Background: Before the implementation of single-use devices (SUD) in health care, medical equipment was sterilized and reused. Now many medical devices are used once and then thrown away, contributing to the 5.9 million tons of medical waste produced yearly. This project explores nursing attitudes toward single-use medical devices, evaluates current recycling practices and examines whether student nurses would be likely to use reprocessed SUDs in their practice if given the option. Methodology: After obtaining IRB approval, students enrolled in nursing research courses were invited to participate in this exploratory study. 157 undergraduate nursing students completed the 46-question survey. Descriptive statistics were used to analyze the survey results, independent t-tests were used to compare groups and content analysis was used to analyze open-ended responses. Results: The typical student was female, age 30, licensed as a registered nurse and enrolled in the RN to BSN program. Most students (84.7%) viewed themselves as environmentally conscious, and most recycle at home (75.5%) and at work (54.7%). Most agreed (96.8%) that hospitals produce a lot of hazardous waste and that it is the hospitals responsibility for environmentally friendly waste disposal. The majority also agreed (80%) that nurses have the ability to impact waste production at a hospital. More than half (67.7%) agreed that SUD disposal contributes to environmental pollution and many (76.6%) felt that nurses should be responsible for environmental health concepts. Most (81.6%) felt that SUDs should be thrown out after one use and few (28.5%) felt that SUDs can be reused if sterilized. Most (74.0%) also believed that SUD reuse contributes to hospital acquired infections, but a little more than half (56.3%) were willing to reuse a SUD that had only touched intact skin if sterilized for reuse. Additionally, most respondents (79.1%) would consider joining a "green team" at work.; Those who recycle at home were more likely to identify as environmentally conscious than those who do not recycle at home. No generational differences existed when considering environmental consciousness. Generation X was more likely to recycle at home than Generation Y, but no generational differences existed when analyzing work recycling habits. Generation X was also more likely to see single-use device disposal as contributing to environmental pollution than Generation Y. Home recyclers were more likely to agree that nurses have the ability to decrease the amount of hospital trash production, and more likely to join a green team than non-recyclers. They also believed that SUD disposal contributes to environmental pollution, SUDs can be reused if sterilized, and disagreed that SUD reuse contributes to hospital acquired infections when compared to those who do not recycle at home. Discussion: While most students agree that hospitals produce large amounts of waste and should be responsible for the disposal of it in an environmentally friendly manner, most are hesitant to use reprocessed SUDs as a means to make the hospital more environmentally friendly. Student responses indicated the largest perceived barriers to SUD reuse were fears of inadequate sterilization and fears of the spread of disease. Conclusions: Most students, especially home recyclers, believe themselves to be environmentally conscious and most were willing to consider reusing some SUDs. Translating this belief into action can happen through education in line with the Scope and Standards of practice for nursing, as well as establishing the safety of SUDs through further research.

Classified for decades as a “least risk medical device,” surgical staplers have been recently associated with at least 41,000 injuries and 360 deaths in the last ten years (FDA Letter to Healthcare Providers, 2019). This shocking development has generated calls for a broad investigation into the errors involved in surgical stapler use and reform of the regulatory protocol for medical devices. Current regulatory infrastructure and framework operate with understandings that combine risk inherent to the device and that which is born by the operator (FDA Classification Call, 2019). This thesis explores the aforementioned classification error and its adverse outcomes from an epistemological standpoint. Social epistemic analysis is applied to FDA regulation and to the comparison of two scenarios in reference to the current status-quo classification and to the proposed risk reclassification of surgical staples. Expert versus novice error avoidance surgical performance capabilities are discussed under these two different classificatory scenarios and epistemic social roles.

No description available.

