Disposable Ureteroscopes in Urology: Current State and Future Prospects.

Ureteroscopy is the most common surgical modality for stone treatment. Reusable flexible ureteroscopes are delicate instruments that require expensive maintenance and repairs. Multiple single use ureteroscopes have been developed recently to combat the expensive and time-intensive sterilization and repair of ureteroscopes. Although multiple studies have looked at different aspects of reusable and single use ureteroscopes, there is significant heterogeneity in performance measures and cost between the 2 categories, and neither has a clear advantage. Both can be used successfully, and individual and institution level factors should be considered when deciding which ureteroscope to use.

Reúso de dispositivos médicos de uso único e implicações para a segurança do paciente / Reuse of single use medical devices and implications for patienty safety / Reutilización de dispositivos médicos de uso individual e implicaciones para la seguridad del paciente

Objetivo: Descrever aspectos do reúso dos dispositivos médicos de uso único e as implicações dessa prática para a segurança do paciente. Método: Ensaio acadêmico, utilizando dados de revisão integrativa e expertise da autora. Resultados: O reúso de produtos de uso único é realidade mundial e ocasiona debates regulatórios, técnicos, econômicos, éticos e de segurança do paciente, denotando diversos interesses dos distintos atores envolvidos: Estado, fabricantes, serviços de saúde, academia, profissionais e usuários. Embora haja risco teórico, dados não identificam relação causal entre evento adverso e reúso desses produtos. Existem argumentos a favor e contra que compreendem riscos e benefícios e justiça distributiva e social. O rótulo desses produtos representa nó crítico e elemento fomentador dos dilemas que permeiam essa prática. Conclusão: Há consenso de que o reúso de um produto médico deve ter o mesmo padrão de segurança, independentemente se rotulado como de uso único ou de multiuso. Alguns produtos ditos de uso único podem ser seguramente reusados, mas essa prática requer condições organoestruturais dos serviços de saúde, além de expertise, adoção de protocolos e supervisão dessas atividades.

Objective: to describe aspects of the reuse of single-use medical devices and implications for patient safety. Method: academic essay, using integrative review data and author's expertise. Results: the reuse of single-use products is a worldwide reality and causes regulatory, technical, economic, ethical and patient safety debates, denoting several interests of the different actors involved: State, manufacturers, health services, academia, professionals and users. Although there is a theoretical risk, data do not identify a causal relationship between adverse events and reuse of these products. There are arguments for and against and are involved: risks and benefits, distributive and social justice. The label of these products represents a critical node and fomenting element of the dilemmas that permeate this practice. Conclusion: There is consensus that the reuse of a medical product should have the same safety standard, regardless of whether labeled as single-use or multipurpose. Some so-called single-use products can be safely reused, but this practice requires organo-structural conditions of health services, as well as expertise, adoption of protocols and supervision of these activities.

Objetivo: Describir aspectos de la reutilización de dispositivos médicos de un solo uso e implicaciones para la seguridad del paciente. Método: ensayo académico, utilizando datos de revisión integradores y la experiencia del autor. Resultados: La reutilización de productos de un solo uso es una realidad mundial y provoca debates regulatorios, técnicos, económicos, éticos y de seguridad del paciente, que denotan diversos intereses de los diferentes actores involucrados: Estado, fabricantes, servicios de salud, academia, profesionales y usuarios. Aunque existe un riesgo teórico, los datos no identifican una relación causal entre el evento adverso y la reutilización de estos productos. Hay argumentos a favor y en contra y están involucrados: riesgos y beneficios, justicia distributiva y social. La etiqueta de estos productos representa un nodo crítico y un elemento que fomenta los dilemas que impregnan esta práctica. Conclusión: Existe un consenso de que la reutilización de un producto médico debe tener el mismo estándar de seguridad, independientemente de si está etiquetado como de uso único o multipropósito. Algunos de los llamados productos de un solo uso pueden reutilizarse de manera segura, pero esta práctica requiere condiciones organoestructurales para los servicios de salud, además de experiencia, adopción de protocolos y supervisión de estas actividades.

