The Voice Is As Mighty As the Pen: Integrating Conversations into Advance Care Planning.

Advance care planning allows patients to articulate preferences for their medical treatment, lifestyle, and surrogate decision-makers in order to anticipate and mitigate their potential loss of decision-making capacity. Written advance directives are often emphasized in this regard. While these directives contain important information, there are several barriers to consider: veracity and accuracy of surrogate decision-makers in making choices consistent with the substituted judgement standard, state-to-state variability in regulations, literacy issues, lack of access to legal resources, lack of understanding of medical options, and cultural disparities. Given these issues, it is vital to increase the use of patient and healthcare provider conversations as an advance care planning tool and to increase integration of such discourse into advance care planning policy as adjuncts and complements to written advance directives. This paper reviews current legislation about written advance directives and dissects how documentation of spoken interactions might be integrated and considered. We discuss specific institutional policy changes required to facilitate implementation. Finally, we explore the ethical issues surrounding the increased usage and recognition of clinician-patient conversations in advance care planning.

Pacemaker recycling: A notion whose time has come.

The purpose of this paper is to summarize the need, feasibility, safety, legality, and ethical perspectives of pacemaker reutilization in low- and middle-income countries (LMICs). It will also describe, in-depth, Project My Heart Your Heart (PMHYH) as a model for pacemaker reuse in LMICs. The primary source of the discussion points in this paper is a collection of 14 publications produced by the research team at the University of Michigan and its collaborative partners. The need for pacemaker reutilization in LMICs is evident. Numerous studies show that the concept of pacemaker reutilization in LMICs is feasible. Infection and device malfunction are the main concerns in regard to pacemaker reutilization, yet many studies have shown that pacemaker reuse is not associated with increased infection risk or higher mortality compared with new device implantation. Under the right circumstances, the ethical and legal bases for pacemaker reutilization are supported. PMHYH is a proof of concept pacemaker donation initiative that has allowed funeral home and crematory directors to send explanted devices to an academic center for evaluation and re-sterilization before donation to underserved patients in LMICs. The time is now to pursue large-scale studies and trials of pacemaker reuse for the betterment of society. PMHYH is leading the way in the effort and is poised to conduct a prospective randomized, non-inferiority, multicenter study to confirm the clinical efficacy and safety of pacemaker reuse, for clinical and legal support.

Cleaning and Sterilization of Used Cardiac Implantable Electronic Devices With Process Validation: The Next Hurdle in Device Recycling.

OBJECTIVES: This study sought to develop a validated, reproducible sterilization protocol, which could be used in the reprocessing of cardiac implantable electronic devices (CIEDs). BACKGROUND: Access to cardiac CIED therapy in high-income and in low- and middle-income countries varies greatly. CIED reuse may reduce this disparity. METHODS: A cleaning and sterilization protocol was developed that includes washing CIEDs in an enzymatic detergent, screw cap and set screw replacement, brushing, inspection, and sterilization in ethylene oxide. Validation testing was performed to assure compliance with accepted standards. RESULTS: With cleaning, the total mean bioburden for each of 3 batches of 10 randomly chosen devices was reduced from 754 to 10.1 colony-forming units. After sterilization with ethylene oxide, with 3 half-cycle and 3 full-cycle processes, none of the 90 biological indicator testers exhibited growth after 7 days. Through cleaning and sterilization, protein and hemoglobin concentrations were reduced from 99.2 to 1.42 µg/cm2 and from 21.4 to 1.03 µg/cm2, respectively. Mean total organic carbon residual was 1.44 parts per million (range 0.36 to 2.9 parts per million). Endotoxin concentration was not detectable at the threshold of <0.03 endotoxin units/ml or <3.0 endotoxin units/device. Cytotoxicity and intracutaneous reactivity tests met the standards set by the Association for Advancement of Medical Instrumentation and the International Organization for Standardization. CONCLUSIONS: CIEDs can be cleaned and sterilized according to a standardized protocol achieving a 12-log reduction of inoculated product, resulting in sterility assurance level of 10-6.

Pacemaker reuse for patients in resource poor countries: is something always better than nothing?

Cardiovascular disease is the most common cause of death across the globe. Large disparities in access to cardiovascular care exist in the world. An estimated one million people die each year due to lack of access to life saving pacemaker therapy. We discuss the concept of justice in health and health care as it relates to the use of refurbished pacemakers in patients in low- and middle- income countries, where financial circumstances severely limit access to brand new devices. Egalitarianism, utilitarianism, and justice as fairness are examined, as they relate to provision of re-processed pacemakers. This practice, since it holds promise to improve human functioning and capabilities, can be morally justified with some conditions: transparency, further research in is its safety and efficacy, and its impact on other needs and priorities in those countries.