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1.
Dent Med Probl ; 61(3): 391-399, 2024.
Article in English | MEDLINE | ID: mdl-38963395

ABSTRACT

BACKGROUND: In Mexico and around the world, water in dental units, including triple syringes, comes from municipal chlorinated water mains. The microbial contamination of dental unit water systems constitutes a risk factor for opportunistic infections. OBJECTIVES: The present work aimed to identify the bacteria present in the triple-syringe water lines of dental units at a dental school of a public university in Mexico, with a hypothesis that opportunistic bacteria of importance to human health would be found. MATERIAL AND METHODS: A cross-sectional study was carried-out. A total of 100 samples of triple-syringe tubing from dental units operated by a dental school of a public university in Mexico were analyzed before and after their use in dental practice. Bacterial biofilm was cultured and isolated from the tubing, using standard microbiological methods, and then the species present were identified through 16S rRNA gene sequencing. The characterization of the biofilm was performed by means of scanning electron microscopy (SEM). RESULTS: Bacterial growth was observed in 20% of the non-disinfected and 10% of the disinfected samples, with 11 strains isolated. Six genera and 11 bacterial species were genetically identified. Coagulasenegative staphylococci (CoNS), considered opportunistic human pathogens, were among the most critical microorganisms. Scanning electron microscopy revealed a thick polymeric matrix with multiple bacterial aggregates. CONCLUSIONS: Opportunistic bacteria from human skin and mucous membranes were detected. Under normal conditions, these bacteria are incapable of causing disease, but are potentially harmful to immunosuppressed patients.


Subject(s)
Biofilms , Equipment Contamination , Syringes , Water Microbiology , Cross-Sectional Studies , Mexico , Humans , Syringes/microbiology , Dental Equipment/microbiology , Microscopy, Electron, Scanning , Bacteria/isolation & purification , Genotype , RNA, Ribosomal, 16S
2.
AMA J Ethics ; 26(7): E527-533, 2024 Jul 01.
Article in English | MEDLINE | ID: mdl-38958421

ABSTRACT

Evidence of harm reduction interventions' morbidity and mortality benefits is abundant and of high quality, so there are good reasons for regional and national groups to advocate for more widespread distribution of legally regulated "drug paraphernalia," including needles, syringes, and fentanyl test strips. But lack of consistency among states' laws means that patients' interstate travel can subject them to being charged with possession of illegal items. This commentary on a case offers guidance to clinicians looking to help patients understand legal risks of interstate travel with supplies that are prescribed or recommended to reduce harms of their drug use and explores the ethical responsibilities of physicians in jurisdictions that legally prohibit these harm reduction interventions.


Subject(s)
Harm Reduction , Humans , Harm Reduction/ethics , Fentanyl , Syringes/ethics , Needles , United States , Equipment and Supplies/ethics , Equipment and Supplies/supply & distribution
3.
J Med Econ ; 27(1): 887-896, 2024.
Article in English | MEDLINE | ID: mdl-38896438

ABSTRACT

AIM: The current study compared preparation time, errors, satisfaction, and preference for a prefilled syringe (PFS) versus two RSV vaccines requiring reconstitution (VRR1 and VRR2) in a randomized, single-blinded time and motion study. METHODS: Pharmacists, nurses, and pharmacy technicians were randomized to a preparation sequence of the three vaccines. Participants read instructions, then consecutively prepared the three vaccines with a 3-5-min washout period in between. Preparations were video recorded and reviewed by a trained pharmacist for preparation time and errors using predefined, vaccine-specific checklists. Participant demographics, satisfaction with vaccine preparation, and vaccine preference were recorded. Within-subjects analysis of variance was used to compare preparation time. Mixed-effects Poisson and ordered logistic regression models were used to compare the number of preparation errors and satisfaction scores, respectively. RESULTS: Sixty-three pharmacists (60%), nurses (35%), and pharmacy technicians (5%) participated at four sites in the United States. The least squares mean preparation time per dose for PFS was 141.8 s (95% CI = 156.8-126.7; p <.0001) faster than for VRR1, 103.6 s (95% CI = 118.7-88.5; p <.0001) faster than for VRR2, and 122.7 s (95% CI = 134.2-111.2; p <.0001) faster than the pooled VRRs. Overall satisfaction (combined "Very" and "Extremely") was 87.3% for PFS, 28.6% for VRR1, and 47.6% for VRR2. Most participants (81.0%) preferred the PFS vaccine. LIMITATIONS: The study is limited by the inability to completely blind observers. To minimize the effects of order, we utilized a 3-sequence block design; however, the order in which the vaccines were prepared may have affected outcomes. Participants were assessed once, whereas if repeated preparations were performed there may have been trained efficiencies gained for each vaccine. CONCLUSION: PFS vaccines can greatly simplify the vaccine preparation process, allowing administrators to prepare almost four times more doses per hour than with vial and syringe systems.


