[Design and application of a disposable self-destructed and sheath-encased sterile acupuncture needle].

A kind of disposable self-destructed and sheath-encased sterile acupuncture needle is designed to efficiently solve the issues of safety and sterilization encountered in the routine operation of acupuncture. The needle consists of three components, i.e. the needle body, the sheath and the locker. The needle body is movable and rotatable in the sheath, but can not be separated from the sheath. It is convenient for the operator to perform the lifting-thrusting and twisting techniques, and to prevent the non-punctured portion of the body from being out off the sheath so that a sterile confined room is formed between the needle and the skin of the operated area. With a locker installed between the sheath and the needle handle, after needle removal, the needle body can be returned and locked in the sheath, avoiding the exposure of needle tip, obtaining the self-destruction of needle and preventing from needling accident and reuse of needle. The devise is operated easily, which is effectively reduce the risk of infection and ensure the safety of medical staffs in practice.

Development of an Integrated Disposable Device for SARS-CoV-2 Nucleic Acid Extraction and Detection.

Objective: To develop a highly sensitive and rapid nucleic acid detection method for the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Methods: We designed, developed, and manufactured an integrated disposable device for SARS-CoV-2 nucleic acid extraction and detection. The precision of the liquid transfer and temperature control was tested. A comparison between our device and a commercial kit for SARS-Cov-2 nucleic acid extraction was performed using real-time fluorescence reverse transcription polymerase chain reaction (RT-PCR). The entire process, from SARS-CoV-2 nucleic acid extraction to amplification, was evaluated. Results: The precision of the syringe transfer volume was 19.2 ± 1.9 µL (set value was 20), 32.2 ± 1.6 (set value was 30), and 57.2 ± 3.5 (set value was 60). Temperature control in the amplification tube was measured at 60.0 ± 0.0 °C (set value was 60) and 95.1 ± 0.2 °C (set value was 95) respectively. SARS-Cov-2 nucleic acid extraction yield through the device was 7.10 × 10 6 copies/mL, while a commercial kit yielded 2.98 × 10 6 copies/mL. The mean time to complete the entire assay, from SARS-CoV-2 nucleic acid extraction to amplification detection, was 36 min and 45 s. The detection limit for SARS-CoV-2 nucleic acid was 250 copies/mL. Conclusion: The integrated disposable devices may be used for SARS-CoV-2 Point-of-Care test (POCT).

Safety and effectiveness of using Disposable Ultrasonic shears to coagulate 5-7 mm blood vessels: protocol for a prospective, multicenter, randomized, parallel controlled, non-inferiority clinical trial.

BACKGROUND: The ultrasonic scalpel is widely used during surgery. It is safe and effective to close the pulmonary artery branch vessels of 7 mm or below with an ultrasonic energy device as reported. However, there have been no multicenter randomized clinical trial to assess the safety and effectiveness of using ultrasonic scalpel to coagulate 5-7 mm blood vessels in thoracic surgery. METHODS: This is a prospective, multicenter, randomized, parallel controlled, non-inferiority clinical trial. A total of 144 eligible patients planning to undergo lung or esophageal surgery will be randomly allocated to the experimental group and the control group. The investigational product (Disposable Ultrasonic Shears manufactured by Reach Surgical, Inc.) and the control product (Harmonic Ace + 7, 5 mm Diameter Shears with Advanced Hemostasis) will be used in each group. The primary endpoint is the success rate of coagulating target blood vessels during surgery. Secondary endpoints include postoperative rebleeding, intraoperative bleeding volume, drainage volume, surgical duration, etc. Postoperative follow-up before and after discharge will be performed. DISCUSSION: This clinical trial aims to evaluate the safety and effectiveness of using the investigational product (Disposable Ultrasonic Shears manufactured by Reach Surgical, Inc.) and that of the control product (Harmonic Ace + 7, 5 mm Diameter Shears with Advanced Hemostasis) to coagulate 5-7 mm blood vessels in thoracic surgery. TRIAL REGISTRATION: ClinicalTrials.gov: NCT06002737. The trial was prospectively registered on 16 August 2023, https://www. CLINICALTRIALS: gov/study/NCT06002737 .

Clinical comparative study of single-use and reusable digital flexible ureteroscopy for the treatment of lower pole stones: a retrospective case-controlled study.

