[Reuse of single use medical devices]
Martin G, Caron L, Obadia A
Record ID 32007000269
French
Authors' recommendations:
In light of the analysis of the different issues raised by the reuse of critical or semi-critical SUDs, the acceptable options for the use of this practice are the following:continue reprocessing SUDs in-house by obliging health-care institutions to meet the highest recognized standards of quality; orsubcontract reprocessing to a third-party reprocessor certifi ed by a regulatory authority and qualifi ed to supply a fi nal product that meets the standards and requirements applicable to all manufacturers of SUDs.In return, each of these options gives rise to certain requirements:A. Any institution wishing to reprocess critical or semi-critical SUDs in-house in order to reuse them must ensure the following:Reprocessing protocols must be developed by the professionals concerned and validated both inside and outside the institution, and their implementation must be closely monitored by a recognized authority.Device-tracking mechanisms must be implemented to ensure disclosure of all necessary information in the event of anyincident, accident or complication;Policies and procedures for reprocessing and reusing SUDs must be adopted openly and offi cially by the health-care facility and endorsed by resolution of the board of directors.Proof of the effectiveness and safety of this practice must be strictly based on scientific evidence or field studies.Proof of the cost-effectiveness of this practice must be clearly established for each SUD, taking into account all the costs associated with the development of best practices for reprocessing them and its potential risks.B. Any health-care institution that wishes to have its critical or semi-critical SUDs reprocessed by a certified reprocessor should ensure the following:Reuse of reprocessed SUDs must meet the conditions for the safe provision of care and this practice must be formally approved by its board of directors;The decision to reprocess and reuse SUDs must be made in accordance with good management principles and mustdemonstrate real and signifi cant cost savings.The contractual terms and conditions that it establishes with a third-party reprocessor (companies are solely in the United States for the time being) must comply with Canada’s and Québec’s regulations and guarantee that the company is applying the highest quality standards, that is, those defined by the U.S. FDA’s regulatory framework.
Authors' methods:
Review
Details
Project Status:
Completed
Year Published:
2009
URL for published report:
http://www.aetmis.gouv.qc.ca/site/download.php?f=af141bf2d15cceca5a483acb3b042399
English language abstract:
An English language summary is available
Publication Type:
Not Assigned
Country:
Canada
MeSH Terms
- Disposable Equipment
- Equipment Reuse
- Infection Control
- Sterilization
Contact
Organisation Name:
Agence d'évaluation des technologies et des modes d'intervention en santé
Contact Address:
2021, avenue Union, Bureau 10.083,Montreal, Quebec H3A S29, Canada.Tel: +1 514 873 2563; Fax: +1 514 873 1369
Contact Name:
demande@inesss.qc.ca
Contact Email:
demande@inesss.qc.ca
Copyright:
Agence d'Evaluation des Technologies et des Modes d'Intervention en Sante (AETMIS)
This is a bibliographic record of a published health technology assessment from a member of INAHTA or other HTA producer. No evaluation of the quality of this assessment has been made for the HTA database.