Reuse of Pacing Catheters: A Survey of Safety and Efficacy

O’Donoghue, Susan; Platia, Edward V.

doi:10.1111/j.1540-8159.1988.tb03988.x

Cited by 28 publications

(12 citation statements)

References 1 publication

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“…The criticisms that can be made of these studies are that one was a retrospective survey that depended on the memory of those who responded. 9 It is possible that isolated events escaped the attention of the participants in the survey or they may have forgotten complicating events. The other prospective studies involved smaller numbers of patients.…”

Section: Limitations Of Available Clinical Datamentioning

confidence: 99%

Reprocessing of Electrophysiology Catheters: Clinical Studies, Regulations, and Recommendations. A Report of the NASPE Task Force on Reprocessing of Electrophysiological Catheters

Lindsay

Kutalek

Cannom

et al. 2001

Pacing Clinical Electrophis

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Section: Limitations Of Available Clinical Datamentioning

confidence: 99%

Reprocessing of Electrophysiology Catheters: Clinical Studies, Regulations, and Recommendations. A Report of the NASPE Task Force on Reprocessing of Electrophysiological Catheters

Lindsay

Kutalek

Cannom

et al. 2001

Pacing Clinical Electrophis

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“…However, a study comparing infection risk in patients undergoing cardiac catheterization with disposable versus reprocessed catheters found that no patient developed infection (Frank et al, 1988). Similarly, in a survey of 12 large medical centers, reuse of pacing catheters was common and was not associated with postprocedure infections (O'Donoghue and Platia, 1988).…”

Section: Discussionmentioning

confidence: 99%

Hemodynamic Catheters: The Reprocessing, Cleanliness and in vitro Biofilm Formation by <i>Enterococcus faecium</i> in a Continuous Flow Model

Silva¹,

Oliveira²,

Guizi³

et al. 2015

American Journal of Infectious Diseases

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Reprocessing single-use devices to cut costs is a common practice in hospitals around the world. In Brazil, there are few studies of reprocessing hemodynamic catheters and thus, this study aimed to evaluate the effectiveness of reprocessing hemodynamic catheters before and after biofilm formation in vitro using a continuous flow model. We used a sterility test and Scanning Electron Microscopy (SEM) to assess the presence of microorganisms, residue and integrity of a New (NC) and Reprocessed (RC) hemodynamic catheter, before and after in vitro biofilm formation by a clinical isolate of Enterococcus faecium (strain 155). NC was considered the negative control. The sterility test did not show the presence of microorganisms in either catheters used as a negative control (NC and RC). On the other hand, changes in integrity were observed by SEM in the RC, with a large number of microcracks and recesses, indicating that this would get worse after reprocessing. After biofilm formation and subsequent sterilization by ethylene oxide, both catheters were examined by SEM and RC showed a dense array of exopolysaccharide and substantial organic waste material, which was not evident in NC, showing changes in surface integrity. Ethylene oxide sterilization is very efficient in the sterilization process but the reprocessed catheters after biofilm formation by strain 155, showed marked surface changes, which increases the adhesion of organic matter and compromises the cleaning process in reprocessing. The results can be used as a parameter for hospitals and companies that reprocess catheters, to develop protocols for standardized and systematic surveillance in reusing materials recommended for single use to prevent infections.

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“…Le specie Bacillus sono state impiegate per la loro documentata resistenza alla sterilizzazione a bassa temperatura, (14)(15)(16)(17)(18) utilizzando colture in cui è stata verificata la presenza sia di forme vegetative che sporali. Enterococcus faecium e Escherichia coli sono ceppi rappresentativi di batteri Grampositivi e Gram-negativi ampiamente diffusi e potenzialmente patogeni e per questo indicati in letteratura come ceppi utili alle valutazioni microbiologiche per la convalida della rigenerazione di dispositivi medici monouso (8).…”

Section: Materiali E Metodiunclassified

“…Da un'analisi della letteratura emergono dati contrastanti circa la sicurezza e l'efficacia di un possibile riutilizzo dei SUDs (1,2,7,9,17). Al giorno d'oggi, la cardiologia interventistica rappresenta uno dei campi in cui questa procedura sembra maggiormente indicata per sicurezza ed efficacia.…”

