Medical Device Regulation and the Proposed Therapeutic Products Bill: Devising a New Regime

Despite medical devices being integral to modern healthcare, New Zealand's regulation of them is decidedly limited, with repeated attempts at reform having been unsuccessful. With the Government now indicating that new therapeutic products legislation may be introduced before the end of the year, the article considers the case for change, including to promote patient safety, before analysing the draft Therapeutic Products Bill previously proposed by the Ministry of Health, and on which any new legislation is expected to be based. It concludes that, while the proposed Bill is a step in the right direction, introducing regulatory oversight where there is currently next to none, there is still significant work to be done. In particular, it identifies a need to clarify whether the regime is indeed to be principles-based and identifies further principles which might be considered for inclusion. It further proposes regulation of cosmetic products which operate similarly to medical devices to promote safety objectives, while finding a need for further analysis around the extent to which New Zealand approval processes should rely on overseas regulators. Finally, it argues that, in an area with such major repercussions for people's health, difficult decisions around how to develop a framework which balances safety with speed to market should not be left almost entirely to an as yet unknown regulator but, rather, more guidance from Parliament is needed.

Medical Device Regulation and the Proposed Therapeutic Products Bill: Devising a New Regime

Despite medical devices being integral to modern healthcare, New Zealand's regulation of them is decidedly limited, with repeated attempts at reform having been unsuccessful. With the Government now indicating that new therapeutic products legislation may be introduced before the end of the year, the article considers the case for change, including to promote patient safety, before analysing the draft Therapeutic Products Bill previously proposed by the Ministry of Health, and on which any new legislation is expected to be based. It concludes that, while the proposed Bill is a step in the right direction, introducing regulatory oversight where there is currently next to none, there is still significant work to be done. In particular, it identifies a need to clarify whether the regime is indeed to be principles-based and identifies further principles which might be considered for inclusion. It further proposes regulation of cosmetic products which operate similarly to medical devices to promote safety objectives, while finding a need for further analysis around the extent to which New Zealand approval processes should rely on overseas regulators. Finally, it argues that, in an area with such major repercussions for people's health, difficult decisions around how to develop a framework which balances safety with speed to market should not be left almost entirely to an as yet unknown regulator but, rather, more guidance from Parliament is needed.

Causes and Outcomes of Dental Malpractice Litigation in the Riyadh Region of the Kingdom of Saudi Arabia

<b><i>Introduction:</i></b> Every health organization aims to provide high-quality service and promote patient safety. However, achieving these goals can be challenging in many healthcare systems around the world. In dentistry, dentists can face medicolegal issues, which can be overcome by exploring the reasons for dental malpractice litigation. In this study, we aim to identify the most common causes and outcomes of dental malpractice litigation in the Kingdom of Saudi Arabia. <b><i>Methods:</i></b> This is a retrospective study. We reviewed all closed cases in dentistry as decided by the Medico-Legal Committee of Saudi Arabia in the Riyadh region over a period of 5 years and 3 months, from January 1, 2014, to March 31, 2019. Descriptive analysis was used to examine the phenomenon of dental malpractice claims. <b><i>Results:</i></b> In total, 151 claims were analyzed. As per our findings, it was determined that the number of closed claims had increased, with the highest number of claims (35%) related to the prosthodontics specialty, followed by endodontics specialty (31%). The most common causes of litigation were failure to conduct the procedure properly (31.5%) and poor documentation (19.7%). With respect to litigation outcomes, 54% ended up with verdict in favor of the plaintiff. <b><i>Conclusions:</i></b> It was determined that there is a rising trend of malpractice litigation in the dentistry field; thus, measures should be taken to address these concerns.

Adverse drug events in hospitalized patients in Brazil: Integrative literature review

Objective: Analyzing studies related to Adverse Drug Events (ADE) in hospitalized patients in Brazil. Method: integrative review, for which the National Library of Medicine (PubMed), Biblioteca Virtual de Saúde (BVS), Repository of the Fundação Oswaldo Cruz (FIOCRUZ) and Capes Journals databases were selected for searching the studies primary, with the descriptors: Patient Safety, Drug-related side effects and adverse reactions, Patient harm, Hospitalization, Inpatients. Results: Twenty articles were identified, 50% (10) were from the southeast region of Brazil. Regarding the methodology adopted to identify the ADEs, 70% (14) used the retrospective data review. The trackers were used in 5 (25%) articles, 3 of which used the triggers proposed by the Institute for Healthcare Improvement, and the other 2 the trackers used were proposed by the researchers themselves. The number of adverse drug reactions ranged from 12 to 96, while the occurrence of AE ranged from 4 to 122. In one study 50% (41) of participants had at least one adverse drug event. Conclusion: There is great variability in scientific production in Brazil, and in the occurrence of Adverse Drug Events as well. There is a need for strategies to identify these events and create strategies to promote patient safety.

