Life Cycle Assessment and Costing Methods for Device Procurement: Comparing Reusable and Single-Use Disposable Laryngoscopes.

BACKGROUND: Traditional medical device procurement criteria include efficacy and safety, ease of use and handling, and procurement costs. However, little information is available about life cycle environmental impacts of the production, use, and disposal of medical devices, or about costs incurred after purchase. Reusable and disposable laryngoscopes are of current interest to anesthesiologists. Facing mounting pressure to quickly meet or exceed conflicting infection prevention guidelines and oversight body recommendations, many institutions may be electively switching to single-use disposable (SUD) rigid laryngoscopes or overcleaning reusables, potentially increasing both costs and waste generation. This study provides quantitative comparisons of environmental impacts and total cost of ownership among laryngoscope options, which can aid procurement decision making to benefit facilities and public health. METHODS: We describe cradle-to-grave life cycle assessment (LCA) and life cycle costing (LCC) methods and apply these to reusable and SUD metal and plastic laryngoscope handles and tongue blade alternatives at Yale-New Haven Hospital (YNHH). The US Environmental Protection Agency's Tool for the Reduction and Assessment of Chemical and other environmental Impacts (TRACI) life cycle impact assessment method was used to model environmental impacts of greenhouse gases and other pollutant emissions. RESULTS: The SUD plastic handle generates an estimated 16-18 times more life cycle carbon dioxide equivalents (CO2-eq) than traditional low-level disinfection of the reusable steel handle. The SUD plastic tongue blade generates an estimated 5-6 times more CO2-eq than the reusable steel blade treated with high-level disinfection. SUD metal components generated much higher emissions than all alternatives. Both the SUD handle and SUD blade increased life cycle costs compared to the various reusable cleaning scenarios at YNHH. When extrapolated over 1 year (60,000 intubations), estimated costs increased between $495,000 and $604,000 for SUD handles and between $180,000 and $265,000 for SUD blades, compared to reusables, depending on cleaning scenario and assuming 4000 (rated) uses. Considering device attrition, reusable handles would be more economical than SUDs if they last through 4-5 uses, and reusable blades 5-7 uses, before loss. CONCLUSIONS: LCA and LCC are feasible methods to ease interpretation of environmental impacts and facility costs when weighing device procurement options. While management practices vary between institutions, all standard methods of cleaning were evaluated and sensitivity analyses performed so that results are widely applicable. For YNHH, the reusable options presented a considerable cost advantage, in addition to offering a better option environmentally. Avoiding overcleaning reusable laryngoscope handles and blades is desirable from an environmental perspective. Costs may vary between facilities, and LCC methodology demonstrates the importance of time-motion labor analysis when comparing reusable and disposable device options.

Reuse and Biocompatibility of Hemodialysis Membranes: Clinically Relevant?

The practice of reprocessing dialyzers for reuse, once predominant in the United States, has been steadily declining over the last 20 years. The professed roles of reuse in improving dialyzer membrane biocompatibility and lowering the risk of first-use syndrome have lost relevance with the advent of biocompatible dialyzer membranes and favorable sterilization techniques. The potential for cost-savings from reuse is also called into question by the easy availability of comparatively cheaper dialyzers and rising regulatory demands and operational cost of reprocessing systems. While the environmental concerns from additional dialyzer-related solid waste from rising single-use practice remains pertinent and requires development of safer dialyzer disposable system technologies, there is no meaningful medical rationale for the continued practice of dialyzer reuse in the twenty-first century.

Comparative life cycle assessment of disposable and reusable laryngeal mask airways.

