Lifecycle of surgical devices: Global, environmental, and regulatory considerations.

BACKGROUND: Technological advancements, improved surgical access, and heightened demand for surgery have fueled unprecedented device and supply turnover impelling wealthy hospitals to upgrade continually and sell, donate, recycle, or dispose of used, expired, antiquated, or surplus goods. This paper reviews the issues related to device and supply lifecycles and discusses the opportunities and challenges they present for sustainable surgical growth in low- and middle-income (LMICs) countries. OBSERVATIONS: This review found, in LMICs countries, regulatory disparities persist that limit effective harmonization secondary to highly variable national policies and a lack of prioritized enforcement. Heterogeneity in the regulatory landscape, specifically in the classification, nomenclature, and identification of medical devices, encumbers effective regulation and distribution. Once devices are sold, donated, or reused in LMICs countries, complexities arise in regulatory compliance, maintenance, and appropriate use of these technologies. At the end of the lifecycle, waste management poses significant obstacles with limited resources hindering the implementation of best practices. CONCLUSION: There are major disparities in access to quality surgical equipment and supplies around the world. Improved communication between relevant stakeholders and harmonization of manufacture and disposal regulations will be needed to ensure adequate and appropriate responses to these challenges. TRIAL REGISTRATION NUMBER: Not applicable.

Expiry dates in surgical equipment: What are the options?

INTRODUCTION: Hospitals and the healthcare system contribute significantly to global warming, due to the energy use, water use and waste produce going directly to landfill. The operating theatre environment contributes to 70% of all hospital waste, and a proportion of this is due to unused surgical supplies, such as those stocked but never used as they go past their use-by date. AIM: To evaluate how use-by dates are identified and assigned to surgical equipment, and if there are opportunities to re-use, or re-sterilise this equipment in order to reduce waste from the operating theatre environment. RESULTS: Use-by dates are assigned to ensure sterility and longevity of the device, and are assigned based on risk analysis, retrospective and prospective assessment. Incineration is the mainstay of disposal of unused medical devices, but there are alternative options such as re-processing in specific circumstances. CONCLUSION: A large volume of hospital waste is due to operating theatres, and there is movement towards developing more sustainable methods of dealing with expired surgical equipment. This is however in the early stages, with further research required to confirm if these methods will be safe for patients, and beneficial to the environment.

[Data-Driven Construction of Operation Evaluation System for Large Medical Equipment in Children's Hospital].

Objective: Through data collection and analysis, the method of evaluating the operation quality of large medical equipment in children's hospital is explored and suggestions on the use and configuration of large medical equipment is put forward. Methods: Collect the equipment operation data through the Internet of Things, and combine the hospital HIS, RIS, HRP and other information system data to establish the operation evaluation system of large medical equipment of children's hospital. CRITIC method is used to quantitatively evaluate single type of equipment and single equipment. Results: Hospital big data platform realizes the longitudinal analysis of the operation data of a single large equipment and forms a visual chart, which is displayed on the PC and mobile terminals. Municipal platform can conduct horizontal analysis on the equipment operation data to realize the comprehensive quantitative evaluation of the operation level of large equipment of children's hospital and put forward suggestions for use and configuration. Conclusion: A large equipment operation evaluation system for children's hospital is established through data collection and analysis, and the fine management level of large medical equipment is improved.

Using an Instrumented Hammer to Predict the Rupture of Bone Samples Subject to an Osteotomy.

Osteotomies are common procedures in maxillofacial and orthopedic surgery. The surgeons still rely on their proprioception to control the progression of the osteotome. Our group has developed an instrumented hammer that was shown to provide information on the biomechanical properties of the tissue located around the osteotome tip. The objective of this study is to determine if this approach may be used to predict the rupture of a bone sample thanks to an instrumented hammer equipped with a force sensor. For each impact, an indicator τ is extracted from the signal corresponding to the variation of the force as a function of time. A linear by part regression analysis is applied to the curve corresponding to the variation of τ as a function of the distance d between the tip of the osteotome and the end of the sample. The experiments were conducted with plywood and bovine trabecular bone samples. The results show that τ starts increasing when the value of d is lower than 2.6 mm on average, which therefore corresponds to a typical threshold detection distance between the osteotome tip and the sample end. These findings open new paths for the development of this instrumented surgical hammer.

