1.Production Research and Risk Factor Analysis of Transfusion and Infusion Warmer Based on Real-World Data.
Hongfeng BI ; Yonggang WANG ; Zhendong WANG ; Yuan FU ; Huifang NIU
Chinese Journal of Medical Instrumentation 2025;49(4):466-472
OBJECTIVE:
To investigate the transfusion and infusion warmer manufacturers, combine the use failures to analyze adverse events, and provide support for enterprise risk management and clinical safe use.
METHODS:
The sentinels from 7 manufacturing enterprises and 11 medical institutions that participated in Shandong Province's key monitoring program during the "14th Five-Year Plan" period were targeted. This was done by understanding the equipment's principles, structures, and quality control. Additionally, real-world data from January 2019 to December 2023 were collected to count adverse events.
RESULTS:
During production, there are risks in switching power supply stability and solder joint firmness. Fifteen kinds of faults occurred during use, and common faults such as inability to heat, unable to turn on the machine, and bubbles in the infusion tube accounted for more than 80%.
CONCLUSION
There are many risk points and failures for transfusion and infusion warmers, so enterprises should improve processes and quality control to address risks, and medical institutions should formulate specifications and maintenance plans to provide targeted theoretical basis for supervision.
Blood Transfusion/instrumentation*
;
Risk Factors
;
Quality Control
;
Humans
;
Risk Management
;
Equipment Failure
2.A Capacitive Venous Transfusion Alertor Based on NB-IoT.
Chinese Journal of Medical Instrumentation 2019;43(4):307-309
This capacitive venous transfusion alertor is based on rise time of RC circuit and input capture function of timer in the microcontroller. The measure element of alertor is integrated with circuit board, it has the advantages of simple structure and low cost. Combined with narrow band intent of things(NB-IoT) technology to upload data, it can reduce the workload of medical personnel and caregivers, avoid unnecessary trouble and danger.
Algorithms
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Blood Transfusion
;
instrumentation
;
standards
;
Equipment Design
;
standards
;
Micro-Electrical-Mechanical Systems
;
standards
3.Effect of autologous blood transfusion device on preventing blood loss in primary total knee arthroplasty using comprehensive hemostatic methods.
Yang LI ; Bang Guo LI ; Ran ZHAO ; Hua TIAN ; Ke ZHANG
Journal of Peking University(Health Sciences) 2018;50(4):651-656
OBJECTIVE:
To analyze the conventional application of using comprehensive hemostatic methods during the perioperative period, and the effect of autologous blood transfusion (ABT) device compared with non-negative pressure drainage on preventing blood loss and allogenic blood transfusion after primary total knee arthroplasty (TKA).
METHODS:
A total of 131 patients (131 knees) with severe knee osteoarthritis who underwent unilateral primary TKA by the same surgeon in Peking University Third Hospital from June 2014 to June 2015 were enrolled in this study. The patients were divided into ABT group (64 patients) and control group (67 patients). ABT devices were used for drainage and blood transfusion in the ABT group while the control group used the non-negative pressure drainage only. The results of the drainage fluid volume, the decrease of hemoglobin, the total blood loss, the hidden blood loss and blood transfusion after TKA were compared between the two groups.
RESULTS:
The drainage fluid volume in ABT group was significantly higher than that in control group [515 mL (80-1 610 mL) vs. 260 mL (40-670 mL), P<0.001]. The autologous blood transfusion in ABT group was 245 mL (60-1 070 mL). There were no significant differences between the two groups in the value of hemoglobin decrease 1 day after surgery (P=0.340) and 3 days after surgery (P=0.524). There were no significant differences in the total blood loss (P=0.101) and the hidden blood loss (P=0.062) between the two groups either. There were 9 patients in the 131 patients who received allogeneic blood transfusion, of whom 5 in the ABT group (5/64, the blood transfusion rate was 7.8%) and 4 in the control group (4/67, the blood transfusion rate was 6.0%), and no significant differences in the blood transfusion rate between the two groups (P=0.943).
CONCLUSION
With the conventional application of using comprehensive hemostatic methods during perioperative period, the ABT device did not show the effective result of controlling postoperative blood loss and failed to reduce the rate of allogeneic blood transfusion in patients with unilateral primary TKA. However, the ABT device could increase the drainage fluid volume and improve the patient's hospitalization expenses. Therefore, there is no need for routine application of ABT device in unilateral primary TKA.
