scholarly journals Toxicologic Pathology Forum Opinion Paper: Considerations for Toxicologic Pathologists Evaluating the Safety of Biomaterials and Finished Medical Devices

2018 ◽  
Vol 46 (4) ◽  
pp. 366-371 ◽  
Author(s):  
Shayne C. Gad ◽  
JoAnn C. L. Schuh
Keyword(s):  
Medical Devices ◽  
New Technologies ◽  
Safety Evaluation ◽  
Foreign Body Response ◽  
The Body ◽  
Target Organs ◽  
Tissue Responses ◽  
Dose Control ◽  
Composition Structure

Safety (“biocompatibility”) assessment of medical devices has evolved along a different path than that of drugs, being historically governed more by the considerations and needs of engineers rather than chemists and biologists. As a result, the involvement of veterinary pathologists has been much more limited—almost entirely to evaluating tissue responses in tissues in direct contact with implanted devices. As devices have become more complex in composition, structure, placement, and use, concerns as to adverse systemic responses in patients have called for more comprehensive and thoughtful evaluations of effects throughout the body. Further complexities arise from the increasing marriage of devices and drug/biologic therapeutics to achieve either better dose control and, specifically, in delivery to target organs/tissues or better tolerance of the body to medical devices (i.e., minimization of the foreign body response). The challenge to pathologists is to integrate in new technologies (such as in vivo imaging and immunology) and ways of viewing interactions with patient bodies. To fail to do so will allow the methods and standards for medical device safety evaluation to be based on chemical analysis and then the limited details inherent in literature-based risk assessments.

scholarly journals Recommendations for Nanomedicine Human Subjects Research Oversight: An Evolutionary Approach for an Emerging Field

2012 ◽  
Vol 40 (4) ◽  
pp. 716-750 ◽  
Author(s):  
Leili Fatehi ◽  
Susan M. Wolf ◽  
Jeffrey McCullough ◽  
Ralph Hall ◽  
Frances Lawrenz ◽  
...  
Keyword(s):  
Medical Devices ◽  
Human Subjects ◽  
High Surface ◽  
The Body ◽  
Biologically Active ◽  
Implantable Medical Devices ◽  
Research Oversight ◽  
Insoluble Drugs ◽  
Drug Eluting

Nanomedicine is yielding new and improved treatments and diagnostics for a range of diseases and disorders. Nanomedicine applications incorporate materials and components with nanoscale dimensions (often defined as 1-100 nm, but sometimes defined to include dimensions up to 1000 nm, as discussed further below) where novel physiochemical properties emerge as a result of size-dependent phenomena and high surface-to-mass ratio. Nanotherapeutics and in vivo nanodiagnostics are a subset of nanomedicine products that enter the human body. These include drugs, biological products (biologics), implantable medical devices, and combination products that are designed to function in the body in ways unachievable at larger scales. Nanotherapeutics and in vivo nanodiagnostics incorporate materials that are engineered at the nanoscale to express novel properties that are medicinally useful. These nanomedicine applications can also contain nanomaterials that are biologically active, producing interactions that depend on biological triggers. Examples include nanoscale formulations of insoluble drugs to improve bioavailability and pharmacokinetics, drugs encapsulated in hollow nanoparticles with the ability to target and cross cellular and tissue membranes (including the bloodbrain barrier) and to release their payload at a specific time or location, imaging agents that demonstrate novel optical properties to aid in locating micrometastases, and antimicrobial and drug-eluting components or coatings of implantable medical devices such as stents.

scholarly journals Ion Leaching from Implantable Medical Devices

2010 ◽  
Vol 638-642 ◽  
pp. 754-759
Author(s):  
Lawrence E. Eiselstein ◽  
Robert D. Caligiuri
Keyword(s):  
Medical Devices ◽  
Stainless Steels ◽  
The Body ◽  
Cobalt Chromium ◽  
Implantable Medical Devices ◽  
Device Development ◽  
Soluble Ions ◽  
Chromium Alloys

