Safety and efficacy of hydrogen peroxide plasma sterilization for repeated use of electrophysiology catheters

Bathina, Murali N.; Mickelsen, Steven; Brooks, Conni; Jaramillo, Joe; Hepton, Trish; Kusumoto, Fred

doi:10.1016/s0735-1097(98)00401-x

Cited by 43 publications

(27 citation statements)

References 9 publications

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“…Bathina et al conclude that hydrogen peroxide gas-plasma sterilization provides a cost-effective means of sterilizing nonlumen electrophysiology catheters without the problem of potentially harmful chemical residuals [145]. Gadri et al and Adler et al arrive at a similar conclusion that plasma sterilization is simple, cost-effective and suitable for online treatment of webs and such three-dimensional workpieces as medical instruments [135,141].…”

Section: Plasma Sterilizationmentioning

confidence: 99%

Plasma-surface modification of biomaterials

Chu

Chen

Wang

et al. 2002

Materials Science and Engineering: R: Reports

1,406

652

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Plasma-surface modification (PSM) is an effective and economical surface treatment technique for many materials and of growing interests in biomedical engineering. This article reviews the various common plasma techniques and experimental methods as applied to biomedical materials research, such as plasma sputtering and etching, plasma implantation, plasma deposition, plasma polymerization, laser plasma deposition, plasma spraying, and so on. The unique advantage of plasma modification is that the surface properties and biocompatibility can be enhanced selectively while the bulk attributes of the materials remain unchanged. Existing materials can, thus, be used and needs for new classes of materials may be obviated thereby shortening the time to develop novel and better biomedical devices. Recent work has spurred a number of very interesting applications in the biomedical field. This review article concentrates upon the current status of these techniques, new applications, and achievements pertaining to biomedical materials research. Examples described include hard tissue replacements, blood contacting prostheses, ophthalmic devices, and other products. #

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Section: Plasma Sterilizationmentioning

confidence: 99%

Plasma-surface modification of biomaterials

Chu

Chen

Wang

et al. 2002

Materials Science and Engineering: R: Reports

1,406

652

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“…In the literature (Block, 1991;Heckert et al, 1997;Johnston et al, 2005;Klapes & Vesley, 1990;Roberts et al, 2006), there are numerous applications of VPHP in the decontamination of fermenters, dialysers, incubators, isolators (Fisher & Caputo, 2004;Lysfjord & Porter, www.intechopen.com Organic Pollutants Ten Years After the Stockholm Convention -Environmental and Analytical Update 406 1998), glove boxes, hazard boxes (Hall et al, 2007), animal houses (Kahnert et al, 2005;Krause et al, 2001), hospital wards (French et al, 2004;Hardy et al, 2007), inner space of airplanes (Krieger & Mielnik, 2005;Shaffstall et al, 2011), ambulances, various large spaces (Krause et al, 2001), lyophylisators (Johnson et al, 1992), ultra centrifuges, sterilization tests (Kokubo et al, 1998), product and pipe lines (Hatanaka & Schibauchi, 1989), dental and surgery instruments (catheters, endoscopes, etc.) (Bathina et al, 1998), contact lenses, hardware space systems (Chung et al, 2008), and food commodities (Forney et al, 1991;Gruhn et al, 1995;Sapers et al, 2003;Simmons et al, 1997). It is a method by which a high selectivity of the process can be achieved due to very precise control of the sterilization conditions (concentration of VPHP, temperature, time of sterilization) and thus only pathogenic microorganisms are destroyed leaving normal living cells unharmed.…”

Section: Vapor Phase Hydrogen Peroxidementioning

confidence: 99%

“…In order to boost up the effects of hydrogen peroxide vapor, its ionization by plasma can be performed (Bathina et al, 1998;U.S. Environmental Protection Agency, 2005;Vassal et al, 1998).…”

Section: Synergism Of Vphp and Related Chemicophysical Factorsmentioning

confidence: 99%

Vapor Phase Hydrogen Peroxide – Method for Decontamination of Surfaces and Working Areas from Organic Pollutants

Kačer¹,

Švrček²,

Syslová³

et al. 2012

Organic Pollutants Ten Years After the Stockholm Convention - Environmental and Analytical Update

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“…Il lungo periodo di incubazione è considerato sufficiente a evidenziare la presenza anche di forme batteriche a vitalità compromessa (batteri "stressati" da disinfettanti e agenti sterilizzanti), specie a lenta crescita e forme sporali. Un'ulteriore particolarità di questa metodica, se messa a confronto con altre riportate in letteratura (1,3,6,12), è rappresentata dalla possibilità di testare il dispositivo nella sua integrità ed interezza. Questo risulta di fondamentale importanza considerato che, sebbene il manipolo non penetri all'interno di distretti corporei sterili, è comunque richiesta la sterilità dell'intero dispositivo per l'impiego sul campo operatorio.…”

Section: Discussioneunclassified

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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Safety and efficacy of hydrogen peroxide plasma sterilization for repeated use of electrophysiology catheters

Cited by 43 publications

References 9 publications

Plasma-surface modification of biomaterials

Plasma-surface modification of biomaterials

Vapor Phase Hydrogen Peroxide – Method for Decontamination of Surfaces and Working Areas from Organic Pollutants

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

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