PMID- 29230637
OWN - NLM
STAT- MEDLINE
DCOM- 20180831
LR  - 20191210
IS  - 1572-8595 (Electronic)
IS  - 1383-875X (Linking)
VI  - 51
IP  - 1
DP  - 2018 Jan
TI  - Conception and validation of a protocol for reuse of non-irrigated 
      electrophysiology catheters in a Brazilian teaching hospital.
PG  - 45-50
LID - 10.1007/s10840-017-0301-3 [doi]
AB  - PURPOSE: Since the Brazilian current legislation permits the reuse of single-use 
      devices under a validated processing protocol, the main purpose of our study was 
      to develop and validate a method for reusing non-irrigated electrophysiology 
      catheter (EC). METHODS: Manual and mechanical processing by ultrasonic washer was 
      associated with the use of enzymatic solution and hydrogen peroxide with a final 
      rinse with filtered water. Validation of the cleaning process, as well as 
      catheter integrity, was done by observing the ECs in stereoscopic microscope at 
      x60 magnification, followed by HemoCheck-S(R) (HCS) test to monitor the presence of 
      residual blood on their surfaces. Ethylene oxide (EO) was used for sterilization, 
      and the final validations of the processing were performed by assays of 
      sterility, pyrogenicity, and EO residuals. Lastly, a cost-minimization study was 
      performed. RESULTS: Cleaning process demonstrated absence of organic material 
      detectable by HCS at the surfaces of the ECs. Assays for sterility were negative, 
      and assays of EO residuals and endotoxins showed levels under established 
      standards. The number of reuses was settled to a maximum of seven uses for the 
      ECs with handle and ten uses for ECS without handle. The cost-minimization study 
      showed an 84% savings, when considering seven reuses. CONCLUSIONS: Processing of 
      ECs was validated at all stages. Therefore, reuse of ECs under the conditions 
      that we designed was considered safe for patients and cost-effective for our 
      institution.
FAU - Leichsenring, Mirtes Loeschner
AU  - Leichsenring ML
AD  - Infection Control Service, University of Campinas Hospital, Campinas, Brazil.
FAU - Psaltikidis, Eliane Molina
AU  - Psaltikidis EM
AD  - Quality Improvement and Patient Safety Division, University of Campinas Hospital, 
      Campinas, Brazil.
FAU - de Oliveira Figueiredo, Marcio Jansen
AU  - de Oliveira Figueiredo MJ
AD  - Electrophysiology Service, University of Campinas Hospital, Campinas, Brazil.
AD  - Department of Internal Medicine, School of Medicine, University of Campinas, 
      Campinas, Brazil.
FAU - Moretti, Maria Luiza
AU  - Moretti ML
AD  - Department of Internal Medicine, School of Medicine, University of Campinas, 
      Campinas, Brazil.
FAU - Trabasso, Plinio
AU  - Trabasso P
AUID- ORCID: 0000-0002-0588-4859
AD  - Department of Internal Medicine, School of Medicine, University of Campinas, 
      Campinas, Brazil. trabasso@fcm.unicamp.br.
LA  - eng
PT  - Journal Article
PT  - Validation Study
DEP - 20171211
PL  - Netherlands
TA  - J Interv Card Electrophysiol
JT  - Journal of interventional cardiac electrophysiology : an international journal of 
      arrhythmias and pacing
JID - 9708966
RN  - 0 (Anti-Infective Agents)
SB  - IM
MH  - Anti-Infective Agents/*pharmacology
MH  - Brazil
MH  - Cardiac Catheterization/*instrumentation/methods
MH  - *Cardiac Catheters
MH  - Cost Savings
MH  - Cross Infection/prevention & control
MH  - Electrophysiology/instrumentation
MH  - Equipment Reuse/economics/*legislation & jurisprudence
MH  - Equipment Safety/economics
MH  - Female
MH  - Hospitals, University
MH  - Humans
MH  - Male
MH  - Sterilization/*methods
OTO - NOTNLM
OT  - Cost-minimization study
OT  - Electrophysiology catheters
OT  - Reprocessing
OT  - Reuse
OT  - Single-use device
OT  - Validation study
EDAT- 2017/12/13 06:00
MHDA- 2018/09/01 06:00
CRDT- 2017/12/13 06:00
PHST- 2016/12/14 00:00 [received]
PHST- 2017/11/29 00:00 [accepted]
PHST- 2017/12/13 06:00 [pubmed]
PHST- 2018/09/01 06:00 [medline]
PHST- 2017/12/13 06:00 [entrez]
AID - 10.1007/s10840-017-0301-3 [pii]
AID - 10.1007/s10840-017-0301-3 [doi]
PST - ppublish
SO  - J Interv Card Electrophysiol. 2018 Jan;51(1):45-50. doi: 
      10.1007/s10840-017-0301-3. Epub 2017 Dec 11.