OBJECTIVES: To compare the clinical efficacy and safety of single-use and reusable digital flexible ureteroscopy for the treatment of lower pole stones. METHODS: We enrolled 135 patients underwent reusable flexible ureteroscopy (FURS) and 78 patients underwent single-use digital FURS. Demographic, clinical variables, anatomical parameters of the lower calyx and perioperative indicators were compared in the two groups. RESULTS: Thirty-six patients in the infundibuloureter angle (IPA) < 45° subgroup had a mini-percutaneous nephrolithotomy (mini-PCNL), including 25 patients in the reusable FURS group and 11 patients in the single-use FURS group. The demographic and clinical variables in the two FURS groups were comparable. There was no statistical difference in the success rate of stone searching (P > 0.05). In terms of the success rate of lithotripsy, there was also no statistical difference in the IPA ≥ 45° subgroup (P > 0.05), whereas single-use FURS was superior in the IPA < 45° subgroup (χ2 = 6.513, P = 0.011). The length of the working fiber in the reusable FURS and single-use FURS groups was 3.20 ± 0.68 mm and 1.75 ± 0.47 mm, respectively (t = 18.297, P < 0.05). The use of a stone basket in the reusable FURS (31/135, 23.0%) was significantly higher than that in the single-use FURS (8/78, 10.3%) (χ2 = 5.336, P = 0.021). Compared with the reusable FURS group, the single-use FURS group had shorter operation times (P < 0.05) and higher stone-free rate (SFR) (χ2 = 4.230, P = 0.040). There was no statistical difference in the intraoperative transfer of mini-PCNL and postoperative complications between the two groups (P > 0.05). CONCLUSIONS: Single-use and reusable FURS are alternative methods for removal of lower pole stones (i.e., 2 cm or less). Single-use FURS has a high success rate of lithotripsy, shorter operation time, and high stone-free rate.

Minimally Invasive Common Bile Duct Stone Management in Gastric Bypass Patients: Laparoscopic Common Bile Duct Exploration with Disposable Bronchoscope.

BACKGROUND: Bariatric surgery patients may develop common bile duct stones, and the alterations in their anatomy present challenges in treating this condition. Methods such as laparoscopic bile duct exploration is impractical in many healthcare facilities, due to the absence of a choledochoscope. This study assesses the feasibility of laparoscopic exploration of the common bile duct using a disposable bronchoscope in these individuals. METHOD: The study involved 32 participants who had undergone gastric bypass surgery. These participants presented with both bile duct stones and bile ducts exceeding 8 mm in diameter, diagnosed through either MRCP or cholangiography conducted during the surgery. Stone extraction was carried out through either choledotomy or transcystic routes using a disposable bronchoscope and endoscopic baskets. RESULTS: The patients' ages ranged from 27 to 66 years, with a mean bile duct diameter of 11.6 mm (SD 3.1 mm). A 100% stone clearance rate was achieved for all patients. None of the patients required conversion to open surgery. No T-tubes were placed. One patient developed biloma and intra-abdominal abscesses, which were successfully treated with a percutaneous drain over the course of a week. No mortalities were recorded during the course of this study. CONCLUSION: Our study results demonstrate that laparoscopic bile duct exploration is both feasible and safe in patients who have undergone gastric bypass surgery. The utilization of a disposable bronchoscope emerges as a practical and cost-effective alternative to a choledochoscope in this procedure.

Does Reusable Instrumentation for Four-Anchor Rotator Cuff Repair Offer Decreased Waste Disposal Costs and Lower Waste-Related Carbon Emissions?

INTRODUCTION: Orthopaedic surgery is culpable, in part, for the excessive carbon emissions in health care partly due to the utilization of disposable instrumentation in most procedures, such as rotator cuff repair (RCR). To address growing concerns about hospital waste, some have considered replacing disposable instrumentation with reusable instrumentation. The purpose of this study was to estimate the cost and carbon footprint of waste disposal of RCR kits that use disposable instrumentation compared with reusable instrumentation. METHODS: The mass of the necessary materials and their packaging to complete a four-anchor RCR from four medical device companies that use disposable instrumentation and one that uses reusable instrumentation were recorded. Using the cost of medical waste disposal at our institution ($0.14 per kilogram) and reported values from the literature for carbon emissions produced from the low-temperature incineration of noninfectious waste (249 kgCO 2 e/t) and infectious waste (569 kgCO 2 e/t), we estimated the waste management cost and carbon footprint of waste disposal produced per RCR kit. RESULTS: The disposable systems of four commercial medical device companies had 783%, 570%, 1,051%, and 478%, respectively, greater mass and waste costs when compared with the reusable system. The cost of waste disposal for the reusable instrumentation system costs on average $0.14 less than the disposable instrumentation systems. The estimated contribution to the overall carbon footprint produced from the disposal of a RCR kit that uses reusable instrumentation was on average 0.37 kg CO2e less than the disposable instrumentation systems. CONCLUSION: According to our analysis, reusable instrumentation in four-anchor RCR leads to decreased waste and waste disposal costs and lower carbon emissions from waste disposal. Additional research should be done to assess the net benefit reusable systems may have on hospitals and the effect this may have on a long-term decrease in carbon footprint. LEVEL OF EVIDENCE: Level II.

