Strengthen Patient Safety Research Articles

New Regulations on Notified Bodies and Conformity Assessment of High- Risk Medical Devices in Europe: Impact on Clinical Investigation from an Industry Perspective

Background: Proposals to a more rigorous medical device regulation concerning Notified Bodies and clinical evidence are met with controversies. The regulatory revision will not only endeavor improvement of patient safety and product quality, but is expected to have a direct impact on manufacturers bygeneratinghigher costs, longer processes to gather a CE mark and increased requirements for clinical evidence. Despite that industry recognizes a need for regulatory improvements, there are uncertainties about the estimated impact the regulatory changes have on European manufacturers. Aim: To determine the impact the new regulations on Notified Bodies and conformity assessment have on clinical investigation of implantable medical devicesin Europe. Methods: Data regarding information to 5 regulatory changes and their impact on different factors of clinical investigation were collected from 22 clinical research specialists working for manufacturers of implantable medical devices. The datawere collected through a cross-sectional, quantitative, descriptive survey and analyzed. Results: It was determined that burden on costs and resources would be affected the most, while innovations and product development would be negatively affected. Additionally, product quality and patient safety would benefit minimally from the proposed regulatory changes. Conclusion: The results obtained are in contrast to the intended aims of the proposed revisions. The proposed regulations may introduce economic and organizational challenges to manufacturers in Europe, particularly when considering the small- and-medium-sized enterprises. It is moreover debatable whether the goal of strengthening patient safety and allowing for rapid and cost-efficient market access for innovative products will be reached.

The Delivery Rates of Pathology Test Results to Patients: A Single-Center Experience in a Secondary Referral Center.

BackgroundDelivery of pathology reports to the patient is a key step in the biopsy pathway, which is important for patient safety in dermatology. Automated systems for facilitating such medical process began in 2010 in our hospital, sending short message service to scheduled patients.ObjectiveThe purpose of this study was to evaluate the delivery of pathology reports to patients and investigate factors that influence this process and annual trends.MethodsWe retrospectively reviewed the medical records of all outpatients (n=2,452) who underwent skin biopsy at our department of dermatology in 2009 and 2014. In each year group, we analyzed the proportion of revisiting patients in terms of year, sex, age, season, biopsy method and diagnosis.ResultsIn 2009, a smaller proportion of patients (205; 91.5%) who had undergone shave or excisional biopsy than of those who had undergone punch biopsy returned (781; 98.0%; p<0.001). This trend was not significant in 2014. Whereas there was no significant difference of return visit ratio between men and women in 2009, a higher proportion of women (754; 98.0%) than men (633; 95.6%) re-visited after skin biopsy to confirm their diagnosis in 2014 (p=0.008). Three patients with either a malignant tumor or suspected malignant lesion that required complete excision did not return to our clinic.ConclusionPathology report delivery rates were fairly satisfactory, regardless of year, age, season, and diagnosis. Sex and biopsy method influenced the return visit ratio. More organized follow-up protocols are required to strengthen patient safety and prevent critical patient drop-out.

Patient safety competence for final-year health professional students: Perceptions of effectiveness of an interprofessional education course

ABSTRACTAs final-year medical and nursing students will soon play key roles in frontline patient care, their preparedness for safe, reliable care provision is of special importance. We assessed patient safety competencies of final-year health profession students, and the effect of a 1-day patient safety education programme on these competencies. A cross-sectional survey was conducted with 233 students in three colleges of medicine, nursing, and traditional medicine in Seoul. A before-and-after study followed to evaluate the effectiveness of the curriculum. Patient safety competency was measured using the Health-Professional Education for Patients Safety Survey (H-PEPSS) and an objective patient safety knowledge test. The mean scores were 3.4 and 1.7 out of 5.0, respectively. The communication domain was rated the highest and the teamwork domain was rated the lowest. H-PEPSS scores significantly differed between the students from three colleges. The 1-day patient safety education curriculum significantly improved H-PEPSS and knowledge test scores. These results indicated that strengthening patient safety competencies, especially teamwork, of students is required in undergraduate healthcare curricula. A 1-day interprofessional patient safety education programme may be a promising strategy. The findings suggest that interprofessional patient safety education needs to be implemented as a core undergraduate course to improve students’ safety competence.

Strengthening patient safety in transitions of care: an emerging role for local medical centres in Norway

BackgroundPatient safety has gained less attention in primary care in comparison to specialised care. We explore how local medical centres (LMCs) can play a role in strengthening patient safety, both locally and in transitions between care levels. LMCs represent a form of intermediate care organisation in Norway that is increasingly used as a strategy for integrated care policies. The analysis is based on institutional theory and general safety theories.MethodsA qualitative design was applied, involving 20 interviews of nursing home managers, managers at local medical centres and administrative personnel.ResultsThe LMCs mediate important information between care levels, partly by means of workarounds, but also as a result of having access to the different information and communications technology (ICT) systems in use. Their knowledge of local conditions is found to be a key asset. LMCs are providers of competence and training for the local level, as well as serving as quality assurers.ConclusionsAs a growing organisational form in Norway, LMCs have to legitimise their role in the health care system. They represent an asset to the local level in terms of information, competence and quality assurance. As they have overlapping competencies, tasks and responsibilities with other parts of the health care system, they add to organisational redundancy and strengthen patient safety.

