal survey with diffuse bone loss and osteomalacia. Secondary causes of metabolic bone disease were ruled out. Of note FGF23 was markedly elevated, but octreotide scan to did not reveal a tumor reflective of TIO. While workup was being done, patient was treated with aggressive phosphate, magnesium, and calcitriol repletion. DOTATATE PET was planned for localization of TIO, but patient became pregnant. After further discussion, she agreed to halt further evaluation until delivery. Discussion Radiation and medications are often harmful to the growing fetus. For this reason, diagnostic procedures are often delayed until after the baby is deliver to prevent unnecessary harm to the fetus. In our case, we argue that a potentially diagnostic DOTA-TOC PET/CT scan is crucial for our patient. Overexpression of FGF23 can be either a genetic disorder or an oncogenic disorder called TIO. Treatment for these conditions is different. If a focus for the TIO could be localized, it could be excised, whereas a genetic disorder could be treated with Burosomab. Given the rapid progression of our patient’s disease, progressing from asymptomatic to disabled in less than a year, we were forced to ask ourselves if we could wait for delivery for diagnosis and treatment. On one hand, radiation from the scan will almost guarantee harm or death of the fetus. On the other hand, delay in treatment may lead to irreversible and permanent harm to the mother and possible indirect harm or death of the fetus. There are no guidelines for addressing TIO in pregnancy. We were unable to find any cases of FGF23 elevations during pregnancy. Informed Decision must be made between the patient and the medical team to ensure that the best decision is made for both the mother and the fetus.

Applying the Global Trigger Tool in German Hospitals: A Pilot in Surgery and Neurosurgery.

ObjectiveThe aim of the study was to assess the feasibility and potential of the Global Trigger Tool (GTT) for identifying adverse events (AEs) in different specialties in German hospitals.MethodsA total of 120 patient records were randomly selected from two surgical and one neurosurgery departments of three university hospitals in Germany for a period of 2 months per department between January and July 2017. The records were reviewed using an adaptation of the German version of the Institute for Healthcare Improvement GTT.ResultsThirty-nine records (32.5%) contained at least one AE. A total of 53 AEs were found in these 39 records. The incidences of AEs were 18.9% and 35.9% in the two surgical departments and 45.3% in neurosurgery. This corresponded to AE rates of 25.5 to 72.1 per 1000 patient-days and from 25.0 to 60.0 per 100 admissions across the three departments. A total of 71.7% of all identified AEs resulted in temporary harm (category E), 26.4% in temporary harm, requiring prolonged hospitalization (category F), and 1.9% in permanent patient harm. We also identified practical challenges, such as the necessary adaptation of the GTT relative to the respective department.ConclusionsThe application of the GTT is feasible and represents an effective instrument for quality measurement when adapted to the departmental specifics. The trigger detection with the GTT is a valuable addition for proactive analyses of high-risk processes.

To destroy a people: Sexual violence as a form of genocide in the conflicts of Bosnia, Rwanda, and Chile

Abstract Throughout history, attacks on women have been common during armed conflict. Frequently military forces have viewed sexual violence as a spoil of war, a punishment to defeated populations, or as the deviance of rogue soldiers. However, conflicts in which sexual violence has been weaponized have been increasing. When a military force's command utilizes systematic and widespread sexual violence as a weapon of war against a specific group, in both intent and effect, it fulfills every condition of the Geneva Convention standards of genocide. In this article, we analyze three cases: Bosnia during the break-up of the former Yugoslavia, Rwanda during its genocide, and Chile under the Pinochet dictatorship. Motivations for each of the conflicts varied, from ethnic cleansing to the elimination of a competing political group, however, the constant in all three was the intended elimination of a specific group and a state sanctioned implementation of a policy of sexual violence in order to do so. Egregious acts of sexual violence were deliberately planned to murder, to incur permanent mental and physical harm, to demoralize and destroy the group's ability to procreate in the future, and to impose measures upon the group to bring about its end. Based on these examples, we argue that, irrespective of the cause of a conflict, systematic and widespread sexual violence used as a weapon of war must be classified as genocide. Our intention is not to expand the definition of genocide, but rather to more clearly specify the definition in light of advancements in the understanding of the impacts of sexual violence on societies.