Flexible ureteroscopy: reuse? Or is single use the new direction?

PURPOSE OF REVIEW: Single-use flexible ureteroscopes (su-fURS) aim at overcoming the main limitations of conventional reusable ureteroscopes in terms of acquisition and maintenance costs, breakages, and reprocessing. However, little data exist to date regarding the superiority of su-fURS at this regard. We aimed to perform a systematic literature review on available su-fURS performance with a focus on clinical data for all articles in the last 10 years. RECENT FINDINGS: To date, more than 10 different su-fURS are available on the market, with different characteristics and performance. Some of these devices have top-level features, almost catching up with those observed in reusable flexible ureteroscopes. Clinical evidence is mainly available only for two models, LithoVue and Uscope PU3022, and to date it is not strong enough to support routine adoption and use of su-fURS, with a consequent lack of consensus of specific clinical indications. Cost-effectiveness analyses seem to indicate an economic disadvantage in the routine adoption of su-fURS. Environmental issues related to the use of su-fURS also remain to be inquired and addressed. SUMMARY: Since their introduction, su-fURS have gained widespread popularity. Despite their ability at addressing reusable ureteroscope limitations, high-cost and a substantial lack of evidence are still limiting their routine adoption.

Picking apart surgical pick lists - Reducing variation to decrease surgical costs.

BACKGROUND: Average costs associated with common procedures can vary by surgeon without a corresponding variation in outcome or case complexity. METHODS: De-identified cost and equipment utilization data were collected from our hospital for elective laparoscopic cholecystectomy performed by 17 different surgeons over a 6-month period. A group of surgeons used this data to design a standardized equipment pick list that became optional (not mandated) for laparoscopic cholecystectomy. Cost and consumable surgical supply utilization data were collected for six months prior to and following the creation of the standardized pick-list. RESULTS: 280 elective laparoscopic cholecystectomies were performed during the study interval. In the 6 months after standardized pick list creation, the cost of disposable supplies utilized per case decreased by 32%. CONCLUSIONS: Surgical cost savings can be achieved with standardized procedure pick lists and attention to the cost of consumable surgical supplies.

Comparison of Metal and Plastic Disposable Laryngoscope Blade with Reusable Macintosh Blade in Difficult and Inhalation Injury Airway Scenario: A Manikin Study.

BACKGROUND: Single-use plastic blades (SUPB) and single-use metal blades (SUMB) for direct laryngoscopy and tracheal intubation have not yet been compared with reusable metal blades (RUMB) in difficult airway scenarios. OBJECTIVE: The purpose of our manikin study was to compare the effectiveness of these different laryngoscope blades in a difficult airway scenario, as well as in a difficult airway scenario with simulated severe inhalation injury. METHODS: Thirty anesthetists performed tracheal intubation (TI) with each of the three laryngoscope blades in the two scenario manikins. RESULTS: In the inhalation injury scenario, SUPB were associated with prolonged intubation times when compared with the metal blades. In the inhalation injury scenario, both metal laryngoscope blades provided a quicker, easier, and safer TI. In the difficult airway scenario, intubation times were significantly prolonged in the SUPB group in comparison to the RUMB group, but there were no significant differences between the SUPB and the SUMB. In this scenario, the RUMB demonstrated the shortest intubation times and seems to be the most effective device. CONCLUSIONS: Generally, results are in line with previous studies showing significant disadvantages of SUPB in both manikin scenarios. Therefore, metal blades might be beneficial, especially in the airway management of patients with inhalation injury.

Approaches to Quality Risk Management When Using Single-Use Systems in the Manufacture of Biologics.

