scholarly journals Study of the effect of radiation sterilization on the properties of polypropylene for injection molded medical products

2020 ◽  
Vol 64 (11) ◽  
pp. 149-153
Author(s):  
Maria S. Lisanevich ◽  
◽  
Reseda Yu. Galimzyanova ◽  
Keyword(s):  
Radiation Dose ◽  
Medical Devices ◽  
Absorbed Dose ◽  
Radiation Sterilization ◽  
Medical Products ◽  
Laboratory Conditions ◽  
Injection Molded ◽  
High Level ◽  
Acidity Level

As you know, laboratory-diagnostic glassware used in medicine is mainly made of polyethylene and polypropylene, transparent polystyrene and other polymers with the properties necessary for use in laboratory conditions. The advantages of plastic laboratory glassware are obvious: products made of it are lightweight, durable, besides, they do not react with urine of any acidity level and have no impurities. The presence of the label allows you to write the necessary data about the patient, which is also provided for by the instructions for sending the material to the laboratory. It is important for manufacturers that after sterilization the physical and mechanical indicators remain at a high level, and also the change in the color of the product turns out to be of no small importance. In the work, injection molded polypropylene grades were studied, which can be used as a material for laboratory-diagnostic glassware: Balen 01270, manufactured by JSC Ufaorgsintez, (PP 01270); Balen 1030, manufactured by JSC Ufaorgsintez, (PP 1030); H 250 GP / 3, produced by LLC Tobolsk-Polymer, Sibur Holding, (PP H 250 GP / 3); H 250, LLP "Company Neftekhim LTD", (PP 250). It was found that the greatest increase in MFI is observed for polypropylene of the Balen 1030 grade, increasing by 27.5 times. The smallest increase in MFI is observed for grades H 250 GP/3 and H 250 by 1.5-1.7 times. With an increase in the absorbed dose, the viscosity naturally increases due to the destruction of PP. The color practically does not change with an increase in the radiation dose. For PP H250. Recommended for manufacturers of medical devices PP H 250 grade polypropylene.

The Effect of Polyquinone and Phenol-Phosphite Stabilizer on the Resistance of Polypropylene to Ionizing Radiation

2019 ◽  
Vol 816 ◽  
pp. 328-332 ◽  
Author(s):  
M.S. Lisanevich ◽  
Elvina R. Rakhmatullina ◽  
Yu.N. Khakimullin ◽  
Rezeda Yu. Galimzyanova ◽  
R.M. Akhmadullin ◽  
...  
Keyword(s):  
Ionizing Radiation ◽  
Medical Devices ◽  
Polymeric Materials ◽  
Melt Flow Index ◽  
Flow Index ◽  
Radiation Sterilization ◽  
Melt Flow ◽  
Medical Products ◽  
Degradation Temperature

For polymeric materials intended for the manufacture of disposable sterile medical devices, resistance to sterilization methods is important. For the manufacture of disposable medical products is widely used polypropylene, destructive during radiation sterilization. It is established that the addition of polyquinone leads to a decrease in the destruction of polypropylene, which is manifested in a decrease in the values of the melt flow index and an increase in the degradation temperature of polypropylene of the irradiated compositions.

scholarly journals Effects of radiation sterilization on the properties of nonwoven medical devices

2020 ◽  
Vol 64 (11) ◽  
pp. 127-134
Author(s):  
Maria S. Lisanevich ◽  
◽  
Reseda Yu. Galimzyanova ◽  
Ildar N. Musin ◽  
◽  
...  
Keyword(s):  
Ionizing Radiation ◽  
Medical Devices ◽  
Human Life ◽  
Low Cost ◽  
Absorbed Dose ◽  
Nonwoven Material ◽  
Radiation Sterilization ◽  
Nonwoven Materials ◽  
Wide Range ◽  
Materials Used

Currently, there is a tendency for a significant increase in production and expansion of areas of application of nonwoven materials (NM), which are used in almost all areas of human life. Such properties of NMs as hydrophilicity or hydrophobicity, air permeability, good barrier and strength indicators at a relative low cost allow them to be effectively used for medical purposes. Nonwovens for medical use (NMMN) are considered. The most important stage in the final processing of medical devices made of NM is radiation sterilization. The influence of the absorbed dose and the type of ionizing radiation on the properties of NMMN of various designs: obtained by spunlace technology, by spunbond-meltblown-spunbond technology, and laminated nonwoven material has been studied. As a result of the conducted research, it was recommended: to sterilize NM with an electron beam, to control the consumer properties of medical devices from NM to check the quality of products after sterilization by assessing the change in the strength index with elongation, additionally to assess for laminated NM – water resistance, spunlace – absorption. In the production of nonwoven materials, various polymers are used, which have correspondingly different resistance to radiation sterilization. Some materials, for example, based on polypropylene, degrade when exposed to radiation, and the level of technical characteristics of the material is significantly reduced. It is also possible for autooxidative reactions initiated by radiation to occur in polymers, which can continue for a long time after irradiation of articles. To use these materials in radiation sterilized medical devices, it is necessary to have an understanding of the effect of ionizing radiation in a wide range of sterilizing doses on the materials used in these devices.