Medication Errors: Is it the Hidden Part of the Submerged Iceberg in Our Health-care System?

Medication error (ME) is an adverse preventable event which happens due to the inappropriate use of medication that leads to patient harm. Such events may be related to professional practice, health-care products, procedures, and systems including prescribing, communication, product labeling, packaging, and nomenclature, compounding, dispensing, distribution, administration, education, monitoring, and use. A major ME is the one, which results in either permanent harm or transfer to the intensive care units or death. When an error is identified, it shall be reported immediately. It must also be nonpunitive so that staff does not have to be afraid of repercussions. An error shall be reported to the concerned consultant immediately. Continuous monitoring and frequent assessments shall be done for the patient. A root cause analysis shall be done for all serious MEs.

Implementation and strength of root cause analysis recommendations following serious adverse events involving paediatric patients in the Queensland public health system between 2012 and 2014.

This study evaluates the implementation rate and strength of the recommendations developed in all root cause analyses (RCAs) performed following serious clinical incidents involving children that have resulted in permanent harm or death in Queensland public hospitals over a 3-year period. Severity assessment classification 1 events were identified from a Queensland Paediatric Quality Council database of paediatric clinical incidents that occurred in Queensland between 1 January 2012 and 31 December 2014. There were 150 recommendations extracted from RCAs pertaining to the 42 serious adverse events involving paediatric patients. Of the recommendations, 82% were implemented; 33% of recommendations were classified as stronger, 33% as intermediate and 34% weaker in terms of their potential to improve patient safety. This study describes the implementation of recommendations and classifies them in terms of potential to prevent patient harm and save lives. Future research is needed to determine if the RCA process does indeed prevent harm.

Mitigating risk of preventable medical errors across a network through event sharing.

234 Background: Medical errors are the 4th leading cause of death in the US. Oncology providers are not immune to preventable medical errors occurring in the treatment of their patients. As a national network of five hospitals that specialize in the treatment of patients fighting complex or advanced-stage cancer, clinicians and quality professionals recognized an opportunity to encourage and formalize the process of sharing safety events, lessons learned, and action plans to mitigate the risk of repeat occurrence. Methods: An Alert Notification process was established consisting of an algorithm depicting two avenues for action when an event occurs. If the event is considered urgent, characterized by immediate high-risk of repeat occurrence or high-risk of severe harm, an alert is called. The hospital nursing officers and quality directors along with the corporate director of pharmacy and vice president of quality/safety convene within 24 hours of the event to: 1) resolve or “halt” the process; 2) escalate if needed; and 3) formulate a communication plan regarding any change in process. If the event does not meet urgent criteria, the hospital conducts a root cause analysis (RCA) or common cause analysis, depending upon the algorithm. A summary of RCAs conducted for events resulting in temporary or permanent severe harm or worse are presented at the network’s monthly safety meeting, with action plans implemented across sites. Results: The notification algorithm was implemented in September 2017. Since its inception, three events have been communicated using the Urgent Alert Notification, including a syringe recall that halted use at all sites until all lot numbers could be checked, and affected syringes pulled. Several events and near misses have been communicated using the non-urgent process, including for example, discussion of a retained foreign object which resulted in review of processes for orienting staff to new products. Conclusions: The process has promoted communication across the five centers as an error prevention strategy. The sharing allows all sites to cross-fertilize resolutions to minimize rework, reduce the risk of repeat events, and build collective knowledge ensuring patient safety is our first commitment.