BACKGROUND: Growing awareness of the negative impacts from the practice of health care on the environment and public health calls for the routine inclusion of life cycle criteria into the decision-making process of device selection. Here we present a life cycle assessment of 2 laryngeal mask airways (LMAs), a one-time-use disposable Unique™ LMA and a 40-time-use reusable Classic™ LMA. METHODS: In life cycle assessment, the basis of comparison is called the "functional unit." For this report, the functional unit of the disposable and reusable LMAs was taken to be maintenance of airway patency by 40 disposable LMAs or 40 uses of 1 reusable LMA. This was a cradle-to-grave study that included inputs and outputs for the manufacture, transport, use, and waste phases of the LMAs. The environmental impacts of the 2 LMAs were estimated using SimaPro life cycle assessment software and the Building for Environmental and Economic Sustainability impact assessment method. Sensitivity and simple life cycle cost analyses were conducted to aid in interpretation of the results. RESULTS: The reusable LMA was found to have a more favorable environmental profile than the disposable LMA as used at Yale New Haven Hospital. The most important sources of impacts for the disposable LMA were the production of polymers, packaging, and waste management, whereas for the reusable LMA, washing and sterilization dominated for most impact categories. DISCUSSION: The differences in environmental impacts between these devices strongly favor reusable devices. These benefits must be weighed against concerns regarding transmission of infection. Health care facilities can decrease their environmental impacts by using reusable LMAs, to a lesser extent by selecting disposable LMA models that are not made of certain plastics, and by ordering in bulk from local distributors. Certain practices would further reduce the environmental impacts of reusable LMAs, such as increasing the number of devices autoclaved in a single cycle to 10 (-25% GHG emissions) and improving the energy efficiency of the autoclaving machines by 10% (-8% GHG emissions). For both environmental and cost considerations, management and operating procedures should be put in place to ensure that reusable LMAs are not discarded prematurely.

A life cycle assessment of reusable and single-use central venous catheter insertion kits.

BACKGROUND: For most items used in operating rooms, it is unclear whether reusable items are environmentally and financially advantageous in comparison with single-use variants. We examined the life cycles of reusable and single-use central venous catheter kits used to aid the insertion of single-use, central venous catheters in operating rooms. We did not examine the actual disposable catheter sets themselves. We assessed the entire financial and environmental costs for the kits, including the influence of the energy source used for sterilization. METHODS: For the reusable central venous catheter kit, we performed a "time-in-motion" study to determine the labor costs and measured the energy and water consumption for cleaning and sterilization at Western Health, Melbourne, Australia. For the majority of the inputs for the single-use kit, we relied upon industry and inventory-sourced databases. We modeled the life cycles of the reusable and single-use central venous catheter kits with Monte Carlo analysis. RESULTS: Inclusive of labor, the reusable central venous catheter insertion kits cost $6.35 Australian ($A) (95% confidence interval [CI], $A5.89 to $A6.86), and the single-use kits cost $A8.65. For the reusable kit, CO(2) emissions were 1211 g (95% CI, 1099 to 1323 g) and for the single-use kit 407 g (95% CI, 379 to 442 g). Water use was 27.7 L (95% CI, 27.0 to 28.6 l) for the reusable kit and 2.5 L (95% CI, 2.1 to 2.9 l) for the single-use kit. For the reusable kit, sterilization had the greatest environmental cost, and for the single-use kit, the manufacture of plastic and metal components had the largest environmental costs. Different sources of electricity to make the reusable kits patient-ready again affected the CO(2) emissions: electricity from hospital gas cogeneration resulted in 436 g CO(2) (95% CI, 410 to 473 g CO(2)), from the United States electricity grid 764 g CO(2) (95% CI, 509 to 1174 g CO(2)), and from the European electricity grid 572 g (95% CI, 470 to 713 g CO(2)). CONCLUSIONS: Inclusive of labor, the reusable central venous catheter insertion kits were less expensive than were the single-use kits. For our hospital, which uses brown coal-sourced electricity, the environmental costs of the reusable kit were considerably greater than those of the single-use kit. Efforts to reduce the environmental footprint of reusable items should be directed towards decreasing the water and energy consumed in cleaning and sterilization. The source of hospital electricity significantly alters the relative environmental effects of reusable items.

A quality and cost-benefit analysis of dialyzer reuse in hemodialysis patients.

