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.

The design and evaluation of a novel algorithm for automated preference card optimization.

BACKGROUND: Inaccurate surgical preference cards (supply lists) are associated with higher direct costs, waste, and delays. Numerous preference card improvement projects have relied on institution-specific, manual approaches of limited reproducibility. We developed and tested an algorithm to facilitate the first automated, informatics-based, fully reproducible approach. METHODS: The algorithm cross-references the supplies used in each procedure and listed on each preference card and uses a time-series regression to estimate the likelihood that each quantity listed on the preference card is inaccurate. Algorithm performance was evaluated by measuring changes in direct costs between preference cards revised with the algorithm and preference cards that were not revised or revised without use of the algorithm. Results were evaluated with a difference-in-differences (DID) multivariate fixed-effects model of costs during an 8-month pre-intervention and a 15-month post-intervention period. RESULTS: The accuracies of the quantities of 469 155 surgeon-procedure-specific items were estimated. Nurses used these estimates to revise 309 preference cards across eight surgical services corresponding to, respectively, 1777 and 3106 procedures in the pre- and post-intervention periods. The average direct cost of supplies per case decreased by 8.38% ($352, SD $6622) for the intervention group and increased by 13.21% ($405, SD $14 706) for the control group (P < .001). The DID analysis showed significant cost reductions only in the intervention group during the intervention period (P < .001). CONCLUSION: The optimization of preference cards with a variety of institution-specific, manually intensive approaches has led to cost savings. The automated algorithm presented here produced similar results that may be more readily reproducible.

Using a Smartphone as an Exoscope Where an Operating Microscope is not Available.

OBJECTIVE: Neurosurgical operating rooms are equipped with microscopes in order to provide a good standard of care. Nevertheless, in developing countries, microscopes are not always available. During a short period in a western Africa hospital, we adapted our smartphones as a valid alternative to the microscope. METHODS: Using a shaped tin can, a smartphone cover, and a rod fixed to the bed, we could make a support for a smartphone creating a simple "homemade" exoscope, which allowed us to have magnification and light in the surgical field. RESULTS: Among others, we performed 5 surgical interventions of both spinal and brain surgery using our smartphone as a magnifier. This allowed us to overcome the absence of a better magnification system. CONCLUSIONS: This simple "smartphone-based exoscope" allows surgeons to get an adequate magnification during surgery when microscopes or magnification goggles are not available. It can be a useful solution in developing countries where often nothing better is available.

Recovery of Surgical Equipment Sterile Processing During a Floodwater Boil Advisory.

Excessive rainfall and dam failures resulted in floodwater contaminating our public water supply. The endotoxin risk in the contaminated water created challenges in recovery of sterile processing for our surgical equipment. Recovery plans should include a potable water source and a method to connect it to the required location. We share our solution of plumbing our sterile processing equipment to tanker-transported potable water sources. (Disaster Med Public Health Preparedness. 2018; 12: 415-418).

Evaluating the Effectiveness and the Impact of Donated Neurosurgical Equipment on Neurosurgical Units in Low- and Middle-Income Countries: The World Federation of Neurosurgical Societies Experience.

BACKGROUND: Surgical practice highly depends on the availability of surgical equipment; this is particularly relevant to low- and middle-income countries (LMICs), where resources are limited. A key part of the efforts to improve surgical provision globally include providing affordable equipment to LMICs; however, the effectiveness and the impact of these initiatives have not yet been assessed. We aimed to evaluate the World Federation of Neurosurgical Societies neurosurgical equipment program in this context. METHODS: Recipients were identified from the World Federation of Neurosurgical Societies records; contact details were gathered. An online survey was used to collect data on equipment, including its current use, any malfunctioning issues, suitability, reliability, serviceability, and the impact it has had on the unit. RESULTS: Responses were received from 16 units, totaling 28 pieces of equipment. A total of 75% of the equipment is still in use; of this, 57% is fully functioning, and 43% is used despite some malfunction. We found that 25% of the equipment is broken and unusable; high-maintenance items, such as high-speed drills, feature in this category (100% broken, n = 3). Units reported an increase in number of operation performed in 74% cases, improved surgery quality in 78%, and breadth of operations in 44%. Satisfaction, equipment suitability, reliability, and serviceability scored highly, with median values of 9 for all fields on a 10-point scale. CONCLUSIONS: Equipment donation positively impacts neurosurgical units in LMICs by allowing expansion of neurosurgical practice, improved safety and quality, and affordability. Adequate follow-up, considerations regarding equipment durability and maintenance needs, and improved support for repairs should be prioritized to ensure maximal benefit.