Distriktssköterskors erfarenheter av telefonrådgivning till ungdomar via tredje part

Background:There has been an evolution from district nurses previously providing patients with the opportunity to contact health services, to them now providing medical assessments and advice via telephone counselling. Telephone counselling is governed by laws that strengthen patient safety, something which may be complicated to accomplish when the call is made via a third party. Aim:The aim was to describe district nurses' experiences of giving telephone advice to young people via a third party. Methods:The design had an inductive approach. Ten district nurses were interviewed and the interviews were analysed using qualitative content analysis. Findings:The district nurses' wanted to avoid calls via a third party. They experienced that third party felt responsible for young people. At the same time, the district nurses' wanted to protect young people, make safe decisions and avoid misleading information. The district nurses' experienced difficulties in making accurate assessments and found it difficult to obtain the correct information. Conclusion:District nurses want to avoid telephone counselling for young people via a third party as they experienced it as difficult. Misleading information from a third party may compromise the safety of patients. Good skills are needed to cope with giving advice to young people on the phone via a third party. Employers should arrange for training in telephone counselling.

Staffing and resource adequacy strongly related to RNs’ assessment of patient safety: a national study of RNs working in acute-care hospitals in Sweden

IntroductionAlthough registered nurses (RNs) are central in patient care, we have not found prior research that specifically addresses how RNs assess the safety of patient care at their workplace and...

A qualitative study comparing experiences of the surgical safety checklist in hospitals in high-income and low-income countries

ObjectiveBold claims have been made for the ability of the WHO surgical checklist to reduce surgical morbidity and mortality and improve patient safety regardless of the setting. Little is known...

RFID in eHealth: How to Combat Medication Errors and Strengthen Patient Safety

A medication error is an adverse event or even a miss in the treatment process that may harm a patient. As a consequence of this, patients' diseases may recrudesce and the mortality rate could rise. Therefore, medication errors have consequences in human terms and result in higher medical costs. Advanced inpatient medication safety systems can help reduce such errors in hospitals. Radio-frequency identification (RFID)-based systems are a promising solution for such applications. In this context, RFID grouping-proofs have been proposed to generate evidence that a collection of tags were read at the same time. These proofs are useful for automating the five rights method (right patient, right drug, right dose, right route, and right time). Wu et al. recently proposed an RFID grouping-proof. Unfortunately, the security level offered by this protocol is too low, as demonstrated here. This study shows how a passive attacker can conduct a full-disclosure attack. The cost of the proposed attack is only 32 O (2^32), which is inappropriate for medical applications, and thus the attack requires only a few minutes on a personal computer. In addition, a de-synchronization attack can be conducted with only two runs of the protocol. Finally, as the idea of using grouping-proofs seems useful to enhance patient safety, a protocol called EKATE is proposed and a security analysis is performed.

A qualitative study on Iranian nurses’ experiences and perspectives on how to provide safe care in clinical practice

Nurses are the healthcare providers who are well positioned to strengthen patient safety through providing safe care in clinical practice. The purpose of this study was to explore and describe the experiences and perspectives of Iranian nurses in relation to how to provide safe care in clinical practice. A qualitative design by using a content analysis approach was applied for the data gathering and analysis. After employing a purposive sampling to choose 16 bachelor’s degree nurses working in the medical and surgical wards of a referral teaching hospital in an urban area of Iran, semi-structured interviews were conducted to collect data. During the data analysis, three main themes emerged: ‘providing safe care as the patient’s right’, with the subthemes: ‘feeling a personal commitment’ and ‘incorporating patients’ feelings of safety into providing safe care’, ‘encouraging reciprocal accountability in healthcare professionals’ and ‘leadership commitment to safe care’. The findings suggest that educators should provide more information during nurses’ education to focus on the moral duty to provide safe care. In addition, the provision of safe care needs the commitment and collaboration of all healthcare professionals, as well as the leadership of nursing for removing obstacles to nurses’ efforts to making the healthcare system safer.

Nursing Education: A Catalyst for the Patient Safety Movement

Creating a culture of safety in healthcare systems is a goal of leaders in the patient safety movement. Commitment of leadership to safety in the Saskatchewan Institute of Applied Science and Technology (SIAST) Nursing Division has resulted in the development of the Patient Safety Project Team (PSPT) and a steady shift in the culture of the organization toward a systems approach to patient safety. Graduates prepared with the competencies necessary to be diligent about their practice and skilled in determining the root causes of system error in healthcare will become leaders in shifting the healthcare culture to strengthen patient safety. The PSPT believes this cultural shift begins with the education system. It involves modifications to curricula content, facilitation of multidisciplinary processes, and inclusion of theory and practice that reflect critical inquiry into healthcare and nursing education systems to ensure patient safety. In this paper the practical approaches and initiatives of the PSPT are reviewed. The integration of Patient Safety Core Curriculum modules for competency development is described. The policy for reporting adverse events and near misses is outlined. In addition, the student-focused reporting tool, the results and the implications for teaching in the clinical setting are discussed. Processes used to engage faculty are also addressed.