Subject(s)
Syringes , Time and Motion Studies , Humans , Female , Male , Adult , Middle Aged , Respiratory Syncytial Virus Vaccines/administration & dosage , Single-Blind Method , Time Factors , Pharmacists , Pharmacy Technicians , Drug Compounding , Nurses , United States
4.
J Radiol Prot ; 44(2)2024 Jun 25.
Article in English | MEDLINE | ID: mdl-38834035

ABSTRACT

Nuclear medicine (NM) professionals are potentially exposed to high doses of ionising radiation, particularly in the skin of the hands. Ring dosimeters are used by the workers to ensure extremity doses are kept below the legal limits. However, ring dosimeters are often susceptible to large uncertainties, so it is difficult to ensure a correct measurement using the traditional occupational monitoring methods. An alternative solution is to calculate the absorbed dose by using Monte Carlo simulations. This method could reduce the uncertainty in dose calculation if the exact positions of the worker and the radiation source are represented in these simulations. In this study we present a set of computer vision and artificial intelligence algorithms that allow us to track the exact position of unshielded syringes and the hands of NM workers. We showcase a possible hardware configuration to acquire the necessary input data for the algorithms. And finally, we assess the tracking confidence of our software. The tracking accuracy achieved for the syringe detection was 57% and for the hand detection 98%.


Subject(s)
Algorithms , Nuclear Medicine , Occupational Exposure , Humans , Occupational Exposure/analysis , Hand/radiation effects , Monte Carlo Method , Artificial Intelligence , Radiometry/methods , Syringes
5.
An Acad Bras Cienc ; 96(3): e20230224, 2024.
Article in English | MEDLINE | ID: mdl-38896739

ABSTRACT

Between 2017 and 2021, the Brazilian Unified Health System (BUHS) administered a total of 527,903,302 doses of immunizations. Each immunization results in the presence of a residual volume (RV) due to syringe dead space (DS). The International Organization for Standardization 7886-1 allows a DS of up to 0.07mL in sterile single-use hypodermic syringes with volumes less than 5mL. This study aims to quantify the DS of immunization devices used in Brazil, study the best combinations of needles and syringes to minimize RV, estimate the number of wasted doses from 2017 to 2021, and evaluate the impact on the BUHS. Pneumococcal 10 vaccine with a 25x6mm needle and a regular 1mL syringe exhibited a significantly higher average RV (0.0826mL) and waste rate (14.42%). It was observed that for some intramuscular vaccines, there is less waste when using a 20x5.5mm needle compared to a 25x6mm needle. The use of syringes with plunger stoppers that penetrate the syringe barrel, denoted as low dead space syringes, results in less RV and an estimated difference in the waste rate of approximately 10% compared to the regular syringe. The estimated number of wasted doses from 2017 to 2021 by BUHS is approximately 32 million doses.


Subject(s)
Vaccines , Brazil , Humans , Syringes , Needles , National Health Programs
6.
Brain Behav ; 14(6): e3304, 2024 Jun.
Article in English | MEDLINE | ID: mdl-38760914

ABSTRACT

BACKGROUND: Contrast-enhanced transcranial Doppler (cTCD) study has been established as one of the most common investigations for detecting right-to-left shunt (RLS). Although the conventional Valsalva maneuver (c-VM) has been used to increase the sensitivity of cTCD for RLS, efforts are still needed to improve the detection rate further. We proposed a new provocation method with a syringe-modified Valsalva maneuver (sm-VM) during cTCD and compared the efficacy of this strategy with cTCD measured at resting and with the provocation of c-VM. METHODS: Consecutive patients with suspicion of RLS who underwent cTCD in our institution between September 27, 2021, and April 1, 2022, were included in this study. Examination of cTCD was performed separately at the resting state and provoked with c-VM and sm-VM. The overall proportion of patients with RLS and their distribution with different RLS grades were compared. RESULTS: A total of 389 patients (mean age: 49.37 years, male: 52.2%) were included in this study. The positive rate for RLS was significantly higher for cTCD detected with sm-VM than those detected at resting state and with c-VM (46.8% vs. 21.6% and 34.2%, all p < .05). Besides, cTCD detected with sm-VM was also associated with a higher proportion of patients with grade III RLS than those detected at resting state and with c-VM (11.3% vs. 1.8% and 0%, all p < .05). CONCLUSIONS: Compared to cTCD detected at resting state and with c-VM, cTCD with sm-VM could further increase the positive detection rate of RLS.


