Reprocessing of electrophysiology material in EHRA countries: an EHRA Young EP survey

Duncker, David; Svetlosak, Martin; Guerra, Federico; Nagy, Klaudia Vivien; Vanduynhoven, Philippe; Mikhaylov, Evgeny N.; Kosiuk, Jędrzej

doi:10.1093/europace/euaa250

Cited by 9 publications

(9 citation statements)

References 17 publications

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“…Despite this, due to their high cost these catheters are reused not just in low income countries but also in many European and North American centres. [1][2] This reuse is supported by extensive literature showing safety in reusing these catheters.…”

mentioning

confidence: 77%

“…1 A 2021 publication surveyed respondents from 34 European countries and found that around two thirds of the electrophysiologists had experience with resterilized equipment and the majority would be using reprocessed ablation and diagnostic catheters. 2 However there is no uniform regulation regarding reprocessing in EU. Spain, Italy, France have banned this.…”

Section: International Practicesmentioning

confidence: 99%

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Reprocessing Cardiac Electrophysiology Catheters: Recommendations of Pak HRS Task Force and Review of Literature

Shafquat¹,

Ali²,

Irfan³

et al. 2022

Pak Heart J

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Cardiac Electrophysiology Study (EPS) and Ablation procedures are definitive treatment for multiple common arrhythmias the major component of the cost of the procedure is the expense of the catheters. Many centres around the world used to reuse these catheters but few years ago started noticing Single Use Device (SUD) labelling appearing on them without any change in the catheters (1). This SUD labelling certifies that this can be safely used once but does not mean that it cannot be used again. Based on this the Federal Drug Authority of the United States shifted the liability of the reused device on the entity reprocessing it. Despite this, due to their high cost these catheters are reused not just in low income countries but also in many European and North American centres (1) (2). This reuse is supported by extensive literature showing safety in reusing these catheters. Currently there are no specific regulatory guidelines either at the federal or provincial levels for reuse of electrophysiology catheters in Pakistan. The Pakistan Heart Rhythm Society created this task force to review the literature and give recommendations to guide both the Heart Rhythm physician community as well as provide basis for discussion with regulatory authorities. This task force includes members from major public and private institutions performing cardiac electrophysiology procedures. The members included specialists in cardiac electrophysiology, infectious diseases and certified infection control staff. This literature review has been done to give recommendations for use of reprocessed electrophysiology catheters specifically for the patients in Pakistan. Since more than 90 percent of EP procedures in Pakistan are for supraventricular tachycardia (SVT) ablations, costs and other measures in this document are calculated using SVT ablation for modelling. Moreover, connecting cables and other equipment that are located outside the body but in the sterile field are not addressed in this document as they do not have significant safety impact. Similarly, catheters with lumens or balloons are not addressed in this document due to paucity of studies to demonstrate safety. The following aspects of using SUD or reprocessed catheters were compared and reviewed before final recommendations of this committee at the end of this paper. Cost Safety Unused expired catheters International practices Ethics Hospital Policies and personnel Cleaning and sterilization procedures

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mentioning

confidence: 77%

Section: International Practicesmentioning

confidence: 99%

Reprocessing Cardiac Electrophysiology Catheters: Recommendations of Pak HRS Task Force and Review of Literature

Shafquat¹,

Ali²,

Irfan³

et al. 2022

Pak Heart J

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“…This sustainable cost-reduction strategy could help enable development of arrhythmia services in LMICs. 84 , 85 , 86 , 87 , 88 , 89 Limited studies demonstrate safety of ablation and mapping catheters, with the Food and Drug Administration determining no increased risk to health from use of remanufacturing. 88 No incidents of prion transmission attributed to use of a reconditioned EP catheter has been identified to date, with the caveat that prion infection may remain indolent for decades.…”

Section: Opportunities To Build Arrhythmia Treatment Capacity In Reso...mentioning

confidence: 99%

Global disparities in arrhythmia care: Mind the gap

Sharif

Ptaszek²

2022

Heart Rhythm O2

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“…Опитування інтервенційних кардіологівчленів European Heart Rhythm Association (EHRA), проведене онлайн у 2020 р., виявило, що 53 % респондентів повторно використовували одноразові інструменти, а європейські інтервенційні електрофізіологи вважають таке використання загалом безпечним та економічно ефективним. З огляду на потенційні фінансові та екологічні переваги переробки, а також законодавчі вимоги протягом останніх десятиліть, необхідні актуальні та надійні дані щодо безпечності та економічної ефективності повторного використання [18].…”

Section: дискусії та обговоренняunclassified

Supporting sustainable development goals and the challenge of reusing of the single use instruments in interventional radiology

Vyval¹,

Shchehlov²,

Chebanyuk³

2022

Ukr. ìnterv. nejroradìol. hìr.

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Interventional radiology has traditionally been at the forefront of the modern medicine, offering minimally invasive alternatives to surgical treatment with reducing of the length of hospital stay. The problem of medical waste and the recycling of medical supplies to support sustainable development goals in the health sector has entred a “green revolution” that aims to overcome global warming and fight with environmental pollution. Operating waste accounts for 20 to 70 % of all hospital waste, and many of them require special disposal. On the other hand, revenues for health care companies continue to rise, as do patient care costs, which are a huge burden for families and health systems, especially in low-income countries during COVID-19 pandemic. The issue of disposal and reuse of unique, expensive disposable radiological profile instruments is not widely reported in the scientific literature, but surveys among interventionists indicate that reuse exists even in countries where it is officially prohibited. Despite the emergence of regulations on the reuse of disposable instruments, it is largely carried out outside the quality standards. Also, manufacturers are not interested in reusing disposable instruments and often refuse to provide information on how they can be properly recycled and sterilized. Although well-remanufactured tools have significant promise, both for reducing healthcare costs and environmental pollution, and for spreading modern interventional technologies to the critical places where resources are limited and they can save lives.

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Reprocessing of electrophysiology material in EHRA countries: an EHRA Young EP survey

Cited by 9 publications

References 17 publications

Reprocessing Cardiac Electrophysiology Catheters: Recommendations of Pak HRS Task Force and Review of Literature

Reprocessing Cardiac Electrophysiology Catheters: Recommendations of Pak HRS Task Force and Review of Literature

Global disparities in arrhythmia care: Mind the gap

Supporting sustainable development goals and the challenge of reusing of the single use instruments in interventional radiology

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