Relational Quality of Registered Nurses and Nursing Assistants: Influence on Patient Safety Culture

Registered nurses (RNs) working within acute care hospitals have an incredible responsibility to provide safe care in a complex environment which requires trust, teamwork, and communication. Nursing assistants (NAs) play a critical role in working with RNs to meet these growing demands of inpatient care. Minimal evidence exists exploring the relational quality between RNs and NAs within hospitals. The aim of this study is to explore RN and NA behaviors and experiences that promote patient safety and teamwork and enhance communication between RNs and NAs within the hospital environment. Qualitative analysis was used, with two focus groups which included six participants within each group (three RNs and three NAs) from two separate inpatient units. Transcripts were reviewed and coded for themes. Collaborative teamwork and two-way communication were commonly reported as behaviors that promote patient safety. Trust between RNs and NAs was identified as a key component of positive relationships between RNs and NAs. Participants identified four common behaviors that build trust, which were accountability, effective conflict resolution, collaborative teamwork, and prioritizing patient needs. Finally, teamwork was identified as a common strategy to increase communication effectiveness between RNs and NAs. High relational quality (RQ) between the RN and NA is an important component of teamwork and patient safety culture.

Acting between guidelines and reality- an interview study exploring the strategies of first line managers in patient safety work

Background Safety culture can be described and understood through its manifestations in the organization as artefacts, espoused values and basic underlying assumptions and is strongly related to leadership-yet it remains elusive as a concept. Even if the literature points to leadership as an important factor for creating and sustaining a mature safety culture, little is known about how the safety work of first line managers’ is done and how they balance the different and often conflicting organizational goals in everyday practice. The purpose of this study was to explore how health care first line managers perceive their role and how they promote patient safety and patient safety culture in their units. Methods Interview study with first line managers in intensive care units in eight different hospitals located in the middle of Sweden. An inductive qualitative content analysis approach was used, this was then followed by a deductive analysis of the strategies informed by constructs from High reliability organizations. Results We present how first line managers view their role in patient safety and exemplify concrete strategies by which managers promote patient safety in everyday work. Conclusions Our study shows the central role of front-line managers in organizing for safe care and creating a culture for patient safety. Although promoted widely in Swedish healthcare at the time for the interviews, the HSOPSC was not mentioned by the managers as a central source of information on the unit’s safety culture.

Acting between guidelines and reality. Managers’ balancing between standardisation and adaptive behaviour in patient safety work- an interview study

Abstract Background: Safety culture can be described and understood through its manifestations in the organisation as artefacts, espoused values and basic underlying assumptions and is strongly related to leadership-yet it remains elusive as a concept. Even if the literature points to leadership as an important factor for creating and sustaining a mature safety culture, little is known about how the safety work of first line managers’ actually is done and how they balance the different and often conflicting organizational goals in everyday practice. The purpose of this study was to explore how health care first line managers perceive their role and how they promote patient safety and patient safety culture in their units. Methods: Interview study with first line managers in intensive care units in eight different hospitals located in the middle of Sweden. An inductive qualitative content analysis approach was used, this was then followed by a deductive analysis of the strategies informed by constructs from High reliability organizations. Results: We present how first line managers view their role in patient safety and exemplify concrete strategies by which managers promote patient safety in everyday work. Conclusions: Our study shows the central role of front-line managers in organizing for safe care and creating a culture for patient safety. Although promoted widely in Swedish healthcare at the time for the interviews, the HSOPSC was not mentioned by the managers as a central source of information on the unit’s safety culture.

ASSESSMENT OF PATIENT SAFETY IN VACCINATION ROOMS

ABSTRACT Objective: identify adherence to patient safety recommendations in the vaccination room. Method: this is a cross-sectional study that analyzed 463 vaccination procedures in six vaccination rooms in Minas Gerais from June to July 2018. Data were obtained with the application of the Patient Safety Checklist for Vaccination Rooms through systematic observation of the vaccination procedure. Descriptive statistics were used for data analysis. Results: 463 vaccination procedures were observed, and the mean overall adherence score was 58.5%, min. 43.3% and max. 74.1%. The items of higher adherence were related to the records of vaccine data (name, date, and batch) on the vaccination card; vaccine application with dose, route of administration, location and correct materials; and records in an information system. The items of lower adherence were related to health guidance; investigation of adverse events following immunization and the health status of the vaccinated person; records of vaccine laboratory and vaccination center on the vaccination card; vaccine workforce handwashing; and proper vaccine preparation. Conclusion: the mean overall score found in this study was 58.5% for the adherence to recommendations for vaccination procedures. This result highlights the need for educational interventions that promote patient safety in the vaccination room and studies analyzing the factors that prevent such adherence.

Acting between checklists and reality. Managers’ balancing between standardization and adaptive behaviour in patient safety work- an interview study

Background: Safety culture can be described and understood through its manifestations in the organisation as artefacts, espoused values and basic underlying assumptions and is strongly related to leadership-yet it remains elusive as a concept. Even if the literature points to leadership as an important factor for creating and sustaining a mature safety culture, little is known about how the safety work of first line managers’ actually is done and how they balance the different and often conflicting organizational goals in everyday practice. The purpose of this study was to explore how health care first line managers perceive their role and how they promote patient safety and patient safety culture in their units. Methods: Interview study with first line managers in intensive care units in eight different hospitals located in the middle of Sweden. An inductive qualitative content analysis approach was used, this was then followed by a deductive analysis of the strategies informed by constructs from High reliability organizations. Results: We present how first line managers view their role in patient safety and exemplify concrete strategies by which managers promote patient safety in everyday work. Conclusions: Our study shows the central role of front-line managers in organizing for safe care and creating a culture for patient safety. Although promoted widely in Swedish healthcare at the time for the interviews, the HSOPSC was not mentioned by the managers as a central source of information on the unit’s safety culture.