scholarly journals TOWARDS A VERIFICATION AND VALIDATING TESTING FRAMEWORK TO DEVELOP BESPOKE MEDICAL PRODUCTS IN RESEARCH-FUNDED PROJECTS

2021 ◽  
Vol 1 ◽  
pp. 3199-3208
Author(s):  
Emanuel Balzan ◽  
Pierre Vella ◽  
Philip Farrugia ◽  
Edward Abela ◽  
Glenn Cassar ◽  
...  
Keyword(s):  
Medical Devices ◽  
Early Stage ◽  
Design Stage ◽  
Concept Design ◽  
Proof Of Concept ◽  
Detailed Design ◽  
Testing Framework ◽  
Medical Products ◽  
Manufacturing Technologies ◽  
Validation Testing

AbstractResearch funded projects are often concerned with the development of proof-of-concept products. Consequently, activities related to verification and validation testing (VVT) are often not considered in depth, even though various design iterations are carried out to refine an idea. Furthermore, the introduction of additive manufacturing (AM) has facilitated, in particular, the development of bespoke medical products. End bespoke products, which will be used by relevant stakeholders (e.g. patients and clinicians) are fabricated with the same manufacturing technologies used during prototyping. As a result, the detailed design stage of products fabricated by AM is much shorter. Therefore, to improve the market-readiness of bespoke medical devices, testing must be integrated within the development from an early stage, allowing better planning of resources. To address these issues, in this paper, a comprehensive VVT framework is proposed for research projects, which lack a VVT infrastructure. The framework builds up on previous studies and methods utilised in industry to enable project key experts to capture risks as early as the concept design stage.

scholarly journals Standard manual reprocessing of angiographic systems in the hybrid OR

2017 ◽  
Vol 3 (2) ◽  
pp. 405-407
Author(s):  
Sebastian Buhl ◽  
Carina Werner ◽  
Clemens Bulitta
Keyword(s):  
Pilot Study ◽  
Medical Devices ◽  
Initial Assessment ◽  
Hybrid Operating Room ◽  
Medical Products ◽  
Fda Guidance ◽  
Microbiological Examination ◽  
Artis Zeego ◽  
Cleaning And Disinfection ◽  
A Current

AbstractA current FDA guidance demands the validation of cleaning and disinfecting protocols even for non-sterile medical devices. The aim of this work is to clarify whether this is already possible using the guidance itself as well as the German DIN EN ISO 17664. An angiography system (Artis Zeego / Pheno - Siemens) was selected as a test object for the validation of a cleaning and disinfection protocol for medical devices in a hybrid operating room. In pilot study prior to the trial, critical points of the system were evaluated by means of questionnaires to clinical users (OTA, surgical technicians). An initial assessment of the in-house cleaning protocols used in the hospitals was done by using a fluorescence assay. The microbiological examination took place subsequently by contact plates and swabbing to determine the amount and type of germs on the surfaces of the system. These experiments were done at three different clinical sites. It was found that there was a significant germ count on several surfaces of the product even after in-house cleaning and disinfection (C&D). After application of an enhanced C&D plan, these germs could be greatly reduced at all verified sites. In addition, it could be shown that DIN EN ISO 17664 can in principle be applied to non-sterile medical products.

scholarly journals Is nuclear medicine really safe?

2002 ◽  
Vol 45 (spe) ◽  
pp. 115-118
Author(s):  
Nicole Colas-Linhart
Keyword(s):  
Nuclear Medicine ◽  
Human Serum Albumin ◽  
Radiation Dose ◽  
Serum Albumin ◽  
Human Serum ◽  
Absorbed Dose ◽  
Cellular Level ◽  
Whole Body ◽  
Absorbed Doses ◽  
Standard Models

In nuclear medicine, radiation absorbed dose estimates calculated by standard models at the whole body or organ are very low. At cellular level, however, the heterogeneity of radionuclide distributions of radiation dose patterns may be significant. We present here absorbed doses at cellular level and evaluate their possible impact on the usually assumed risk/benefit relationships in nuclear medicine studies. The absorbed dose values calculated are surprisingly high, and are difficult to interpret. In the present study, we show calculated doses at the cellular level and discuss possible biological consequences, for two radiopharmaceuticals labelled with technetium-99m: human serum albumin microspheres used for pulmonary scintigrapies and HMPAO used to labelled leukocytes.

Radiation Dose to Patients and Personnel during Fluoroscopy at Percutaneous Renal Stone Extraction

1989 ◽  
Vol 30 (2) ◽  
pp. 201-206 ◽  
Author(s):  
K. Geterud ◽  
A. Larsson ◽  
S. Mattsson
Keyword(s):  
Radiation Dose ◽  
Effective Dose ◽  
Renal Stone ◽  
Absorbed Dose ◽  
Effective Dose Equivalent ◽  
Dose Equivalent ◽  
Organ Doses ◽  
The Mean ◽  
Total Effective Dose Equivalent ◽  
Total Effective Dose