Subject(s)
Ultrasonography, Doppler, Transcranial , Valsalva Maneuver , Humans , Male , Ultrasonography, Doppler, Transcranial/methods , Female , Middle Aged , Adult , Contrast Media/administration & dosage , Aged , Syringes , Foramen Ovale, Patent/diagnostic imaging , Foramen Ovale, Patent/physiopathology
7.
Int J Drug Policy ; 128: 104422, 2024 Jun.
Article in English | MEDLINE | ID: mdl-38703621

ABSTRACT

BACKGROUND: Personal syringe reuse (i.e., reuse of one's own syringes) can place people who inject drugs at increased risk for infectious disease but has received relatively little attention in published literature. The purpose of this study is to identify factors associated with syringe reuse among people who inject drugs in rural Kentucky. METHODS: Participants (n = 238) completed interviewer-administered questionnaires on syringe reuse and demographic, behavioral, and service access characteristics. Unadjusted negative binomial regression with cluster-robust standard errors was used to model the associations with a logged offset for number of injections in the past 30 days. RESULTS: The average age of the sample was 35 and 59.7 % were male. Most participants (77.7 %) reused syringes at least once in the past 30 days, using each syringe a median of three times. Reuse was higher among those who were older and reported a higher street price for syringes. Syringe reuse was lower among people who were within walking distance to a syringe service program (SSP) and who obtained most of their syringes from SSPs or pharmacies. CONCLUSION: Syringe reuse among people who inject drugs in rural Kentucky is common. However, these data suggest that increased access to syringes from SSPs and pharmacies, as well as policy-level interventions that reduce street syringe price, might reduce syringe reuse and related harms.


Subject(s)
Equipment Reuse , Needle-Exchange Programs , Rural Population , Substance Abuse, Intravenous , Syringes , Humans , Kentucky , Male , Substance Abuse, Intravenous/epidemiology , Adult , Female , Syringes/supply & distribution , Rural Population/statistics & numerical data , Equipment Reuse/statistics & numerical data , Needle-Exchange Programs/statistics & numerical data , Middle Aged , Surveys and Questionnaires , Young Adult , Appalachian Region
8.
Talanta ; 276: 126177, 2024 Aug 15.
Article in English | MEDLINE | ID: mdl-38718643

ABSTRACT

A novel sample double dilution calibration method (SDDCM) and an automatic flow system with in-syringe reaction and spectrophotometric detection were developed for determining lithium in biological samples. The method is based on the reaction of lithium with Thorin in an alkaline medium and the signal was measured at 480 nm. The reaction was performed simultaneously for both standards and samples in three syringes of the automatic flow system. The method was validated and successfully applied to the determination of lithium in synthetic and pharmaceutical samples, with results consistent with the ICP OES method. The novel calibration method, developed for the determination of lithium in biological samples, uses a sample with two dilution degrees. Using the method, the concentration of the analyte is determined by relating the signal for a less diluted sample to the calibration plot for a more diluted sample and vice versa. The implementation of the calibration method was facilitated by preparing solutions directly in the flow system. The use of two sample dilutions makes it possible to determine the analyte in the sample without preliminary preparation. Moreover, obtaining two results based on signals for a sample diluted to different degrees allows them to be verified for accuracy. The proposed approach was successfully verified by the determination of lithium in certified reference materials of blood serum and urine. Using the developed method lithium was determined within the concentration range of 0.06-1.5 mg L-1, with precision (CV, %) less than 6.7, and accuracy (RE, %) better than 6.9. The detection limit was 0.03 mg L-1.