Pilot Use of a Novel Tool to Assess Neurosurgical Capacity in Uganda.

INTRODUCTION: There is a significant burden of unmet surgical need in many low- and middle-income countries (>80% in parts of Africa). This need is even larger for specialties such as neurosurgery. Surgical capacity tools have been developed and used to assess needs and plan for resource allocation. This study piloted a new tool to assess neurosurgical capacity and describes its use. METHODS: A surgical capacity tool was adapted to assess neurosurgical capacity. An expert panel of neurosurgeons and researchers reviewed the Surgeons OverSeas PIPES (personnel, infrastructure, procedures, equipment, and supplies) assessment and added additional items essential to perform common neurosurgery procedures. This tool was then piloted at 3 public hospitals in Uganda and each hospital was given a score of neurosurgical capacity. At 1 hospital, 3 respondents were asked to answer the survey to assess reliability. RESULTS: The hospital with the largest neurosurgery caseload and 5 neurosurgeons scored the highest on our survey, followed by a regional hospital with 1 practicing neurosurgeon. The third hospital, without a neurosurgeon, scored the lowest on the scale. At the hospital that completed the reliability assessment, scores were varied between respondents. CONCLUSIONS: NeuroPIPES survey scores were in keeping with the number of neurosurgeons and respective caseloads of each hospital. However, the variation in scores between respondents at the same hospital suggests that adaptations could be made to the tool that may improve reliability and validity. The methodology used to create NeuroPIPES may be successfully applied to a variety of other surgical subspecialties for similar assessments.

An Observational Assessment of Anesthesia Capacity in Madagascar as a Prerequisite to the Development of a National Surgical Plan.

BACKGROUND: The global lack of anesthesia capacity is well described, but country-specific data are needed to provide country-specific solutions. We aimed to assess anesthesia capacity in Madagascar as part of the development of a Ministry of Health national surgical plan. METHODS: As part of a nationwide surgical safety quality improvement project, we surveyed 19 of 22 regional hospitals, representing surgical facilities caring for 75% of the total population. The assessment was divided into 3 areas: anesthesia workforce density, infrastructure and equipment, and medications. Data were obtained by semistructured interviews with Ministry of Health officials, hospital directors, technical directors, statisticians, pharmacists, and anesthesia providers and through on-site observations. Interview questions were adapted from the World Health Organization Situational Analysis Tool and the World Federation of Societies of Anaesthesiologists International Standards for Safe Practice of Anaesthesia. Additional data on workforce density were collected from the 3 remaining regions so that workforce density data are representative of all 22 regions. RESULTS: Anesthesia physician workforce density is 0.26 per 100,000 population and 0.19 per 100,000 outside of the capital region. Less than 50% of hospitals surveyed reported having a reliable electricity and oxygen supply. The majority of anesthesia providers work without pulse oximetry (52%) or a functioning vaporizer (52%). All the hospitals surveyed had very basic pediatric supplies, and none had a pediatric pulse oximetry probe. Ketamine is universally available but more than 50% of hospitals lack access to opioids. None of the 19 regional hospitals surveyed was able to completely meet the World Federation of Societies of Anaesthesiologists' standards for monitoring. CONCLUSIONS: Improving anesthesia care is complex. Capacity assessment is a first step that would enable progress to be tracked against specific targets. In Madagascar, scale-up of the anesthesia workforce, investment in infrastructure and equipment, and improvement in medication supply-chain management are needed to attain minimal international standards. Data from this study were presented to the Ministry of Health for inclusion in the development of a national surgical plan, together with recommendations for the needed improvements in the delivery of anesthesia.

Burn Care on Cruise Ships-Epidemiology, international regulations, risk situation, disaster management and qualification of the ship's doctor.