Biologics manufacturing technology has made great progress in the last decade. One of the most promising new technologies is the single-use system, which has improved the efficiency of biologics manufacturing processes. To ensure safety of biologics when employing such single-use systems in the manufacturing process, various issues need to be considered including possible extractables/leachables and particles arising from the components used in single-use systems. Japanese pharmaceutical manufacturers, together with single-use suppliers, members of the academia and regulatory authorities have discussed the risks of using single-use systems and established control strategies for the quality assurance of biologics. In this study, we describe approaches for quality risk management when employing single-use systems in the manufacturing of biologics. We consider the potential impact of impurities related to single-use components on drug safety and the potential impact of the single-use system on other critical quality attributes as well as the stable supply of biologics. We also suggest a risk-mitigating strategy combining multiple control methods which includes the selection of appropriate single-use components, their inspections upon receipt and before releasing for use and qualification of single-use systems. Communication between suppliers of single-use systems and the users, as well as change controls in the facilities both of suppliers and users, are also important in risk-mitigating strategies. Implementing these control strategies can mitigate the risks attributed to the use of single-use systems. This study will be useful in promoting the development of biologics as well as in ensuring their safety, quality and stable supply.

A simulation comparing the cost-effectiveness of adult incontinence products.

PURPOSE: To compare leak point volumes and cost-effectiveness of a variety of adult incontinence products. METHODS: Adult incontinence products were purchased from local retail stores and categorized into moderate absorbency pads, moderate absorbency briefs, maximum absorbency pads, and maximum absorbent briefs. The leak point for each product was determined by applying fluid to the pad until the first drop of leakage from the pad or brief occurred. Cost-effectiveness was calculated by dividing the cost per product by the amount of fluid absorbed prior to the leak point. The leak points and cost-effectiveness of incontinence products were compared within and between categories. RESULTS: Significant differences in leak point volumes were present within all product categories except moderate absorbency pads. When comparing product categories, moderate absorbency pads were the least cost-effective, followed by maximum absorbency pads and absorbent briefs (P < .01). CONCLUSIONS: As a group, absorbent briefs are more cost-effective than incontinence pads, although products of similar absorbency category and design demonstrated varying leak points and cost-effectiveness. These findings may influence physician assessment of urinary incontinence as well as patient selection of incontinence products.

Pilot statewide study of pediatric emergency department alignment with national guidelines.

BACKGROUND: The American Academy of Pediatrics, American College of Emergency Physicians, and Emergency Nursing Association have developed consensus guidelines for pediatric emergency department policies, procedures, supplies, and equipment. Kentucky received funding from the Health Resources and Services Administration through the Emergency Medical Services for Children program to pilot test the guidelines with the state's hospitals. In addition to providing baseline data regarding institutional alignment with the guidelines, the survey supported development of grant funding to procure missing items. METHODS: Survey administration was undertaken by staff and members of the Kentucky Board of Emergency Medical Services Emergency Medical Services for Children work group and faculty and staff of the University of Kentucky College of Public Health and the University of Louisville School of Medicine. Responses were solicited primarily online with repeated reminders and offers of assistance. RESULTS: Seventy respondents completed the survey section on supplies and equipment either online or by fax. Results identified items unavailable at 20% or more of responding facilities, primarily the smallest sizes of equipment. The survey section addressing policy and procedure received only 16 responses. CONCLUSIONS: Kentucky facilities were reasonably well equipped by national standards, but rural facilities and small hospitals did not stock the smallest equipment sizes because of low reported volume of pediatric emergency department cases. Thus, a centralized procurement process that gives them access to an adequate range of pediatric supplies and equipment would support capacity building for the care of children across the entire state. Grant proposals were received from 28 facilities in the first 3 months of funding availability.

Carbon dioxide and oxygen levels in disposable individually ventilated cages after removal from mechanical ventilation.