Ureteral stent encrustation in an HIV patient treated with disposable flexible ureteroscope: a case report.

Human immunodeficiency virus prevalence was increasing worldwide. Medication-associated urinary calculi are very commonly caused by medications used to treat HIV-positive patients. We present a case of an HIV-positive 39-year-old male with ureteral stent encrustation and kidney stone. Ureterolithotripsy using a disposable flexible ureteroscope is performed. The postoperative evolution was favorable. The disposable flexible ureteroscope is effective in the treatment of HIV combined with ureteral stent encrustation.

Comparative analysis of two methods in circumcision: a new disposable device versus classic sleeve technique.

PURPOSE: Circumcision is the most common surgical procedures performed in males. Medical circumcision is recommended for diseases such as phimosis, paraphimosis, balanoposthitis and common urinary tract infections, although there is no exact indication. Conversely, Jewish and Muslim individuals commonly undergo circumcision regardless of medical necessity. Circumcision devices are designed to shorten surgery time, achieve an aesthetic appearance and ensure safe surgery. The aim of this study is to evaluate the effectiveness of the NeoAlis clamp, a disposable circumcision device, by comparing it with the sleeve technique in children. MATERIALS AND METHODS: Between 2017 and 2023, retrospective evaluation of 2626 patients who underwent circumcision using either the NeoAlis clamp (group 1) or the sleeve technique (group 2) was conducted. Operation time, results, cost, complications were compared between the two groups. RESULTS: The study encompassed 2626 patients who fulfilled the inclusion criteria. Group 1 comprised 2403 patients, whereas Group 2 consisted of 223 patients. The overall complication rate, as denoted by n = 47, was 1.7%. Group 1 operation time was shorter than group 2. Bleeding, the most feared complication in the early period, was higher in the second group. No statistically significant difference was observed between the two groups regarding cost comparison. CONCLUSION: The primary concern during circumcision is to avoid complications related to general anesthesia in newborns and infants. The use of disposable ring devices has been facilitated by the shorter operation time and the absence of the need for sutures when performing circumcision under local anesthesia. However, knowledge of advanced surgical circumcision techniques is necessary in cases of bleeding and inappropriate ring placement.

Disposable Gastrointestinal Scopes: A Systematic Review.

OBJECTIVE: Endoscopes are an essential tool in the diagnosis, screening, and treatment of gastrointestinal diseases. In 2019, the Food and Drug Administration issued a news release, recommending that duodenoscope manufacturers and health care facilities phase out fully reusable duodenoscopes with fixed endcaps in lieu of duodenoscopes that are either fully disposable or those that contain disposable endcaps. With this study, we systematically reviewed the published literature on single-use disposable gastrointestinal scopes to describe the current state of the literature and provide summary recommendations on the role of disposable gastrointestinal endoscopes. MATERIALS AND METHODS: For our inclusion criteria, we searched for studies that were published in the year 2015 and afterward. We performed a literature search in PubMed using the keywords, "disposable," "reusable," "choledochoscope," "colonoscope," "duodenoscope," "esophagoscope," "gastroscope," and "sigmoidoscope." After our review, we identified our final article set, including 13 articles relating to disposable scopes, published from 2015 to 2023. RESULTS: In this review, we show 13 articles discussing the infection rate, functionality, safety, and affordability of disposable gastrointestinal scopes in comparison to reusable gastrointestinal scopes. Of the 3 articles that discussed infection rates (by Forbes and colleagues, Ridtitid and colleagues, and Ofosu and colleagues), each demonstrated a decreased risk of infection in disposable gastrointestinal scopes. Functionality was another common theme among these articles. Six articles (by Muthusamy and colleagues, Bang and colleagues, Lisotti and colleagues, Ross and colleagues, Kang and colleagues, and Forbes and colleagues) demonstrated comparable functionality of disposable scopes to reusable scopes. The most reported functionality issue in disposable scopes was decreased camera resolution. Disposable scopes also showed comparable safety profiles compared with reusable scopes. Six articles (by Kalipershad and colleagues, Muthusamy and colleagues, Bang and colleagues, Lisotti and colleagues, Luo and colleagues, and Huynh and colleagues) showed comparable rates of AEs, whereas 1 article (by Ofosu and colleagues) demonstrated increased rates of AEs with disposable scopes. Lastly, a cost analysis was looked at in 3 of the articles. Two articles (by Larsen et al and Ross and colleagues) remarked that further research is needed to understand the cost of disposable scopes, whereas 1 article (by Kang and colleagues) showed a favorable cost analysis. CONCLUSIONS: After a review of the literature published since the 2015 Food and Drug Administration safety communication, disposable scopes have been shown to be effective in decreasing infection risks while maintaining similar safety profiles to conventional reusable scopes. However, more research is required to compare disposable and reusable scopes in terms of functionality and cost-effectiveness.

