Reuse of pacemakers and implantable cardioverter-defibrillators: systematic review, meta-analysis and quality assessment of the body of evidence

Psaltikidis, Eliane Molina; Costa, Eliana Auxiliadora Magalhães; Graziano, Kazuko Uchikawa

doi:10.1080/17434440.2021.1927706

Cited by 14 publications

(14 citation statements)

References 32 publications

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“…The literature suggests that reuse of properly sterilized CIEDs in other patients is safe. In fact, the most recent metaanalysis found no significant differences in terms of infection (OR 0.98; 95% CI 0.60-1.60), malfunction (OR 1.58; 95% CI 0.56-4.48), premature battery depletion (OR 1.96; 95% CI 0.81-4.72), or device-related deaths comparing reused devices with new devices [7]. However, no randomized clinical trials have yet been conducted on this topic.…”

Section: Discussionmentioning

confidence: 98%

“…As CIEDs must be removed from deceased patients who will be cremated, due to the risk of explosion of the devices when subjected to the high temperatures of the crematorium and approximately 21% of the explanted devices could be reusable, they could be an important resource for LMIC [6]. Furthermore, it has been stated that the reutilization of used devices is a safe practice, provided that they are reprocessed and sterilized appropriately [7]. For this reason, initiatives that recover used CIEDs in the USA and France, recondition and implant them on LMIC where national regulations allow device reutilization have emerged [8][9][10].…”

Section: Introductionmentioning

confidence: 99%

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Spanish Rhythm Association member´s perspectives on cardiac implantable electronic device reuse in low- and middle-income countries

Ruiz

Arantzamendi

Marichalar-Mendía

2022

J Interv Card Electrophysiol

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Background Postmortem explanted cardiac implantable electronic devices (CIEDs) from developed countries could provide patients unable to afford new devices in low- and middle-income countries (LMIC) a treatment they lack. This study describes the preferences of electrophysiologists and device implanting cardiologists from Spain on the management of explanted CIEDs and opinions and concerns regarding reuse in LMIC. Methods A nationwide self-administered questionnaire was sent to members of the Spanish Rhythm Association (n = 1110), between December 2020 and January 2021. Results Forty-two physician responses were obtained (response rate 5%). There was a strong preference to donate explanted devices for reuse in humans (61.9%) or animals (31%). The vast majority of the participants thought device reutilization was safe, ethical, and a reasonable alternative if a new device is not accessible. Moreover, they indicated they would be comfortable asking patients to consider post-mortem donation, and willing to implant post-mortem explanted and resterilized devices if they were unable to obtain new ones. 57.1% of respondents considered it would be beneficial for patients to have a document so they could reflect their wishes regarding device handling after their death. The most mentioned concerns regarding device reuse were malfunction (57.1%) and infection (54.8%). Conclusions The majority of respondents support reusable CIED donation to LMIC. It would be interesting to study the feasibility of a nationwide device reutilization program.

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Section: Discussionmentioning

confidence: 98%

Section: Introductionmentioning

confidence: 99%

Spanish Rhythm Association member´s perspectives on cardiac implantable electronic device reuse in low- and middle-income countries

Ruiz

Arantzamendi

Marichalar-Mendía

2022

J Interv Card Electrophysiol

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“…Similar studies have been conducted in subsequent years, without showing significant differences in infection rates, device malfunction, premature battery depletion, and therefore device-related deaths; thus, in 2018, a meta-analysis was performed on studies from the period 2009–2017 (2114 patients) 34 ; in 2021, a systematic review and a meta-analysis were published based on the articles that had a control group from 1989 to 2020 12 ; in 2022, the analysis was performed on 36 studies, of which 3 were meta-analyses or systematic reviews and 13 cohort and case-control studies. 9…”

Section: Ethics and Therapeutic Advancesmentioning

confidence: 98%

“…Reduced access to resources and the technical possibility of reusing pacemakers have made reimplantation a viable, necessary alternative for patients in some countries. 12…”

Section: Introductionmentioning

confidence: 99%

Reimplantation of Implantable Cardiac Devices—An Ethical Controversy?