Disposable individually ventilated cages have lids that restrict air exchange when the cage is not mechanically ventilated. This design feature may cause intracage CO2 to increase and O2 to decrease (hypercapnic and hypoxic conditions, respectively) when the electrical supply to the ventilated rack fails, the ventilated rack malfunctions, cages are docked in the rack incorrectly, or cages are removed from the ventilated rack for extended periods of time. We investigated how quickly hypercapnic and hypoxic conditions developed within disposable individually ventilated cages after removal from mechanical ventilation and compared the data with nondisposable static cages, disposable static cages, and unventilated nondisposable individually ventilated cages. When disposable individually ventilated cages with 5 adult mice per cage were removed from mechanical ventilation, CO2 concentrations increased from less than 1% at 0 h to approximately 5% at 3 h and O2 levels dropped from more than 20% at 0 h to 11.7% at 6 h. The breathing pattern of the mice showed a prominent abdominal component (hyperventilation). Changes were similar for 4 adult mice per cage, reaching at least 5% CO2 at 4 h and 13.0% O2 at 6 h. For 3 or 2 mice per cage, values were 4.6% CO2 and 14.7% O2 and 3.04% CO2 and 17.1% O2, respectively, at 6 h. These results document that within disposable individually ventilated cages, a hypercapnic and hypoxic microenvironment develops within hours in the absence of mechanical ventilation.

[The evaluation of bacteria penetration by medical textiles for multiple use and disposable multilayer surgical drapes, according to the PN-EN ISO 22610 standard]. / Badanie przenikania bakterii przez tkaniny medyczne przeznaczone do wielokrotnego uzycia oraz wielowarstwowe oblozenia chirurgiczne jednorazowego uzytku, wedlug normy PN-EN ISO 22610.

INTRODUCTION: Cotton as well as synthetic textile medical products are widely used as barrier materials and individual protection against displacement of biological infectious factors. The required level of protection of these products for multiple use and disposable multilayer laminates against the penetration of microbes depends on the risk connected with type of surgical procedure defined in normative documents. METHODS. Cotton and syntetic medical textiles for multiple use, 30-times subjected to processes simulating conditions of the use as well as disposable multilayer surgical drapes were tested. Resistance to microbial wet penetration was conducted according to the PN-EN ISO 22610: 2007 standard. RESULTS: The barrier of cotton fabrics was reduced after first washing and then systematically grew after each often cycles to the value close to the value at the beginning. From the twentieth cycle of simulated conditions of the use, barrier index was reduced. The barrier of the synthetic textile stayed on the average level, while multilayer disposable products ensured the full impermeability for the bacteria. CONCLUSIONS: Natural cotton textiles for multiple use could be apply on operative blocks in limited range because of the changes of the cotton structure caused by repeated laundering process and sterilization. Synthetic materials also have limited application, although are more resistant to cleaning and sterilization processes. Disposable synthetic laminates with many layers use guarantee impermeability for bacteria and may be applied in operative blocks without restrictions.

A real-world study of patients with type 2 diabetes initiating basal insulins via disposable pens.

INTRODUCTION: Real-world data comparing outcomes of type 2 diabetes mellitus (T2DM) patients initiating different insulin regimens can help with treatment decisions and patient management. Clinical and economic outcomes following initiation with insulin glargine disposable pen (GLA-P) or insulin detemir disposable pen (DET-P) in T2DM patients were compared over 1-year follow-up. METHODS: This retrospective cohort analysis was conducted on data in a US national managed care claims database (July 2006 to September 2010) from patients initiating insulin treatment with GLA-P or DET-P. Treatment persistence, adherence, glycated hemoglobin (A1C), hypoglycemic events, and healthcare costs during follow-up were compared. RESULTS: In all, 1682 patients were identified; 1016 (60.4%) started using GLA-P, 666 (39.6%) started using DET-P. After 1:1 propensity score matching, each cohort comprised 640 patients. Patients initiating GLA-P were significantly more likely to persist and adhere to treatment, and used a lower daily consumption dose. Over the last quarter of follow-up, fewer GLA-P users switched to DET-P compared with those switching from DET-P to GLA-P. GLA-P was associated with lower A1C levels and higher reduction of A1C levels from baseline, with no significant difference in the number of patients having hypoglycemic events. Patients in both cohorts had similar total and diabetes-related healthcare costs, but healthcare costs were lower in the GLA-P cohort for each 1% reduction in A1C from baseline. CONCLUSION: This real-world study demonstrates that patients initiating GLA-P were more likely to persist with and adhere to treatment, with better glycemic control and similar overall hypoglycemia rate at no increase in healthcare cost.