A Life Cycle Assessment of Reusable and Disposable Surgical Caps.

INTRODUCTION: Surgical cap attire plays an important role in creating a safe and sterile environment in procedural suites, thus the choice of reusable versus disposable caps has become an issue of much debate. Given the lack of evidence for differences in surgical site infection (SSI) risk between the two, selecting the cap option with a lower carbon footprint may reduce the environmental impact of surgical procedures. However, many institutions continue to recommend the use of disposable bouffant caps. METHODS: ISO-14044 guidelines were used to complete a process-based life cycle assessment to compare the environmental impact of disposable bouffant caps and reusable cotton caps, specifically focusing on CO2 equivalent (CO2e) emissions, water use and health impacts. RESULTS: Reusable cotton caps reduced CO2e emissions by 79% when compared to disposable bouffant caps (10 kg versus 49 kg CO2e) under the base model scenario with a similar reduction seen in disability-adjusted life years. However, cotton caps were found to be more water intensive than bouffant caps (67.56 L versus 12.66 L) with the majority of water use secondary to production or manufacturing. CONCLUSIONS: Reusable cotton caps have lower total lifetime CO2e emissions compared to disposable bouffant caps across multiple use scenarios. Given the lack of evidence suggesting a superior choice for surgical site infection prevention, guidelines should recommend reusable cotton caps to reduce the environmental impact of surgical procedures.

Assessing neophyte response to daily disposable silicone hydrogel contact lenses: A randomised clinical trial investigation over one month.

OBJECTIVE: This randomised clinical trial assessed the impact on symptoms, tear film dynamics and ocular surface integrity of daily disposable silicone-hydrogel contact lenses (CLs) over a month, paying special attention to lid wiper epitheliopathy (LWE) and its implications for CL discomfort. METHODS: Neophyte CL wearers (n = 44, 21.09 ± 5.00 years old) were randomly assigned to either the experimental (n = 24) or control group (n = 20). Participants assigned to the experimental group were required to wear daily disposable CLs for 1 month for at least 8 h/day and 6 days/week. All participants were healthy subjects (no history of ocular surgery or active ocular disease) with spherical refractive errors between -8.00 and +5.00 D and cylindrical power <0.75 D. At the baseline and 1-month sessions, the Dry Eye Questionnaire 5 (DEQ-5) was completed, together with the measurement of tear film osmolarity with the TearLab osmometer, tear meniscus height (TMH) and lipid layer pattern (LLP) using a slit-lamp with Tearscope Plus attached, fluorescein break-up time (FBUT), maximum blink interval (MBI), corneal staining with fluorescein under cobalt blue light and LWE with lissamine green under slit lamp and halogen white light. RESULTS: At the baseline session, LWE showed a negative correlation with DEQ-5 (r = -0.37, p = 0.02). Significant differences in FBUT and LWE (p = 0.04) and a positive correlation between LWE and DEQ-5 (r = 0.49, p = 0.007) were observed at 1 month. Intrasession analysis at 1 month showed significant differences between the experimental and control groups in DEQ-5, FBUT and LWE (all p ≤ 0.02). Intersession analysis in the experimental group showed variations in DEQ-5, FBUT and LWE (all p ≤ 0.02) but no significant variation in the control group (all p ≥ 0.11). CONCLUSION: The presence of LWE was significantly correlated with higher symptom values in the DEQ-5. Also, participants in the experimental group presented higher values of LWE after 1 month of CL wear, in comparison with the control group.

