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1.
Gastrointest Endosc ; 100(2): 312-316, 2024 Aug.
Article in English | MEDLINE | ID: mdl-38462055

ABSTRACT

BACKGROUND AND AIMS: Duodenoscopes with single-use end caps were introduced to minimize infection risk, but they are unstudied in pediatrics. METHODS: We collected clinical data and endoscopists' evaluations of duodenoscopes with single-use end caps versus reusable duodenoscopes over 18 months. RESULTS: A total of 106 ERCPs were performed for patients aged 1 to 18 (mean, 14.2) years. Forty-six involved single-use end caps, with 9 requiring crossover to reusable duodenoscopes. ERCPs involving single-use end caps resulted in more instances of mucosal trauma (10 vs 0; P < .05) and post-ERCP pancreatitis (4 vs 1; P < .05) and accounted for 8 of 9 ERCPs requiring advanced cannulation techniques. No post-ERCP infections occurred. Reported challenges included single-use end cap stiffness and difficulty with their alignment for cannulation. CONCLUSIONS: We report difficulty with advancement, greater reliance on advanced cannulation techniques, and higher rates of post-ERCP pancreatitis when using duodenoscopes with single-use end caps in pediatric ERCP. This area warrants further study.


Subject(s)
Cholangiopancreatography, Endoscopic Retrograde , Duodenoscopes , Humans , Cholangiopancreatography, Endoscopic Retrograde/adverse effects , Duodenoscopes/microbiology , Child , Adolescent , Child, Preschool , Infant , Female , Male , Pancreatitis/prevention & control , Pancreatitis/etiology , Equipment Reuse/economics , Equipment Design , Disposable Equipment/economics , Retrospective Studies , Catheterization
2.
Am J Obstet Gynecol ; 231(2): 273.e1-273.e7, 2024 08.
Article in English | MEDLINE | ID: mdl-38761838

ABSTRACT

BACKGROUND: Single-use materials and equipment are regularly opened by the surgical team during procedures but left unused, potentially resulting in superfluous costs and excess environmental waste. OBJECTIVE: This study aimed to estimate the excess use of surgical supplies in minimally invasive benign gynecologic surgeries. STUDY DESIGN: This is a prospective observational study conducted at a university-affiliated single tertiary medical center. Designated study personnel were assigned to observe surgical procedures performed during July to September 2022. Surgical teams were observed while performing surgeries for benign indications. The teams were not informed of the purpose of the observation to avoid potential bias. Disposable materials and equipment opened during the procedure were documented. Excess supplies were defined as those opened but left unused before being discarded. Costs per item of the excess supplies were estimated on the basis of material and equipment costs provided by the hospital. RESULTS: A total of 99 surgeries were observed, including laparoscopic (32%), robotic (39%), hysteroscopic (14%), vaginal (11%), and laparotomy procedures (3%). Excess use of surgical supplies was documented in all but one procedure. The total cost across all surgeries reached $6357. The contained tissue extraction bag was the most expensive item not used (Applied Medical, Rancho Santa Margarita, CA; $390 per unit) in 4 procedures, contributing 25.54% to the total cost. Raytec was the most common surgical waste, with a total of n=583 opened but unused (average n=5.95 per surgery). A significant difference was found in the rate of excess supplies across the surgical approaches, with robotic surgery contributing 52.19% of the total cost (P=.01). CONCLUSION: Excess use of disposable materials and equipment is common in minimally invasive benign gynecologic surgeries and contributes to superfluous costs and excess environmental waste. It is predominantly attributed to the opening of inexpensive materials that are left unused during the procedure. Increased awareness of costs and generated waste may reduce excess use of surgical supplies and should be further explored in future research.