Medical device usability directly impacts the practitioner's ability to perform their diagnostic task in an effective, efficient, and safe manner. A device with poor usability may frustrate the practitioner, increasing the worker's stress level in a high-stress work environment. In addition, a device with poor usability may facilitate operator error, increasing the patient's risk of injury. Designers of healthcare systems and devices face a unique conundrum that has been documented in the literature (Martin, Murphy, Crowe, & Norris, 2006; Martin, Norris, Murphy, & Crowe, 2007; Ward & Clarkson, 2007). Standards require the use of user research techniques, yet patient privacy standards prevent designers from observing users in context. The inability to observe users in their work environment impedes understanding the context-of-use. Since understanding context-of-use is required to ensure usability, further exploration into alternative methods for requirements gathering is needed. This study explored the storytelling as an elicitation method for medical device requirements by comparing the information elicited from nurses during requirements gathering for an infusion pump by two methods: focus groups followed by interviews (Group #1) and focus groups followed by storytelling sessions (Group #2). Results suggest further exploration of storytelling is warranted as Group #2 contributed similar quantity and breadth of information in significantly less time. Results also indicate potential support for the efficacy of storytelling within the healthcare domain as Group #2 participants contributed more distinct context-of-use information with an emphasis on the social context. Contributions of this study include a plan for mixed-method data analysis, a protocol for conducting a storytelling session, and a framework for defining requirements within the healthcare domain. / Master of Science

Implantable medical devices face numerous complications when interfacing with soft tissue, and are plagued by negative responses from host tissue. One such class devices are percutaneous osseointegrated prosthetics (POP). POP consist of a bone anchored titanium post that extrudes through the skin and attaches to an external prosthetic. Compared to the traditional socket interface, POPs offer better stability, limb functionality, and osseoperception for both upper and lower prosthetic limbs. Although the POP surgery technique is well established, the main disadvantage to this technology remains the titanium (Ti) - skin interface. Some of the complications that can arise include epithelial downgrowth, mechanical tearing, and infection. Various types of coatings, surface structure, and antibiotic release technologies have been used to coat Ti in an effort to mitigate POP's associated obstacles, but these methods have failed to translate into published clinical studies and mainstream medical use. One potential solution may be to mimic an interface already found in the human body, the fingernail-skin interface, which is infection-free and mechanically stable. The same keratins that make up the cortex of human hair fibers are found in the fingernail. These cortical human hair keratins can be extracted and purified, and fingernail-specific dimeric complexes coated onto Ti surfaces using silane coupling chemistry. Keratin has been used in other studies for its cell adhesion and differentiation properties, and it has been suggested that the Leu-Asp-Val (LDV) amino acid motif is the primary site responsible for cellular attachment. In the present work, keratins extracted from human hair fibers and recombinant keratin nanomaterials (KN) were used to create biomimetic coatings on silanized Ti surfaces. These coatings were characterized and investigated for surface topography, elemental composition, cell adhesion motifs, and cell adhesion. Both keratin substrates showed the ability to create uniform coatings that retain a protein conformation that exhibits cell adhesion motifs. The coatings exhibit the ability to support cell adhesion of both epithelial and connective tissue cells. Application of fluid shear stress was used to test the mechanical adhesion strength of cells on keratin coatings. The structure, biochemical stability and sustained cellular adhesion of these coatings support keratin's capacity to provide a stable interface between POPs and skin. Side-by-side studies of extracted and recombinant keratins reveals that the recombinant form of these materials may provide distinct advantages for their use in POP devices. Overall, this study confirmed that a uniform, silane-coupled keratin coating was feasible. We demonstrated the substrates contain a biological function in terms of cellular adhesion and phenotypic changes in skin-relevant cells. These results support the biomimetic function of keratin on silanized Ti, which may provide a suitable coating to translate percutaneous medical device coating applications toward clinical use. / Ph. D.

Master of Science / Department of Computing and Information Sciences / Eugene Vasserman / As medical systems expand to allow for the increase the number of devices, new ways to protect patient safety have be developed. The Integrated Clinical Environment, ICE, standard sets up a set of standards that define what an integrated hospital system is. Within the specification is a direct call for a forensic logger that can be used to review patient and system data. The MDCF is one implementation of the ICE standard, but it lacked a key component the ICE standard requires, a logger. Many loggers exist in industry, with varying rates of success and usefulness. A medically sound logger has to be able to completely retell exactly what happened during an event, including patient, device, and system information, so that the right medical professional can provide the best care. Several loggers have been built for MDCF, but few were practical due to the invasiveness of the service. A universal subscriber, a service that is able to connect to all publishing data streams, logging service was built for the MDCF which has the ability to record all information that passes over the MDCF messaging service. This implementation was then stress tested with varying numbers of devices and amounts of data. A reviewing tool was also built that allows for replay of device data that is similar to the original device UI. Future work will include looking into storing system information such as state changes within MDCF and system health. There is also a push to further integrate the forensic reviewer into the core MDCF UI.

