The geography of patient safety: A topical analysis of sterility

Many studies on patient safety are geared towards prevention of adverse events by eliminating causes of error. In this article, I argue that patient safety research needs to widen its analytical scope and include causes of strength as well. This change of focus enables me to ask other questions, like why don't things go wrong more often? Or, what is the significance of time and space for patient safety? The focal point of this article is on the spatial dimension of patient safety. To gain insight into the ‘geography’ of patient safety and perform a topical analysis, I will focus on one specific kind of space (sterile space), one specific medical procedure (insertion of an intravenous line) and one specific medical ward (neonatology). Based on ethnographic data from research in the Netherlands, I demonstrate how spatial arrangements produce sterility and how sterility work produces spatial orders at the same time. Detailed analysis shows how a sterile line insertion involves the convergence of spatially distributed resources, relocations of the field of activity, an assemblage of an infrastructure of attention, a specific compositional order of materials, and the scaling down of one's degree of mobility. Sterility, I will argue, turns out to be a product of spatial orderings. Simultaneously, sterility work generates particular spatial orders, like open and restricted areas, by producing buffers and boundaries. However, the spatial order of sterility intersects with the spatial order of other lines of activity. Insight into the normative structure of these co-existing spatial orders turns out to be crucial for patient safety. By analyzing processes of spatial fine-tuning in everyday practice, it becomes possible to identify spatial competences and circumstances that enable staff members to provide safe health care. As such, a topical analysis offers an alternative perspective of patient safety, one that takes into account its spatial dimension.     

Health interventions and the persistence of rumour: The circulation of sterility stories in African public health campaigns

Public health programmes have done enormous good in Africa and elsewhere in the global south, but have also been met with skepticism. This skepticism often takes the form of rumours about the motives or the results of the public health intervention. One recurrent theme in such rumours is the centrality of reproductive bodies (both male and female), and the perception that these bodies are being rendered sterile by toxic compounds given under the guise of improving health. Public health operations research has identified these rumours as significant obstacles to programme delivery, but they have been treated primarily as failures in communication, to be rectified by the provision of more accurate information. Using reports of such rumours from public health interventions in Africa, with emphasis on vaccines, I argue that these rumours are more than simply stories which are not true. The widespread rumour of sterility is a way of articulating broadly shared understandings about reproductive bodies, collective survival, and global asymmetries of power. I use Foucault's notion of biopolitics to theorize international public health programmes, and introduce the concept of counter-epistemic convergence to account for the ubiquity and persistence of sterility rumours.     

Medications to ease intrauterine device insertion: a systematic review

BackgroundPotential barriers to intrauterine device (IUD) use include provider concern about difficult insertion, particularly for nulliparous women.ObjectiveThis study aims to evaluate the evidence on the effectiveness of medications to ease IUD insertion on provider outcomes (i.e., ease of insertion, need for adjunctive insertion measures, insertion success).Search strategyWe searched the PubMed database for peer-reviewed articles published in any language from database inception through February 2016.Selection criteriaWe included randomized controlled trials (RCTs) that examined medications to ease interval insertion of levonorgestrel-releasing IUDs and copper T IUDs.ResultsFrom 1855 articles, we identified 15 RCTs that met our inclusion criteria. Most evidence suggested that misoprostol did not improve provider ease of insertion, reduce the need for adjunctive insertion measures or improve insertion success among general samples of women seeking an IUD (evidence Level I, good to fair). However, one RCT found significantly higher insertion success among women receiving misoprostol prior to a second IUD insertion attempt after failed attempt versus placebo (evidence Level I, good). Two RCTs on 2% intracervical lidocaine as a topical gel or injection suggested no positive effect on provider ease of insertion (evidence Level I, good to poor), and one RCT on diclofenac plus 2% intracervical lidocaine as a topical gel suggested no positive effect on provider ease of insertion (evidence Level I, good). Limited evidence from two RCTs on nitric oxide donors, specifically nitroprusside or nitroglycerin gel, suggested no positive effect on provider ease of insertion or need for adjunctive insertion measures (evidence Level I, fair).ConclusionsOverall, most studies found no significant differences between women receiving interventions to ease IUD insertion versus controls. Among women with a recent failed insertion who underwent a second insertion attempt, one RCT found improved insertion success among women using misoprostol versus placebo.     