RETROGRADE INTRARENAL LITHOTRIPSY USING DISPOSABLE FLEXIBLE URETEROSCOPE.

This research aims to characterize efficiency of a flexible ureteroscope that is of single use with regard to surgical time, absence of stone, and complications. From March 2022 to April 2023, the Basrah Urological Centre carried out this anticipated work. After excluding patients with untreated urinary tract infections, excessive blood urea, and ureteral strictures, the study involved ninety-eight patients. All patients were above 20 years of age. Patients were operated on by the same surgeon. This study involved 108 patients in this study composed of 42 (39.8%) men and 65 (60.2%) women. With a standard deviation of 10.9 years, the patient's mean age was 39.2 years. The total stone burden ranged from 6.9 to 14.5 mm, averaging 9.7±2.9 mm. The stone density ranged from 820-1411 HU, averaging 1000.8±279.3 HU. According to the current study, treating renal stones with a single-use flexible ureteroscope is less complicated and more successful.

Advanced trainee perceptions of disposable duodenoscopes and disposable endcaps: results of a nationwide survey.

INTRODUCTION: Disposable duodenoscopes and duodenoscopes with disposable endcaps are being used in clinical practice to reduce or eliminate the risk of transmitting infections. The study aim was to assess perceptions and experiences regarding the use of these duodenoscopes among advanced endoscopy fellows in a nationally representative sample. METHODS: A 17-item electronic survey was sent to 74 advanced endoscopy training programs. The survey was completed by 50 participants and their responses were included for analysis. RESULTS: Most participants were from academic training programs (82.7%) and identified as being in their 7th year of post graduate training (92%; PGY-7). Participants performed an average of 414 ERCPs. 29% reported difficulty with cannulation using disposable duodenoscopes versus 15.7% with duodenoscopes with disposable endcaps (vs. standard duodenoscope). 96% of trainees perceived disposable duodenoscopes as not cost effective and 92% stated they would not use this device during independent practice. 100% of trainees stated that they would use duodenoscopes with disposable endcaps during independent practice. For their most challenging cases, 90% of trainees preferred using standard reprocessable duodenoscopes while no trainee indicated they would prefer using a disposable duodenoscope in this scenario. 82% of participants stated that disposable duodenoscopes and disposable endcaps should be used exclusively or preferentially for high-risk patients citing cost, functionality, and concerns regarding environmental impact. DISCUSSION: Advanced endoscopy fellows perceive disposable duodenoscopes as impacting technical maneuverability. Concerns about functionality, cost effectiveness and environmental impact are barriers to adoption.

Disposable grasper-integrated flexible cystoscope for ureteral stent removal in transplanted patients; focus on feasibility, safety, and patient experience. Results and micro-cost analysis from a tertiary referral center.

INTRODUCTION & OBJECTIVES: To evaluate ureteral stent removal (SR) using a grasper-integrated disposable flexible cystoscope (giFC-Isiris ®, Coloplast ®) after kidney transplantation (KT), with a focus on feasibility, safety, patient experience, and costs. MATERIAL AND METHODS: All consecutive KT undergoing SR through giFC were prospectively enrolled from January 2020 to June 2023. Patient characteristics, KT and SR details, urine culture results, antimicrobial prescriptions, and the incidence of urinary tract infections (UTI) within 1 month were recorded. A micro-cost analysis was conducted, making a comparison with the costs of SR with a reusable FC and grasper. RESULTS: A total of 136 KT patients were enrolled, including both single and double KT, with 148 stents removed in total. The median indwelling time was 34 days [26, 47]. SR was successfully performed in all cases. The median preparation and procedure times were 4 min [3,5]. and 45 s[30, 60], respectively. The median Visual Analog Scale (VAS) score was 3 [1, 5], and 98.2% of patients expressed willingness to undergo the procedure again. Only one episode of UTI involving the graft (0.7%) was recorded. Overall, the estimated cost per SR procedure with Isiris ® and the reusable FC was 289.2€ and 151,4€, respectively. CONCLUSIONS: This prospective series evaluated the use of Isiris ® for SR in a cohort of KT patients, demonstrating feasibility and high tolerance. The UTI incidence was 0.7% within 1 month. Based on the micro-cost analysis, estimated cost per procedure favored the reusable FC.