[Surgical Equipment for Neuroendoscopic Surgery].

The development of endonasal endoscopic surgery has been advanced one step further by the image quality and expressiveness of endoscopes. The widespread use of HD endoscopic cameras has enabled tumor dissection, preservation of vital vessels, and delicate dissection of nerves during endonasal surgery through the close and detailed observation of intracranial structures. The observation of high image quality is essential. In addition, instruments that can be carefully manipulated are essential for achieving this image quality. Traditionally, endoscopic surgery has relied on axial back-and-forth movement in many situations due to the inability of the instruments to move sufficiently laterally, and it has been said that precise and effective instrument movement cannot be achieved. However, the ingenuity of surgical techniques to create an adequate operative field, movements specific to endoscopic surgery, and the emergence of specialized instruments have made delicate manipulation possible. Exoscopes, which appear as adjuncts to endoscopic surgery or alternatives to microscopic surgery, have also influenced the form of endoscopic surgery because, like endoscopes, they are heads-up surgeries. Recent developments in the peripheral equipment related to neuroendoscopic surgery have been described.

[Analysis and Research on Comprehensive Evaluation Method of Operation Performance of Hospital Valuable Equipment].

OBJECTIVE: To study the effective method of comprehensive evaluation and analysis of hospital valuable medical equipment performance. METHODS: The operation performance of 6 valuable equipment was evaluated by cost-benefit method, comprehensive index method and public evaluation method. RESULTS: Utilize equipment information management methods for data collection and evaluation, and construct an assessment data model based on evaluation indicators from three aspects: equipment operation status, profitability status, and scientific research contribution. CONCLUSIONS: Through the performance analysis of different types of valuable medical equipment, a more real and comprehensive quantitative analysis is carried out, which plays a key role in the reasonable purchase, efficient operation and avoiding idling.

[Research on Cost Control and Rationalization Application Supervision of Medical Equipment Consumables Based on Analytic Hierarchy Process].

OBJECTIVE: To analyze the medical equipment operation data of 44 clinical departments in the hospital from three aspects: materials and consumables, operation and maintenance depreciation, and operation management. METHODS: To formulate the evaluation standards and scoring criteria for the operation indicators, the lowest score is 0 points, and the highest score is 5 points. Based on the operation indicators of medical equipment, establish a hierarchical structure model, determine the criterion layer and sub-criteria layer, construct a judgment matrix, normalize it, and calculate the weight coefficient. RESULTS: Count equipment operation data in 2021 and 2022. Score according to the assessment standards, assign weights through the analytic hierarchy process, calculate the total score and sort, and making a special analysis on the top 10 departments and departments with a score below 4 points, and formulate a rectification plan. CONCLUSIONS: The establishment of index assessment standards and the weight distribution of AHP can effectively enhance the control of equipment operating costs.

Gender Disparity in Surgical Device Patents: A Five-year Trend From Canada and the United States.

INTRODUCTION: Despite an increasing number of women pursuing careers in science, engineering, and medicine, gender disparities in patents persist. This study sought to analyze trends in inventor's gender for surgical device patents filed and granted in Canada and the United States from 2015 to 2019. METHODS: This study analyzed patents filed and granted by the Canadian Intellectual Property Office (CIPO) in the category of "Diagnosis; Surgery; Identification" and the United States Patent and Trademark Office (USPTO) in the category of "Surgery" from 2015 to 2019. The gender of the patent applicants was determined using a gender algorithm that predicts gender based on first names. Gender matches with names having a probability of less than 95% were excluded. RESULTS: We identified 14,312 inventors on patents filed and 12,737 inventors on patents granted by the CIPO for "Diagnosis; Surgery; Identification". In the USPTO category of "Surgery," we identified 75,890 inventors on patents filed and 44,842 inventors on patents granted. Female inventors accounted for 7%-10% of inventors from 2015 to 2019 for both patents filed and granted. The proportion of female inventors on patents granted was significantly lower than for patents filed for four of the 5 y analyzed for both the USPTO and CIPO. CONCLUSIONS: Female representation in surgical device patenting has stagnated, between 7 and 10%, from 2015 to 2019 in Canada and the United States. This underrepresentation of female inventors in surgical device patenting represents sizable gender disparity.