不育妇女心理状况的相关性研究

采用症状自评量表、Ｅｙｓｅｎｃｋ个性问卷、社会支持评定量表和一般情况问卷对８６例不育妇女进行调查，对其心理状况作相关性分析。结果显示：不育妇女的心理状况与其年龄、职业、文化程度、婚龄、不育年限、性生活满意程度及对待不育的态度等因素密切相关；心理状况的部分因子与就诊次数及就诊费用有关。不育妇女的个性及所得到的社会支持亦与心理状况有关。     

Sociological refigurations of patient safety; ontologies of improvement and ‘acting with’ quality collaboratives in healthcare

The increasing focus on patient safety in the field of health policy is accompanied by research programs that articulate the role of the social sciences as one of contributing to enhancing safety in healthcare. Through these programs, new approaches to studying safety are facing a narrow definition of ‘usefulness’ in which researchers are to discover the factors that support or hamper the implementation of existing policy agendas. This is unfortunate since such claims for useful involvement in predefined policy agendas may undo one of the strongest assets of good social science research: the capacity to complexify the taken-for-granted conceptualizations of the object of study. As an alternative to this definition of ‘usefulness’, this article proposes a focus on multiple ontologies in the making when studying patient safety. Through such a focus, the role of social scientists becomes the involvement in refiguring the problem space of patient safety, the relations between research subjects and objects, and the existing policy agendas. This role gives medical sociologists the opportunity to focus on the question of which practices of ‘effective care’ are being enacted through different approaches for dealing with patient safety and what their consequences are for the care practices under study.In order to explore these questions, this article draws on empirical material from an ongoing evaluation of a large quality improvement collaborative for the care sectors in the Netherlands. It addresses how issues like ‘effectiveness’ and ‘client participation’ are at present articulated in this collaborative and shows that alternative figurations of these notions dissolve many ‘implementation problems’ presently experienced. Further it analyzes how such a focus of medical sociology on multiple ontologies engenders new potential for exploring particular spaces for ‘acting with’ quality improvement agents.     

Experiencing objectified health: turning the body into an object of attention

In current phenomenology of medicine, health is often understood as a state of transparency in which our body refrains from being an object of explicit attention. In this paper, I argue that such an understanding of health unnecessarily presupposes an overly harmonious alignment between subjective and objective body, resulting in the idea that our health remains phenomenologically inaccessible. Alternatively, I suggest that there are many occasions in which one’s body in health does become an object of attention, and that technologies mediate how a relation with one’s body is formed. First, I show prominent accounts in current phenomenology of medicine understand health in terms of a harmonious alignment between objective and subjective body. Second, I argue that there are many occasions in which there is a disharmony between objective and subjective body, and suggest that also in health, we cannot escape being an object that we often relate to. Then, I draw on postphenomenology to show how technologies such as digital self-tracking applications and digital twins can be understood as mediating the relationship with one’s own body in a specific way. In conclusion, I argue that both technologies make present the objective body as a site for hermeneutic inquiry such that it can be interacted with in terms of health parameters. Furthermore, I point to some relevant differences in how different technologies make aspects of our own body phenomenologically present.

     

Improving patient safety during insertion of peripheral venous catheters: an observational intervention study