<p>This licentiate thesis uses descriptive, mainly official,Swedish statistics to analyse industrial structure, productionand foreign trade in an industry that is traditionallydifficult to describe in numbers, that of medical devices. Forthe purposes of the thesis, the Swedish Medical Device industryis defined as companies classified in the SE-SIC manufacturingcodes 33101 (medical equipment and instruments, etc), 33102(dental products) and 35430 (invalid vehicles). Also otherbranches contribute, notably parts of SIC 51460 (wholesale inmedical equipment and pharmaceutical goods) and 73103 (medicalresearch and development) although their medical device volumecannot be specified. Additional items have been identified interms of specific product groups rather than as "belonging" toa specific SIC industrial code.</p><p>Taken together, this is considered to correspond reasonablywell to the scope of the field as defined by the Global MedicalDevice Nomenclature (GMDN), a new European standard forclassifying medical devices in a more generic way than do theEuropean Medical Device Directives (or other pieces oflegislation). No quantification according to GMDN can be madeas yet, however, as that requires changing reporting habits inindustry as well as in official statistical classification andnomenclature regimes.</p><p>With the manufacturing code SE-SIC 33101 as main object, thestudy for the first time presents data on the regionaldistribution, size classes of employment, company starting timeand company dynamics, in the form of entries to and exits fromthe code, over a six-year period. The latter analysis includesa follow-up of the "exits", some firms reappearing in otherparts of industry and others disappearing–surprisinglyfew among them being limited companies. Although this industryis comparatively mature, considerable mobility among themid-sized companies is indicated for reasons of real changes or(to some degree) factors inherent in the industrialclassification system. Some structural changes in companies inthe ≥50 employees bracket are identified. It is notedthat American actors, directly or indirectly, are increasinglyinvolved with the medical device industry in Sweden, and that anumber of technology-based companies that were started mostlyin the early eighties have recently reached the 50+ employeelevel.</p><p>The analysis of identifiable production and internationaltrade in medical devices spans a period of 17 years based onofficial statistics following the HS/CN nomenclatures. Adatabase has been built, bottom-up, from the 8-digit CN levelwith production, exports and imports values for close to 100items collected in 12 product groups, for presentation purposesgrouped under three main headings. Compound annual growth ratesfor the latter are presented for three five-year periods1985-2000, showing that Swedish production and exports have hadan overall growth of 10 per cent p.a. This has kept Swedenahead of the international overall growth of 6- 7 per cent p.a.in recent years, products in the main group "Aids&Implants" growing more than 20 per cent p.a. Growth rates inthe most recent five-year period are lower, however. Healthynet exports figures are presented, the figure for 2002nominally representing 40 per cent of the production value incurrent as well as constant prices.</p><p>Production figures are given at industry (local unit) levelas well as at product group level. The product-based figuresidentified for Production 2001 are estimated to SEK 13,3billion, Exports to SEK 13,7 billion and Imports to SEK 9,7billion. Figures for the Apparent Domestic Market arecalculated for the corresponding entities. It is obvious,however, that the statistics do not capture the real productionvalue as exports exceed production both at overall level and inmajor product groups, particularly those on a high systemstechnology level. The situation is not uncommon for a number ofreasons; further, cases in the statistics methodologyliterature confirm that medical instrument-related codes areliable to this phenomenon. Corrections, including adjustmentsof both production and exports values, are possible butdemanding already at one individual 4-digit HS/CN level. This,therefore, must be considered outside the scope of an academicstudy.</p><p>The basic tablework developed for this thesis will be madefreely available to external parties for their own use providedthe author, with contact details, is named as the source.(Processing for commercial purposes is not expected, however.)Any suggestions for improvements are welcomed.</p>