Subject(s)
Lithium , Syringes , Calibration , Lithium/blood , Lithium/chemistry , Humans , Automation , Spectrophotometry/methods , Limit of Detection
9.
Res Social Adm Pharm ; 20(8): 778-785, 2024 Aug.
Article in English | MEDLINE | ID: mdl-38734511

ABSTRACT

BACKGROUND: Pharmacy syringe sales are effective structural interventions to reduce bloodborne illnesses in populations, and are legal in all but two states. Yet evidence indicates reduced syringe sales in recent years. This study was designed as a feasibility test of an intervention to promote syringe sales by pharmacies in Arizona. METHODS: A four-month pilot among three Arizona pharmacies measured feasibility and acceptability through monthly surveys to 18 enrolled pharmacy staff members. RESULTS: Pharmacy staff reported increased ease of dispensing syringes across the study. Rankings of syringe dispensing as 'easiest' among 6 measured pharmacy practices increased from 38.9 % at baseline to 50.1 % post intervention module training, and to 83.3 % at pilot conclusion. The majority (72.2 %) of pharmacy staff agreed that intervention materials were easy to use. Over 70 % indicated that the intervention was influential in their "being more open to selling syringes without a prescription to someone who might use them for illicit drug use," and 61.1 % reported that in the future, they were highly likely to dispense syringes to customers who would use them to inject drugs. A vast majority (92 %) reported being likely to dispense subsidized naloxone if available to their pharmacy at no cost. CONCLUSIONS: An education-based intervention was found to be feasible and acceptable to pharmacy staff and had an observed impact on perceptions of ease and likelihood of dispensing syringes without a prescription to people who may use them to inject drugs.


Subject(s)
Syringes , Humans , Syringes/supply & distribution , Arizona , Pilot Projects , Pharmacies/statistics & numerical data , Feasibility Studies , Blood-Borne Pathogens , Community Pharmacy Services , Commerce , Pharmacists , Narcotic Antagonists/therapeutic use , Narcotic Antagonists/supply & distribution , Narcotic Antagonists/administration & dosage , Naloxone/supply & distribution , Naloxone/therapeutic use , Naloxone/administration & dosage
10.
Chemosphere ; 359: 142327, 2024 Jul.
Article in English | MEDLINE | ID: mdl-38754483

ABSTRACT

Prefiltration before chromatographic analysis is critical in the monitoring of environmental micropollutants (MPs). However, in an aqueous matrix, such monitoring often leads to out-of-specification results owing to the loss of MPs on syringe filters. Therefore, this study investigated the loss of seventy MPs on eight different syringe filters by employing Random Forest, a machine learning algorithm. The results indicate that the loss of MPs during filtration is filter specific, with glass microfiber and polytetrafluoroethylene filters being the most effective (<20%) compared with nylon (>90%) and others (regenerated-cellulose, polyethersulfone, polyvinylidene difluoride, cellulose acetate, and polypropylene). The Random Forest classifier showed outstanding performance (accuracy range 0.81-0.95) for determining whether the loss of MPs on filters exceeded 20%. Important factors in this classification were analyzed using the SHapley Additive exPlanation value and Kruskal-Wallis test. The results show that the physicochemical properties (LogKow/LogD, pKa, functional groups, and charges) of MPs are more important than the operational parameters (sample volume, filter pore size, diameter, and flow rate) in determining the loss of most MPs on syringe filters. However, other important factors such as the implications of the roles of pH for nylon and pre-rinsing for PTFE syringe filters should not be ignored. Overall, this study provides a systematic framework for understanding the behavior of various MP classes and their potential losses on syringe filters.


Subject(s)
Filtration , Machine Learning , Syringes , Water Pollutants, Chemical , Filtration/instrumentation , Filtration/methods , Water Pollutants, Chemical/analysis , Environmental Monitoring/methods , Algorithms
11.
Tomography ; 10(5): 686-692, 2024 May 09.
Article in English | MEDLINE | ID: mdl-38787013

ABSTRACT

(1) Background: Bacterial contamination has been shown to occur during angiographies, although data on its frequency and relevance are sparse. Our aim was to evaluate the incidence of bacterial contamination of syringes used under sterile conditions during neuroangiographies. We sought to differentiate between contamination of the outside of the syringes and the inside and to detect the frequency, extent and germ spectrum of bacterial contamination. (2) Methods: We prospectively collected 600 samples from 100 neuroangiographies. Per angiography, fluid samples from the three routinely used syringes as well as the syringes themselves were analyzed. We analyzed the frequency and extent of contamination and determined the germ spectrum. (3) Results: The majority of samples (56.9%) were contaminated. There was no angiography that showed no contamination (0%). The outer surfaces of the syringes were contaminated significantly more frequently and to a higher extent than the inner surfaces. Both the frequency and extent of contamination of the samples increased with longer duration of angiographic procedures. Most of the bacterial species were environmental or skin germs (87.7%). (4) Conclusions: Bacterial contamination is a frequent finding during neuroangiographies, although its clinical significance is believed to be small. Bacterial contamination increases with longer duration of angiographic procedures.