Subject(s)
Gynecologic Surgical Procedures , Robotic Surgical Procedures , Humans , Female , Gynecologic Surgical Procedures/instrumentation , Gynecologic Surgical Procedures/economics , Gynecologic Surgical Procedures/statistics & numerical data , Prospective Studies , Robotic Surgical Procedures/economics , Robotic Surgical Procedures/statistics & numerical data , Robotic Surgical Procedures/instrumentation , Minimally Invasive Surgical Procedures/economics , Minimally Invasive Surgical Procedures/instrumentation , Laparoscopy/economics , Laparoscopy/statistics & numerical data , Laparoscopy/instrumentation , Hysteroscopy/economics , Hysteroscopy/statistics & numerical data , Disposable Equipment/economics , Disposable Equipment/supply & distribution , Laparotomy/economics , Adult , Middle Aged
3.
BJU Int ; 133(6): 638-645, 2024 Jun.
Article in English | MEDLINE | ID: mdl-38438065

ABSTRACT

OBJECTIVE: To explore the data comparing single- vs multi-use catheters for clean intermittent catheterisation (CIC), consider if the widespread use of single-use catheters is warranted given the cost and environmental impact, and put forth ideas for future consideration. METHODS: A primary literature review was performed in PubMed over the past 50 years. Studies that performed comparative analysis of single- and multi-use catheters were included in our review. All studies that reported on primary data were narratively summarised. RESULTS: A total of 11 studies were identified that reported on primary data comparing single- and multi-use catheters. There was no appreciable evidence suggesting reusable multi-use catheters were inferior to single-use catheters from an infection or usability standpoint. In addition, the environmental and monetary burden of single-use catheters is significant. CONCLUSIONS: The intermittent catheter landscape in the USA has a complex past: defined by policy, shaped by industry, yet characterised by a paucity of data demonstrating superiority of single-use over multi-use catheters. We believe that the aversion to reusable catheters by many patients and healthcare professionals is unwarranted, especially given the cost and environmental impact. Moving forward, better comparative data and more sustainable practices are needed.


Subject(s)
Equipment Reuse , Humans , Equipment Reuse/economics , Disposable Equipment/economics , Environment , Urinary Catheters , Intermittent Urethral Catheterization/instrumentation
4.
World J Urol ; 42(1): 188, 2024 Mar 23.
Article in English | MEDLINE | ID: mdl-38520528

ABSTRACT

PURPOSE: Artifacts from poor ureteroscopes' light design with shadowing and dark areas in the field of view have been reported. The aim was to quantify effects of light obstruction in a kidney calyx model. METHODS: We evaluated a series of contemporary flexible ureteroscopes including the Storz Flex-Xc and Flex-X2s, Olympus V3 and P7, Pusen 7.5F and 9.2F, as well as OTU Wiscope using an enclosed 3D-printed pink in vitro kidney calyx model submerged in saline, where the field of light was intentionally partially obstructed alternatively at 12, 3, 6, and 9 o'clock. A color spectrometer was used for illuminance measurements at a 45° opening position in the background of the model. RESULTS: Overall and mean background illuminance for each obstructive situation were significantly different between scopes for both 50% and 100% brightness settings (ANOVA p < 0.001). At 50% brightness setting, almost all scopes had their highest and lowest background illuminance with the 6 o'clock and 3 o'clock obstructive situation, respectively. At 100% brightness setting, these became 6 o'clock and 12 o'clock obstructive situations. Considering each obstructive situation individually, the Flex-Xc was consistently the scope with highest background illuminance and the Pusen 7.5F the lowest. Background illuminance for each obstructive situation varied significantly for each scope individually, with the greatest range of variability for Pusen 7.5F and V3. CONCLUSIONS: Illuminance performance of ureteroscopes within an obstructed calyx model differ significantly for various obstructive situations. Urologists should be aware of this to help guide their choice of ureteroscope.


Subject(s)
Lighting , Ureteroscopes , Humans , Equipment Design , Urologists , Disposable Equipment , Ureteroscopy
5.
J Surg Res ; 299: 112-119, 2024 Jul.
Article in English | MEDLINE | ID: mdl-38749314

ABSTRACT

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.