The radiation dose to patients and personnel was estimated during 11 percutaneous renal stone extractions. For the patients the energy imparted, the mean absorbed dose to various organs, and the effective dose equivalent were estimated. For different personnel categories some organ doses and the effective dose equivalent were also estimated. Large differences in the radiation dose between patients were observed. The mean effective dose equivalent to the patient was 4.2 (range 0.6–8.3) mSv, and the energy imparted 285 (range 50–500) mJ. These figures are comparable to those reported for routine colon examination and urography. For the personnel there were also large differences between individuals and categories. The highest radiation dose was received by the radiologist. It was estimated that a radiologist who performs 150 percutaneous renal stone extractions per year will receive a yearly contribution to his/her effective dose equivalent of 2.4 mSv. Even when the contribution from other diagnostic and interventional radiologic procedures is added, the total effective dose equivalent hardly exceeds 5 mSv or 1/10 of the present dose limit for persons engaged in radiologic work. For the hands of the radiologist there is a risk of doses closer to the present limit for single organs or tissues of 500 mSv/year.

scholarly journals Preclinical and clinical validation of a novel injected molded swab for molecular assay detection of SARS-CoV-2 virus

2021 ◽  
Author(s):  
Chiara Elia Ghezzi ◽  
Devon R Hartigan ◽  
Justin Hardick ◽  
Rebecca Gore ◽  
Miryam Adelfio ◽  
...  
Keyword(s):  
Health Care Providers ◽  
Medical Devices ◽  
Clinical Studies ◽  
Nasal Swab ◽  
Cost Effective ◽  
Slight Reduction ◽  
Care Providers ◽  
Significant Difference ◽  
Injection Molded

During the COVID-19 public health emergency, many actions have been undertaken to help ensure that patients and health care providers had timely and continued access to high-quality medical devices to respond effectively. The development and validation of new testing supplies and equipment, including collection swab, help expand the availability and capability for various diagnostic, therapeutic, and protective medical devices in high demand during the COVID-19 emergency. Here, we report the validation of a new injection-molded anterior nasal swab, ClearTip™, that was experimentally validated in a laboratory setting as well as in independent clinical studies in comparison to gold standard flocked swabs. We have also developed an in vitro anterior nasal tissue model, that offers an efficient and clinically relevant validation tool to replicate with high fidelity the clinical swabbing workflow, while being accessible, safe, reproducible, time and cost effective. ClearTi™ displayed a greater efficiency of release of inactivated virus in the benchtop model, confirmed by greater ability to report positive samples in a clinical study in comparison to flocked swabs. We also quantified in multi-center pre-clinical and clinical studies the detection of biological materials, as proxy for viral material, that showed a statistically significant difference in one study and a slight reduction in performance in comparison to flocked swabs. Taken together these results underscore the compelling benefits of non-absorbent injected molded anterior nasal swab for COVID-19 detection, comparable to standard flocked swabs. Injection-molded swabs, as ClearTip™, could have the potential to support future swab shortage, due to its manufacturing advantages, while offering benefits in comparison to highly absorbent swabs in terms comfort, limited volume collection, and potential multiple usage.

scholarly journals Preclinical Validation of a Novel Injection-Molded Swab for the Molecular Assay Detection of SARS-CoV-2

Diagnostics ◽  
2022 ◽  
Vol 12 (1) ◽  
pp. 206
Author(s):  
Chiara E. Ghezzi ◽  
Devon R. Hartigan ◽  
Justin P. Hardick ◽  
Rebecca Gore ◽  
Miryam Adelfio ◽  
...  
Keyword(s):  
Health Care Providers ◽  
Medical Devices ◽  
Clinical Studies ◽  
Cost Effective ◽  
Care Providers ◽  
Nasal Tissue ◽  
Significant Difference ◽  
Injection Molded ◽  
Development And Validation

During the COVID-19 public health emergency, many actions have been undertaken to help ensure that patients and health care providers have timely and continued access to high-quality medical devices to respond effectively. The development and validation of new testing supplies and equipment, including collection swabs, has helped to expand the availability and capability for various diagnostic, therapeutic, and protective medical devices in high demand during the COVID-19 emergency. Here, we report the initial validation of a new injection-molded anterior nasal swab, ClearTip™, that was experimentally validated in a laboratory setting as well as in independent clinical studies in comparison to gold standard flocked swabs. We have also developed an in vitro anterior nasal tissue model which offers a novel, efficient, and clinically relevant validation tool to replicate the clinical swabbing workflow with high fidelity, while being accessible, safe, reproducible, and time- and cost-effective. ClearTip™ displayed greater inactivated virus release in the benchtop model, confirmed by its greater ability to report positive samples in a small clinical study in comparison to flocked swabs. We also quantified the detection of biological materials, as a proxy for viral material, in multi-center pre-clinical and clinical studies which showed a statistically significant difference in one study and a reduction in performance in comparison to flocked swabs. Taken together, these results emphasize the compelling benefits of non-absorbent injection-molded anterior nasal swabs for COVID-19 detection, comparable to standard flocked swabs. Injection-molded swabs, as ClearTip™, could have the potential to support future swab shortages, due to its manufacturing advantages, while offering benefits in comparison to highly absorbent swabs in terms of comfort, limited volume collection, and potential multiple usage.

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