Rate of complications due to carotid angioplasty in a tertiary university hospital

Introduction: Stenoses greater than 50% in the cervical internal carotid artery cause up to 8% of all ischemic strokes. Carotid artery stenting (CAS) is an effective alternative to prevent cerebrovascular events to occur. According to recommendations from the American Heart Association/American Stroke Association, CAS is indicated for symptomatic patients with internal carotid stenosis greater than 70% (measured by non-invasive methods), as long as the risk for periprocedural stroke or death is less than 6%. There is few information about complication rates of CAS in developing countries. Objectives: The primary goal of this study was to evaluate the frequency of any stroke or death until hospital discharge after CAS in symptomatic patients with carotid stenosis in a tertiary university hospital. Other complication rates were also assessed as secondary aims. Methods: A single-center retrospective study based on the analysis of charts from patients submitted to CAS between April 2011 and March 2016. Inclusion criteria were: age ≥ 18 years old, admission and follow-up by neurologists from the Neurology Ward, performance of CAS according to the hospital´s protocol (carotid stenosis ≥70%, patients with transient ischemic attack (TIA), amaurosis fugax or minor stroke in the last 180 days, and life expectancy greater than a year). Patients not followed by neurologists after CAS were excluded. Results: A total of 65 patients were included: 3 (4.6%) suffered stroke or death after CAS. Two of these patients presented ischemic strokes and one, an hemorrhagic stroke that lead to death. Myocardial infarctions were not identified, as well as carotid ruptures or dissections, hyperperfusion syndrome, artery perforations, stent thrombosis or encephalopathy. Minor complication rates were: 12.3% for hypotension, 9.2% for bradycardia, 1.5% for TIA, 3.1% for carotid vasospasm and 6.2% for acute kidney injury. The total rate of minor complications was 23.1%, and none of then led to permanent harm. Conclusions: The rate of stroke or death in a reference tertiary service in a developing country was in line with international recommendations.

Aggregate analysis of sentinel events as a strategic tool in safety management can contribute to the improvement of healthcare safety.

To examine if clustering of root causes of sentinel events (SEs) can contribute to organisational improvement of healthcare and patient safety by providing insight into organisational risk factors, patterns and trends. Retrospective, cross-sectional review of SEs from a hospital database reported to the Board of directors in 2016. A regional teaching hospital in the Netherlands. Clustering of characteristics and variables of SEs to establish vulnerabilities and patterns of failure factors of the organisation. Characteristics and contributory causes of failure of SEs identified via root cause analysis (RCA). Outcomes reported using descriptive statistics. A total of 21 events were included involving 21 patients. Mean age was 56.7 years (SD 24.4), 71.4% were above 50 years of age. In 81.8%, the care was multi-disciplinary and in 76.2% the event resulted in permanent harm or injury. Of the 132 identified contributory root causes, most were related to human factors (53.8%) and organisational factors (40.2%). Technical and patient-related factors were identified in 3.0%. Organisational improvement strategies focused on the care of elderly patients, patients subjected to multi-disciplinary care and on improving knowledge, protocols and coordination of care. Clustering variables of SEs and contributory factors of failure through RCA helps to delineate a hospital-specific profile by providing a detailed insight into risk factors, patterns and trends in an organisation and to determine the best strategies for improvement by drawing lessons across events.

Incident Reporting to Improve Patient Safety: The Effects of Process Variance on Pediatric Patient Safety in the Emergency Department.