Arthroplasty, Replacement, Knee
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Blood Loss, Surgical/prevention & control*
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Blood Transfusion
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Blood Transfusion, Autologous/instrumentation*
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Hemostatics
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Humans
4.Effects of Two Placement Ways for Storage of Blood Bag on Biochemical Indexes of Leukodepleted Red Blood Cells.
Rui-Jun ZHANG ; Bing-Zheng DUAN ; Chun-Mei JU ; Su-Qin SUI ; Yan BAI ; Huan CAO
Journal of Experimental Hematology 2016;24(2):607-610
OBJECTIVETo investigate the effects of 2 different ways of storage bag placement on some biochemical indexes of leukodepleted red blood cells (LD-RBC) to as to ensure the efficacy and safety of clinical blood transfusion.
METHODSThe whole blood samples of 20 donors (400 ml/donor) were selected for preparating the LP-RBC, which were divided evenly into 10 bags. The 10 bags were randomly divided into 2 groups; the bags in 1 group were placed uprightly, while the bags in another group were placed horizontally. The bags of 2 groups were stored in the same conditions. One storage bag from each group was taken randomly on day 7, 14, 21, 28, 35 respectively, and then the biochemical indexes of samples were detected and analyzed.
RESULTSThe values of K(+) and LAC on day 14, the value of LDH on day 28 in the uprightly placed group were higher than those in the horizontally placed group (P < 0.05), the value of Na(+) on day 28, and the value of Glu on day 35 in the uprightly placed group were lower than those in horizontally placed group (P < 0.05), but there was no significant difference in Cl(-) level between 2 groups (P > 0.05).
CONCLUSIONThe storage bags placed by different ways during the storage show different influence on some biochemical indexes of LD-RBC in the storage period.
Blood Specimen Collection ; instrumentation ; methods ; Blood Transfusion ; Erythrocytes ; Humans ; Random Allocation
5.A comparative study of the therapeutic effect between long and short intramedullary nails in the treatment of intertrochanteric femur fractures in the elderly.
Xue-Feng GUO ; Ke-Ming ZHANG ; Hong-Bo FU ; Wen CAO ; Qiang DONG
Chinese Journal of Traumatology 2015;18(6):332-335
PURPOSETo compare the clinical effects of long vs. short intramedullary nails in the treatment of intertrochanteric fractures in old patients more than 65 years old.
METHODSA retrospective analysis of 178 cases of intertrochanteric fractures of the femur (AO type A1 and A2) in the elderly was conducted from January 2008 to December 2013. There were 85 males (47.8%) and 93 females (52.2%) with the age of 65e89 (70.2±10.8) years. The patients were treated by closed reduction and long or short intramedullary nail (Gamma 3) fixation. The length of short nail was 180 mm and that for long nail was 320e360 mm. The general data of patients, operation time, intraoperative blood loss, length of hospital stay, preoperative hemoglobin level, blood transfusion rate, postoperative periprosthetic fractures, infections, complications, etc were carefully recorded.
RESULTSThere were 76 cases (42.7%) in the long intramedullary nail group and 102 cases (57.3%) in the short nail group. All the cases were followed up for 12e48 (21.3±6.8) months, during which there were 21 deaths (11.8%), mean (13.8±6.9) months after operation. The intraoperative blood loss was (90.7±50.6) ml in short nail group, greatly less than that in long nail group (127.8±85.9) ml (p=0.004). The short nail group also had a significantly shorter operation time (43.5 min±12.3 min vs. 58.5 min±20.3 min, p=0.002) and lower rate of postoperative transfusion (42.3% vs. 56.7%, p=0.041). But the length of hospital stay showed no big differences. After operation, in each group there was 1 case of periprosthetic fracture with a total incidence of 1.1%, 1.3% in long nail group and 0.9% in short nail group. At the end of the follow-up, all patients achieved bony union. The average healing time of the long nail group was (6.5±3.1) months, and the short nail group was (6.8±3.7) months, revealing no significant differences (p=0.09). Postoperative complications showed no great differences either.
