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PloS One 2018The goal of this research was to evaluate how material curl, package structure and handling of pouches containing medical devices affect rates of contact between...
OBJECTIVES
The goal of this research was to evaluate how material curl, package structure and handling of pouches containing medical devices affect rates of contact between non-sterile surfaces and sterile devices during aseptic transfer.
METHODS
One hundred and thirty-six individuals with practical experience in aseptic technique were recruited. Participants were asked to present the contents of four different pouch designs (a standard, one designed to curl in, another to curl out and one that incorporated a tab) using two transfer techniques. During the first block of trials "standard technique" was used; participants presented using their typical methods to the sterile field. Trials in the second block employed "modified technique"; participants were instructed to grab the package at the top center and present package contents using a single, fluid motion. The outside of the pouch and the backs of the participants' hands were coated using a simulated contaminant before each trial. The simulant was undetectable in the visible spectrum, but fluoresced under a black light. The dependent variable was recorded in a binary fashion and analyzed using a generalized linear mixed model.
RESULTS
Participants were between 20-57 and the averaged year 5.1 years of experience in aseptic technique. The data analysis was based on generalized linear mixed effects (GLMM) model, which accommodates the repeated measurements within the same participant. The effect of the pouch design was significant (P‹0.001), but the effect of aseptic technique did not suggest significance (P = 0.088). Specifically, pouches designed with the material curled outward resulted in significantly fewer contacts with non-sterile surfaces than the other styles, including the inward, tab, and standard styles; this was true regardless of the used aseptic technique, standard (P = 0.0171, P = 0.0466, P = 0.0061, respectively) or modified (P‹0.0001 for all comparisons)).
CONCLUSION
Results presented here contribute to a growing body of knowledge that investigates packaging as a potential route of contamination for sterile devices during aseptic presentation. Specifically, we provide insights regarding how both package design and opening technique can be informed in ways that build safety into the healthcare system.
Topics: Adult; Asepsis; Cross Infection; Equipment Contamination; Equipment and Supplies; Female; Humans; Male; Nurses; Product Packaging; Young Adult
PubMed: 30403724
DOI: 10.1371/journal.pone.0206892 -
The American Journal of Managed Care Sep 2014To quantify the potential reduction in hospital costs from adoption of best local practices in supply chain management and discharge planning.
OBJECTIVES
To quantify the potential reduction in hospital costs from adoption of best local practices in supply chain management and discharge planning.
STUDY DESIGN
We performed multivariate statistical analyses of the association between total variable cost per procedure and medical device price and length of stay, controlling for patient and hospital characteristics.
METHODS
Ten hospitals in 1 major metropolitan area supplied patient-level administrative data on 9778 patients undergoing joint replacement, spine fusion, or cardiac rhythm management (CRM) procedures in 2008 and 2010. The impact on each hospital of matching lowest local market device prices and lowest patient length of stay (LOS) was calculated using multivariate regression analysis controlling for patient demographics, diagnoses, comorbidities, and implications.
RESULTS
Average variable costs ranged from $11,315 for joint replacement to $16,087 for CRM and $18,413 for spine fusion. Implantable medical devices accounted for a large share of each procedure's variable costs: 44% for joint replacement, 39% for spine fusion, and 59% for CRM. Device prices and patient length-of-stay exhibited wide variation across hospitals. Total potential hospital cost savings from achieving best local practices in device prices and patient length of stay are 14.5% for joint replacement, 18.8% for spine fusion;,and 29.1% for CRM.
CONCLUSIONS
Hospitals have opportunities for cost reduction from adoption of best local practices in supply chain management and discharge planning.
Topics: Aged; Arthroplasty, Replacement; Cost Control; Equipment and Supplies; Hospital Costs; Humans; Length of Stay; Middle Aged; Pacemaker, Artificial; Patient Discharge; Purchasing, Hospital; Spinal Fusion
PubMed: 25364878
DOI: No ID Found -
International Journal of Environmental... May 2020In an era of global aging, spinal and other joint degeneration issues have become a major problem for many elders. Bone-related operations have become the largest...