Medical errors threaten patient safety, especially in the pediatric emergency department (ED) where overcrowding, multiple handoffs, and workflow interruptions are common. Errors related to process variance involve situations that are not consistent with standard ED operations or routine patient care. We performed a planned subanalysis of the Pediatric Emergency Care Applied Research Network incident reporting data classified as process variance events. Confidential deidentified incident reports (IRs) were collected and classified by 2 independent investigators. Events categorized as process variance were then subtyped for severity and contributing factors. Data were analyzed using descriptive statistics. The study intention was to describe and measure reported medical errors related to process variance in 17 EDs in the Pediatric Emergency Care Applied Research Network from 2007 to 2008. Between July 2007 and June 2008, 2906 eligible reports were reviewed. Process variance events were identified in 15.4% (447/2906). The majority were related to patient flow (35.4%), handoff communication (17.2%), and patient identification errors (15.9%). Most staff involved included nurses (47.9%) and physicians (28%); trainees were infrequently reported. The majority of events did not result in harm (65.7%); 17.9% (80/447) of cases were classified as unsafe conditions but did not reach the patient. Temporary harm requiring further treatment or hospitalization was reported in 5.6% (25/447). No events resulted in permanent harm, near death, or death. Contributing factors included human factors (92.1%), in particular handoff communication, interpersonal skills, and compliance with established procedures, and system-level errors (18.1%), including unclear or unavailable policies and inadequate staffing levels. Although process variance events accounted for approximately 1 in 6 reported safety events, very few led to patient harm. Because human and system-level factors contributed to most of these events, our data provide an insight into potential areas for further investigation and improvements to mitigate errors in the ED setting.

Diagnostic errors in paediatric cardiac intensive care.

Paediatric cardiac ICU practitioners including attending and trainee physicians, nurse practitioners, physician assistants, and registered nurses at three North American tertiary cardiac centres were surveyed between October 2014 and January 2015. The response rate was 46% (N=200). Most respondents (81%) perceived that diagnostic errors harm patients more than five times per year. More than half (65%) reported that errors permanently harm patients, and up to 18% perceived that diagnostic errors contributed to death or severe permanent harm more than five times per year. Medication side effects and psychiatric conditions were thought to be most commonly misdiagnosed. Physician groups also ranked pulmonary overcirculation and viral illness to be commonly misdiagnosed as bacterial illness. Inadequate care coordination, data assessment, and high clinician workload were cited as contributory factors. Delayed diagnostic studies and interventions related to the severity of the patient's condition were thought to be the most commonly reported process breakdowns. All surveyed groups ranked improving teamwork and feedback pathways as strategies to explore for preventing future diagnostic errors. Paediatric cardiac intensive care practitioners perceive that diagnostic errors causing permanent harm are common and associated more with systematic and process breakdowns than with cognitive limitations.

Learning From Incident Reporting? Analysis of Incidents Resulting in Patient Injuries in a Web-Based System in Swedish Health Care.

Incident reporting (IR) systems have the potential to improve patient safety if they enable learning from the reported risks and incidents. The aim of this study was to investigate incidents registered in an IR system in a Swedish county council. The study was conducted in the County Council of Östergötland, Sweden. Data were retrieved from the IR system, which included 4755 incidents occurring in somatic care that resulted in patient injuries from 2004 to 2012. One hundred correctly classified patient injuries were randomly sampled from 3 injury severity levels: injuries leading to deaths, permanent harm, and temporary harm. Three aspects were analyzed: handling of the incident, causes of the incident, and actions taken to prevent its recurrence. Of the 300 injuries, 79% were handled in the departments where they occurred. The department head decided what actions should be taken to prevent recurrence in response to 95% of the injuries. A total of 448 causes were identified for the injuries; problems associated with procedures, routines, and guidelines were most common. Decisions taken for 80% of the injuries could be classified using the IR system documentation and root cause analysis. The most commonly pursued type of action was change of work routine or guideline. The handling, causes, and actions taken to prevent recurrence were similar for injuries of different severity levels. Various forms of feedback (information, education, and dialogue) were an integral aspect of the IR system. However, this feedback was primarily intradepartmental and did not yield much organizational learning.

The prevalence of medication-related adverse events in inpatients-a systematic review and meta-analysis.