Subject(s)
Equipment Contamination , Syringes , Syringes/microbiology , Humans , Prospective Studies , Bacteria/isolation & purification , Cerebral Angiography/methods , Radiography, Interventional/methods
12.
BMJ Open Qual ; 13(Suppl 2)2024 May 07.
Article in English | MEDLINE | ID: mdl-38719523

ABSTRACT

In 2017, a severe shortage of infusion bags resulted in a paradigm change in medication administration practice from intermittent infusion to intravenous push. The Institute for Safe Medication Practices proposed safe practice guidelines for adult intravenous push medications. A different study showed that ready-to-administer medication prepared in the sterile area of a pharmacy reduces the risk of harm, nurses' time for medication administration and the cost of medications. Based on the recommendation of the Institute for Safe Medication Practices, we decided to conduct a pilot study on the implementation of sterile compounding and administration of intravenous push medication in adult patients admitted to the hospital. In the study, the stability of five intravenous push antibiotic syringes was also determined in the syringes.


Subject(s)
Anti-Bacterial Agents , Syringes , Tertiary Care Centers , Humans , Syringes/standards , Anti-Bacterial Agents/administration & dosage , Anti-Bacterial Agents/therapeutic use , Tertiary Care Centers/organization & administration , Tertiary Care Centers/statistics & numerical data , Pilot Projects , Adult , Administration, Intravenous/methods , Drug Stability , Infusions, Intravenous/methods , Infusions, Intravenous/instrumentation , Infusions, Intravenous/standards
13.
Antimicrob Resist Infect Control ; 13(1): 53, 2024 May 20.
Article in English | MEDLINE | ID: mdl-38764050

ABSTRACT

BACKGROUND: Stenotrophomonas maltophilia is a gram-negative bacterium that can cause hospital infections and outbreaks within hospitals. This study aimed to evaluate an outbreak of Stenotrophomonas maltophilia, caused by ready-to-use commercial syringes containing liquid lithium and heparin for arterial blood gas collection in a university hospital. METHODS: Upon detecting an increase in Stenotrophomonas maltophilia growth in blood cultures between 15.09.2021 and 19.11.2021, an outbreak analysis and a case-control study (52 patients for the case group, 56 patients for the control group) were performed considering risk factors for bacteremia. Samples from possible foci for bacteremia were also cultured. Growing bacteria were identified by matrix-assisted laser desorption ionization time-of-flight mass spectrometry. The genetic linkage and clonal relationship isolates were investigated with pulsed-field gel electrophoresis (PFGE) in the reference laboratory. RESULTS: In the case-control study, the odds ratio for the central venous catheter [3.38 (95% confidence interval [CI]: 1.444, 8.705 ; p = 0.006)], for surgery [3.387 (95% confidence interval [CI]: 1.370, 8.373 ; p = 0.008)] and for arterial blood gas collection history [18.584 (95% confidence interval [CI]:4.086, 84.197; p < 0.001)] were identified as significant risk factors. Stenotrophomonas maltophilia growth was found in ready-to-use commercial syringes used for arterial blood gas collection. Molecular analysis showed that the growths in the samples taken from commercial syringes and the growths from blood cultures were the same. It was decided that the epidemic occurred because the method for sterilization of heparinized liquid preparations were not suitable. After discontinuing the use of the kits with this lot number, the outbreak was brought under control. CONCLUSIONS: According to our results, disposable or sterile medical equipment should be included as a risk factor in outbreak analyses. The method by which injectors containing liquids, such as heparin, are sterilized should be reviewed. Our study also revealed the importance of the cooperation of the infection control team with the microbiology laboratory.