Subject(s)
Disposable Equipment , Equipment Reuse , Equipment Reuse/standards , Humans , Carbon Footprint , Cotton Fiber/analysis , Surgical Drapes , Surgical Wound Infection/prevention & control , Surgical Wound Infection/etiology
6.
Clin Transplant ; 38(5): e15321, 2024 May.
Article in English | MEDLINE | ID: mdl-38716774

ABSTRACT

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.


Subject(s)
Cystoscopy , Device Removal , Disposable Equipment , Feasibility Studies , Kidney Transplantation , Stents , Humans , Female , Male , Kidney Transplantation/economics , Middle Aged , Stents/economics , Device Removal/economics , Prospective Studies , Follow-Up Studies , Disposable Equipment/economics , Cystoscopy/economics , Cystoscopy/methods , Cystoscopy/instrumentation , Postoperative Complications , Tertiary Care Centers , Prognosis , Adult , Ureter/surgery , Urinary Tract Infections/etiology , Urinary Tract Infections/economics , Costs and Cost Analysis
7.
BJOG ; 131(5): 709-715, 2024 Apr.
Article in English | MEDLINE | ID: mdl-37806784

ABSTRACT

OBJECTIVE: To determine the user experience of wearing comfort of reusable sterile surgical gowns and compare these gowns with conventional disposable surgical gowns. DESIGN: Cross-sectional survey. SETTING: An academic hospital in the Netherlands. POPULATION: Gynaecologists, surgeons, residents and operating room assistants (n=80). METHODS: Quantitative and qualitative data were obtained via a written questionnaire. Participants provided subjective comments and scored the reusable gown on each individual topic with a score from 1 to 5 (1 = unsatisfactory, 2 = moderate, 3 = good, 4 = very good, 5 = excellent) and compared the reusable gown with the conventional disposable alternative (better, equal or worse). MAIN OUTCOME MEASURES: Wearing comfort: ventilation and temperature regulation, fit and length, functionality, barrier function and ease of use. RESULTS: The results of the overall scores of the reusable gown are scored as 'very good' (mean 4.3, SD ± 0.5) by its users. Regarding comparison of the gowns, more than 79% (lowest score 79%, highest score 95%) of the participants scored the reusable gown equal or higher on six of seven topics. The topic 'ease of use' was scored equal or higher by 59% of the participants. Subjective comments provided information on possible improvements. CONCLUSIONS: The findings of this study demonstrate that there is professional acceptance regarding the utilisation of reusable surgical gowns. To facilitate broader adoption, it is imperative to foster collaboration among suppliers and healthcare institutions. The reusable surgical gown is an environmentally sustainable, safe and comfortable alternative in the operating room.


Subject(s)
Surgical Attire , Humans , Cross-Sectional Studies , Operating Rooms , Protective Clothing , Health Facilities , Disposable Equipment
8.
Surg Endosc ; 38(6): 3361-3367, 2024 Jun.
Article in English | MEDLINE | ID: mdl-38710887

ABSTRACT

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.


Subject(s)
Disposable Equipment , Duodenoscopes , Disposable Equipment/economics , Humans , Attitude of Health Personnel , Surveys and Questionnaires , Cholangiopancreatography, Endoscopic Retrograde , Internship and Residency , United States
9.
Dig Dis Sci ; 69(6): 1956-1962, 2024 Jun.
Article in English | MEDLINE | ID: mdl-38466461