Management of Less Than 10-mm-Sized Pedunculated (Ip) Polyps with Thin Stalk: Hot Snare Polypectomy Versus Cold Snare Polypectomy.

BACKGROUND: Although the use of cold snare polypectomy (CSP) has spread rapidly, its safety for pedunculated (Ip) polyps remains controversial. In particular, the outcomes of hot snare polypectomy (HSP) and CSP for Ip polyps have not been previously compared. AIMS: This study evaluated whether the rate of delayed postpolypectomy bleeding (DPPB) after CSP for Ip polyps was higher than that after HSP for Ip polyps and compared other outcomes (the rates of immediate bleeding and pathological margins) between the HSP and CSP procedures. METHODS: A total of 5905 colorectal polyps in 4920 patients were resected at Omori Red Cross Hospital between October 2012 and June 2019. The polyps were divided into two groups: the HSP group (86 polyps, 64 patients) and the CSP group (102 polyps, 87 patients). The primary outcome measure was the incidence of DPPB. The secondary outcome measures were the incidences of immediate bleeding during the procedure and pathological margins of the resected specimen. RESULTS: The rate of immediate bleeding during CSP was significantly higher than that for the HSP group [38.2% (39/102) versus 3.5% (3/86); p < 0.001]. However, the rate of DPPB was significantly higher in the HSP group than in the CSP group [4.7% (4/86) versus 0% (0/102); p < 0.001]. The rate of DPPB after CSP was 0%. CONCLUSIONS: This is the first study to compare the outcomes of HSP and CSP for Ip polyps. CSP is safer than HSP for Ip polyps measuring < 10 mm in diameter.

Clinical utility of the pocket-creation method with a traction device for colorectal endoscopic submucosal dissection.

BACKGROUND: Colorectal endoscopic submucosal dissection (ESD) is technically demanding while ensuring safety, especially in cases with fibrosis and/or poor maneuverability. To overcome such difficulties, we developed a novel method called the pocket-creation method with a traction device (PCM with TD). We then evaluated the effectiveness and safety of PCM with TD in colorectal ESD compared to other conventional methods. METHODS: In total, 324 colorectal lesions treated with ESD from July 2018 to June 2019 were included. The following three treatment strategies were used: conventional ESD (CE), CE with TD, and PCM with TD. Patient backgrounds and treatment outcomes were retrospectively compared and analyzed. RESULTS: As ESD methods, CE, CE with TD, and PCM with TD account for 58% (187/324), 24% (78/324), and 18% (59/324), respectively. No significant difference was observed among the three groups in en bloc and R0 resection rates or adverse events. The rate of lesions with fibrosis and poor maneuverability was significantly higher in the PCM with TD group (CE group vs CE with TD group vs PCM with TD group: fibrosis, 24% vs 47% vs 64%, p < 0.001; poor maneuverability, 5.3% vs 13% vs 20%, p = 0.002). Dissection speed was significantly higher in the PCM with TD than in the CE with TD group (p = 0.003). CONCLUSIONS: PCM with TD can achieve a stable en bloc resection rate and R0 dissection rate without adverse events even in the hands of trainees, irrespective of the size and location of the lesion, presence of fibrosis, and under poor maneuverability conditions.

Artists With Anatomical Knowledge After Anathomia (1316) and Before Fabrica (1543).

