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.

Cost and outcomes of open versus laparoscopic cholecystectomy in Mongolia.

BACKGROUND: Laparoscopic cholecystectomy (LC) is the standard of care for biliary disease in developed countries. LC in resource-limited countries is increasing. This prospective, observational study evaluates costs, outcomes, and quality of life (QoL) associated with laparoscopic versus open cholecystectomy (OC) in Mongolia. METHODS: Patient demographics, outcomes, and total payer and patient costs were elicited from a convenience sample of patients undergoing cholecystectomy at four urban and three rural hospitals (February 2016-January 2017). QoL was assessed preoperatively and postoperatively using the five-level EQ-5D instrument. Perioperative complications, surgical fees, and QoL scores were evaluated for LC versus OC. Multivariate regression models were generated to adjust for differences between these groups. RESULTS: Two hundred and fifteen cholecystectomies were included (LC 122, OC 93). LC patients were more likely to have attended college and have insurance. Preoperative symptoms were comparable between groups. Total complication rate was 21.8% (no difference between groups); LC patients had less superficial infections (0% versus 10.8%). Median hospital length of stay (HLOS) and days to return to work were shorter after LC. QoL improved after surgery for both groups. Mean total payer and patient costs were higher for LC, but not significant (P-value 0.126). After adjustment, LC had significantly less complications, shorter HLOS, fewer days to return to work, greater improvement in QoL scores, and no increase in cost. CONCLUSIONS: LC is safe and beneficial to patients with biliary disease in Mongolia, and cost effective from the patient's and payer's perspective. Although equipment costs for LC may be more expensive than OC, there are likely significant cost savings related to reduced HLOS, shorter time off work, fewer complications, and improved QoL.

Global Surgical Ecosystems: A Need for Systems Strengthening.

BACKGROUND: As surgery is gaining recognition as a critical component of universal health care worldwide, surgical communities have come together with unprecedented unity to advocate for systems to support surgical care. This community has long believed that much care could be performed in a cost-effective manner even in low resource settings, despite skepticism voiced by many in public health. To do so will require the development of new systems and re-vamping of old systems that are not effective. In the last five years, coalitions, expert panels, commissions, consortia and alliances have emerged to address these issues and there has been landmark success in advocacy with a new resolution at the 2015 World Health Assembly to include surgical care as a component of universal health coverage. It is critical to understand the ecosystem that constitutes the surgical environment. A surgical ecosystem could be described as a network of people, processes, and materials necessary for surgical services in the context of the facilities and environment in which it functions. METHODS: We describe components of a functioning surgical ecosystem in terms of administration, support staff and clinicians, and the necessary sub-systems for providing consumable materials such as anesthetic medication and suture and sterile instruments. Related systems that must be integrated are facilities and utilities such as electricity, lighting, plumbing and waste management and even laundry. But especially in low and middle income countries (LMICs) lack of any one of these may be rate-limiting. The World Health Organization (WHO) has developed situational analyses and checklists for first level district hospitals to identify missing elements. CONCLUSIONS: A siloed approach cannot solve a systems problem. However, to scale up rapidly and to develop and sustain quality standards, a holistic "ecosystem" approach, including local and global professional societies and advocacy organizations will need to become engaged.

Paradoxical effects of apolipoprotein E on cognitive function and clinical progression in mice with experimental autoimmune encephalomyelitis.

Multiple sclerosis (MS) is an inflammatory demyelinating disease characterized by sensory, motor, and cognitive impairments. Apolipoprotein E (apoE) plays an important role in cholesterol and lipid metabolism in the brain and in susceptibility to cognitive impairment and pathology following brain injury. Studies in mice with a mild form of experimental autoimmune encephalomyelitis (EAE), an MS animal model, support only protective roles for apoE in MS. We examined behavioral and cognitive changes prior to onset of clinical disease and the onset and progression of a more severe form of EAE in female Apoe(-/-) and C57Bl/6 wild-type mice. Apoe(-/-) mice had a later day of onset, a later day of peak symptoms and disease severity, and a lower cumulative disease index compared to wild type mice. Apoe(-/-) mice also showed decreased CD4+ cell invasion following EAE induction compared to wild type mice, and less spinal cord demyelination at 17 but not 30 days following EAE induction. In contrast, EAE-challenged Apoe(-/-) mice showed reduced exploratory activity, rotorod performance, and impaired contextual fear conditioning compared to wild type animals. These data indicate paradoxical effects of apoE on EAE-induced behavioral and cognitive changes and the onset and progression of clinical disease.

The role of the dentate gyrus, CA3a,b, and CA3c for detecting spatial and environmental novelty.

It has been suggested that the dentate gyrus (DG) and CA3 cooperate to efficiently process spatial information. The DG has been proposed to be important for fine spatial discrimination, and the CA3 has been proposed to mediate larger scale spatial information processing. To evaluate the roles of the DG and CA3a,b for spatial processing, we developed a task that measures responses to either overall environmental novelty or a response to more subtle changes within the environment. Animals with lesions to the DG showed impaired novelty detection for both environment as well as smaller changes in the environment, whereas animals with lesions to CA3a,b showed no such deficits. A closer look at the lesions suggested that the CA3 lesions included only CA3a and CA3b, but spared CA3c. To test the role of the spared CA3c region, animals with selective lesions to CA3c that spared CA3a,b were run on the same task and showed an intermediate pattern of deficits. These results suggest that the DG is critical for spatial information processing. These data also suggest that CA3 is a heterogeneous structure, with CA3c lesioned animals showing greater spatial processing deficits than CA3a,b lesioned animals. These findings extend our knowledge of hippocampal function and need to be accounted for in future computational models.

Dissociating the roles of dorsal and ventral CA1 for the temporal processing of spatial locations, visual objects, and odors.

The differential contributions of the dorsal and ventral hippocampus for learning and memory have long been of interest. The present experiments were designed to evaluate the contributions of dorsal CA1 and ventral CA1 for temporal processing. Animals were run on three temporal ordering paradigms: one with visual objects, one with olfactory stimuli, and one with spatial locations. Animals with lesions to dorsal CA1 showed deficits for the temporal ordering of visual objects relative to control animals, and deficits for the temporal ordering of spatial locations relative to control and ventral CA1 lesioned animals. Animals with lesions to ventral CA1 showed deficits for the temporal ordering of olfactory information relative to control and dorsal CA1 lesioned animals, and a mild deficit for the temporal ordering of visual objects relative to control animals, but not as severe as those shown by the dorsal CA1 lesioned animals. These data suggest that dorsal CA1 and ventral CA1 contribute to temporal ordering processes, and that dorsal CA1 and ventral CA1 are dissociable for temporal ordering based upon the nature of the information that is processed.