ABSTRACT

BACKGROUND AND AIMS: In response to documented duodenoscope-related infectious outbreaks of multidrug-resistant organisms, the Food and Drug Administration has recommended a transition to duodenoscopes with innovative designs, including duodenoscopes with disposable components or fully disposable duodenoscopes. We aim to characterize the learning curve (LC) for a single-use disposable duodenoscope. METHODS: We performed a retrospective analysis of a prospectively collected database from 31 patients who underwent ERCP by a single, experienced operator using the EXALT Model D® (Boston Scientific, Marlborough) disposable duodenoscope at a single tertiary referral center. The LC for this device was described by the number of cases needed to achieve proficiency using cumulative sum (CUSUM) analysis. Number of attempts to cannulate and time to cannulate the desired duct were assessed as separate endpoints. The overall mean number of attempts and overall mean time to cannulation were used as the target values in the respective CUSUM analyses. Proficiency was defined as the number of procedures where an inflection point was reached in the CUSUM graph. This observation indicates improving operator performance as shown by a decrease in the number of attempts and shortening of cannulation time after the defined number of procedures. RESULTS: Overall, 31 patients underwent ERCP using the EXALT Model D disposable duodenoscope by a single experienced endoscopist. 6 (19%) patients had a native papilla and the majority of these procedures were classified as ASGE complexity level 2 or above. The procedure was completed using solely the disposable duodenoscope in 27 patients (87%), while a reusable duodenoscope was required for procedure completion in 4 patients (13%). The cross-overs were distributed evenly across the performance period. Procedure-related adverse events included: post-ERCP pancreatitis (3%), bleeding (3%) and no perforations. In the analyses of both endpoints, an inflection of the CUSUM curves is achieved at 10 cases, indicating sustained reduction of cannulation attempts and time to cannulation. CONCLUSION: Among experienced pancreaticobiliary endoscopists, approximately 10 ERCPs is the threshold whereby procedure-related factors including cannulation success and procedural time improves. Procedure-related adverse events are consistent with those expected with reusable duodenoscopes. The need to cross-over from single-use duodenoscope to reusable duodenoscope did not appear to be related to the learning curve, as they were evenly distributed across the study period. These results can be used to guide adoption of single-use duodenoscopes into clinical practice.


Subject(s)
Cholangiopancreatography, Endoscopic Retrograde , Disposable Equipment , Duodenoscopes , Learning Curve , Humans , Duodenoscopes/microbiology , Retrospective Studies , Cholangiopancreatography, Endoscopic Retrograde/instrumentation , Cholangiopancreatography, Endoscopic Retrograde/methods , Male , Female , Middle Aged , Aged , Clinical Competence , Equipment Design
10.
Anesth Analg ; 139(1): 220-225, 2024 Jul 01.
Article in English | MEDLINE | ID: mdl-38195082

ABSTRACT

BACKGROUND: Operating room (OR) expenditures and waste generation are a priority, with several professional societies recommending the use of reprocessed or reusable equipment where feasible. The aim of this analysis was to compare single-use pulse oximetry sensor stickers ("single-use stickers") versus reusable pulse oximetry sensor clips ("reusable clips") in terms of annual cost savings and waste generation across all ORs nationally. METHODS: This study did not involve patient data or research on human subjects. As such, it did not meet the requirements for institutional review board approval. An economic model was used to compare the relative costs and waste generation from using single-use stickers versus reusable clips. This model took into account: (1) the relative prices of single-use stickers and reusable clips, (2) the number of surgeries and ORs nationwide, (3) the workload burden of cleaning the reusable clips, and (4) the costs of capital for single-use stickers and reusable clips. In addition, we also estimated differences in waste production based on the raw weight plus unit packaging of single-use stickers and reusable clips that would be disposed of over the course of the year, without any recycling interventions. Estimated savings were rounded to the nearest $0.1 million. RESULTS: The national net annual savings of transitioning from single-use stickers to reusable clips in all ORs ranged from $510.5 million (conservative state) to $519.3 million (favorable state). Variability in savings estimates is driven by scenario planning for replacement rate of reusable clips, workload burden of cleaning (ranging from an additional expense of $618k versus a cost savings of $309k), and cost of capital-interest gained on investment of capital that is freed up by the monetary savings of a transition to reusable clips contributes between $541k (low-interest rates of 2.85%) and $1.3 million (high-interest rates of 7.08%). The annual waste that could be diverted from landfill by transitioning to reusable clips was found to be between 587 tons (conservative state) up to 589 tons (favorable state). If institutions need to purchase new vendor monitors or cables to make the transition, that may increase the 1-time capital disbursement. CONCLUSIONS: Using reusable clips versus single-use stickers across all ORs nationally would result in appreciable annual cost savings and waste generation reduction impact. As both single-use stickers and reusable clips are equally accurate and reliable, this cost and waste savings could be instituted without a compromise in clinical care.