In an era of global aging, spinal and other joint degeneration issues have become a major problem for many elders. Bone-related operations have become the largest percentage of surgeries, accounting for 40% of the top 10 operations in the United States. Further, these spine-related operations are now ranked second among all bone-related operations. Due to this enormous and daily increasing market demand, more and more firms have started to pay closer attention to related medical devices and products. The global venture capitalists (VCs) have also started to follow the mega trend and will continue to invest heavily in this industry. Although most VCs recognize that investing in firms that produce innovative spinal products or devices is a must, very few practical managers or research scholars have defined the appropriate evaluation methods for these firms to use. The traditional net present value (NPV) method, which does not consider operation flexibility and changes in strategy, is far from the reality. The real option method can reveal the vagueness and flexibilities of the values being embedded in the investment projects at spinal medical device firms. However, the real option method is strictly quantitative. Usually, the evaluation aspects contain qualitative factors or local criteria which are hard to quantify in monetary terms. Thus, the adoption of multiple criteria decision making (MCDM) methods that can manipulate both quantitative and qualitative factors will be very helpful in evaluating and selecting investment cases like the spinal medical device firms, where both quantitative and qualitative factors should be considered. An analytical framework that consists of hybrid MCDM methods and the real option method will thus be very useful to evaluate the newly established firms producing spinal medical devices. Therefore, the authors propose a real option valuation as well as the Decision-Making Trial and Evaluation Laboratory (DEMATEL) based analytic network process (DANP) and the modified VIšekriterijumsko KOmpromisno Rangiranje (VIKOR) method (DANP-mV) based MCDM framework for evaluating the investment projects offered by these firms of spinal medical devices. An empirical study based on three newly established spinal medical device companies specializing in vertebral compression fracture (VCF) surgical devices was used to demonstrate the feasibility of the proposed analytical framework. Sensitivity analysis is performed to determine the influence of modeling parameters on ranking results of alternatives. This analytical framework can thus serve as a tool for VCs to use to determine the value of a potential candidate for investment. The proposed method can also serve as an effective and efficient tool for investment projects in other fields.
Topics: Empirical Research; Equipment and Supplies; Fractures, Compression; Humans; Investments; Manufacturing Industry; Research Design; Spinal Fractures
PubMed: 32403356
DOI: 10.3390/ijerph17093335 -
Circulation Journal : Official Journal... Feb 2018Delays in the introduction to the Japanese market of drug-eluting stents (DES) developed overseas (i.e., "device lag") decreased sharply between 2004 and 2012. The... (Review)
Review
Delays in the introduction to the Japanese market of drug-eluting stents (DES) developed overseas (i.e., "device lag") decreased sharply between 2004 and 2012. The reduction accompanied a shift in clinical development from a succession pattern (initial product development and approval overseas followed by eventual entrance into the Japanese market) to parallel development (employing multiregional clinical trials (MRCTs)). Although resource-intensive in the short-term, MRCTs are proving to be an effective tool in simultaneous global product development. Creative study designs and the absence of significant ethnic differences in Japanese subjects regarding DES safety and efficacy and the pharmacokinetic behavior of their coating drugs propel this process. More general factors such as medical need and industry incentivization also encourage this shift. Physicians' preference for DES over other percutaneous coronary interventions, the expanding global DES market, and streamlined development and approval prospects each motivate industry to continue investing in DES product development. The efforts of various stakeholders were also integral to overcoming practical obstacles, and contributions by 'Harmonization by Doing' and a premarket collaboration initiative between the USA and Japan were particularly effective. Today, USA/Japan regulatory cooperation is routine, and Japan is now integrated into global medical device development. MRCTs including Japanese subjects, sites, and investigators are now commonplace.