ABSTRACT: In the Renaissance, anatomical science was a major source of inspiration for artists. By the 15th century, interest had emerged in anatomy, and the artists of the period dissected cadavers. The aim of this paper was to analyze the works of 15th century artists who had a good knowledge of human anatomy.In PubMed and Google, "Renaissance" and "artist" and ("anatomy" or "cadaver" or "corpse") were searched. In the book Lives of the Painters, Sculptors, and Architects by Vasari, the terms "cadaver" or "dissect" or "corps" or "anatomy" were searched. Fourteen artists (Donato di Niccolò di Betto Bardi, Piero della Francesca Andrea del Castagno, Antonio del Pollaiuolo, Andrea del Verrocchio, Leonardo da Vinci, Michelangelo di Lodovico Buonarroti Simoni, Domenico di Pace Beccafumi, Baccio Bandinelli, Giovanni Antonio Lappoli, Rosso Fiorentino, Silvio Cosini of Fiesole, Jan van Calcar, and Taddeo Zucchero) who learned anatomy or performed dissections were identified, and artworks representing their knowledge of human anatomical structures were analyzed.In this review, we identified artists who had a good knowledge of anatomy and applied anatomical knowledge of features such as muscle shape and volume in their works.The artists sought to accurately portray facial expressions, positions, reflexive motions, and draped clothing. Observation of living subjects is the primary source of artists' expertise. Dissection provides fixed model without flowing blood, which cannot be used as an animated model. It is thought that these artists learned about the origins of vivid expressions from the anatomy of the muscles lying beneath the skin.

Use of a Bipolar Vessel-Sealing Device for Splenic Parenchymal Resection in Three Dogs and One Cat.

Based on splenic abnormalities noted during surgery, four client-owned animals (three dogs, one cat) undergoing exploratory laparotomy were identified as candidates for partial splenectomy. In three cases, small mass lesions of the spleen were identified on elective exploratory laparotomy. In one case, the patient was referred for emergency surgery for diaphragmatic hernia with entrapment of stomach and spleen. The discovery of avulsion of a significant portion of the splenic mesentery led to the decision to perform partial splenectomy in this case. All animals included in the study underwent partial splenectomy by one of two board-certified veterinary surgeons at a multispecialty hospital between 2014 and 2018. The same type of bipolar vessel-sealing device was used in each surgery, and three of four partial splenectomy cases recovered uneventfully. One patient went into cardiopulmonary arrest hours after surgery and died; however, this is not suspected to be due to the described partial splenectomy technique. The bipolar vessel-sealing device is suitable for use in resection of the splenic parenchyma in some canine and feline patients. This technique is designed to decrease surgical time, provide effective hemostasis, and preserve the important functions of the spleen that are lost when total splenectomy is undertaken.

[Research on Self-perception and Active Warning Model of Medical Equipment Operation and Maintenance Status Based on Machine Learning Algorithm].

The panoramic perception of medical equipment operation and maintenance status is the basic guarantee for the implementation of smart medical care, the machine learning algorithm-based autonomous perception and active early warning model of medical equipment operation and maintenance status is proposed. Introduce deep learning multi-dimensional perception of medical equipment multi-source heterogeneous fault data training sample characteristics to realize autonomous perception of medical equipment operation and maintenance status, introduce reinforcement learning to realize autonomous decision-making of test sample fault characteristics, and build the active early warning mechanism for medical equipment faults. Taking the equipment department of hospital as the carrier of model effectiveness verification, the effectiveness simulation of the model was carried out, the results show that the model has the advantages of comprehensive fault information perception, strong compatibility of medical equipment, high efficiency of active early warning.

Inactivation Methods for Prions.

Incidences of iatrogenic Creutzfeldt-Jakob disease (iCJD) are caused by transplantation of prion-contaminated hormones, cornea and dura mater as well as contact with prion- contaminated medical devices, such as stereotactic electrodes, used in neurosurgery. Because prions are highly resistant and difficult to inactivate, prion contamination is a severe risk when medical instruments are reused after surgical procedures involving suspicious and confirmed cases of patients with prion diseases. Therefore, when high-risk procedures such as cerebral surgery, craniotomy surgery, orthopaedic spinal surgery and ophthalmic surgery are performed for high-risk patients or individuals with prion diseases, it is neces- sary to appropriately treat the medical devices using scientifically proven prion inactivation methods. In this chapter, we introduce fundamental aspects of prion inactivation methods, looking specifically at the practical issues involved in their implementation.

Evaluation of a novel esophageal retractor utilizing vacuum suction and mechanical force for deviating the esophagus.