BACKGROUND: To evaluate the benefits of dialyzer reuse for hemodialysis (HD) patients, including the cost of HD treatment and patient's survival, a comparison was made regarding the standard practice of single-use dialysis. METHODS: From January 1, 2005, to December 31, 2005, a total of 128,232 successive HD treatments in 822 patients in Chang Gung Memorial Hospital-Kaohsiung Medical Center were included in this study. RESULTS: Approximately 54.25% (446/822) of patients reused dialyzers. The average times of dialyzer reuse was 2.54. The annual hollow fiber cost is reduced by $241,054.08 U.S. dollars (NT $7,834,257.60). The annual cost of hollow fiber was reduced by $540.48 U.S. dollars (NT $17,565.60) in one patient with dialyzer reuse. The mortality rates in dialyzer reuse and single use groups were 3.1% and 10.9% within one year (p < 0.0001). Multiple logistic regressions showed that single use compared with reuse was associated with higher mortality after adjusting co-morbid conditions including age, diabetes mellitus, etc. CONCLUSIONS. We concluded that the benefits of dialyzer reuse included safety in our center and reduction in cost during a 12-month period. Dialyzer reuse may be a safe alternative.

Effects of sandblasting and silica coating on the bond strength of rebonded mechanically retentive ceramic brackets.

INTRODUCTION: The aim of this study was to determine the bond strength of rebonded mechanically retentive ceramic brackets after treatment with 2 abrasive techniques. METHODS: In addition to a group of new brackets, 3 groups were treated according to the following conditions of debonded ceramic bracket bases: sandblasting, sandblasting + silane, and silica coating + silane (15 in each group). Treated ceramic brackets were rebonded on premolars. The samples were stored in distilled deionized water for 24 hours at 37 degrees C in an incubator and then thermocycled for 1000 times between 5 degrees C and 55 degrees C. Shear force was applied to the enamel-adhesive interface until debonding. RESULTS: The highest bond strength values were in the silica coating + silane and the new bracket groups (12.7 and 12.0 MPa, respectively), followed by the sandblasting + silane group (10.5 MPa). The sandblasting group had a significantly lower bond strength value (4.5 MPa). No enamel fracture was noted in any sample tested. In the new bracket and the sandblasting + silane groups, 20% of the samples had adhesive remnant index scores of 2, and 80% had scores of 3. In the sandblasting group, all specimens debonded at the bracket-adhesive interface. The silica coating + silane group showed mixed failures. CONCLUSIONS: Sandblasting + silane and silica coating + silane applications on debonded ceramic bracket base can produce bond strengths comparable with new brackets.

Cost comparison of reusable and disposable air/water syringe tips in a large French teaching hospital

Air/water syringe (AWS) tips can be used in any type of dental care. They may be disposable (plastic) or reusable (stainless steel or plastic). We assessed the costs of using both sorts of tips in a French teaching hospital. A systematic use of one AWS tip per dental consultation was considered. Consultations performed with reusable AWS (stainless steel) tips give rise to costs linked to initial purchase of tips, their sterilisation, and replacement. Consultation costs of disposable AWS tips were calculated at their current purchase price. Replacing reusable tips was evaluat-ed in two different situations: annual replacement or replacement in case of visual deterioration. Results showed that the number of consultations must lie beyond a certain threshold in order to make reusable tips more economical in use than disposable counterparts. If the reusable tips are replaced every year, this threshold is higher (e.g.: 1,366consultations at the University of Bordeaux) than under a rule of tip replacement in case of visual deterioration (e.g. at the Bordeaux University: 1,267consultations in case of an annual replacement rate of 10%, or 1,289 with a re-placement rate of 30%). This is the first study regarding the costs of disposable versus reusable AWS tips. We suggest that disposable tips might be more cost-effective than reusable tips, not-ably because of their reduced risk of crosscontamination. The choice of the use of one or an-other AWS tip crucially depends on the number of consultations, as well as on their practical utilisation and on infection control issues.

Use of resterilized polypropylene mesh in inguinal hernia repair: a prospective, randomized study.