With the increasing numbers of passengers and crew on board vessels that are becoming larger and larger, the demand for ship's doctors who can adequately treat burns on board has also increased. In the cruise ship industry it is usually those doctor's with internal and general medical training who are recruited from an epidemiological point of view. Training content or recommendations for the treatment of thermal lesions with the limited options available in ship's hospitals and where doctors with no surgical training operate do not yet exist. The guidelines recommended by the Cruise Lines International Association (CLIA) regarding medical staff have only included physicians with minor surgical skills until now. With the introduction of the ATLS(®) course developed by the American College of Surgeons, the requirements for the qualification of the ship's doctor on board cruise ships shall change from January 2017. The article discusses the question of whether having completed the ATLS(®) course, the ship's doctor is trained to adequately treat thermal lesions or severe burns persons on-board, and presents the current discussion on the training content for ship's doctors within the International Maritime Health Association (IMHA). It also provides an overview of existing international regulatory frameworks, the risks presented by a fire on board, the problem of treating burns victims out of reach of coastal rescue services, and alternative training concepts for ship's doctors regarding the therapy of thermal lesions on-board.

A cross-sectional survey of emergency and essential surgical care capacity among hospitals with high trauma burden in a Central African country.

BACKGROUND: As the overwhelming surgical burden of injury and disease steadily increases, disproportionately affecting low- and middle-income countries, adequate surgical and trauma care systems are essential. Yet, little is known about the emergency and essential surgical care (EESC) capacity of facilities in many African countries. The objective of this study was to assess the EESC capacity in different types of hospitals across Cameroon. METHODS: This cross-sectional survey used the WHO Tool for Situational Analysis to Assess EESC, investigating four key areas: infrastructure, human resources, interventions, and equipment and supplies. Twelve hospitals were surveyed between August and September 2009. Facilities were conveniently sampled based on proximity to road traffic and sociodemographic composition of population served in four regions of Cameroon. To complete the survey, investigators interviewed heads of facilities, medical advisors, and nursing officers and consulted hospital records and statistics at each facility. RESULTS: Seven district hospitals, two regional hospitals, two general hospitals, and one missionary hospital completed the survey. Infrastructure for EESC was generally inadequate with the largest gaps in availability of oxygen concentrator supply, an on-site blood bank, and pain relief management guidelines. Human resources were scarce with a combined total of six qualified surgeons, seven qualified obstetrician/gynecologists, and no anesthesiologists at district, regional, and missionary hospitals. Of 35 surgical interventions, 16 were provided by all hospitals. District hospitals reported referring patients for 22 interventions. Only nine of the 67 pieces of equipment were available at all hospitals for all patients all of the time. CONCLUSIONS: Severe shortages highlighted by this survey demonstrate the significant gaps in capacity of hospitals to deliver EESC and effectively address the increasing surgical burden of disease and injury in Cameroon. This data provides a foundation for evidence-based decision-making surrounding appropriate allocation and provision of resources for adequate EESC in the country.

Global public health impact of recovered supplies from operating rooms: a critical analysis with national implications.

BACKGROUND: In modern operating rooms, clean and unused medical supplies are routinely discarded and can be effectively recovered and redistributed abroad to alleviate the environmental burden of donor hospitals and to generate substantial health benefits at resource-poor recipient institutions. METHODS: We established a recovery and donation program to collect clean and unused supplies for healthcare institutions in developing nations. We analyzed items donated over a 3-year period (September 2010-November 2013) by quantity and weight, and estimated the projected value of the program under potential nationwide participation. To capture the health benefits attributable to the donated supplies at recipient institutions, we partnered with two tertiary-care centers in Guayaquil, Ecuador and conducted a pilot study on the utility of the donated supplies at the recipient institutions (October 2013). We determined the disability-adjusted life years (DALY) averted for all patients undergoing procedures involving donated items and estimated the annual attributable DALY as well as the cost per DALY averted both by supply and by procedure. RESULTS: Approximately, 2 million lbs (907,185 kg) per year of medical supplies are recoverable from large non-rural US academic medical centers. Of these supplies, 19 common categories represent a potential for donation worth US $15 million per year, at a cost-utility of US $2.14 per DALY averted. CONCLUSIONS: Hospital operating rooms continue to represent a large source of recoverable surgical supplies that have demonstrable health benefits in the recipient communities. Cost-effective recovery and need-based donation programs can significantly alleviate the global burden of surgical diseases.

Inter-rater reliability of the PIPES tool: validation of a surgical capacity index for use in resource-limited settings.

