Abstract
BackgroundEndolaser probes have been designed and sold for single-use only. However, in Brazil, they are not included in the list of single-use medical products that are prohibited from being reprocessed and could potentially be reused if safety requirements are accomplished. Therefore, this study aimed to determine and compare the quality, safety and costs of reprocessed versus original single-use endolaser probes of a specific brand and model.MethodsThe study, conducted at a university hospital in Sao Paulo, Brazil, was divided in two phases. The first one tested the feasibility, sterility and physical integrity of ten reprocessed laser probes. In the second phase, all vitrectomy procedures using endolaser probes (reprocessed and original ones) from August 2017 to October 2019 were evaluated. The operated cases were followed for any signs of infection and number of defective probes for each group were counted. The cost of acquiring a new probe and for all reprocessing stages were evaluated and quantified in US dollars($).ResultsMicrobiologic, residual ethilen oxide and microscopic evaluation of integrity of reprocessed laser probes were all within acceptable range. The second phase of this study included 590 endolaser probes, of which 375 were original and 215 were reprocessed. Functionality rates differed significantly between groups. Among the original probes, 373 (99.47%) were functioning and 2 (0.53%) were non-functioning. Among the reprocessed ones, 201 (93.5%) were functioning and 14 (6.5%) were non-functioning (p < .001). The average cost of one reprocessing was $3.00, and the average cost of an original probe was $150.00. Considering the loss rates, potential savings were $147.60 for each once-reprocessed probe. The frequency of infectious endophthalmitis was null in both groups.ConclusionsOur study showed that a single cycle endolaser probe reprocessing was safe and efficient, not associated with increase in endophthalmitis rate and proved to be significantly cost-effective, even considering a greater malfunction rate when compared to the original devices.
Highlights
Endolaser probes have been designed and sold for single-use only
This study was conducted at the University of Sao Paulo Medical School Clinics Hospital (HCFMUSP), located in Sao Paulo-SP, Brazil, and it was approved by the Institutional Review Board, under registration number 31251520.1.0000.0068
As for the presence of endotoxins, the amount of pyrogen detected was minimal (< 0.5 Units of endotoxin per milliliter (EU/mL)), and ethylene oxide (ETO), ethylene chlorohydrin (ETC) and ethylene glycol (ETG) residues were within the recommended safe limit (< 25PPM, < 25PPM, and < 250PPM, respectively)
Summary
In Brazil, they are not included in the list of single-use medical products that are prohibited from being reprocessed and could potentially be reused if safety requirements are accomplished. Endolaser probes are a useful tool for the induction of chorioretinal adhesions and to ablate ischemic retina. This instrument plays an important role in the surgical treatment of common diseases, such as rhegmatogenous retinal detachment, retinal tears and proliferative diabetic retinopathy [3]. According to its resolution number 2605, published on August 11th, 2006, endolaser probes are not included in the list of single-use medical products that are prohibited from being reprocessed and could potentially be reprocessed [5]. Many manufacturers add a single use label on the packing, that inhibits any reprocessing initiative
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