Subject(s)
Cost Savings , Disposable Equipment , Equipment Reuse , Operating Rooms , Oximetry , Operating Rooms/economics , Oximetry/economics , Oximetry/instrumentation , Equipment Reuse/economics , Humans , United States , Disposable Equipment/economics , Models, Economic , Hospital Costs
11.
BMC Urol ; 24(1): 149, 2024 Jul 18.
Article in English | MEDLINE | ID: mdl-39026274

ABSTRACT

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.


Subject(s)
Equipment Reuse , Kidney Calculi , Ureteroscopes , Ureteroscopy , Humans , Ureteroscopy/methods , Ureteroscopy/instrumentation , Male , Female , Retrospective Studies , Kidney Calculi/surgery , Middle Aged , Adult , Case-Control Studies , Treatment Outcome , Equipment Design , Disposable Equipment , Aged
12.
BMC Urol ; 24(1): 126, 2024 Jun 14.
Article in English | MEDLINE | ID: mdl-38877524

ABSTRACT

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.


Subject(s)
Circumcision, Male , Disposable Equipment , Equipment Design , Circumcision, Male/instrumentation , Circumcision, Male/adverse effects , Circumcision, Male/methods , Humans , Male , Retrospective Studies , Child , Child, Preschool , Infant , Operative Time , Adolescent , Postoperative Complications/epidemiology , Postoperative Complications/prevention & control
13.
BMC Ophthalmol ; 24(1): 376, 2024 Aug 26.
Article in English | MEDLINE | ID: mdl-39187788

ABSTRACT

BACKGROUND: Warm compresses are the routine treatment for Meibomian gland dysfunction (MGD) in daily life, but in order to achieve satisfactory efficacy, the treatment needs to be sustained over a long time, which can have an impact on the patient compliance. A more convenient warm compresses will help improve the patient compliance. Therefore, the purpose of the study is to investigate the efficacy and safety of the disposable eyelid warming masks for treatment of dry eye disease (DED) due to MGD. METHODS: This was a randomized, controlled, non-masked, two-center clinical trial. One hundred and forty-four patients were treated by the masks or the hot towel twice daily for 12 weeks. Patients were evaluated at baseline, 4-week and 12-week visits for subjective symptoms, objective signs and safety assessments, including ocular symptom scores, ocular surface disease index (OSDI), tear break-up time (BUT), corneal fluorescein staining (CFS), Schirmer I test (SIT), meibum quality, meibum expressibility, and adverse events (AEs). RESULTS: A totle of 134 patients were followed in the study. The mean age of the masks group (14 males and 52 females) and the hot towel group (20 males and 48 females) was 43.7 ± 13.5 years and 39.5 ± 13.9 years, respectively. At 4-week visit, there were significant statistical differences in ocular symptom scores, OSDI and CFS between two groups (P < 0.05). Except for SIT, the treatment group showed a greater improvement in subjective symptoms and objective signs than the control group at 12-week visit. (P < 0.05). In addition, 40 AEs occurred in 27 patients (37.5%) in the treatment group, and 34 AEs occurred in 21 patients (29.17%) in the control group. No serious AEs were reported. CONCLUSIONS: The masks had a good efficacy and safety in the treatment of DED due to MGD, and might offer an attractive treatment option for some patients. TRIAL REGISTRATION: The study was registered at Chinese Clinical Trial Registry (ChiCTR1900025443) on August 26, 2019.


