Medical Economics
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Summary
Presently, the original packaging of the vast majority of catheters used in angioradiology and hemodynamics reads "for single use only". Nonetheless, as this can result in considerable savings, this type of equipment is being reused in a good number of Canadian, American and European hospitals. However, few hospitals have a formal catheter reutilization policy and procedures to ensure the safety and effectiveness of interventions performed with reused catheters.
Theoretically, for patients who undergo hemodynamic, angioradiologic and angioplastic procedures, the risks involved in this practice are infections, pyrogenic reactions, toxicity, particulate contamination, catheter breakage and biological incompatibility. These risks are not nil even when new equipment is used.
A review of the literature and the results of studies undertaken at the Hopital du Sacr»-Coeur de Montr»al and the Hotel-Dieu de Quebec at the request of the Conseil d'evaluation des technologies de la sante du Quebec, have led to the conclusion that the risk of infection is not significantly higher with reused catheters than with new ones, provided an effective cleaning and sterilization procedure is followed.
Similarly, good cleaning and rinsing procedures with pyrogen-free water can a of ethylene oxide absorbed by the catheter material during sterilization. The literature has not demonstrated any effect of reuse on catheter biocompatibility.
As for the risk of a catheter breaking during a procedure, mechanical tests on several types of diagnostic catheters sold for single use revealed that they did not become more fragile after multiple reuses. However, this aspect of safety must be established for each new type of catheter placed on the market.
As for the staff involved in the different steps of reutilization, the risk to which they are exposed is no greater than that for physicians and clinical personnel who perform any angioradiologic or hemodynamic procedures, as long as the appropriate precautions are taken.
As for clinical effectiveness, generally speaking, if the cleaning and sterilization procedures are carried out properly, an undamaged, reused diagnostic catheter will present the same characteristics and the same effectiveness as a new catheter. In the case of balloon catheters, reuse can occasionally alter the shape of the balloon, but this is of no major consequence to the procedure. Good quality control during the cleaning and sterilization process and at the time of the medical procedure allow elimination of catheters with significant flaws.
It is possible that the practice of reuse causes a slight increase in the number of catheters used during diagnostic or angioplastic procedures and thus causes some increase in the duration of these procedures because a catheter will occasionally have to be replaced.
As for the optimum number of reuses, it is impossible to establish a general rule for all catheters. Experience, the cost of the catheter, its physical characteristics and the cost of reuse will serve as a guide in making a decision. Eventually, after a certain number of reuses, the risk must increase; especially the risk of bending with the number of times the catheter is manipulated, with increasing presence of particles of microscopic debris, and also with normal aging of the materials from which the catheter is made, even if it is not reused. In addition, the annual savings realized decrease hyperbolically as the number of reuses increases. In practice, with most diagnostic catheters, the annual savings are minimal after five reuses. In the case of balloon catheters, the savings decrease appreciably after three reuses.
In the United States, the Joint Commission on Accreditation of Hospitals is no longer opposed to reuse. Nor is the Food and Drug Administration but it does set out three main principles that should govern this practice. In Canada, the Canadian Standards Association has only given its opinion on resterilization. Health and Welfare Canada does not recommend reuse unless it is closely regulated. As for the manufacturers, they oppose reuse.
Under federal legislation, which is not very clear in this regard, it is possible that an institution that reuses a single-use catheter may be considered comparable to a manufacturer. It must therefore be able to provide, upon the request of the Health Protection Branch, evidence of the safety and effectiveness of these reused devices. To this end, it must obviously be able to establish that the necessary procedures have been put in place and that they give adequate results.
Under Qu»bec civil law, as part of a hospital's responsibility, the institution has an "obligation of result" with regard to supplying devices in good condition. The reuse of catheters would, therefore, as such, not constitute a fault as long as the desired results were achieved using appropriate procedures. However, should damage nevertheless occur following the use of such a catheter, the burden of proof of non-liability would be heavier for the institution: it would have to prove that the damage actually resulted from an external cause that could not be attributed to it. A fault committed by a staff member would not be an external cause, since the hospital would have to answer for it.
The physician, obliged to act with prudence, diligence and skill when administering care and treatment ("obligation of means"), is answerable only for improper use of the device, not for its quality, unless the latter is obviously lacking.
The patient's specific consent to the use of a reused catheter is not necessary if there is no increase in the risk or inconvenience. However, straightforward answers must be given to any questions. The existence of a catheter reutilization policy, if the hospital has one, should never be concealed.
In any case, it is important to show that all the steps involved in the practice of reuse, such as cleaning and sterilization, have been officially approved by the institution.
In Qu»bec, the Association des hopitaux du Quebec protects hospitals that reuse equipment, through its insurance program. For its part, the Canadian Medical Protective Association says that, if a mishap attributable to the reuse of a so-called non-reusable catheter gives rise to a lawsuit against a physician, his eligibility to receive assistance from the association would not be compromised in any way [Doucet 1992].
Reusing catheters can cause moderate savings. It is estimated that using diagnostic catheters five times will generate net savings of about $50,000 per 1,000 catheterizations. Using angioplasty catheters three times will produce savings of about $300,000 per 300 angioplastic procedures.
In summary, the practice of reusing diagnostic and angioplasty catheters, when governed by a strict, clear and realistic policy and procedures covering all aspects of reuse, including quality control and staff training, does not present unacceptable risks and can be considered as clinically effective as using only new catheters.
Few hospitals have formal, systematic and standardized procedures for the cleaning, sterilization and quality control concerning catheter reutilization. Clear and strict procedures urgently need to be established along to the guidelines set out in Appendix I. They must be formally and openly approved by each institution in which catheters labelled "for single use only" are reused. The procedures must cover all aspects of reuse. Furthermore, technological developments in the market place must be monitored on an ongoing basis.
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