CONCLUSIONBoth the intramedullary long and short nail fixation has a good clinical effect in treating intertrochanteric femur fractures in the elderly. They showed no significant difference in terms of therapeutic effect, hospital stay and postoperative complications. The incidence of periprosthetic fractures treated by either length of nails was low. But short intramedullary nailing can obviously decrease the intraoperative blood loss, operation time and postoperative blood transfusion.
Aged ; Aged, 80 and over ; Blood Loss, Surgical ; statistics & numerical data ; Blood Transfusion ; statistics & numerical data ; Female ; Fracture Fixation, Intramedullary ; instrumentation ; Hip Fractures ; surgery ; Humans ; Length of Stay ; statistics & numerical data ; Male ; Operative Time ; Postoperative Complications ; epidemiology ; Recovery of Function ; Retrospective Studies ; Treatment Outcome
6.Minimally invasive percutaneous compression plating versus dynamic hip screw for intertrochanteric fractures: a randomized control trial.
Qiang CHENG ; Wei HUANG ; Xuan GONG ; Changdong WANG ; Xi LIANG ; Ning HU
Chinese Journal of Traumatology 2014;17(5):249-255
OBJECTIVEIntertrochanteric femur fracture is a common injury in elderly patients. The dynamic hip screw (DHS) has served as the standard choice for fixation; however it has several drawbacks. Studies of the percutaneous compression plate (PCCP) are still inconclusive in regards to its efficacy and safety. By comparing the two methods, we assessed their clinical therapeutic outcome.
METHODSA total of 121 elderly patients with intertrochanteric femur fractures (type AO/OTA 31.A1-A2, Evans type 1) were divided randomly into two groups undergoing either a minimally invasive PCCP procedure or a conventional DHS fixation.
RESULTSThe mean operation duration was significantly shorter in the PCCP group (55.2 min versus 88.5 min, P<0.01). The blood loss was 156.5 ml±18.3 ml in the PCCP group and 513.2 ml±66.2 ml in the DHS group (P<0.01). Among the patients treated with PCCP, 3.1% needed blood transfusions, compared with 44.6% of those that had DHS surgery (P<0.01). The PCCP group displayed less postoperative complications (P<0.05). The mean American Society of Anesthesiologists score and Harris hip score in the PCCP group were better than those in the DHS group. There were no significant differences in the mean hospital stay, mortality rates, or fracture healing.
CONCLUSIONDue to several advantages, PCCP has the potential to become the ideal choice for treating intertrochanteric fractures (type AO/OTA 31.A1-A2, Evans type 1), particularly in the elderly.
Aged ; Blood Transfusion ; statistics & numerical data ; Bone Plates ; Bone Screws ; Female ; Femoral Fractures ; mortality ; surgery ; Fracture Fixation, Internal ; instrumentation ; methods ; Fracture Healing ; Hospital Mortality ; Humans ; Length of Stay ; statistics & numerical data ; Male ; Minimally Invasive Surgical Procedures ; Operative Time ; Postoperative Complications ; epidemiology ; Treatment Outcome
7.Closed-loop blood transfusion management system based on PDA.
Yiyi CHEN ; Canda CHEN ; Luo LUO ; Zhou YIN ; Min ZHOU ; Qiong XIE ; Min XU ; Qiutao ZHANG
Chinese Journal of Medical Instrumentation 2013;37(5):376-378
A closed-loop transfusion management system is constructed that covers blood preservation, transportation, transfer, distribution of blood, distribution, clinical blood specimen collection and blood transfusion process, which can monitor the implementation of doctor's advice, view the transport process of blood and blood samples, and record blood transfusion and adverse reaction information. These measurements can play a good effect in reduction of manual records and handover links in blood transfusion management, enhance the blood bank management, guarantee safely using blood, and realize the goal of real-time monitoring and closed-loop management.
Blood Transfusion
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instrumentation
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nursing
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Medical Informatics Applications
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Monitoring, Physiologic
;
instrumentation
8.A new solution for performance test of disposable syringe and other transfusion apparatus.
Chinese Journal of Medical Instrumentation 2012;36(3):210-212
The method and process for main performance test of regular medical apparatus is proposed based on test standards for medical package. This provides a comprehensive testing solution for the quality supervision, drug administration and major enterprises in medical industry.