Subject(s)
Cross Infection , Disease Outbreaks , Gram-Negative Bacterial Infections , Stenotrophomonas maltophilia , Stenotrophomonas maltophilia/isolation & purification , Humans , Case-Control Studies , Gram-Negative Bacterial Infections/epidemiology , Gram-Negative Bacterial Infections/microbiology , Male , Female , Cross Infection/epidemiology , Cross Infection/microbiology , Middle Aged , Aged , Adult , Risk Factors , Bacteremia/epidemiology , Bacteremia/microbiology , Hospitals, University , Syringes/microbiology , Electrophoresis, Gel, Pulsed-Field , Aged, 80 and over , Heparin/pharmacology
14.
Farm Hosp ; 48(3): T133-T140, 2024.
Article in English, Spanish | MEDLINE | ID: mdl-38705829

ABSTRACT

OBJECTIVE: The off-label use in clinical practice of non-approved syringes for intravitreal drug administration has resulted in the detection of silicone oil drops in the vitreous of some patients. This situation derives from the lack of approved syringes for intraocular use in the Spanish market. The aim of this work is to review the use of syringes for intraocular administration, as well as to search for alternatives that meet the legal requirements for these unmet needs. METHOD: A systematic review was performed following the PRISMA 2020 guidelines by searching PubMed with the descriptors: (silicone) AND (syringes) AND ((intraocular) OR (intravitreal)) and filtering all existing publications from January 2006 to December 2023, including all those articles dealing with silicone oil release in intravitreal injections and analysing the possible consequences. RESULTS: Sixty-eight results were found, 23 of which were excluded because they did not deal with the subject under study, leaving a total of 45 articles for the systematic review. These were classified according to the conclusions obtained in 4 groups: the adverse reactions produced by silicone; the administration technique; the physicochemical aspects of silicone release; and the characteristics of the medical device. After reviewing the current manufacturers and technical data sheets of commercialised syringes, the existing syringes for this use have been collected, finding 2 that will probably be commercialised in Spain at the beginning of 2024: Zero Residual™ 0.2 ml SiO-free and VitreJect® Ophthalmic. CONCLUSIONS: From the results obtained, it can be interpreted that the use of syringes and needles with silicone for intravitreal use is a concern for health professionals due to the implications and consequences that may arise in patients, the most important being adverse reactions, so it is necessary to have silicone-free syringes on the market that are specific for intraocular use. Safety and legality in the use of intraocular syringes and needles is essential to guarantee ocular integrity and patient health.


Subject(s)
Intravitreal Injections , Silicone Oils , Syringes , Humans , Off-Label Use , Spain
15.
Skin Res Technol ; 30(5): e13747, 2024 May.
Article in English | MEDLINE | ID: mdl-38720480
16.
Br J Oral Maxillofac Surg ; 62(5): 459-463, 2024 Jun.
Article in English | MEDLINE | ID: mdl-38670905

ABSTRACT

Bone removal is commonly used in the extraction of third molars and the heat generated during the process can interfere with the repair of bone. The aim of this study was to evaluate the temperature variation presented in bone removal performed with a high-speed turbine (400000 rpm), implant motor with straight piece (100000 rpm), low-speed micromotor (20000 rpm) and piezoelectric saw (30 kHz) in pig mandibles. For this, bone removal was carried out around 20 posterior teeth, under constant saline solution irrigation with a syringe and needle. In addition, the time required to perform bone removal was recorded. The results indicated a mean (SD) temperature variation of 0.96 °C (0.6 °C) for the high-speed turbine, 1.38 °C (0.5 °C) with the implant motor, 2.22 °C (0.7 °C) for the low-speed micromotor and 2.90 °C (1.3 °C) for the piezoelectric saw. The conventional variance was calculated discounting the variation of time used for bone removal around the teeth. There was a statistically significant difference in temperature variation between the high-speed turbine vs the micromotor (p = 0.009) and the high speed micromotor vs the piezoelectric saw (p = 0.04). We conclude that there is a statistically significant difference in temperature variation between the instruments used in oral and maxillofacial surgery, with higher rotation speeds resulting in the lowest temperature variations and a reduced surgical time.


Subject(s)
Mandible , Molar, Third , Piezosurgery , Temperature , Tooth Extraction , Animals , Molar, Third/surgery , Swine , Mandible/surgery , Piezosurgery/instrumentation , Therapeutic Irrigation/instrumentation , Osteotomy/instrumentation , Osteotomy/methods , Time Factors , Dental High-Speed Equipment , Operative Time , Equipment Design , Saline Solution , Hot Temperature , Needles , Syringes
17.
Sci Rep ; 14(1): 8975, 2024 04 18.
Article in English | MEDLINE | ID: mdl-38637597