Subject(s)
Dry Eye Syndromes , Meibomian Gland Dysfunction , Humans , Female , Male , Dry Eye Syndromes/therapy , Dry Eye Syndromes/physiopathology , Middle Aged , Meibomian Gland Dysfunction/therapy , Adult , Masks/adverse effects , Meibomian Glands , Treatment Outcome , Disposable Equipment , Aged , Tears/physiology , Tears/metabolism , Hyperthermia, Induced/instrumentation , Hyperthermia, Induced/methods , Hyperthermia, Induced/adverse effects
14.
Ophthalmic Physiol Opt ; 44(4): 686-692, 2024 Jun.
Article in English | MEDLINE | ID: mdl-38433496

ABSTRACT

PURPOSE: To determine the number of previous contact lens (CL) wearers who could be comfortably refitted into delefilcon A (DAILIES TOTAL1®) CLs. METHODS: This was a 6-month, three-visit study that recruited subjects who discontinued CLs within the past 2 years because of discomfort or dryness symptoms. Subjects were required to have Standard Patient Evaluation of Eye Dryness (SPEED) questionnaire scores ≤3 and to be able to wear spherical study CLs. Subjects were asked to complete a ±50 comfort visual analogue scale (VAS) at 1 month and a Likert questionnaire after 1 and 6 months of CL wear to understand the subjects' CL experience. RESULTS: All 60 subjects who were fitted with the study CLs were still wearing them after 1 month, while one subject had dropped out by 6 months. Subjects had a median (interquartile range) age of 24.0 (7.0) years (71.7% female). They reported a median VAS score of 44.0 (8.0) units at the 1-month visit, with all reporting a comfortable score. At the 1-month/6-month visits, 98.3%/93.2%, 86.5%/78.0% and 93.2%/91.5% of subjects responded that they were very satisfied or satisfied with their vision, their end-of-day CL comfort and overall CL comfort, respectively. The same subjects responded that they were very likely or likely to continue to wear the study CLs at 1 (89.6%) and 6 months (80.7%) and to recommend the study CLs to a friend at 1 (98.3%) and 6 months (93.2%). CONCLUSIONS: The results suggest that when encountering a CL dropout, a practitioner could educate a patient about trying an alternative CL and consider delefilcon A lenses as an option.


Subject(s)
Contact Lenses , Dry Eye Syndromes , Contact Lenses/adverse effects , Contact Lenses/psychology , Disposable Equipment , Humans , Dry Eye Syndromes/etiology , Surveys and Questionnaires , Male , Female , Adolescent , Young Adult , Adult
15.
Ophthalmic Physiol Opt ; 44(5): 876-883, 2024 Jul.
Article in English | MEDLINE | ID: mdl-38712751

ABSTRACT

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.


Subject(s)
Contact Lenses, Hydrophilic , Disposable Equipment , Dry Eye Syndromes , Tears , Humans , Male , Female , Tears/physiology , Tears/metabolism , Young Adult , Dry Eye Syndromes/physiopathology , Dry Eye Syndromes/diagnosis , Adult , Refractive Errors/therapy , Refractive Errors/physiopathology , Silicones , Adolescent , Surveys and Questionnaires , Eyelid Diseases/physiopathology , Eyelid Diseases/therapy , Osmolar Concentration
16.
Postgrad Med J ; 100(1184): 407-413, 2024 May 18.
Article in English | MEDLINE | ID: mdl-38330500