INTRODUCTION: In response to the need for simple, rapid means of quantifying surgical capacity in low resource settings, Surgeons OverSeas (SOS) developed the personnel, infrastructure, procedures, equipment and supplies (PIPES) tool. The present investigation assessed the inter-rater reliability of the PIPES tool. METHODS: As part of a government assessment of surgical services in Santa Cruz, Bolivia, the PIPES tool was translated into Spanish and applied in interviews with physicians at 31 public hospitals. An additional interview was conducted with nurses at a convenience sample of 25 of these hospitals. Physician and nurse responses were then compared to generate an estimate of reliability. For dichotomous survey items, inter-rater reliability between physicians and nurses was assessed using the Cohen's kappa statistic and percent agreement. The Pearson correlation coefficient was used to assess agreement for continuous items. RESULTS: Cohen's kappa was 0.46 for infrastructure, 0.43 for procedures, 0.26 for equipment, and 0 for supplies sections. The median correlation coefficient was 0.91 for continuous items. Correlation was 0.79 for the PIPES index, and ranged from 0.32 to 0.98 for continuous response items. CONCLUSIONS: Reliability of the PIPES tool was moderate for the infrastructure and procedures sections, fair for the equipment section, and poor for supplies section when comparing surgeons' responses to nurses' responses-an extremely rigorous test of reliability. These results indicate that the PIPES tool is an effective measure of surgical capacity but that the equipment and supplies sections may need to be revised.

Partnership for sustainability in cardiac surgery to address critical rheumatic heart disease in sub-Saharan Africa: the experience from Rwanda.

IMPORTANCE: Rheumatic heart disease (RHD) in the developing world results in critical disability among children, adolescents, and young adults-marginalizing a key population at its peak age of productivity. Few regions in sub-Saharan Africa have independently created an effective strategy to detect and treat streptococcal infection and mitigate its progression to RHD. OBJECTIVE: We describe a unique collaboration, where the Rwanda Ministry of Health, the Rwanda Heart Foundation, and an expatriate humanitarian cardiac surgery program have together leveraged an innovative partnership as a means to expand Rwanda's current capacity to address screening and primary prevention, as well as provide life-saving cardiac surgery for patients with critical RHD. EVIDENCE REVIEW: Interviews with key personnel and review of administrative records were conducted to obtain qualitative and quantitative data on the recruitment of clinical personnel, procurement of equipment, and program finances. The number of surgical cases completed and the resultant clinical outcomes are reviewed. FINDINGS: From 2008 to 2013, six annual visits were completed. A total of 128 prosthetic valves have been implanted in 86 complex patients in New York Heart Association (NYHA) class III or IV heart failure, with excellent clinical outcomes (5 % 30-day mortality). Postoperative complications included a cerebrovascular accident (n = 1) and hemorrhage, requiring reoperation (n = 2). All procedures were performed with participation of local personnel. CONCLUSIONS AND RELEVANCE: This strategy provides a reliable and consistent model of sophisticated specialty care delivery; inclusive of patient-centered cardiac surgery, mentorship, didactics, skill transfer, and investment in a sustainable cardiac program to address critical RHD in sub-Saharan Africa.

Role of the battalion surgeon in the Iraq and Afghanistan War.

The battalion surgeon is an invaluable asset to a deploying unit. The primary role of a battalion surgeon is to provide basic primary care medicine and combat resuscitation. Other expectations include health care screening, vaccinations, supervision of medics, and being a medical advisor to the unit's commander. As many physicians who fill this role previously worked at medical treatment facilities or medical centers without prior deployment experience, the objective of this article is to highlight some of the challenges a battalion surgeon may encounter before, during, and following deployment.

Availability of anesthesia equipment in Chinese hospitals: is the safety of anesthesia patient care assured?

Availability of physiologic monitoring equipment to ensure the safe administration of anesthesia is an expected standard in many parts of the world. Many hospitals in China may not have an adequate quantity and variety of anesthesia delivery and patient monitoring equipment to assure safe administration of anesthesia patient care. We present some typical cases of hospitals of different sizes and located in regions with different economic levels; our data demonstrate that there is a lack of available anesthesia administration and patient monitoring equipment in small hospitals and hospitals in economically underdeveloped regions.