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.

[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.

[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.

Review of Enhanced Handheld Surgical Drills.

The handheld drill has been used as a conventional surgical tool for centuries. Alongside the recent successes of surgical robots, the development of new and enhanced medical drills has improved surgeon ability without requiring the high cost and consuming setup times that plague medical robot systems. This work provides an overview of enhanced handheld surgical drill research focusing on systems that include some form of image guidance and do not require additional hardware that physically supports or guides drilling. Drilling is reviewed by main contribution divided into audio-, visual-, or hardware-enhanced drills. A vision for future work to enhance handheld drilling systems is also discussed.

[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.

Improvisation of surgical light: Another way round the obstacle.

The importance of surgical lighting is to illuminate the operative site on and within a patient for proper visualisation by operating theatre staff during a surgical procedure. With a good surgical illumination, a higher level of efficacy and safety can be achieved during surgery thus reducing the risk of complications. A rechargeable home LED bulb was converted into an improvised surgical lamp after removing the shade. This was mounted into the lamp holders of an old operating room lamp. This operating room lamp was plugged into an alternating current socket for power supply and recharging of the bulbs. This improvised surgical lamp provided a low temperature light source for more than 4 h. It is not however intended to replace standard operating lamps but is a viable alternative in resource challenged environments.

Analysis of alternate material Onyx™ for total knee arthroplasty instrumentation sets.

CONTEXT: A 25-pound weight limit is currently set on containerized instrumentation sets by the Association of periOperative Registered Nurses (AORN) and the Association for the Advancement of Medical Instrumentation (AAMI), in order to reduce strain on the staff and ensure that the sets are not too crowded in order to preserve sterilization and drying of the instruments. This is pushing companies to reduce the weight and number of instrumentation sets for the operating room. One solution has been to explore the viability of new, lighter materials such as Onyx. OBJECTIVES: The goal of this study is to evaluate the novel material Onyx as a viable material utilized in reusable total knee arthroplasty (TKA) instrumentation sets utilizing traditional steam sterilization as the sterilization method. METHODS: Mechanical and biocompatibility tests according to the American Society for Testing Materials (ASTM) and International Organization for Standardization (ISO) 10,993 were run to evaluate the Onyx Material to see if it would be a viable alternative to the stainless and martensitic steel that is currently being utilized. RESULTS: Gross warping and cracking after 10 rounds of sterilization was observed. This was qualitatively worse in the Onyx without a carbon fiber component. The Onyx material did not meet biocompatibility standards for its application. CONCLUSIONS: Onyx was determined to not be a viable material for TKA instruments regarding multiple high-pressure and -temperature sterilizations and cytotoxic cell testing.

How does congenital cervicothoracic scoliosis bring about early trunk tilt and coronal imbalance during curve progression: a radiographic analysis to dissect the mechanism of proximal takeoff phenomenon.

PURPOSE: To dissect the mechanism of how congenital cervicothoracic scoliosis (CTS) drive the occurrence of early trunk tilt, namely proximal takeoff phenomenon (PTO) during curve progression. METHODS: CTS patients were stratified into case and control groups according to the presence of PTO. The radiographic deformity parameters of head-neck-shoulder complex were measured and compared between the two groups. The main risk factors for PTO were identified through multiple linear regression analysis. RESULTS: 16 CTS patients with PTO were recruited, and the non-PTO group consisted of 19 CTS patients without PTO. The average Cobb angle was 64.9 ± 19.8° in PTO group and 57.7 ± 21.9° in control group (p > 0.05). Significant difference could be observed for head shift, neck tilt, trunk inclination, apex-C7 deformity angular ratio (DAR), apex translation ratio, C6 tilt, clavicle angle (CA), radiographic shoulder height (RSH), head-neck translation and coronal balance distance (CBD) (All p < 0.05) but not head tilt (p > 0.05). Multiple linear regression analysis revealed that head shift, but not neck tilt correlated significantly with the severity of trunk inclination (β = 0.106, p = 0.003), while apex-C7 DAR and apex translation ratio were the two factors contributing significantly to the severity of head shift (β = 0.620, p = 0.020; β = - 0.371, p = 0.004). CONCLUSIONS: Development and progression of head shift rather than neck tilt is a significant causative factor initiating the occurrence of trunk tilt and proximal takeoff in CTS. A higher apex-C7 DAR representing a short angular upper hemi curve and a lower apex translation ratio representing poor proximal coronal compensation are key risk factors predisposing to head shift.

[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.

Relationship between surgical field contamination by patient's exhaled air and the state of the drapes during eye surgery.

The coronavirus disease (COVID-19) pandemic has led to a dramatic increase in facemask use. Consequently, it has been reported that exhaled airflow toward the eyes can cause the dispersal of bacteria into the eyes, potentially increasing the incidence of postoperative endophthalmitis. In addition to wearing a facemask, gaps between the surgical drape and skin can also direct exhaled airflow toward the eyes. Here, we aimed to examine how the risk of contamination varies depending on the state of the drapes. We used a carbon dioxide imaging camera to visualize changes in exhaled airflow under different drape conditions and a particle counter to evaluate changes in the number of particles around the eye. The results revealed airflow present around the eye and a significant increase in the number of particles when the nasal side of the drape was detached from the skin. However, when a metal rod called "rihika" was used to create space above the body, the airflow and number of particles were significantly reduced. Thus, if drape coverage becomes incomplete during surgery, exhaled airflow toward the eye may contaminate the surgical field. On hanging up the drape, airflow can escape in the direction of the body, potentially preventing contamination.