Implantable medical devices must be able to withstand the corrosive environment of the human body for 10 or more years without adverse consequences. Most reported research and development has been on developing materials and devices that are biocompatible and resistant to corrosion-fatigue, pitting, and crevice corrosion. However, little has been directly reported regarding implantable materials with respect to the rate at which they generate soluble ions in-vivo. Most of the biocompatibility studies have been done by examining animal implants and cell cultures rather than examining the rate at which these materials leach ions into the body. This paper will discuss what is currently known about the rate at which common implant materials (such as stainless steels, cobalt-chromium alloys, and nitinol) elute ions under in vitro conditions, what the limitations are of such data, and how this data can be used in medical device development.

scholarly journals Effect of Sterilization on 3-point Dynamic Response to in Vitro Bending of an Mg Implant

2020 ◽  
Author(s):  
Luis Humberto Campos Becerra ◽  
Marco Antonio Loudovic Hernández Rodríguez ◽  
Raúl Lesso Arroyo ◽  
Hugo Esquivel S ◽  
Alejandro Torres Castro
Keyword(s):  
Fatigue Resistance ◽  
Medical Devices ◽  
Initial Period ◽  
The Body ◽  
Sterilization Method ◽  
Toxicological Effects ◽  
Intramedullary Implant ◽  
We43 Alloy

Abstract Background: The aim of the study is to characterize a biomedical magnesium alloy and highlighting the loss of mechanical integrity due to the sterilization method. Ideally, when using these alloys is to delay the onset of degradation so that the implant can support body loads and avoid toxicological effects due to the release of metal ions into the body. Methods: The experimentation was carried out according to the standards of ASTM-F-1264 and ISO-10993-5 for mechanical and biological tests respectively, this testing methodology is carried out in accordance with the monographs of the Pharmacopoeia for the approval of medical devices and obtaining a health registration. An intramedullary implant (IIM) manufactured in magnesium (Mg) WE43 can support loads of the body in the initial period of bone consolidation without compromising the integrity of the fractured area. A system with these characteristics would improve morbidity and health costs by avoiding secondary surgical interventions. As a property, the fatigue resistance of Mg in aggressive environments such as the body environment undergoes progressive degradation, however, the autoclave sterilization method drastically affects fatigue resistance, as demonstrated in tests carried out under in vitro conditions. Coupled with this phenomenon, the relatively poor biocompatibility of Mg WE43 alloys has limited applications where they can be used due to low acceptance rates from agencies such as the FDA. However, Mg alloy with elements such as yttrium and rare earth elements (REEs) have been shown to delay biodegradation depending on the method of sterilization and the physiological solution used.Results: With different sterilization techniques, it may be possible to keep toxicological effects to a minimum while still ensuring a balance between the integrity of fractured bone and implant degradation time. Therefore, the evaluation of fatigue resistance of WE43 specimens sterilized and tested in immersion conditions (enriched Hank's solution) and according to ASTM F-1264, along with the morphological, crystallinity, and biocompatibility characterization of the WE43 alloy allows for a comprehensive evaluation of the mechanical and biological properties of WE43. Conclusions: These results will support decision-making to generate a change in the current perspective of biomaterials utilized in medical devices (MDs), to be considered by manufacturers and health regulatory agencies. An implant manufactured in WE43 alloy can be used as an intramedullary implant, considering keeping elements such as yttrium-REEs below as specified in its designation and with the help of a coating that allows increasing the life of the implant in vivo.

scholarly journals Potential target for mitigation of COVID-19 by food-derived bioactive peptides

2021 ◽  
Vol 16 ◽  
Author(s):  
Kenji Sato
Keyword(s):  
Bioactive Peptides ◽  
Protein Hydrolysate ◽  
Renin Angiotensin System ◽  
The Body ◽  
Food Protein ◽  
Beneficial Effects ◽  
Target Organs ◽  
Acid Metabolites ◽  
Therapeutic Activities

Oral administration of food protein hydrolysate and naturally occurring peptides exert beneficial effects beyond conventional nutritional functions by supplying amino acids for protein synthesis. These peptides are referred to as food-derived bioactive peptides. The coronavirus disease 2019 (COVID-19) is caused by sever acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. Some host and viral proteins are involved in the entry of SARS-CoV-2 into cells and their replication. Peptides with specific sequences can interact with these proteins and have potential prophylactic and therapeutic activities against COVID-19. However, it is difficult to deliver food-derived peptides to target organs without degradation by exopeptidases in the body. Alternatively, food-derived peptides and amino acid metabolites have been suggested to decrease risk factors of COVID-19 by modulating the renin-angiotensin system, the innate immune system, and the antioxidant system. This mini-review is based on in vivo responses to food-derived peptides and aims to introduce potential targets for these peptides in decreasing the risk and severity of COVID-19. 