Section: Introduzioneunclassified

La sterilità dei dispositivi monouso rigenerati. Studio su cateteri per cardiologia interventistica dopo riutilizzo simulato

Caola¹,

Tessarolo²,

Caciagli³

et al. 2006

Microbiol Med

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INTRODUZIONELa medicina moderna fa largo uso di tecnologie minimamente invasive basate su dispositivi medici monouso (SUDs), ma il crescente numero di interventi e il conseguente carico economico per il sistema sanitario, ha indotto molti paesi all'adozione di una politica di rigenerazione (5,10,16,20). Da un'analisi della letteratura emergono dati contrastanti circa la sicurezza e l'efficacia di un possibile riutilizzo dei SUDs (1,2,7,9,17). Al giorno d'oggi, la cardiologia interventistica rappresenta uno dei campi in cui questa procedura sembra maggiormente indicata per sicurezza ed efficacia. Tuttavia vi è carenza di studi europei sulla fattibilità del riutilizzo e di convalida di procedure di rigenerazione. Questa scarsità di prove tecniche e cliniche si riflette su una mancanza di approccio armonizzato della Comunità Europea nei confronti di una politica di rigenerazione. In Italia è stata diffusa una Circolare del Ministero della Salute del 1 aprile 2005 che scoraggia la pratica di rigenerazione e riutilizzo dei dispositivi medici monouso, riconoscendo nel medesimo tempo l'assenza di un esplicito, specifico divieto nella normativa vigente in materia di dispositivi medici (4). Per un riutilizzo dei dispositivi in condizioni di sicurezza e efficienza, la procedura di rigenerazione deve garantire il riapprontamento di tutte le caratteristiche igieniche e funzionali proprie di un disposi- Sterility evaluation after simulated use and reprocessing of interventional cardiology disposable catheters SUMMARYThe reuse of single use devices is of particular interest in interventional cardiology where the economic load of the devices represents a significant share of the whole procedure. The sterility of the reprocessed device must be tested and warranted, together with chemical-physical and functional performances. This study evaluates the efficiency and limitations of an experimental reprocessing protocol in order to assess the sterility of cardiac electrophysiology catheters and the maximum number of regeneration cycles sustainable by the device. A first lot of 54 devices, collected after clinical use in the Cardiology Department of S.Chiara Hospital in Trento, was reprocessed and tested for sterility. Devices underwent repeated cycles of simulating-use (bacteria spiked blood) and regeneration (decontamination, cleaning and hydrogen peroxide gas plasma sterilization): 36, 24, 28, 35, 22 devices were regenerated respectively 2, 3, 4, 5 and 6 times. Entire devices were cultured for 28 days in trypticase soy broth.On the whole, we tested 199 samples, six cycles of regeneration and four inoculation species. No positive sample to inoculated strain was found until the fourth cycle of reprocessing. The inoculated Bacillus subtilis strain was recovered in samples reprocessed five and six times. Reprocessing procedures following the adopted protocol turned out efficient to guarantee device's sterility up to five reuses in experimental conditions representing the worst case scenario for bacterial load. However, complexity of...

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Reuse of Pacing Catheters: A Survey of Safety and Efficacy

Cited by 28 publications

References 1 publication

Reprocessing of Electrophysiology Catheters: Clinical Studies, Regulations, and Recommendations. A Report of the NASPE Task Force on Reprocessing of Electrophysiological Catheters

Reprocessing of Electrophysiology Catheters: Clinical Studies, Regulations, and Recommendations. A Report of the NASPE Task Force on Reprocessing of Electrophysiological Catheters

Hemodynamic Catheters: The Reprocessing, Cleanliness and in vitro Biofilm Formation by <i>Enterococcus faecium</i> in a Continuous Flow Model

La sterilità dei dispositivi monouso rigenerati. Studio su cateteri per cardiologia interventistica dopo riutilizzo simulato

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