Topics: Drug-Eluting Stents; Equipment Design; Equipment and Supplies; Health Care Sector; Humans; Internationality; Japan; Prostheses and Implants
PubMed: 28883226
DOI: 10.1253/circj.CJ-17-0533 -
AAPS PharmSciTech Feb 2014Tridimensional scaffolds can promote bone regeneration as a framework supporting the migration of cells from the surrounding tissue into the damaged tissue and as...
Tridimensional scaffolds can promote bone regeneration as a framework supporting the migration of cells from the surrounding tissue into the damaged tissue and as delivery systems for the controlled or prolonged release of cells, genes, and growth factors. The goal of the work was to obtain an advanced medical device for bone regeneration through coating a decellularized and deproteinized bone matrix of bovine origin with a biodegradable, biocompatible polymer, to improve the cell engraftment on the bone graft. The coating protocol was studied and set up to obtain a continuous and homogeneous polylactide-co-glycolide (PLGA) coating on the deproteinized bone matrix Orthoss® block without occluding pores and decreasing the scaffold porosity. The PLGA-coated scaffolds were characterized for their morphology and porosity. The effects of PLGA polymer coating on cell viability were assessed with the 3-(4,5-dimethyl-2-thiazolyl)-2,5 diphenyl-2H-tetrazolium assay. The polymer solution concentration and the number of polymeric layers were the main variables affecting coating efficiency and porosity of the original decellularized bone matrix. The designed polymer coating protocol did not affect the trabecular structure of the original decellularized bone matrix. The PLGA-coated decellularized bone matrix maintained the structural features, and it improved the ability in stimulating fibroblasts attachment and proliferation.
Topics: Absorbable Implants; Bone Matrix; Bone Regeneration; Cells, Cultured; Coated Materials, Biocompatible; Equipment and Supplies; Fibroblasts; Humans; Lactic Acid; Polyglycolic Acid; Polylactic Acid-Polyglycolic Acid Copolymer; Polymers; Porosity; Tissue Engineering; Tissue Scaffolds
PubMed: 24146118
DOI: 10.1208/s12249-013-0033-3 -
Regulatory Toxicology and Pharmacology... May 2024Novel medical devices must conform to medical device regulation (MDR) for European market entry. Likewise, chemicals must comply with the Registration, Evaluation,...
Novel medical devices must conform to medical device regulation (MDR) for European market entry. Likewise, chemicals must comply with the Registration, Evaluation, Authorization and Restriction of Chemicals (REACh) regulation. Both pose regulatory challenges for manufacturers, but concordantly provide an approach for transferring data from an already registered device or compound to the one undergoing accreditation. This is called equivalence for medical devices and read-across for chemicals. Although read-across is not explicitly prohibited in the process of medical device accreditation, it is usually not performed due to a lack of guidance and acceptance criteria from the authorities. Nonetheless, a scientifically justified read-across of material-based endpoints, as well as toxicological assessment of chemical aspects, such as extractables and leachables, can prevent failure of MDR device equivalence if data is lacking. Further, read-across, if applied correctly can facilitate the standard MDR conformity assessment. The need for read-across within medical device registration should let authorities to reconsider device accreditation and the formulation of respective guidance documents. Acceptance criteria like in the European Chemicals Agency (ECHA) read-across assessment framework (RAAF) are needed. This can reduce the impact of the MDR and help with keeping high European innovation device rate, beneficial for medical device patients.
Topics: Equipment and Supplies; Humans; Risk Assessment; Medical Device Legislation; Europe; Device Approval; Animals
PubMed: 38588771
DOI: 10.1016/j.yrtph.2024.105622 -
Annales de Biologie Clinique Apr 2017
Topics: Calibration; Equipment and Supplies; France; Humans; Medical Device Legislation; Product Surveillance, Postmarketing
PubMed: 28377325
DOI: 10.1684/abc.2017.1231 -
Journal of Biomedical Informatics Feb 2013The aims of this study were to investigate how a variety of research methods is commonly employed to study technology and practitioner cognition. User-interface issues... (Review)
Review
PURPOSE
The aims of this study were to investigate how a variety of research methods is commonly employed to study technology and practitioner cognition. User-interface issues with infusion pumps were selected as a case because of its relevance to patient safety.