scholarly journals Toxic Effects of Di-2-ethylhexyl Phthalate: An Overview

2018 ◽  
Vol 2018 ◽  
pp. 1-10 ◽  
Author(s):  
Sai Sandeep Singh Rowdhwal ◽  
Jiaxiang Chen
Keyword(s):  
Animal Models ◽  
Human Health ◽  
Waste Disposal ◽  
Medical Devices ◽  
Daily Basis ◽  
The Body ◽  
Repeated Use ◽  
Ethylhexyl Phthalate

Di-2-ethylhexyl phthalate (DEHP) is extensively used as a plasticizer in many products, especially medical devices, furniture materials, cosmetics, and personal care products. DEHP is noncovalently bound to plastics, and therefore, it will leach out of these products after repeated use, heating, and/or cleaning of the products. Due to the overuse of DEHP in many products, it enters and pollutes the environment through release from industrial settings and plastic waste disposal sites. DEHP can enter the body through inhalation, ingestion, and dermal contact on a daily basis, which has raised some concerns about its safety and its potential effects on human health. The main aim of this review is to give an overview of the endocrine, testicular, ovarian, neural, hepatotoxic, and cardiotoxic effects of DEHP on animal models and humansin vitroandin vivo.

scholarly journals Orthopedic Surgeons’ Perspectives on the Decision-Making Process for the Use of Bioprinter Cartilage Grafts: Web-Based Survey (Preprint)

2019 ◽  
Author(s):  
Àngels Salvador Verges ◽  
Luis Fernández-Luque ◽  
Francesc López Seguí ◽  
Meltem Yildirim ◽  
Bertran Salvador-Mata ◽  
...  
Keyword(s):  
New Technologies ◽  
Cell Attachment ◽  
Therapeutic Option ◽  
Medical Science ◽  
The Body ◽  
Cartilage Defects ◽  
Body Parts ◽  
Clinical Value ◽  
Orthopedic Surgeons

BACKGROUND Traumatic and degenerative lesions in the cartilage are one of the most difficult and frustrating types of injuries for orthopedic surgeons and patients. Future developments in medical science, regenerative medicine, and materials science may allow the repair of human body parts using 3D bioprinting techniques and serve as a basis for new therapies for tissue and organ regeneration. One future possibility is the treatment of joint cartilage defects with in vivo 3D printing from biological/biocompatible materials to produce a suitable cell attachment and proliferation environment in the damaged site and employ the natural recovery potential of the body. This study focuses on the perspectives of orthopedic surgeons regarding the key factors/determinants and perceived clinical value of a new therapeutic option. OBJECTIVE This study aimed to determine the knowledge and expectations of orthopedic surgeons regarding the clinical use of bioprinted cartilage. METHODS The survey, conducted anonymously and self-managed, was sent to orthopedic surgeons from the Catalan Society of Orthopedic and Traumatology Surgery. In accordance with the method devised by Eysenbach, the Checklist for Reporting Results of Internet E-Surveys was used to analyze the results. The following factors were taken into consideration: the type and origin of the information received; its relevance; the level of acceptance of new technologies; and how the technology is related to age, years, and place of experience in the field. RESULTS Of the 86 orthopedic surgeons included, 36 believed the age of the patient was a restriction, 53 believed the size of the lesion should be between 1 and 2 cm to be considered for this type of technology, and 51 believed that the graft should last more than 5 years. Surgeons over 50 years of age (38/86, 44%) gave more importance to clinical evidence as compared to surgeons from the other age groups. CONCLUSIONS The perspective of orthopedic surgeons depends highly on the information they receive and whether it is specialized and consistent, as this will condition their acceptance and implementation of the bioprinted cartilage.

scholarly journals Effect of sterilization on 3-point dynamic response to in vitro bending of an Mg implant