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.

Effectiveness of iodine-impregnated incise drapes for preventing surgical site infection in patients with clean or clean contaminated wounds: A systematic literature review and cost-consequence analysis.

BACKGROUND: Surgical site infection is a serious complication associated with significant morbidity, mortality and health care expenditure. AIMS: To determine the clinical effectiveness and economic impact of using iodine-impregnated incise drapes for preventing surgical site infection. METHODS: MEDLINE, Embase, Cochrane Library and CINAHL databases were systematically searched. Critical appraisal and synthesis of clinical evidence informed a decision analytical cost-consequence model. FINDINGS: Nine studies were included in the systematic literature review. Evidence from cardiac surgery patients was considered appropriate to inform the cost analysis. The economic model evaluation estimated cost savings of £549 per patient with the iodophor-impregnated drape in the deterministic analysis and a mean cost saving per patient of £554,172 per 1000 in the probabilistic analysis. CONCLUSION: Using iodine-impregnated drapes in cardiac surgery patients may effectively reduce infections and provide cost-savings, but further research is required.

Characterization of Ultrasound Surgical Devices.

This article is a review of the techniques for characterizing ultrasound surgical devices, as a guide to those undertaking a program of measurement, and as a basis for further standardization of those methods. The review covers both acoustic and nonacoustic measurements, with an emphasis on proper techniques, devices, and analyses according to the IEC Standard 61847. Low-frequency hydrophone measurements are presented, which are centered on simple acoustic theory. Inertial cavitation measurements are described based on detailed analyses of shock wave propagation. Cutting force tests are also presented as a basis for determining relative performance characteristics and determining mechanisms of action. Example data from each type of test are given. Comparison between acoustic output measurements, in vitro data, and clinical outcomes help establish that inertial cavitation is the predominant mechanism of soft tissue erosion and emulsification. The test results also demonstrate approaches to improving efficiency while minimizing undesired effects. Finally, recommendations are made for updates to the 61847 Standard and for other device labeling that would improve patient safety.

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.

Ultra-sounding out a technique that sticks.

Ultrasound can be used to promote the physical interlocking of adhesives and tissues.

C-arm contamination of the surgical field: Can contamination be reduced with an intervening drape?

INTRODUCTION: Contamination of the surgical field by the C-arm in orthopaedic procedures is a significant potential source for surgical site infections. The purpose of this study was to explore the utility of a split sheet to aid in prevention of secondary contamination from the C-arm on the C-arm side of the operative field. METHODS: A C-arm and a surgical table were draped by standard techniques. The surgical table was split in thirds: the surgeon's side, the C-arm side of the operative field, and the middle for contamination analysis. Fluorescent powder was used to simulate a contaminant and placed on the C-arm, floor and lower portions of drapes. The C-arm was cycled between PA and Lateral positions. Powder transfer to the field was visualized with a camera under uniform UV light. Photographs were taken to measure fluorescent pixels prior to cycling the C-arm and at 5, 10 and 15 cycles. This protocol was repeated using a split sheet (U-drape) to isolate the C-arm below the operative field. Image J was utilized to calculate differences in the number of pixels brighter than the control image. RESULTS: Using standard draping techniques, there was contamination of the surgical field with the C-arm side of the operative field having the highest level of fluorescent pixels. The number of fluorescent pixels was linearly correlated with the number of PA to Lateral cycles. At the end of 15 cycles, the average number of fluorescent pixels for the intervening draping technique was 2.9 pixels compared to the standard draping technique of 3939 pixels (p = 0.0078). DISCUSSION: The addition of a U-drape between the C-arm and the table results in a statistically significant reduction in surgical field contamination as a result of secondary transfer from the C-arm. LEVEL OF EVIDENCE: II.

Efficacy of Ring Drape and Unused Sterile Instruments for Incisional SSI After Hepatectomy.

BACKGROUND/AIM: The aim of this study was to verify the efficacy of wound protection with a plastic ring wound protector (ring drape) and using new sterile instruments when closing the abdominal wall (wound closure set), both of which were used to prevent incisional surgical site infection (SSI) after hepatectomy. PATIENTS AND METHODS: The incidence of incisional SSIs and the clinical courses of 572 patients who underwent hepatectomy between January 2010 and December 2015 were studied retrospectively. The patients were divided into three period groups according to the period when each infection countermeasure was started. RESULTS: Incisional SSI incidence decreased significantly with additional countermeasures: 1st period 10.1%; 2nd period 2.08% (p=0.0114); 3rd period, 1.63% (1st vs. 3rd period, p=0.0016). A multivariate analysis showed that postoperative bile leakage [odds ratio (OR)=4.12, p=0.012] and not using a ring drape (OR=0.176, p=0.003) were independent factors for incisional SSI. CONCLUSION: Incisional SSI incidence was significantly reduced by using ring drape after hepatectomy.