Background: Peripheral venous catheters are frequently used in hospitalized patients but increase the risk of nosocomial bloodstream infection. Evidence-based guidelines describe specific steps that are known to reduce infection risk. However, the degree of guideline implementation in clinical practice is not known. The aim of this study was to determine the use of specific steps for insertion of peripheral venous catheters in clinical practice and to implement a multimodal intervention aimed at improving both compliance and the optimum order of the steps.Methods: The study was conducted at University Hospital Hamburg. An optimum procedure for inserting a peripheral venous catheter was defined based on three evidence-based guidelines (WHO, CDC, RKI) including five steps with 1A or 1B level of evidence: hand disinfection before patient contact, skin antisepsis of the puncture site, no palpation of treated puncture site, hand disinfection before aseptic procedure, and sterile dressing on the puncture site. A research nurse observed and recorded procedures for peripheral venous catheter insertion for healthcare workers in four different departments (endoscopy, central emergency admissions, pediatrics, and dermatology). A multimodal intervention with 5 elements was established (teaching session, dummy training, e-learning tool, tablet and poster, and direct feedback), followed by a second observation period. During the last observation week, participants evaluated the intervention.Results: In the control period, 207 insertions were observed, and 202 in the intervention period. Compliance improved significantly for four of five steps (e.g., from 11.6% to 57.9% for hand disinfection before patient contact; p<0.001, chi-square test). Compliance with skin antisepsis of the puncture site was high before and after intervention (99.5% before and 99.0% after). Performance of specific steps in the correct order also improved (e.g., from 7.7% to 68.6% when three of five steps were done; p<0.001). The intervention was described as helpful by 46.8% of the participants, as neutral by 46.8%, and as disruptive by 6.4%.Conclusions: A multimodal strategy to improve both compliance with safety steps for peripheral venous catheter insertion and performance of an optimum procedure was effective and was regarded helpful by healthcare workers.     

The classification and nomenclature of ‘medically unexplained symptoms’: Conflict,performativity and critique

Persistent medically unexplained symptoms (MUS) – including the many syndromes that fall under this umbrella – involve a discrepancy between professional knowledge and lay experience and are often associated with latent or explicit dynamics of conflict. Although this conflictual dimension has been amply documented, little critical attention has been paid to how nomenclature and classification feed into the conflictual dynamic and are informed by it in turn. In this paper I engage with this question from a social-theoretical perspective informed by the concept of performativity. The paper offers a critical review of debates around the medical terminology in use, and a discussion of the alternative terminology developed by social scientists. Based on these, I argue that medical and social scientific discourse unwittingly collude in a disavowal of the psychological dimension of ‘MUS’. I then discuss the paradoxical character of this disavowal and suggest that it tends to perpetuate polemical modes of engagement around ‘MUS’. I conclude with suggestions on how further research might counteract this tendency.     

On the analysis of medical work: general practitioners, opiate abusing patients and medical sociology

Abstract Although general practice has provided the setting for a wide range of medical sociological analyses, those analyses have rarely focussed upon the care of specific patient groups or illness conditions. In the main, medical sociologists have chosen to portray general practice more in terms of their own secular interests in the processes of, for example, power, domination and communication - processes which although evident within the consultation are not unique to it. This topical neglect of the care of specific patient groups within general practice is, I argue, part of a broader neglect of the topic of medical work as conceived by practitioners, which arises at least in part from a combination of methodological, theoretical, ideological and attitudinal factors. This paper uses the opportunity of a study focussing upon general practitioners' treatment of opiate abusing patients to explore these and related issues and concludes with a call for an applied sociology of medical practice.     

Corporal diagnostic work and diagnostic spaces: clinicians’ use of space and bodies during diagnosis

An emerging body of literature in sociology has demonstrated that diagnosis is a useful focal point for understanding the social dimensions of health and illness. This article contributes to this work by drawing attention to the relationship between diagnostic spaces and the way in which clinicians use their own bodies during the diagnostic process. As a case study, we draw upon fieldwork conducted with a multidisciplinary clinical team providing deep brain stimulation (DBS) to treat children with a movement disorder called dystonia. Interviews were conducted with team members and diagnostic examinations were observed. We illustrate that clinicians use communicative body work and verbal communication to transform a material terrain into diagnostic space, and we illustrate how this diagnostic space configures forms of embodied ‘sensing‐and‐acting’ within. We argue that a ‘diagnosis’ can be conceptualised as emerging from an interaction in which space, the clinician‐body, and the patient‐body (or body‐part) mutually configure one another. By conceptualising diagnosis in this way, this article draws attention to the corporal bases of diagnostic power and counters Cartesian‐like accounts of clinical work in which the patient‐body is objectified by a disembodied medical discourse.     