BACKGROUND: Inguinal hernia repair consumes considerable health-care resources worldwide. Open mesh repairs are commonly used and the feasibility of using a resterilized mesh, which is a general practice in certain countries, has not been evaluated. STUDY DESIGN: In this randomized prospective study, original and resterilized meshes were used in two groups of patients with unilateral inguinal hernia. Microbiologic changes, textile mechanical properties, overall complication rates, and cost-effectiveness of resterilized mesh were investigated. A time period of 3 years was determined for patient enrollment to this pilot feasibility study, with the goal of 100 patients in each group. RESULTS: Ninety-one patients were enrolled in the original group and 93 in the resterilized mesh group. Median followup was 735 and 739 days and calculated interquartile ranges were 454 and 513 days, respectively. Average tensile strength of the original polypropylene mesh changed slightly with resterilization, as maximum load decreased from a mean of 66.6 to 58.2 N/cm. Overall complication rates were similar in the two groups. The 6.6% infection rate in the original mesh group was not statistically different from the 7.5% rate in the resterilized group (p = 0.80, relative risk = 0.88, 95% confidence interval, 0.31-2.51). There was only one recurrence in the original mesh group in the 21st month. Use of a resterilized mesh decreased the overall cost of operation by decreasing the cost of mesh from 15.9% to 8.3% of the total amount. CONCLUSIONS: Use of a resterilized mesh for inguinal hernia repair is feasible without considerable changes in infection and recurrence rates.

Technical and economic feasibility of reusing disposable perfusion cannulas.

OBJECTIVE(S): The reuse of disposable devices is a potential source of significant cost savings to hospitals. Venous and arterial perfusion cannulas under new and reused conditions were selected to identify the clinical, safety, technical, logistic, and economic issues that must be addressed to realize these savings. METHODS: Single- and dual-stage venous and arterial cannulas from two manufacturers were tested when new, after initial clinical use, and after a single clinical use plus up to nine simulated reuses. Reuse was simulated by end-to-end bending, coupling and uncoupling of the connectors, and by two 1-hour soaks in plasma at 4 degrees and 40 degrees C, respectively. Cannulas were decontaminated and then processed by a peracetic acid-based liquid chemical sterilization system after each use/reuse. Sterilization was validated by eliminating Bacillus subtilis spores from the cannulas on each of five consecutive cycles. Cannulas were tested for physical changes, functional integrity, biocompatibility, and in vivo performance in sheep. A cost analysis was also performed. RESULTS: Sterilization was successfully achieved. Mechanical changes were less than 20% on all variables studied and were undetectable by experienced cardiac surgeons in selective evaluation. No clinically important differences were found between new and reused cannulas, even after nine simulated reuses. Reusing cannulas four times would reduce the cost per procedure from $53 to $19 (64%). CONCLUSIONS: Preliminary data suggest that the perfusion cannulas tested can be safely and efficaciously used five times. Limited reuse of these disposable cannulas is technically feasible and cost-effective. Cannula reuse would result in a small incremental savings; however, with more expensive devices and higher-volume sterilization procedures, the savings could be considerably greater. This program provides a model for evaluation of other single-use medical devices for reuse.

Extended reuse of polysulfone hemodialysis membranes using citric acid and heat.