ABSTRACT

PURPOSE: Retroflexed endoscopic rubber band ligation (ERBL) for treating Grade II and III internal hemorrhoids using disposable endoscopes has not been previously assessed. We therefore compared the safety and effectiveness of ERBL for internal hemorrhoids using novel disposable endoscopes versus traditional reusable endoscopes. METHODS: This prospective randomized controlled trial involved 42 patients who underwent ERBL for Grade II and III internal hemorrhoids using either a disposable endoscope (n = 21) or a reusable endoscope (n = 21). Safety was assessed by the incidence of equipment failure, device-related adverse events, and in-procedure stability of vital signs. Effectiveness was assessed by the postoperative therapeutic effect, feasibility of retroflexed ERBL, and incidence of complications. RESULTS: In terms of safety, no life-threatening events, equipment failure, or device-related adverse effects occurred during the procedures in either group. The rate of diastolic blood pressure stability was significantly different between the two groups (P = .049), but the rates of systolic blood pressure and heart rate stability were similar. In terms of effectiveness, the therapeutic effects on postoperative Day 30 were similar in both groups. Image clarity and endoscopic flexibility in the disposable endoscope group were mildly inferior to those in the reusable endoscope group, but without statistical significance. Matching between the endoscope and ligating device was 100% in both groups. The incidence of complications on postoperative Days 1 and 10 was not significantly different between the two groups. CONCLUSION: Compared with reusable endoscopes, disposable endoscopes are equally safe, feasible, and reliable in ERBL for internal hemorrhoids.


Subject(s)
Disposable Equipment , Hemorrhoids , Humans , Hemorrhoids/surgery , Ligation/instrumentation , Ligation/methods , Female , Male , Pilot Projects , Middle Aged , Prospective Studies , Treatment Outcome , Endoscopes , Adult , Aged , Endoscopy/methods
17.
Urol Int ; 108(4): 367-376, 2024.
Article in English | MEDLINE | ID: mdl-38599181

ABSTRACT

INTRODUCTION: Disposable (single-use) flexible ureteroscopes are alternatives to reusable ureteroscopes. With their superior surgical efficacy and safety in the presence of upper urinary calculi, disposable ureteroscopes aim to overcome the main limitations of conventional reusable ureteroscopes. However, studies on the performance of the most recently developed models of single-use flexible ureteroscopes are scarce. This study aimed to compare the in vitro performance of several recently introduced, single-use, flexible ureteroscopes. METHODS: Five disposable flexible ureteroscopes were tested in vitro to evaluate their mechanical and optical characteristics. To this end, their degrees of deflection, irrigation flow rates, and image qualities were investigated. The models examined were Innovex US31-B12, OTU-100RR, Redpine RP-U-C12, Sciavita SUV-2A-B, and Seplou URS3016E. Their performance was also compared with that of a reusable flexible ureteroscope, Olympus URV-F. RESULTS: The OTU device had the highest degrees of deflection and the smallest loop diameter of the disposable ureteroscopes. The single-use ureteroscopes had identical image resolutions at a distance of 1 cm. The Innovex and Redpine devices had the best color representation. CONCLUSIONS: Of the tested disposable ureteroscopes, the OTU device had the best mechanical attributes, given its small loop diameter, high deflection angles, and low irrigation flow loss. As to their optical properties, the resolutions of all 5 single-use models were identical at an image distance of 1 cm.


Subject(s)
Disposable Equipment , Equipment Design , Ureteroscopes , Humans , Optical Phenomena , Mechanical Phenomena , Pliability , Materials Testing , Ureteroscopy/instrumentation
18.
BMC Surg ; 24(1): 212, 2024 Jul 19.
Article in English | MEDLINE | ID: mdl-39030560

ABSTRACT

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 .