Human factors engineering and patient safety

The case study and analyses presented here illustrate the crucial role of human factors engineering (HFE) in patient safety. HFE is a framework for efficient and constructive thinking which includes methods and tools to help healthcare teams perform patient safety analyses, such as root cause analyses. The literature on HFE over several decades contains theories and applied studies to help to solve difficult patient safety problems and design issues. A case study is presented which illustrates the vulnerabilities of human factors design in a transport monitor. The subsequent analysis highlights how to move beyond the more obvious contributing factors like training to design problems and the establishment of informal norms. General advice is offered to address these issues and design issues specific to this case are discussed.     

DNA vaccine coding for the rhesus prostate specific antigen delivered by intradermal electroporation in patients with relapsed prostate cancer

We tested safety, clinical efficacy and immunogenicity of a DNA vaccine coding for rhesus prostate specific antigen (PSA) delivered by intradermal injection and skin electroporation. Fifteen patients with biochemical relapse of prostate cancer without macroscopic disease participated in this phase I study. Patients were started on a 1 month course of androgen deprivation therapy (ADT) prior to treatment. Vaccine doses ranged from 50 to 1600 μg. Study subjects received five vaccinations at four week intervals. All patients have had at least one year of follow-up. No systemic toxicity was observed. Discomfort from electroporation did not require analgesia or topical anesthetic. No clinically significant changes in PSA kinetics were observed as all patients required antiandrogen therapy shortly after completion of the 5 months of vaccination due to rising PSA. Immunogenicity, as measured by T-cell reactivity to the modified PSA peptide and to a mix of overlapping PSA peptides representing the full length protein, was observed in some patients. All but one patient had pre-study PSA specific T-cell reactivity. ADT alone resulted in increases in T-cell reactivity in most patients. Intradermal vaccination with skin electroporation is easily performed with only minor discomfort for the patient. Patients with biochemical relapse of prostate cancer are a good model for testing immune therapies.     

The Ethics of Care: Normative Structures and Empirical Implications

In this article I argue that the ethics of care provides us with a novel reading of human relations, and therefore makes possible a fresh approach to several empirical challenges. In order to explore this connection, I discuss some specific normative features of the ethics of care??primarily the comprehension of the moral agent and the concept of care??as these two key elements contribute substantially to a new ethical outlook. Subsequently, I argue that the relational and reciprocal mode of thinking with regard to the moral agent must be extended to our understanding of care. I term this comprehension ??mature care??. Citing conflicts of interests as examples, I demonstrate how this conceptualization of care may further advance the ethics of care??s ability to take on empirical challenges. Finally, I discuss political implications that may emanate from the ethics of care and the concept of mature care.     

Diet order entry by registered dietitians results in a reduction in error rates and time delays compared with other health professionals

In January 2009, registered dietitians (RDs) at St Michael's Hospital (Toronto, Ontario, Canada) were granted approval for nonmedication order entry of physician-approved nutrition-related orders for the patients to whom RDs provided care. The aim of this project was to document any changes in the numbers and types of diet order errors and time delays that were associated with this policy change. A retrospective chart audit was conducted to document the error rate in 672 nutrition-related orders placed before, and in 633 orders placed after, implementation of RD diet order entry on high-risk inpatient units. Error rates for all nutrition-related orders decreased by 15% after RD order entry access (P<0.01). Error rates for diet orders entered by RDs were significantly lower in comparison with those entered by clerical assistants or registered nurses (P<0.001). Time delays for orders electronically entered were reduced by 39% (from 9.1 to 5.7 hours; P<0.01). Allowing RDs access to the electronic order entry system has improved overall timeliness of nonmedication order entries and improved patient safety by decreasing error rates in diet orders. This study supports this institutional policy change and provides evidence that RDs have the knowledge and skills to accurately process nonmedication order entries for the patients they have assessed. Finally, the current findings support the need for ongoing education and training of all health professionals in nonmedication order entry to reduce errors and improve safety.     