Blood Transfusion
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instrumentation
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Solutions
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Syringes
9.Evaluation of Two Automated Instruments for Pre-transfusion Testing: AutoVue Innova and Techno TwinStation.
So Youn SHIN ; Kye Chul KWON ; Sun Hoe KOO ; Jong Woo PARK ; Chi Seon KO ; Jeong Hoon SONG ; Ji Youn SUNG
The Korean Journal of Laboratory Medicine 2008;28(3):214-220
BACKGROUND: Despite the advances in total laboratory automation, a considerable amount of work in blood banks is still done using outdated manual methods. Some automated pre-transfusion testing instruments have recently been developed. Of these, we evaluated and compared the AutoVue Innova (Ortho, USA) and the Techno TwinStation (DiaMed AG, Switzerland). METHODS: Forward and reverse ABO/Rh typing and unexpected antibody screening and identification tests were performed on 4,628 samples using the manual method and the two automated instruments. Two different anticoagulants (EDTA and citrate) were compared in ABO/Rh typing and unexpected antibody screening tests. Titrating studies were conducted on the following 7 dilutions using 5 samples of irregular antibodies with anti-E, anti-E & -c, anti-D, and anti-Le(a) with anti-Fy(a): 1:2, 1:4, 1:8, 1:16, 1:32, 1:64, and 1:128. The test throughput per hour, the time required to perform 1 and 100 tests, and a simulation test for total events occurring in 1 day were also measured. RESULTS: No erroneous results were reported between the two instruments and the manual method. Discrepancies observed in 10 cases (0.4%) of ABO/Rh typing were of higher intensity with AutoVue Innova than with the manual method. AutoVue Innova exhibited the highest sensitivity in the titrating study and throughput performance compared with the manual method and the Techno TwinStation. Especially in the throughput and time required to complete 100 antibody screening tests, AutoVue Innova had a 3.3- and 3.5-fold higher performance, respectively, than Techno TwinStation. CONCLUSIONS: Because both of the two fully automated instruments (AutoVue Innova and Techno TwinStation) had high levels of accuracy and performance, it is expected that use of fully automated instruments will reduce human labor, turnaround time, and operator error in the blood bank.
ABO Blood-Group System/blood
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Antibodies/blood
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Automation
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Blood Grouping and Crossmatching/*instrumentation
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Blood Transfusion
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Cost-Benefit Analysis
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False Positive Reactions
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Humans
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Rh-Hr Blood-Group System/blood
10.Effectiveness of bacterial screening in preventing and controlling platelet bacterial contamination.
Jun-Jie LIN ; Zhong XU ; Ming CHEN ; Ying-Jie QIU ; Xi ZHANG ; Xiang-Rong KONG ; Xiao-Yan ZHOU ; Qing MA ; Kai-Chen QIAN
Journal of Experimental Hematology 2008;16(1):189-191
This study was purposed to investigate the effectiveness of bacterial screening with 24 hours holding in preventing and controlling bacterial contamination of platelets. Bacterial screening of apheresis platelets preserved for 24 hours was performed by using BacT/ALERT automatic bacterial culture system. The samples from 5 bags of platelet were taken in aseptic condition and were merged into 1 bag. The final sample was inoculated into aerobic and anaerobic bottle respectively for testing, meanwhile the screened platelet samples were held for 24 hours. If the platelets were cultured for 24 hours and identification of bacterial strains showed negative, the platelets could be released, and the original platelet samples should be rescreened if initiate positive was found. The results showed that in screening 8017 samples of apheresis platelets the initiate positive results were 16 (0.2%) and confirmed positive were 4 (0.05%). Out of 4 confirmed positive strains, three were Staphylococcus aureus and another was Staphylococcus auricularis. It is concluded that it is necessary for blood center to apply the method of bacterial screening of platelet with 24 hours holding as conventional screening method, which is an effective and feasible way to prevent and control bacterial contamination of platelets.
Bacteria
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isolation & purification
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Bacterial Infections
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prevention & control
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Bacteriological Techniques
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instrumentation
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Blood Platelets
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microbiology
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Blood Preservation
;
methods
;
standards
;
Humans
;
Platelet Transfusion
;
adverse effects
;
Plateletpheresis
;
instrumentation

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