BACKGROUND: Deviation of the esophagus prevents esophageal injury during atrial fibrillation ablation. OBJECTIVES: This study is to evaluate, in animals, safety and effectiveness of a novel esophageal retractor that utilizes vacuum suction and mechanical force to deviate the esophagus. METHODS: Following general anesthesia, a radiopaque ruler was placed behind the animal perpendicular to the esophagus. The esophageal retractor was inserted and esophagram was completed. Suction force (280-300 mm Hg) was applied to the distal aspect of the device that resulted in adherence of the esophagus in a circumferential manner. Then movement of a deflecting arm was used to deviate the esophagus. Four animal studies completed: (a) deviation distance and presence of trailing edge; (b) effect of 1 hour continuous suction and deviation upon esophageal cellular architecture; (c) impact on luminal esophageal temperature (LET) during high power ablation; and (d) compatibility of esophageal retractor with electroanatomic mapping system. RESULTS: The distance of deviation to the right (26.6 ± 2.5 mm) was higher than to the left (18.7 ± 2.3 mm; P < .01). There was no esophageal trailing edge in 65/68 deviations (96%). With continuous suction for 1 hour, pathology revealed small, <1mm, circular area of hyperemia in the esophageal mucosa. During high power ablation, the maximum increase in LET was 0.2°C. Finally, there was no interference between the device and electro-anatomical mapping system. CONCLUSION: In animal models, the esophageal retractor utilizing vacuum suction was successful at deviating the esophagus without significant trailing edge and with minor (1 mm) injury with prolonged continuous suction.

Reflection-based lab-in-fiber sensor integrated in a surgical needle for biomedical applications.

Recently, lab-in-fiber (LIF) sensors have offered a new paradigm in many different scenarios, such as optofluidics, due to their ability to integrate different multiphysics sensor elements in a small space. In this Letter, the design and manufacture of a multiparameter sensing device is proposed, through the combination of an in-fiber air microcavity and a plane-by-plane fiber Bragg grating (FBG). The reflection-based sensor, with a length of less than 300 µm, is located at the end of a single-mode fiber and integrated into a surgical needle for exploitation in biomedical applications. Here we present the first (to our knowledge) ultra-short LIF sensor reported under the "touch and measure" approach. In this first prototype, the detection of axial tensile strain (6.69pm/µÎµ in air cavity) and surrounding refractive index (11.5 nm/RIU in FBG) can be achieved simultaneously.

Vaginal surgery: don't get bent out of shape.

Vaginal hysterectomy rates in the United States are decreasing, despite it being the recommended hysterectomy route for benign hysterectomy by multiple societies. Visualization issues are a known barrier to a medical student learning in the operating room, and it is likely that this also extends to resident training. In addition, vaginal surgery can be taxing on both the surgeons and assistants, with high rates of musculoskeletal work disorders reported in vaginal surgeons. The use of a camera is integral to endoscopic surgery, and table-mounted retractor systems have been used for decades in open surgery. We bring these 2 features into vaginal surgery, that is, using a table-mounted camera system and a table-mounted vaginal retractor. When used together as demonstrated in this video, these tools can improve visualization and may improve ergonomics for the entire surgical team, including learners, during vaginal surgery.

Enhancing Medical Students' Interprofessional Teamwork Through Simulated Room of Errors Experience.

BACKGROUND: Fostering medical students' appreciation for team members particularly those from other disciplines with varying levels of experience promotes a promising beginning to a health care career. METHODS: During surgical clerkship orientation, third-year medical students completed 30-item TeamSTEPPS Teamwork Attitudes Questionnaire preintervention and postintervention, spent 7 min identifying errors in a simulated operating room, followed by recorded physician-led 30-min discussions. RESULTS: Postintervention (67) compared with preintervention (141) mean TeamSTEPPS Teamwork Attitudes Questionnaire domain scores were statistically significantly higher for team structure (4.59, 4.70; P = 0.03) and higher but not significant for leadership (4.74, 4.75; P = 0.86), situation monitoring (4.62, 4.68; P = 0.32), communication (4.40, 4.50; P = 0.14), and decreased for mutual support (4.43, 4.36; P = 0.43). Medical students identified 2%-93% of 33 staged errors and 291 additional errors, which were placed into 14 categories. Soiled gloves in the operative field and urinary bag on the floor were the most frequently identified staged errors. Experienced nurses compared with medical students identified significantly more errors (mean, 17.7 versus 11.7, respectively; P < 0.001). Recognizing errors when lacking familiarity with the operative environment and appreciating teammates' perspectives were themes that emerged from discussions. CONCLUSIONS: This well-received teamwork exercise enabled medical students to appreciate team members' contributions and other disciplines' perspectives, in addition to the synergy that occurs with multidisciplinary teams.