Adverse drug events (ADEs) have been internationally recognized as a major threat to patient safety. The purpose of this study was to conduct a meta-analysis focusing on inpatient ADEs in the Western World to provide better estimate of the current state of medication safety in these countries. The studies for meta-analysis were identified through electronic search in Cochrane, Scopus, Medline, and Web of science databases. Included articles focused on adult inpatient ADEs, had commonly accepted definition for ADE, and were conducted between 2000 and 2016. Disease or ADE-specific studies were excluded. Meta-analysis was conducted on the prevalence of inpatient ADEs and fatal adverse drug reactions (FADRs). The pooled estimate of the prevalence of inpatient ADEs was formed by 46,626 patient records included in 9 articles. Inpatient ADE prevalence was 19 and 32.3% of these ADEs were assessed preventable (MD 28.6%, SD 22.6%). Three articles including 3385 patients focused on inpatient FADRs, but the pooled estimate of this was disregarded due to low number and high heterogeneity of the included studies. ADEs are estimated to affect 19% of inpatients during hospitalization. Most of the ADEs are moderate in severity causing no permanent harm to the patient. Only a small amount of ADEs cause inpatient deaths, but in this meta-analysis, however, we were unable to give direct estimate of the prevalence.

Safety Events in High Risk Prehospital Neonatal Calls

Objective: The objective of this study was to quantify and characterize patient safety events during high-risk neonatal transports in the prehospital setting. Method: We conducted a retrospective chart review of all “lights and sirens” ambulance transports of neonates ≤30 days old over a four-year period in a metropolitan area. Each case was independently reviewed for potential patient safety events that may have occurred in clinical assessment and decision making, resuscitation, airway management, fluid or medication administration, procedures performed, and/or equipment used. Results: Twenty-six patients ≤30 days old were transported by ambulance using lights and sirens during the four-year study period. Overall, safety events occurred in 19 patients and severe safety events (potentially causing permanent injury or harm, including death) occurred in ten. The incidence of safety events related to medication administrations was 90% (70% severe), resuscitation 64.7% (47.1% severe), procedures 64.7% (35.3% severe), fluid administration 50% (25% severe), clinical assessment and decision making 50% (30.8% severe), airway management 47.6% (28.6% severe), equipment use 25.5% (10.0% severe), and systems processes 19.2% (7.7% severe). Conclusions: High-risk neonatal calls are infrequent and prone to a high incidence of serious patient safety events.

Trading Safety for Innovation and Access: An Empirical Evaluation of the FDA's Premarket Approval Process

Congress created the Premarket Approval (PMA) process to provide a rigorous safety evaluation of high-risk medical devices before they may be sold on the U.S. market. Evaluating a PMA application requires the FDA to conduct a lengthy, complex, and costly assessment of the extensive data a manufacturer must submit. But other policy concerns, notably a fear of hampering innovation and a desire to assure timely access to new technologies, have led Congress to relax some of the rigorous data requirements the PMA process imposes on manufacturers. Congress mandates that the FDA employ the “least burdensome” approach to regulation that allows a reasonable assurance of safety. The FDA has interpreted this as permitting it, among other things, to approve high-risk devices based on small, short-duration clinical trials the designs of which fall short of the most rigorous scientific standards. Congress also created “PMA Supplement” pathways that allow manufacturers to modify their PMA-approved devices with only limited supporting data. And Congress included several provisions in the recently-enacted 21st Century Cures Act that further tip the balance away from ensuring device safety. Scholars writing in the medical literature have raised concerns that the standards for PMA approval have become too relaxed, potentially compromising device safety. But most empirical studies have focused on the less rigorous 510(k) pathway, which is designed for low- and medium-risk devices. These studies provide limited evidence about how frequently PMA-approved devices fail. And no empirical work has examined whether these failures are related to the statutes and regulations through which Congress and the FDA have attempted to balance safety against innovation and access. This Article begins such an examination, presenting the results of a new empirical study of PMA-approved devices. The study finds that at least 4.6-6% of PMA-approved devices will fail in such a way as to threaten death or serious and permanent harm. Complex cardiovascular devices and devices that have been frequently and rapidly modified through certain PMA supplements are most likely to fail. Based on the concerns that have been raised and on the findings of this study, this Article suggests that Congress and the FDA should take steps to readjust the balance between safety on one hand and innovation and access on the other. The FDA should insist on scientifically rigorous, longer-duration clinical trials before approving PMA applications. Further, the FDA should limit the number of significant modifications that manufacturers of certain devices are permitted to make to a device through PMA supplements before a thorough safety assessment is required, and should limit how soon after one significant modification is approved that a second modification will be considered. Finally, Congress should amend the 21st Century Cures Act to avoid further tipping the balance between safety, innovation, and access away from the FDA’s primary mission of ensuring medical device safety.