Subject(s)
Disposable Equipment , Humans , Prospective Studies , Ultrasonic Surgical Procedures/instrumentation , Ultrasonic Surgical Procedures/methods , Hemostasis, Surgical/instrumentation , Hemostasis, Surgical/methods , Male , Female , Blood Loss, Surgical/prevention & control , Adult , Esophagus/surgery , Multicenter Studies as Topic , Treatment Outcome , Equivalence Trials as Topic , Middle Aged , Thoracic Surgical Procedures/methods , Thoracic Surgical Procedures/instrumentation
19.
Surgeon ; 22(4): 236-241, 2024 Aug.
Article in English | MEDLINE | ID: mdl-38862376

ABSTRACT

INTRODUCTION: As hospitals strive to reduce their environmental footprint, there is an ongoing debate over the environmental implications of reusable versus disposable linens in operating rooms (ORs). This research aimed to compare the environmental impact of reusable versus single-use OR bed covers and lift sheets using life cycle assessment (LCA) methodology. METHODS: LCA is an established tool with rigorous methodology that uses science-based processes to measure environmental impact. This study compared the impacts of three independent system scenarios at a single large academic hospital: reusable bed covers with 50 laundry cycles and subsequent landfill disposal (System 1), single-use bed covers with waste landfill disposal (System 2), and single-use bed covers with waste disposal using incineration (System 3). RESULTS: The total carbon footprint of System 1 for 50 uses was 19.83 â€‹kg carbon dioxide equivalents (CO2-eq). System 2 generated 64.99 â€‹kg CO2-eq. For System 3, the total carbon footprint was 108.98 â€‹kg CO2-eq. The raw material extraction for all the material to produce an equivalent 50 single-use OR bed cover kits was tenfold more carbon-intensive than the reusable bed cover. Laundering one reusable OR bed cover 50 times was more carbon intensive (12.12 â€‹kg CO2-eq) than landfill disposal of 50 single-use OR bed covers (2.52 â€‹kg CO2-eq). DISCUSSION: Our analysis demonstrates that one reusable fabric-based OR bed cover laundered 50 times, despite the carbon and water-intensive laundering process, exhibits a markedly lower carbon footprint than its single-use counterparts. The net difference is 45.16 â€‹kg CO2-eq, equivalent to driving 115 miles in an average gasoline-powered passenger vehicle. This stark contrast underscores the efficacy of adopting reusable solutions to mitigate environmental impact within healthcare facilities.


Subject(s)
Carbon Footprint , Equipment Reuse , Operating Rooms , Humans , Bedding and Linens , Disposable Equipment , Environment , Recycling
20.
Med Oral Patol Oral Cir Bucal ; 29(4): e517-e526, 2024 Jul 01.
Article in English | MEDLINE | ID: mdl-38615258

ABSTRACT

BACKGROUND: This study aimed to evaluate the surgical accuracy of a new universal disposable stop system for implant drills (FCA Universal Drill Stop). MATERIAL AND METHODS: A total of 60 bovine ribs were included in this in vitro study. The ribs were randomized into three study groups (n=20 ribs per group). In each study group (Group1: drills without stop or control group, Group 2: prefabricated drills with stop or gold standard group, and Group 3: drills with FCA Universal Drill Stop) a total of 100 osteotomies were performed with implant drills in each group, following the drilling sequence for the placement of a dental implant of 10 mm length and 4 mm diameter. The accuracy of the depth of the osteotomies was quantified clinically (with periodontal probe) and radiologically, using ImageJ version 1.48v software. RESULTS: The order of highest to lowest accuracy (clinical and radiological) in the depth of osteotomies was: FCA Universal Drill Stop> prefabricated drills with a stop>drills without stop, with statistically significant differences being observed between both systems with stop with respect to the control group, although not between them. CONCLUSIONS: The new universal disposable stop system for implant drills, offers similar accuracy to prefabricated drills with stop, with both systems being much more accurate than implant drills without stop. Although this experimental evaluation showed favourable results, further clinical studies are necessary.


Subject(s)
Osteotomy , Ribs , Animals , Cattle , Osteotomy/instrumentation , Osteotomy/methods , Ribs/surgery , Equipment Design , Disposable Equipment , In Vitro Techniques , Dental Implants , Random Allocation
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