METHODS
Starting from a Cognitive Systems Engineering perspective, we developed an Impact Flow Diagram showing the relationship of computer technology, cognition, practitioner behavior, and system failure in the area of medical infusion devices. We subsequently conducted a systematic literature review on user-interface issues with infusion pumps, categorized the studies in terms of methods employed, and noted the usability problems found with particular methods. Next, we assigned usability problems and related methods to the levels in the Impact Flow Diagram.
RESULTS
Most study methods used to find user interface issues with infusion pumps focused on observable behavior rather than on how artifacts shape cognition and collaboration. A concerted and theory-driven application of these methods when testing infusion pumps is lacking in the literature. Detailed analysis of one case study provided an illustration of how to apply the Impact Flow Diagram, as well as how the scope of analysis may be broadened to include organizational and regulatory factors.
CONCLUSION
Research methods to uncover use problems with technology may be used in many ways, with many different foci. We advocate the adoption of an Impact Flow Diagram perspective rather than merely focusing on usability issues in isolation. Truly advancing patient safety requires the systematic adoption of a systems perspective viewing people and technology as an ensemble, also in the design of medical device technology.
Topics: Cognition; Equipment and Supplies; Humans; Infusion Pumps; User-Computer Interface
PubMed: 23159499
DOI: 10.1016/j.jbi.2012.10.005 -
Value in Health Regional Issues May 2019Most of the industrial sectors of India have undergone major changes in the post-liberalization period. During this period, India has become self-reliant in drugs;...
Most of the industrial sectors of India have undergone major changes in the post-liberalization period. During this period, India has become self-reliant in drugs; however, still, 75% of the medical devices are imported in India. According to WHO, almost all devices present in the developing countries have been designed for use in the industrialized countries. With the increase in incidence of non-communicable diseases and decrease in communicable diseases; increase in survival rates and decrease in mortality rates, and increase in ageing population, the healthcare demands have changed in the last decade. In addition to these parameters, aware patients and healthcare professionals, requirement of achieving national targets of healthcare and close proximity to the developed world, is giving a push to the development of indigenous medical device industry. However, the rules and regulations governing medical devices are ambiguous and vague. The Health Ministry of India has notified Medical Devices Rules, 2016, for regulating manufacturing/import/sale/clinical investigation and other related matters concerning medical devices. In addition, the government is funding the start-up industries in medical devices sector. Furthermore, government has taken the initiative of inverted duty structure in India. Also, special med tech zones are being set-up, which will enhance the production at local levels for the local population and will also generate employment for local people.
Topics: Developing Countries; Equipment and Supplies; Humans; India; Industrial Development
PubMed: 30412914
DOI: 10.1016/j.vhri.2018.06.004 -
Biocontrol Science Mar 2011There are several well-developed rapid microbiological methods now becoming available that may have useful applications in pharmaceutical and medical devices. They are... (Review)
Review
There are several well-developed rapid microbiological methods now becoming available that may have useful applications in pharmaceutical and medical devices. They are ATP bioluminescence, fluorescent labeling, electrical resistance, and nucleic acid probes. In choosing to employ rapid methods, the microbiologist should examine their prospective performances against the specific requirements for that sector. Some methods may require expensive equipment and offer full automation, and others represent only a small investment. The regulatory view of these methods is changing and they still officially have not been approved in medical and pharmaceutical area, but it will still be up to the microbiologist to demonstrate that the method chosen is fit for the purpose intended.
Topics: Equipment and Supplies; Microbiological Techniques; Nucleic Acid Amplification Techniques; Sterilization; Technology, Pharmaceutical
PubMed: 21467625
DOI: 10.4265/bio.16.13