| BackgroundNosocomial infection is one of the most important issues which affect medical safety today,it is a difficult problem in hospital management. With the development of medical science, hospital infection have been increased because of the increasing trend of invasive operation. The surgical instruments used in surgeries are mostly passive temporary contact organizations invasive medical devices,they affected the patient’s safety and health directly. The quality control and safety management of surgical instruments is one of the most important issues national medical risk management, has important clinical implications for the protection of the patient’s medical safety and reduce nosocomial infections.The number of orthopedic surgeries, mainly hip and knee replacement surgeries, have increased because of technologic advances, a total of400,000prosthetic surgeries are estimated a year in the worldwide. With the development of orthopedic surgeries and orthopedic instruments, healthcare facilities need more items for the surgeries.But some of these items are very complicated and expensive or sophisticated devices that are new to the facility, healthcare facilities often have a need to borrow instrumentation and surgical implants for a surgical or invasive procedure from a specific vendor or neighboring healthcare facility,the items they borrowed were called loaner instrumentation. Loaner instrumentation often consists of multiple trays and many types of instruments and/or implants,they are heavy and large volume, so the management of loaner instrumentation and implants in healthcare facilities is recognized as a problem by many healthcare professionals today. The data obtained from the international literature show that1%to5%of hip arthroplasties become infected, resulting in morbidities because of prolonged hospitalization, repeated surgical procedures, permanent loss of the implant and shortening of the affected limb, severe and permanent deformities, as well as death as the outcome of fulminating infections. A formalized program, specific policies and established controls must be in place to effectively manage loaner instrumentation and implants to ensure safe patient care. Many researchers have given positive attention on the use of loaner instrumentation,most mainly summarized the management process and the experience in sterilization. And domestic reports are mainly about wet packages after the pressuresteam sterilization, more research about the relation between the use of loaner instrumentation and infection rate of orthopedic operative incision and the trace condensed water should be done.ObjectiveTo analysis the relation between the use of loaner instrumentation and infection rate of orthopedic operative incision by comparing positive rate of monitoring the loaner orthopedic instrumentation and OR instrumentation; investigate the impact of trace condensate water on the loaner instrumentation after pressure steam sterilization. Provide a theoretical basis and reference for the pressure steam sterilization and use of loaner orthopedic instrumentation.Method1. Analysis of the comparisons between the contaminate of loaner instrumentation and OR instrumentation during orthopedic surgeriesFrom June-September,2012,in a hospital in Guangzhou City,we collected the samples during the orthopedic surgeries in the principles of convenience sampling.①Object:Choose the unused loaner instrumentation and OR instrumentation that was exposed to the air since the operative started. The two sets of equipment were used at the same time, respectively. According to the literature and clinical operating theater experts recommend,collected the samples at2.5h,3.5h,5h after the surgery start.Exclusion criteria:surgery lasted less than2.5h, emergency surgery, infection site surgery, the equipment was contaminated,instrument has been used in surgery or patient contact body fluids, blood, etc.. Meet any one of the aboves are hereby excluded.②Methods:When the surgery went for2.5h、3.5h and5h, collected all the samples by the scrub nurses. Each surgery only select one time points, after that the instruments were no longer used in the operations,so we try to collect the samples at the end of the surgeries.③Cultures:All samples were sent to culture within two hours, were put in the incubator chamber at37degrees,then we observed and record the result after72hours, turbid broth, biofilm formation was considered positive, transparent and clear broth considered negative.④Quality control:The surgical procedures were mainly hip and knee replacement, pine plate fixation, the lumbar laminectomy fixation, lumbar reduction plate internal fixation and so on. All the operating rooms’ layout and environment were the same, temperature of20℃-24℃, humidity of50%-70%, burglary number were7-10. The intraoperative device packaging were all made of a cotton cloth, the sterilization and package save were qualified according to national hygiene standard WS310(2009).