The concomitant use of citric acid and prolonged exposure to heat (CAH) is an increasingly common alternative to purely chemical means of reusing dialyzers. However, there are no data on the effects of reprocessing dialyzers with CAH beyond 15 uses. Increasing the number of reuses with CAH cannot be systematically undertaken unless its safety is documented. We hypothesized that discarding polysulfone dialyzers after the 25th rather than the 15th use would result in increased clearance of beta2-microglobulin (beta2MG) without clinically significant changes in small solute clearance or albumin loss. We studied 15 Fresenius F80B polysulfone dialyzers in five chronic hemodialysis patients. Dialyzers were reprocessed using 1.5% citric acid solution heated to 95 degrees C. Representative fractional collection and 10 minute timed collections of dialysate were performed at baseline and during uses 5, 10, 15, 20, and 25 for each dialyzer. Dialysate-side urea, creatinine, and beta2MG clearances were calculated, and total albumin was measured in dialysate. We used a mixed model to adjust for repeated measures (both within a given dialyzer and for the multiple dialyzers per patient). Of the 15 dialyzers studied, 3 (20%) failed before the 25th use. There was no significant change in urea or creatinine clearance with additional reuse (overall p values 0.20 and 0.60, respectively). A sustained increase in beta2MG clearance was observed after the fifth treatment compared with the first use (p < 0.001). Fractional collection showed that dialysate albumin loss increased significantly with additional reuses (p < 0.001) but did not increase significantly above baseline until treatment 25. Reprocessing of polysulfone dialyzers with CAH 25 times significantly increased albumin loss and beta2MG clearance but did not appear to affect urea or creatinine clearance. Increasing the maximum number of uses to 20 may permit cost savings compared with current practice without additional risk.

The effect of blood contact and reuse on the transport properties of high-flux dialysis membranes.

The effect of blood contact and reprocessing using bleach on the convective transport of both neutral and positively charged dextrans was determined for cellulose triacetate (CT), polyacrylonitrile (PAN), and polysulfone (PS) dialyzers (Fresenius USA, F60B, Concord, CA). For neutral dextrans, blood contact reduced the convective permeability, determined by differences in the sieving coefficient profile for both the PAN and PS, but not for CT dialyzers. Reprocessing of the dialyzers with bleach (up to 15 reuses) did not affect the convective transport of dextrans through CT or PAN, but did enhance the permeability of the blood contacted PS dialyzers. However, sieving coefficients for the blood contacted and reprocessed PS (F60B) dialyzers were significantly lower than those for the other dialyzers studied, approaching zero for dextrans larger than 18 k molecular weight. Sieving coefficients for positively charged, diethylaminoethyl (DEAE) dextrans were a function not only of solute size, but also of the membrane's capacity for adsorption of charged molecules. The majority of smaller, filtered DEAE dextrans adsorbed to the PAN membrane. Adsorption of DEAE dextrans to PAN was not observed for larger dextrans, or for DEAE dextrans of any size with CT, despite the lower permeability of both membranes for DEAE dextran compared to that for neutral dextrans.

Technical and economic feasibility of reusing disposable perfusion cannulae.

The reuse of disposable devices is a potential source of significant cost savings to hospitals. Venous and arterial perfusion cannulae under new and reused conditions were selected to identify the clinical, safety, technical, logistic, and economic issues that must be addressed to realize these savings. Single- and dual-stage venous and arterial cannulae from two manufacturers were tested when new, after initial clinical use, and after a single clinical use plus up to nine simulated reuses. Reuse was simulated by end-to-end bending, coupling and uncoupling the connectors, and by two 1-hour soaks in plasma at 4 degrees C and 40 degrees C, respectively. Cannulae were decontaminated and then sterilized by a peracetic acid based liquid chemical sterilization system following each use/reuse. Sterilization was validated by eliminating Bacillus subtilis spores from the cannulae on each of five consecutive cycles. Cannulae were tested for physical changes, functional integrity, biocompatibility, and in vivo performance in sheep. A cost minimization analysis was also performed. No clinically important differences were found between new and reused cannulae, even after nine simulated reuses. Mechanical changes were less than 20% on all variables studied and were undetectable by experienced cardiac surgeons in selective evaluation. Sterilization was successfully achieved. Reusing cannulae for times would reduce the cost per procedure from $53 to $19 (64%). Perfusion cannulae tested can be safely and efficaciously used five times. This study suggests that reuse would result in a small incremental savings; however, with more expensive devices and higher-volume sterilization procedures, the savings could be exponentially greater. Although this study demonstrates that it may be technically feasible and cost-effective to reuse disposable cannulae, the U.S. Food and Drug Administration does not sanction the reuse of disposable cannulae.

Dialyzer reuse: justified cost saving for south Asian region.