"Security for medical devices has gained some attractions in the recent years following some well- publicized attacks on individual devices, such as pacemakers and insulin pumps. This has resulted in solutions being proposed for securing these devices, usually in stand-alone mode. Medical devices are however becoming increasingly interconnected and interoperable as a way to improve patient safety, decrease false alarms, and reduce clinician cognitive workload. Given the nature of interoperable medical devices (IMDs), attacks on IMDs can have devastating consequences. This work outlines our effort in understanding the threats faced by IMDs, an important first step in eventually designing secure interoperability architectures. A useful way of performing threat analysis of any system is to use attack trees. Attack trees are conceptual, multi-leveled diagrams showing how an asset, or target, might be attacked. They provide a formal, methodical way of describing the threats to a system. Developing attack trees for any system is however non-trivial and requires considerable expertise in identifying the various attack vectors. IMDs are typically deployed in hospitals by clinicians and clinical engineers who may not posses such expertise. We therefore develop a methodology that will enable the automated generation of attack trees for IMDs based on a description of the IMD operational workflow and list of safety hazards that need to be avoided during its operation. Additionally, we use the generated attack trees to quantify the security condition of the IMD instance being analyzed. Both these pieces of information can be provided by the users of IMDs in a care facility. The contributions of this paper are: (1) a methodology for automated generation of attack trees for IMDs using process modeling and hazard analysis, and (2) a demonstration of the viability of the methodology for a specific IMD setup called Patient Controlled Analgesia (PCA- IMD), which is used for delivering pain medication to patients in hospitals."

Background: The globalization of markets, competition in the market place, shareholder activism has compelled firms to rethink their way of doing business. In today’s world stakeholders are placing much emphasis on supplier relationships given that the survival of firms depends on the type of relationship that exists between the supplier and the buying firm. The maintenance of supplier relationships is a complex task due to differences in interest and the opportunistic behaviour which may be on the part of the supplier or the buyer. For this reason, firms have to look out for supplier relationships that can improve their business performance and enhance their competitive advantage. Purpose:     The purpose of the study was to investigate the relationship that exists between medical devices manufacturers in Sweden and their key suppliers, and the reasons for establishing relationships. The authors were also interested in knowing how this relationship ultimately leads to improved business performance. Method: The authors used positivist perspective and a deductive approach for this thesis. The sampled firms in this study are Arcoma AB, Baxter and Cellavision and a convenience sampling method was used in selecting the companies. The empirical data for this study was collected through interviews with senior management personnel of the three companies whose head offices are located Lund and Växjö in Sweden. Results, conclusions: The supplier relationships established by Arcoma, Baxter and Cellavision, and their key suppliers was found to be collaborative. The quests to improve on quality, reduce cost and increase the responsiveness of the supply chain are some of the reasons why firms establish collaborative relationships. Establishing collaborative relationships with key suppliers leads to improved operational and financial business performance. Improvements in operational business performance could be in the form of reduction in defects, improved compliance with quality standards, and improvement in delivery reliability and reduced lead times. The benefits to the firms in terms of financial performance stems from cost reduction and the offering of competitive prices in the marketplace which leads to increased market share and revenue expansion.

The thesis develops a coherent and comprehensive supply chain management framework for managing health care goods provided as humanitarian assistance in complex political emergencies. The objective of the research is improving the effectiveness and efficiency of logistics services which enable humanitarian organizations to reduce suffering, morbidity, disability and mortality of populations affected by armed conflicts. The framework is deduced from models and concepts developed for commercial logistics and supply chain management by considering the objectives and constraints of humanitarian organizations, the context in which they work as well as the characteristics of health care goods. For the logistics processes of item selection, sourcing, storage, transport and customer service frameworks are developed at the levels of supply network design, supply chain planning and supply chain operations. For each category, decision criteria are proposed according to the phase of the crisis, the distance from the crisis area as well as the criticality of health care goods. The framework allows humanitarian organizations to develop strategic, tactical as well as operational plans for providing logistical support to specific humanitarian assistance programmes within their constraints and in the context of the respective complex political emergency. (author's abstract)