Legal and Normative Requirements Related to Medical Devices for Individual Supply in Clinical Practice

This article has the form of a communication presenting recent legal changes in relation to medical devices. Until 26 May 2021, three medical directives were in force, namely Directive 98/79 / EC, Council Directive 93/42/ EEC and Council Directive 90/385 / EEC. They have been replaced by two regulations: Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices. The article presents the reasons for introducing the changes and the new obligations that these changes bring for manufacturers of medical devices, in particular, products manufactured individually on a special order as necessary for the implementation of personalized therapies in clinical practice. There are also forecasts for the industry and end users of medical devices manufactured to order and used individually at medical centers.

Dying Wishes: Understanding Advance Medical Directives from the Malaysian and Islamic Law Perspectives

The respect for patient autonomy is a bioethical principle that has acquired a compelling degree of prevalence in modern medical practice. While a doctor is ethically and lawfully bound to respect a patient’s preference and personal values in administering the requisite treatment, the duty to do so is more intricate in end-of-life care, when most patients are unable to partake in the decision-making process. An advance medical directive thus provides an assurance that the patient’s right to make autonomous decisions is preserved and will not be defeated by any future incapacity. It also serves to alleviate the ethical dilemma faced by doctors and assist them to determine the course of treatment according to the incompetent patient’s wishes. In turn, this facilitates healthcare providers to effectuate a more functional allocation of resources, which include costly life-sustaining equipment. In Malaysia, although advance care planning and advance medical directives are fairly novel concepts, there have been recent calls by certain sectors to increase awareness among the public and incorporate such measures into the delivery of healthcare services. This paper seeks to discuss the viability of integrating advance medical directives into the Malaysian regulatory framework on the provision of healthcare. Accordingly, this will also include deliberation on the Islamic standpoint with regard to the subject matter, in view of Malaysia’s religious demography and the position of Islam as the official religion of the country.

Current Scenario of Euthanasia in India

Euthanasia is a recently talked topic now a days in India. Few societies like Jainism etc. practicing santhara/ salekhana/ ichhamaran as of now embodied in passive euthanasia permitted by Supreme Court of India on 3rd March, 2018 to a person who is above the age of 18 years. Various types of euthanasia are there but only Passive euthanasia will be permitted as per law to terminally ill patients who give advance medical directives to treating doctor to end his life in a dignified manner. Advance medical directions given by the patient should clearly mention under which circumstances passive euthanasia (removing life support from patient but palliative care may be continued) should be administered by following legal formalities.

LO20: The characteristics, clinical course and disposition of long-term care patients treated by paramedics during an emergency call: Exploring the potential impact of community paramedicine

Introduction: An increasing number of Canadian paramedic services are creating Community Paramedic programs targeting treatment of long-term care (LTC) patients on-site. We explored the characteristics, clinical course and disposition of LTC patients cared for by paramedics during an emergency call, and the possible impact of Community Paramedic programs. Methods: We completed a health records review of paramedic call reports and emergency department (ED) records between April 1, 2016 and March 31, 2017. We utilized paramedic dispatch data to identify emergency calls originating from LTC centers resulting in transport to one of the two EDs of the Ottawa Hospital. We excluded patients with absent vital signs, a Canadian Triage and Acuity Scale (CTAS) score of 1, and whose transfer to hospital were deferrable or scheduled. We stratified remaining cases by month and selected cases using a random number generator to meet our apriori sample size. We collected data using a piloted standardized form. We used descriptive statistics and categorized patients into groups based on the ED care received and if the treatment received fit into current paramedic medical directives. Results: Characteristics of the 381 included patients were mean age 82.5 years, 58.5% female, 59.7% hypertension, 52.6% dementia and 52.1% cardiovascular disease. On arrival at hospital, 57.7% of patients waited in offload delay for a median time of 45 minutes (IQR 33.5-78.0). We could identify 4 groups: 1) Patients requiring no treatment or diagnostics in the ED (7.9%); 2) Patients receiving ED treatment within current paramedic medical directives and no diagnostics (3.2%); 3) Patients requiring diagnostics or ED care outside current paramedic directives (54.9%); and 4) patients requiring admission (34.1%). Most patients were discharged from the ED (65.6%), and 1.1% died. The main ED diagnoses were infection (18.6%) and musculoskeletal injury (17.9%). Of the patients that required ED care but were discharged, 64.1% required x-rays, 42.1% CT, and 3.4% ultrasound. ED care included intravenous fluids (35.7%), medication (67.5%), antibiotics (29.4%), non-opioid analgesics (29.4%) and opioids (20.7%). Overall, 11.1% of patients didn't need management beyond current paramedic capabilities. Conclusion: Many LTC patients could receive care by paramedics on-site within current medical directives and avoid a transfer to the ED. This group could potentially grow using Community Paramedics with an expanded scope of practice.

Improving timely analgesia administration for musculoskeletal pain in the emergency department

Delays to adequate analgesia result in worse patient care, decreased patient and provider satisfaction and increased patient complaints. The leading presenting symptom to emergency departments (EDs) is pain, with approximately 34 000 such patients per year in our academic hospital ED and 3300 visits specific for musculoskeletal (MSK) injuries. Our aim was to reduce the time-to-analgesia (TTA; time from patient triage to receipt of analgesia) for patients with MSK pain in our ED by 55% (to under 60 min) in 9 months’ time (May 2018). Our outcome measures included mean TTA and ED length of stay (LOS). Process measures included rates of analgesia administration and of use of medical directives. We obtained weekly data capture for Statistical Process Control (SPC) charts, as well as Mann-Whitney U tests for before-and-after evaluation. We performed wide stakeholder engagement, root cause analyses and created a Pareto Diagram to inform Plan–Do–Study–Act (PDSA) cycles, which included: (1) nurse-initiated analgesia at triage; (2) a new triage documentation aid for medication administration; (3) a quick reference medical directive badge for nurses; and (4) weekly targeted feedback of the project’s progress at clinical team huddle. TTA decreased from 129 min (n=153) to 100 min (22.5%; n=87, p<0.05). Special cause variation was identified on the ED LOS SPC chart with nine values below the midline after the first PDSA. The number of patients that received any analgesia increased from 42% (n=372) to 47% (n=192; p=0.13) and those that received them via medical directives increased from 22% (n=154) to 44% (n=87; p<0.001). We achieved a significant reduction of TTA and an increased use of medical directives through front-line focused improvements.