In spite of controversies, dialyzer reuse has remained an integral part of hemodialysis because of lower cost, good overall safety record, and improved membrane biocompatibility. Reuse declined in developed countries from the beginning of this century because of mass production of hemodialyzers at favourable price with better biocompatible membrane. Abandoning dialyzer reuse became challenging in South Asian region, where more than 40% of the population live below the International Poverty Line of $1.25 per day, less than 10% of end stage renal disease patients receive renal replacement therapy, and upto 70% of those starting dialysis stop treatment due to cost within the first 3 months. Dialyzer reuse is an efficient cost-saving method that allows the use of more efficient and expensive biocompatible synthetic membranes, thereby providing high-quality dialysis to individuals living in countries with limited medical resources without compromising the safety or effectiveness of the treatment.

Resterilized mesh in repair of abdominal wall defects in rats.

A variety of negative opinions about repeated usage of relatively expensive resterilized synthetic meshes have been considered. It had been stated that resterilized polypropylene meshes inhibits fibroblastic activity, decreases proliferative activity, and increases apoptosis in human fibroblast culture, in vitro. The purpose of this study is the in vivo evaluation of the resterilized mesh repairs of abdominal hernia defects in rat models of incisional hernia by comparing primer repair and original mesh repairs. The rats (n = 22) were separated into three groups. While the abdominal defect was repaired by primary suture in the control group (CG), the defects were repaired by original mesh (OG) or resterilized mesh (RG) in mesh-repaired groups. After 21 days, the rats were evaluated for tissue tensile strengths, tissue hydroxyproline levels, tissue inflammation, fibrosis, and apoptosis. Although the tensile strengths in OG and RG were significantly higher than those of CG (p < .05 and p < .05), there was no significant difference between two groups. The tissue hydroxyproline levels in OG and RG were also higher than those of CG. The difference was not significant between the two groups. The inflammation and fibrosis indexes in OG and RG were significantly higher than those of CG (p < .0001 for both), but there was no difference between groups. While the apoptosis index in OG and RG was also higher than that of CG (p < .0001 for both), there was no significant difference between OG and RG. The usage of resterilized mesh in abdominal wall repair did not reduce the tissue tensile strength, did not affect the tissue hydroxyproline levels, did not decrease the fibrosis, and did not increase the tissue inflammation and apoptosis. In conclusion, usage of resterilized meshes in abdominal wall defects was as safe as sterilized meshes.

Patient and parent opinion of the use of recycled orthodontic brackets: an international comparison.

The aim of this study was to determine the opinion of patients and parents to the use of recycled orthodontic brackets. The design consisted of a questionnaire survey, which took place in the orthodontic departments of two teaching hospitals (Cardiff, Wales, and Dunedin, New Zealand). The subjects were patients (and parents of those under 18 years) undergoing active fixed appliance treatment and similar groups of those on the waiting list for fixed appliance treatment. There were no significant differences of opinion between gender, patient, parent, or centre. There were significant differences of opinion between those under treatment and those on the waiting list; those under treatment were less concerned about wearing recycled brackets than those waiting for treatment. All respondents felt that they should be told if recycled brackets were to be used, and any savings arising from their use passed on to the consumer.

A clinical project to evaluate reuse of a CAPD disconnect system minicap as a safe, effective practice.

The current health care environment is being driven by approaches to health care services that focus on quality and at the same time cost-effectiveness. With this in mind, a clinical project was designed to investigate the possibility of reusing the disconnect minicap as a safe, effective clinical practice. During a two-phase project, continuous ambulatory peritoneal dialysis (CAPD) disconnect caps were purposely touch contaminated and cultured before and after povodine iodine was instilled in the minicap. During the second phase of the project a simulated peritoneal effluent system was constructed and fluid cultures obtained. The specimen analyses demonstrated negative reports of the minicap after dwelling in povidine iodine and fluids after reuse of the minicap. The pilot project opens an area of research for nephrology nurses that could potentially lead to cost savings in the provision of care for patients with chronic renal failure.