The limits of sterility assurance

Sterility means the absence of all viable microorganisms including viruses. At present, a sterility assurance level (SAL) of 10^–6 is generally accepted for pharmacopoeial sterilization procedures, i.e., a probability of not more than one viable microorganism in an amount of one million sterilised items of the final product. By extrapolating the reduction rates following extreme artificial initial contamination, a theoretical overall performance of the procedure of at least 12 lg increments (overkill conditions) is demanded to verify an SAL of 10^–6. By comparison, other recommendations for thermal sterilization procedures demand only evidence that the difference between the initial contamination and the number of test organisms at the end of the process amount to more than six orders of magnitude. However, a practical proof of the required level of sterility assurance of 10^–6 is not possible. Moreover, the attainability of this condition is fundamentally dubious, at least in non-thermal procedures. Thus, the question is discussed whether the undifferentiated adherence to the concept of sterility assurance on the basis of a single SAL of 10^–6 corresponds with the safety requirements in terms of patient or user safety, costs and energy efficiency. Therefore, in terms of practical considerations, a concept of tiered SALs is recommended, analogous to the comparable and well-established categorization into “High-level disinfection”, “Intermediate-level disinfection” and “Low-level disinfection”. The determination of such tiered SALs is geared both to the intended application of the sterilized goods, as well as to the characteristics of the products and the corresponding treatment options.In the case of aseptic preparation, filling and production procedures, a mean contamination probability of 10^–3 is assumed. In automated processes, lower contamination rates can be realized. In the case of the production of re-usable medical devices, a reduction of at least 2 lg increments can be achieved through prior cleaning in validated cleaning and disinfecting devices. By chemical disinfection, a further reduction of ≥5 lg increments is achieved. In the case of sterilized surgical instruments, an additional concern is that they lay opened in contaminated air for the duration of the operation, at least in conventionally ventilated operating theaters. Finally, the amount of pathogens necessary to cause an infection must be considered. By logical consideration of all aspects, it seems possible to partially reduce sterility assurance levels without any loss of safety. Proceeding from this, we would like to make the following suggestions for tiered SAL values, adjusted according to the respective sterilization task:

• SAL 10^–6 for heat-resistant pharmaceutical preparations (parenterals), suggested term: “Pharmaceutical sterilization”,
• SAL 10^–4 for heat-resistant medical devices, suggested term: “High-level sterilization”,
• SAL 10^–3 for heat-sensitive re-usable medical devices, under the precondition of a validated cleaning efficacy of >4 lg increments, suggested term: “Low-level sterilization”.

     

Risk-based regulation and reforms to fitness to practise tribunals in the United Kingdom: Serving the public interest?

In this paper, I outline recent policy reforms to the General Medical Council (GMC) and how these are designed to promote greater public confidence in its management of the patient complaint and fitness to practise tribunal process. I explore how in spite of a decade of reform, potential for bias remains in relation to how issues of race and ethnicity, disability, age, class, gender and English language proficiency intersect with complaint making and case progression. I draw on reviews of and data from the GMC to examine the key issues surrounding the representativeness of the medical tribunal process, in terms of members’ age, gender and race and ethnicity. I note that, as in other high-income countries, there is a tendency within the United Kingdom (UK) for the risk-focused regulatory system to focus its reforming agenda on the more effective performance management of cost and risk, rather than on inculcating a more diverse patient presence and biographical profile within the day-to-day operation of regulatory regimes. I argue that this might unintentionally lead to the promotion of an optimism bias within risk-focused regulatory systems, potentially leading to a failure to communicate realistic perceptions of medical risk to patients and their families, and in doing so perhaps serving to further exacerbate the situation when instances of medical error and negligence occur. I conclude that current regulatory reforms in the UK are unlikely as a result to as fully promote the public interest and patient safety as they intend.     

Male Sterility Associated with Familial Translocation Heterozygosity: t(8;15) (q22;p11)

During the investigation of the family of a subject consulting for primary sterility, the same oligoteratospermia was found in two of his brothers. The three karyotypes of these subjects exhibited an equilibrated reciprocal autosomal translocation t(8;15) (q22;p11), which was also detected in their mother. The karyotypes of the remaining siblings, one brother and one sister, were normal. The semen analysis of the sterile subjects suggests that the block of gamete production occurs at the beginning of spermiogenesis. The chromosomal anomaly, which has no effect on the reproduction of the mother, leads to sterility of the male offspring bearing it.