ABSTRACT

For the majority of cytotoxic drug preparations, such as bortezomib, the unit dose information is not available. In addition, there is a lack of information on the physicochemical stability of the pharmaceutical preparation after opening; this information is crucial for its administration to patients in successive visits, and the per-patient cost can be affected. The purpose of our proposed physicochemical stability study is to determine the shelf life of the reconstituted liquid product under refrigeration and clinical practice conditions. This evaluation was extended to both vials and ready-to-use syringes prefilled with the contents of the open vial. The stability test design includes the specified storage conditions and the critical physicochemical parameters of reconstituted injectable bortezomib. Furthermore, this approach includes the determination of impurities, the monitoring of the purity of the mean peak using a photodiode array, the control of the mass balance, the monitoring of subvisible particles using a laser diffraction analyser, and the setting of stability specifications. For the chemical stability study, the amount of bortezomib and its degradation products were determined using a stability-indicating HPLC method. The physical inspection of the samples was performed throughout the stability study, and their pH values were also monitored. Bortezomib (2.5 mg/mL) in 0.9% sodium chloride remained stable for 7 days when stored in both polypropylene syringes and vials at 5 ± 3 °C (refrigeration) and shielded from light. Additionally, it exhibits stability for 24 h under storage conditions simulating clinical use (20-30 °C and protected from light). The proposed protocol provides the stability in the vials once reconstituted and in prefilled refrigerated syringes; this protocol can be used to reduce waste and increase cost savings.


Subject(s)
Antineoplastic Agents , Drug Packaging , Humans , Bortezomib , Polypropylenes/chemistry , Drug Stability , Syringes , Chromatography, High Pressure Liquid , Pharmaceutical Solutions/chemistry
18.
AAPS PharmSciTech ; 25(4): 76, 2024 Apr 05.
Article in English | MEDLINE | ID: mdl-38580881

ABSTRACT

For liquid drug products, e.g., solutions or suspensions for oral or parenteral dosing, stability needs to be demonstrated in primary packaging during storage and in dosing devices during in-use periods per quality guidelines from the International Conference on Harmonisation (ICH) and the European Agency for the Evaluation of Medicinal Products (EMEA). One aspect of stability testing for liquid drug products is in-use stability, which typically includes transferring the liquid samples into another container for further sample preparation with extraction diluent and necessary agitation. Samples are then analyzed with traditional chromatography methods, which are laborious, prone to human errors, and time-consuming, especially when this process needs to be repeated multiple times during storage and in-use periods. Being able to analyze the liquid samples non-destructively would significantly improve testing efficiency. We investigated different Raman techniques, including transmission Raman (TRS) and back scatter Raman with a non-contact optic (NCO) probe, as alternative non-destructive tools to the UHPLC method for API quantitation in in-use liquid samples pulled into plastic dosing syringes. The linearity of the chemometric methods for these two techniques was demonstrated by cross-validation sample sets at three levels over an API concentration range of 60 to 80 mg/mL. The accuracy of the chemometric models was demonstrated by the accurate prediction of the API concentrations in independent samples from four different pilot plant batches manufactured at different sites. Both techniques were successful in measuring a signal through a plastic oral dosing syringe, and predicting the suspension API concentration to within 4% of the UHPLC-measured value. For future work, there are opportunities to improve the methodology by exploring additional probes or to expand the range of applications by using different sample presentations (such as prefilled syringes) or formulation matrices for solutions and suspensions.


Subject(s)
Bulk Drugs , Syringes , Humans , Drug Packaging , Suspensions , Excipients
19.
Appl Ergon ; 118: 104263, 2024 Jul.
Article in English | MEDLINE | ID: mdl-38537520

ABSTRACT

The movements of syringes and medications during an anesthetic case have yet to be systematically documented. We examine how syringes and medication move through the anesthesia work area during a case. We conducted a video-based observational study of 14 laparoscopic surgeries. We defined 'syringe events' as when syringe was picked up and moved. Medications were administered to the patient in only 48 (23.6%) of the 203 medication or syringe events. On average, 14.5 syringe movements occurred in each case. We estimate approximately 4.2 syringe movements for each medication administration. When a medication was administered to the patient (either through the IV pump or the patient port), it was picked up from one of 8 locations in the work area. Our study suggests that the syringe storage locations vary and include irregular locations (e.g., patient bed or provider's pockets). Our study contributes to understanding the complexity in the anesthesia work practices.


Subject(s)
Laparoscopy , Syringes , Humans , Male , Female , Anesthesiology , Adult , Movement , Middle Aged , Video Recording
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