Authors' objectives:

Given a new regulation restricting the use of EtO/CFC as a sterilization process for medical material, the purpose of the bulletin was to review the scientific evidence regarding the effectiveness and the safety of alternative methods to EtO/CFC for sterilizing reused "single-use only" devices, particularly cardiac catheters and pacemakers.

Authors' results and conclusions: 1) As used in the QPHL study, the plasma technologies (Sterrad and Plazlyte) are not an option for sterilizing angioplasty catheters. 2) Bearing in mind that the results of the QPHL study apply only to the models of catheter studied, the 100% ethylene oxide process can be considered an effective alternative for sterilizing catheters. 3) If the Regulation respecting ozone-depleting substances is amended to permit the use of HCFCs for a few more years, the effectiveness of sterilizers converted to EtO/HCFC in sterilizing cardiac catheters will have to be evaluated before basing their reuse on this process, bearing in mind that this solution will only be a temporary one.4) In the light of the data available at this time, it seems unlikely that the EtO/CO2 mixtures are promising options for replacing EtO/CFC.5) Tests should be conducted to rigorously demonstrate the effectiveness of glutaraldehyde in sterilizing catheters and demonstrate that the process does not increase the risk of breakage or malfunction.6) As for pacemakers, none of the technologies currently considered for replacing EtO/CFC has yet been tested to check their effectiveness in sterilizing these devices for the purpose of reuse.

Authors' recommendations: Given the paucity of rigorous, specific, scientific data on the effectiveness of the methods currently available as alternatives to EtO/CFC for sterilizing cardiac catheters and pacemakers, CETS is insistent about cautioning institutions against the risk of applying the positive conclusions of its previous reports on reutilization to any practice based on a sterilization method other than EtO/CFC. This warning applies not only to the reuse of catheters and pacemakers, but also to the reuse of other single-use devices, especially those with complex geometry or a narrow lumen. These include a number of single-use devices reused in laparoscopic surgery.

Authors' methods: Review

Project Status: Completed

URL for project: http://www.aetmis.gouv.qc.ca/

Year Published: 1995

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: Canada

Organisation Name: Conseil d'Evaluation des Technologies de la Santé du Québec

Contact Address: Conseil d'Evaluation des Technologies de la Santé du Québec, 2021, avenue Union, #1040, Montréal, Québec H3A S29, Canada. Tel: 514-873-2563; FAX: 514-873-1369

Contact Name: aetmis@aetmis.gouv.qc.ca

Contact Email: aetmis@aetmis.gouv.qc.ca

Copyright: Conseil d'Evaluation des Technologies de la Sante du Quebec (CETS)