Psychiatric Leadership and Collaboration Toward a Culture of Safety

Back to table of contents Previous article Professional NewsFull AccessPsychiatric Leadership and Collaboration Toward a Culture of SafetyYad M. Jabbarpour,M.D., , Julia S. Finken,R.N., B.S.N., M.B.A.Yad M. Jabbarpour,Search for more papers by this authorM.D., , Julia S. Finken,Search for more papers by this authorR.N., B.S.N., M.B.A.Published Online:28 Apr 2017https://doi.org/10.1176/appi.pn.2017.4b4The Joint Commission recently released a Sentinel Event Alert on the essential role of leadership in developing a safety culture. The field of psychiatry should take note—for a few reasons.We practice in a litigious environment. We must be mindful that sometimes bad things happen—bad things that sometimes can be attributed to the culture in which the event occurs rather than to the clinicians involved. As clinicians, psychiatrists are essential leaders in instilling a culture of safety in health care. We are positioned to transform care through a collaborative approach that will catalyze and strengthen cultural change, collaborating with colleagues in health care as well as policymakers, family members, and patients. What is a safety culture? The Joint Commission defines it is as “the product of individual and group beliefs, values, attitudes, perceptions, competencies, and patterns of behavior that determine an organization’s commitment to quality and patient safety.”Contributing factors to poor safety culture include insufficient support for reporting patient safety events, intimidation of staff who report events, and refusal to consistently prioritize and implement safety recommendations, according to the Joint Commission Center for Transforming Healthcare. In contrast, a strong culture of safety supports clinicians who in turn support the individuals we serve. Clinicians, leaders, and policymakers in our field all have a duty to support a culture of safety and to remove the barriers that block change toward achieving it. Much of psychiatric practice focuses not only on the support of an individual’s recovery but also on keen and dedicated attention to safety. Safety manifests itself in the practice of our ethical principles, including primum non nocere (first do no harm); as well as beneficence, justice, and autonomy. Psychiatrists are experts in suicide risk assessment and risk management; violence risk assessment and management associated with mental illness is also a core psychiatric competency. Given our principles, we should be experts in safety culture as well. As psychiatrists, we also are not strangers to sentinel events—those patient safety events that can occur and result in death, permanent harm, or severe temporary harm that require intervention to sustain life, but are not related to the natural course of a patient’s illness or underlying condition. In psychiatric settings, they can include self-inflicted injuries, elopements, falls, and restraint-related events, as well as delays in treatment, medication errors, and even criminal events. In our nation, suicide is the second most frequently reported sentinel event to The Joint Commission. Psychiatric hospitals are the second most frequent location for reported sentinel events; hospital psychiatric units, third; and behavioral health care sites, sixth.An analysis of sentinel-event data compiled by The Joint Commission demonstrates that leadership’s failure to create an effective safety culture is a contributing factor to many types of these adverse events. This even further creates an urgency for leadership to set the vision and path toward a strong safety culture.The time is right and critical to establish and improve safety culture for our country. In a move toward a more integrated system and with psychiatric collaborative leadership and clinical expertise, psychiatrists are positioned not only to be a part of this transformation, but also to be at the forefront in establishing, improving, and maintaining a culture of safety. ■The Sentinel Event Alert describes 11 tenets for health care leaders to address safety culture. Also available is a downloadable infographic.Yad M. Jabbarpour, M.D., is chief medical officer of Catawba Hospital in Catawba, Va. Julia S. Finken, R.N., BS.N., M.B.A., is executive director of behavioral health care accreditation at The Joint Commission. ISSUES NewArchived