Is it the technique or wound protection that is key to reducing wound infections in Roux-en-Y gastric bypass procedures?

INTRODUCTION: An unusually high surgical site infection (SSI) rate after Roux-en-Y gastric bypass (RYGB) was noted on routine outcomes review. Surgeon A, who had a rate of 8.9%, utilized the transoral technique (passage down esophagus into gastric pouch) for anvil insertion for the circular-stapled gastrojejunostomy. By comparison, SSI rate was 0% for Surgeon B, who inserted anvil transabdominally (direct passage into stomach via gastrotomy) and used wound protection (wound protector and plastic drape over stapler). We sought to determine if it was the technique for anvil insertion (transoral or transabdominal) or use of wound protection that could help reduce SSIs. METHODS: In mid-2017, Surgeon A added wound protection (wound protector and plastic drape over stapler) to the transoral technique to minimize oral flora wound contamination. Surgeon B made no changes. In this study, wound-related outcomes are examined, comparing patients who underwent surgery before (Group 1) versus after (Group 2) this intervention. Statistical analysis performed utilizing t tests and Chi square analysis; p < 0.05 considered significant. RESULTS: Three hundred and thirty-three patients underwent RYGB. Group 1 consisted of 182 patients over 17 months; 151 patients over 13 months were in Group 2. Groups were similar in age, BMI, gender, and prevalence of diabetes. There was a decrease in SSIs between Group 1 and Group 2 (5 vs. 0, p = 0.04). 11 wound complications occurred in Group 1 (5 SSIs, 4 seromas and 2 hematomas); whereas 2 wound complications occurred in Group 2 (1 seroma and 1 hematoma); decrease from 6 to 1.3%, p = 0.03. CONCLUSIONS: This study demonstrates that changing technique can lead to best outcomes. There was a dramatic reduction of wound complications and complete elimination of SSIs with a change in operative technique. The higher risk of SSI with the transoral anvil insertion when preforming a circular-stapled anastomosis can be mitigated with use of wound protection.

Cost containment: an experience with surgeon education and universal preference cards at two institutions.

BACKGROUND: As the cost of health care increases in the US, focus has been placed upon efficiency, cost reduction, and containment of spending. Operating room costs play a significant role in this spending. We investigated whether surgeon education and universal preference cards can have an impact on reducing the disposable supply costs for common laparoscopic general surgery procedures. METHODS: General surgeons at two institutions participated in an educational session about the costs of the operative supplies used to perform laparoscopic appendectomies and cholecystectomies. All the surgeons at one institution agreed upon a universal preference card, with other supplies opened only by request. At the other, no universal preference cards were created, and surgeons were free to modify their own existing preference cards. Case cost data for these procedures were collected for each institution pre- (July 2014-December 2014) and post-intervention (February 2015-November 2017). RESULTS: At the institution with an education only program, there was no statistically significant change in supply costs after the intervention. At the institution that intervened with the combined education and universal preference card program, there was a statistically significant supply cost decrease for these common laparoscopic procedures combined. This significant cost decrease persisted for each appendectomies and cholecystectomies when analyzed independently as well (p = 0.001 and p < 0.001 respectively). CONCLUSIONS: In this study, surgeon education alone was not effective in reducing operating room disposable supply costs. Surgeon education, combined with the implementation of universal preference cards, significantly maintains reductions in operating room supply costs. As health care costs continue to increase in the US and internationally, universal preference cards can be an effective tool to contain cost for common laparoscopic general surgery procedures.