Authors' objectives:

This report takes stock of the situation with several months' hindsight. It presents the latest scientific developments concerning the outbreak of bovine spongiform encephalopathy (BSE), the possible link between BSE and the emergence of a new variant of CJD, and the modes of inter-human CJD transmission, including the risk of blood-borne transmission. This report also includes an estimate of the risk of a patient being exposed to a catheter previously used in an individual with CJD. These elements will enable CETS to assess the potential risk of CJD transmission associated with the reuse of single-use angioplasty and angiography catheters.

Authors' results and conclusions: CETS is of the opinion that single-use devices, such as cardiac catheters, should not be reused if they have come in contact with the blood of a patient consideredto pose a risk of being a vector for CJD'. Such an approach requires a greater vigilance in hospitals in identifying patients who have, are suspected of having or might develop CJD, and in instituting the appropriate procedures. As for individuals who do not fit the definition ofpatient posing a risk of being a vector for CJD', CETS is of the opinion that, given the current state of knowledge, the reuse of single-use angioplasty and angiography catheters does not pose any unacceptable risks as regards the possible transmission of Creutzfeldt-Jakob disease. The other risks associated with the reuse of single-use catheters include equipment breakage, loss of functional integrity, contamination and pyrogenic reactions. According to an analysis performed by the ECRI in the United States, the studies published since CETS issued its first notice on the matter (The reuse of single-use catheters) do not contain any new scientific evidence suggesting that the reuse of single-use catheters is associated with an unacceptable level of risk. However, research has not produced any new evidence for drawing any conclusions as to the safety of the practice or the conditions that could guarantee such safety either. It should be noted that none of these studies examined the risks associated with the transmission of CJD or nv-CJD. This paucity of studies on the risks associated with the transmission of these diseases through the reuse of single-use catheters, any other single-use device or even reusable devices, calls for vigilance. Furthermore, given the unknowns about the characteristics of the new variant of CJD observed in Europe, the measures proposed above should be accompanied by close monitoring of the changes in the variant's prevalence in North America and of the developments in the scientific knowledge of this disease.

Authors' recommendations: Given the scientific evidence at our disposal concerning the modes of CJD transmission, CETS considers it essential that Quebec adopt a policy and protocols aimed at preventing iatrogenic CJD transmission through the reuse of medical devices (disposable or otherwise). The said policy and protocols should be based on the four factors mentioned above in order to take into account the level of risk involved in each situation (eg neurosurgery, ophthalmologic surgery, cardiac surgery) and to ensure that the measures adopted are commensurate with each level of risk. Given the uncertainty still surrounding the blood-borne transmissibility of CJD via the peripheral route, CETS is of the opinion that the protocols to be developed in response to the recommendation above should take into consideration the infectivity of blood based on the level of risk posed by the patient.

Authors' methods: Review

Project Status: Completed

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

Year Published: 1997

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)