2021 ◽  
Vol 25 (1) ◽  
Author(s):  
Luis Humberto Campos Becerra ◽  
Marco Antonio Loudovic Hernández Rodríguez ◽  
Raúl Lesso Arroyo ◽  
Hugo Esquivel Solís ◽  
Alejandro Torres Castro
Keyword(s):  
Fatigue Resistance ◽  
Medical Devices ◽  
Initial Period ◽  
The Body ◽  
Sterilization Method ◽  
Toxicological Effects ◽  
Intramedullary Implant ◽  
We43 Alloy

Abstract Background The aim of the study is to characterize a biomedical magnesium alloy and highlighting the loss of mechanical integrity due to the sterilization method. Ideally, when using these alloys is to delay the onset of degradation so that the implant can support body loads and avoid toxicological effects due to the release of metal ions into the body. Methods Standardized procedures according to ASTM F-1264 and ISO-10993-5 were used, respecting detailed methodological controls to ensure accuracy and reproducibility of the results, this testing methodology is carried out in accordance with the monographs of the Pharmacopoeia for the approval of medical devices and obtaining a health registration. An intramedullary implant (IIM) manufactured in magnesium (Mg) WE43 can support loads of the body in the initial period of bone consolidation without compromising the integrity of the fractured area. A system with these characteristics would improve morbidity and health costs by avoiding secondary surgical interventions. Results As a property, the fatigue resistance of Mg in aggressive environments such as the body environment undergoes progressive degradation, however, the autoclave sterilization method drastically affects fatigue resistance, as demonstrated in tests carried out under in vitro conditions. Coupled with this phenomenon, the relatively poor biocompatibility of Mg WE43 alloys has limited applications where they can be used due to low acceptance rates from agencies such as the FDA. However, Mg alloy with elements such as yttrium and rare earth elements (REEs) have been shown to delay biodegradation depending on the method of sterilization and the physiological solution used. With different sterilization techniques, it may be possible to keep toxicological effects to a minimum while still ensuring a balance between the integrity of fractured bone and implant degradation time. Therefore, the evaluation of fatigue resistance of WE43 specimens sterilized and tested in immersion conditions (enriched Hank’s solution) and according to ASTM F-1264, along with the morphological, crystallinity, and biocompatibility characterization of the WE43 alloy allows for a comprehensive evaluation of the mechanical and biological properties of WE43. Conclusions These results will support decision-making to generate a change in the current perspective of biomaterials utilized in medical devices (MDs), to be considered by manufacturers and health regulatory agencies. An implant manufactured in WE43 alloy can be used as an intramedullary implant, considering keeping elements such as yttrium-REEs below as specified in its designation and with the help of a coating that allows increasing the life of the implant in vivo.

scholarly journals REVIEW ON NOVEL OSMOTIC DRUG DELIVERY SYSTEM

2018 ◽  
Vol 8 (5-s) ◽  
pp. 87-93
Author(s):  
AS Bansode ◽  
K Sarvanan
Keyword(s):  
Drug Delivery ◽  
Drug Release ◽  
Drug Delivery Systems ◽  
New Technologies ◽  
Extended Period ◽  
Dosage Forms ◽  
Delivery Systems ◽  
The Body

Novel drug delivery systems (NDDS) are the key area of pharmaceutical research and Development. The reason is relatively low development cost and time required for introducing a NDDS as compared to new chemical entity. Many conventional drug delivery systems have been designed to modulate the release a drug over an extended period of a time. Various designs are available to control or modulate the drug release from a dosage forms. Majority of oral CR dosage forms fall in the category of matrix, reservoir or osmotic systems. Osmotically controlled drug delivery systems (OCDDS) is one of the most promising drug delivery technology that use osmotic pressure as a driving force for controlled delivery of active agents. Drug release from OCDDS is independent of pH and hydrodynamic conditions of the body because of the semipermeable nature of the Rate controlling membrane and the design of deliver orifice used in osmotic systems, so a high degree of In vitro/In vivo correlation is achieved. Osmotic drug delivery systems release the drug with the zero order kinetics which does not depend on the initial concentration and the physiological factors of GIT. This review brings out new technologies, fabrication and recent clinical research in osmotic drug delivery. Keywords: Osmotic, Matrix, Reservoir, Fabrication

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