⑤Statistical methods:Data were entried and analysised by SPSS13.0. Use percentage toexpress the count data, comparisons between the group and within-group use Pearson chi-square test analysis,when the theoretical frequency is less than5,the data were analysis with Fisher exact test. P<0.05was considered statistically significant.2. The impact of condensate water to the loaner instrumentation contamination rate after pressure steam sterilization①Object:Loaner instrumentation and OR instrumentation that is sterilized,there is the residual condensate water in the loaner instrumentation package,but the outside of the package was dry and in good condition, chemical indicator card and the3M chemical indicator tape discoloration qualified.The OR instrumentation is the ordinary surgical instruments used in the OR.②Collecting step:(1)Open the instrument package after sterilization:One person weared sterile gloves and rubbed the surface of the instruments e repeatedly with a swab in the help of another person.Loaner instrumentation required to focus rubbed the condensate residue position.(2) Open the instrument package stand for4h:two sets of instruments are opened in a static laminar flow operating room, there is the residual condensate water in the loaner instrumentation package,collect the samples after4h according to the principles of aseptic technique sterile offer.③Statistical methods:Same as the first part.Results1. Analysis of the comparisons between the contaminate of loaner instrumentation and OR instrumentation during orthopedic surgeries(1)①We collected136loaner orthopedic instrumentation samples as group A, positive in31cases, the positive rate of22.8%,and119OR instrumentation samples as group B, positive in10cases, the positive rate of8.4%, there is statistic significance in comparision of the two groups (P<0.05).②We collected the samples of unused instrumentations during the orthopedic surgeries when the surgery went for2.5h、3.5h and5h,the loaner instrumentation group sampling positive rates are12.3%,30.2%,45%, and operating room equipment group sampled positive rates are5.1%,10.0%,30.0%. At3.5h the positive rate of group A is higher than group B, there is statistic significance in comparision of the two groups (P<0.05). At2.5h and5h the positive rate of group A is higher than group B,but without significant statistic variation (P>0.05).(2)①The loaner instrumentation group internal comparison:there is statistic significance in comparision among the three time points(P<0.05), and there is statistic significance in comparision between the2.5h VS3.5h and2.5h VS5h (P<0.05). Without significant statistic variation between3.5h VS5h (P>0.05).②The OR instrumentation group internal comparison:there is no statistic significance in comparision among the three time points(P>0.05), and there is statistic significance in comparision between the2.5h VS5h (P<0.05). Without significant statistic variation between2.5h VS3.5h and3.5h VS5h (P>0.05).After mergered the samples before and after3.5h, there is statistic significance in comparision of the before3.5h VS5h (P<0.05),and there is no statistic significance in comparision of the2.5h VS after3.5h(P>0.05),(3) Combine all the sample data, we can have the overall monitoring sample information of all surgical instruments used in orthopedic surgery,2.5h,3.5h,5h sampling positive rates were8.6%,21.9%,40.0%. There is statistic significance in comparision among the three time points(P<0.05), and there is statistic significance in comparision between the2.5h VS3.5h and2.5h VS5h (P<0.05). Without significant statistic variation between3.5h VS5h (P>0.05)2. The impact of condensate water to the loaner instrumentation contamination rate after pressure steam sterilization(1) Open two sets of equipment package and collect the samples after pressure steam sterilization, all the samples culture results were negative;(2) samples collected after packages were opend for4h in the hundred static laminar flow operating room, there is no statistic significance in comparision of the two groups (P>0.05)Conclusion1.During the orthopedic surgery,the monitoring of the use of loaner instrumentation is not optimistic. The contamination rate of loaner instrumentation was higher than operating room instruments, especially2.5h after the start of surgery. The use of loaner orthopedic instrumentation have a greater risk of surgical infection than operating room instruments.3.Clinical managers need to pay attention to the surgical instruments used in orthopedic surgery. Invasive loaner orthopedic instrumentation in2.5h after the surgery start, the contamination rate extended with the operation time tended to increase, the rate of operating room instruments contaminated showed an increasing trend in3.5h after the surgery started.4.Instruments used in orthopedic surgery overall contamination rate is high, especially in the3.5h after the surgery started;orthopedic surgery instruments overall contamination rate tended to increase with the operation time extension. |
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