Astărăstoae

Rogozea

2023

American Journal of Therapeutics

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Background: Cardiovascular diseases are an important public health problem, the main cause of death in both men and women, with a continuous increasing prevalence and consequences upon morbidity in economic, physical, and psychological terms. The new technology have made possible the development of innovative devices, which have increased the possibility of therapeutic interventions today, extending the life of the population with cardiovascular pathology, transforming the patient care, and providing a complex, personalized therapeutic approach. Fields of Uncertainty: The aim of the study was to evaluate from an ethical perspective the need, feasibility, and safety of reusing cardiac pacemakers to revise the legal terms and requirements. In recent years, the problem of accessibility to cardiovascular drugs has been increasingly accompanied by the accessibility to technology, interventional cardiology advancing recently, and becoming an increasingly important standard of care. Data Sources: A review of the specialized literature was performed in March 2023, using keywords such as implantable cardiac devices, reuse, ethics from PubMed, Scopus, Web of Science, and Google Scholar, as well as official documents issued at the international level (World Health Organization). Ethics and Therapeutic Advances: An ethical analysis assesses the extent to which a medical act (PM reimplantation) is covered by the 4 universally accepted principles: nonmaleficence, beneficence, autonomy (respect for the person), and social justice, the analysis addressing to the risk–benefit ratio based on studies that analyzed the phenomenon over the past 50 years. The ethical analyzed issues start from the fact that although 80% of pacemakers, most of them working perfectly, with a battery life of more than 7 years are buried with their owners, while approximately 3 million patients die annually due to the lack of access to these devices in undeveloped and developing countries. But beyond the ethical issues, legal practice has meant that in many countries, reusing of these devices is prohibited, mostly being single-use devices. Low-income countries continue to accept this practice as the only one economically accessible to them, considering the prohibition of reusing them to be an economic rather than a medical issue. Conclusions: Reusing implantable cardiac devices is of great interest because of the costs, being in certain situations, the only possibility that certain people can have access to a therapeutic method that ensures their health recovery and increases their quality of life. But this is not possible without clear procedures, without clear criteria on how sterilization should be performed, how the technique should be performed, without obtaining a truly informed consent, and especially without a proper patient's follow-up.

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“…Single-use devices, on the other hand, are intended for use on a single patient during a single procedure. However, several studies have shown that reutilizing single-use devices, such as pacemakers and implantable defibrillators, can provide cost benefits without increasing the risk of infection or mortality [10] [11] [12]. The regulations on reprocessing single-use medical devices vary depending on the country or region.…”

Section: A Reuse Of Medical Devicesmentioning

confidence: 99%

Trusted Traceability and Certification of Refurbished Medical Devices Using Dynamic Composable NFTs

et al. 2023

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Medical devices play a crucial role in the global healthcare system, but their high cost has led to the increasing adoption of refurbished medical devices as a sustainable alternative for hospitals and patients around the world. The repositioning of refurbished devices into the market, however, is accompanied by a number of challenges, including concerns about quality and safety, as well as the risk of fraudulent activities such as counterfeiting. To address these challenges, we propose an NFT-based solution for managing refurbished medical devices that creates a secure, transparent, and verifiable record of the refurbishment process to ensure the safety and quality of these devices. The proposed solution utilizes dynamic composable NFTs as digital representations of medical devices, with replacement parts and certificate documents embedded in a parent-child NFT hierarchy, and reprocessing steps captured and reflected through the evolution of the dynamic tokens. This serves to authenticate and track the movement of refurbished devices while also providing a trustworthy means of managing individual devices and their ownership. Furthermore, the integration of non-transferable NFTs as certificates of refurbishment acts as an effective mechanism for detecting suspect medical devices and instances of fraudulent labeling, thereby increasing buyer confidence and promoting user safety. We leverage the Interplanetary File System to store and keep track of the metadata of the tokenized components of the system. We present the system architecture and implementation details with tested algorithms. We develop a front-end decentralized application (DApp) to interact with the designed smart contracts and showcase their functionalities. We also conduct security analysis to demonstrate our system is resistant to common vulnerabilities and exploits. The smart contract code is made available on GitHub.

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Reuse of pacemakers and implantable cardioverter-defibrillators: systematic review, meta-analysis and quality assessment of the body of evidence

Cited by 14 publications

References 32 publications

Spanish Rhythm Association member´s perspectives on cardiac implantable electronic device reuse in low- and middle-income countries

Spanish Rhythm Association member´s perspectives on cardiac implantable electronic device reuse in low- and middle-income countries

Reimplantation of Implantable Cardiac Devices—An Ethical Controversy?

Trusted Traceability and Certification of Refurbished Medical Devices Using Dynamic Composable NFTs

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