Reliability of tonosafe disposable tonometer prisms: clinical implications from the Veterans Affairs Boston Healthcare System Quality Assurance Study.

PURPOSE: Given the Veterans Affairs Boston Healthcare System's recent introduction of single-use Tonosafe disposable tonometer prisms as an alternative to Goldmann applanation tonometers (GATs), this study had two aims: to conduct a large-scale quality assurance trial to assess the reliability of intraocular pressure (IOP) measurements of the Tonosafe disposable tonometer compared with GAT, particularly at extremes of pressure; to evaluate the suitability of Tonosafe disposable tonometer prisms as an acceptable substitute for GATs and for clinic-wide implementation in an academic tertiary referral setting. METHODS: Ophthalmology resident physicians measured the IOPs of patients in general and specialty eye clinics with the Tonosafe disposable tonometer and GAT. Tonosafe test-retest reliability data were also collected. A retrospective review of patient charts and data analysis were performed to determine the reliability of measurements. RESULTS: The IOPs of 652 eyes (326 patients) were measured with both GAT and Tonosafe, with a range of 3-34 mm Hg. Linear regression analysis showed R=0.93, slope=0.91, both of which supported the proposed hypothesis, and the y-intercept=-1.05 was significantly different from the hypothesized value. The Tonosafe test-retest repeatability (40 eyes of 40 patients), r=0.977, was very high, which was further supported by linear regression slope=0.993, y-intercept=0.118, and a Tonosafe repeatability coefficient of 2.06, similar to GAT repeatability. CONCLUSIONS: The IOP measurements by Tonosafe disposable prisms correlated closely with Goldmann measurements, with similar repeated measurement variability to GAT. This suggests that the Tonosafe is an acceptable substitute for GAT to measure IOP in ophthalmology clinic settings.

Disposables in downstream processing.

Disposable equipment has been used for many years in the downstream processing industry, but mainly for filtration and buffer/media storage. Over the last decade, there has been increasing interest in the use of disposable concepts for chromatography, replacing steel and glass fixed systems with disposable plastic modules that can be discarded once exhausted, fouled or contaminated. These modules save on cleaning and validation costs, and their reduce footprints reduce buffer consumption, water for injection, labor and facility space, contributing to an overall reduction in expenditure that lowers the cost of goods. This chapter examines the practical and economic benefits of disposable modules in downstream processing.

Economic analysis of reprocessing single-use medical devices: a systematic literature review.

BACKGROUND: Although an increasing number of medical devices are labeled "for single use only," cleaning and reuse of single-use medical devices continues, because of the economic incentive. We conducted a survey of the economic literature to obtain the current evidence available and to assess the costs and benefits of reusing single-use medical devices. METHODS: A comprehensive literature search was carried out to identify articles that compared single use and reuse of single-use medical devices and that met specific scientific criteria, including evaluation of economic outcomes. Each selected article was independently reviewed by 2 reviewers to extract cost and clinical outcome data and to assess the quality of the study. RESULTS: Nine published articles met the selection criteria. The savings were about 49% of the direct cost. These savings would be offset by adverse-event costs, but none were detected. However, quality of the studies was generally poor. CONCLUSIONS: There is little available evidence of quality in the published literature to assess the practice of reuse of single-use medical devices. Moreover, data on clinical outcomes are missing and, where available, cannot be attributed specifically to the reuse of single-use medical devices.

The not-so-hidden costs of surgical site infections.

Surgical site infections (SSIs) adversely affect approximately 500,000 patients annually, causing immense human suffering and taking a huge financial toll on patients, hospitals, insurance companies, and the government. National organizations have made recommendations for reducing SSIs, and many advances have been made in evidence-based practice recommendations that result in fewer SSIs. Reusable electrocardiogram (ECG) lead wires can be a significant source of infection. One medical center near Richmond, VA, began using a disposable ECG lead wire set and wireless transceiver system and subsequently experienced a 40% decrease in SSIs.