Instructions For Use Research Articles

PathogenDx DetectX Combined Demonstrates Equivalent Performance in Comparison to Four AOAC Certified Methods for the Detection of Aspergillus Species, Salmonella Species, and STEC in Dried Hemp Flower.

The PathogenDx DetectX Combined method is a certified Performance Tested MethodSM (012201) that is enrichment-free and utilizes a DNA microarray-based end point PCR method for the simultaneous detection of Aspergillus (A. flavus, A. fumigatus, A. niger, and A. terreus), Salmonella spp., and a broad range of Shiga toxin-producing Esherichia coli (STEC) from hemp and cannabis flower, edibles, and concentrates. This study aimed to compare the PathogenDx DetectX Combined enrichment-free method to four AOAC INTERNATIONAL certified molecular methods that utilize enrichment prior to quantitative PCR (qPCR) amplification in hemp flower for the detection of Aspergillus (A. flavus), S. enterica, and Escherichia coli 026. In this method comparison study, each method was evaluated according to the AOAC validated instructions for use (IFU) and the AOAC Appendix J validation guidelines. A total of 16 samples at three levels of contamination (0, 0.7, and 2 CFU/10g test portion) were analyzed by each method. The results for all methods were evaluated by using the probability of detection statistical model (POD). Results of the validation study demonstrate that the PathogenDx DetectX Combined enrichment-free method is equivalent in performance to the three proprietary methods evaluated in this study. The method comparison study indicated that the PathogenDx DetectX Combined enrichment-free method provides equivalent detection of the target analytes (A. flavus, Salmonella, and a broad range of STEC) in hemp flower. The performance of The PathogenDx DetectX Combined method is significantly faster and possesses a higher or equivalent degree of sensitivity and specificity. Implementation of this method for routine microbial pathogen analysis in laboratories would save significant time and resources.

SG-APSIC1174: High-value instrument management: Rigid endoscopes

Background: After 3 years, we discovered that a high-value instrument, rigid endoscopes, needed to be used and cleaned properly. If those instruments are damaged from inappropriate handling or reprocessing, they can pose infection risks to patients. Furthermore, the hospital incurs additional repair costs. Objectives: We sought to ensure that specialized instruments are handled and used appropriately in accordance with the manufacturers’ recommendations and that all related units handle and use instruments appropriately. Methods: A meeting was convened to establish the purposes and scope of the work, and related data were collected. As a result, we created registration forms for high-risk instruments as well as a survey list for rigid endoscopes. These forms were distributed to appropriate units. We analyzed outcomes, monitored the indicators, and audited work processes. The operating room registered high-value instruments on a form that included instructions for use. A dealer demonstrated how to handle the rigid endoscopes. The CSSD team visited the operating room to emphasize the importance of handling and reprocessing to ensure compliance. The BEM team inspected all endoscopes after use. We created group communication within the software. Using T-DOC, we analyzed and monitored outcomes. We measured the rate of high-risk instrument registration as well as the completeness of registration. We also measured the rate of damage to rigid endoscopes. Results: We collected data related to rigid endoscopes and educated the staff to handle and reprocess the instruments appropriately, including instructions for use. High-risk instrument registration forms and surveys were created to record information in the T-DOC system. The staff was invited to educational workshops. The rates of registration, registration completeness, and readiness were measured using the plan–do–check–act (PDCA) method. The results of every indicator reached the expected rates of 100%. Conclusions: We achieved our goal of 100% compliance with the new program. All high-value instruments should be registered, and all related staff should be trained to use them appropriately.

SG-APSIC1177: Improving the quality of sterile medical devices to international standards

Objectives: The central sterile services department (CSSD) offers a variety of procedures, including collecting contaminated medical equipment from various agencies through a process of washing, cleaning, packing, and sterilization, followed by storage and distribution to internal and external departments. Plans to expand and open service to the Center of Excellence continue, which will result in a rapid increase in the processing of specialized medical devices. The Center of Excellence is a source of education, learning, teaching, and practice in the cleaning, disposal, and sterile treatment of medical devices. We sought to improve the quality of sterile medical equipment to satisfy international standards of safety. Methods: We implemented a 7-stage process in the CSSD and we developed a checklist with 8 categories of environmental development based on APSIC guidelines. We provided knowledge to CSSD employees, developed their skills, and promoted attitudes in various areas, including sterile work standards, the use of sterilization machines, and infection prevention and control both inside and outside the facility. Results: We established inventory control systems, storage guidelines, and disbursement of medical supplies and equipment in the CSSD. To improve machine use in sterilization treatment or disposal, we educated staff and provided practice of machine skills according to instructions for use. Information technology (IT) was used for the distribution process, medical device identification, recording sterilization, and statistical logging of sterilization and sterile services. Conclusions: Overall, we improved the quality of CSSD services and knowledge and practice of CSSD staff, and we achieved compliance with international standards. These measures ensure the safety of service providers and patients and build trust in the quality of CSSD services and output.

SG-APSIC1127: Digital transformation of the central sterile supply department: Justify by tracking system

Background: Avoidable infections in healthcare (healthcare-associated infections or HAIs) occur globally. The causes of HAI are influenced by a complex combination of gaps in policies, infrastructure, organization, knowledge, healthcare worker behavior, and patient-related factors. Through knowledge, best practices, and infrastructure improvement, the infection prevention and control (IPC) team aims to prevent harm to patients and healthcare workers due to HAIs. The most common HAIs are surgical site infections (SSIs) caused by harmful device-reuse practices, inadequate sterilization, and/or inadequate decontamination procedures. Disinfection and sterilization of instruments and medical devices play very important roles in HAI and SSI prevention. World Health Organization (WHO) Collaborating Centre in Quality Improvement Program certification, the first pilot project in Thailand, included the Central Sterilizing Services Association of Thailand and 15 hospital central sterile supply departments (CSSDs). This quality improvement program for sterilization reprocessing aimed to prevent harm to patients and healthcare workers due to HAIs. Objectives: We sought to reduce damage to instruments caused by inadequate reprocessing sterilization to zero incidents. We sought to reduce inadequate packing to ≤3 events per month. We sought to reduce the need to resterilize instruments by >80%. Methods: A root-cause analysis meeting was held by CSSD staff, and an IT vendor was consulted about developing an electronic alert system. The following changes were implemented: Staff packed instruments using a list of pictures for each set. Sticker labels were applied showing the proper number of pieces in the set. Identification O-rings were added to instruments with inventory dates, serial numbers, and instructions for use. Stickers were added to indicate the method of sterilization, such as ethylene oxide gas only or hydrogen peroxide only. Results: Reports of damage due to the sterilization process decreased to zero. No events related to the packing process were reported, and resterilization of instruments decreased by 98.94%. Conclusions: In this project, we implemented a quality improvement process and tracking system, reduced defects, and increased healthcare worker competency to improve patient safety.

Transcatheter Edge-to-Edge Repair in Patients With Anatomically Complex Degenerative Mitral Regurgitation

BackgroundMitral valve transcatheter edge-to-edge repair is safe and effective in treating degenerative mitral regurgitation (DMR) patients at prohibitive surgical risk, but outcomes in complex mitral valve anatomy patients vary. ObjectivesThe PASCAL IID registry assessed safety, echocardiographic, and clinical outcomes with the PASCAL system in prohibitive risk patients with significant symptomatic DMR and complex mitral valve anatomy. MethodsPatients in the prospective, multicenter, single-arm registry had 3+ or 4+ DMR, were at prohibitive surgical risk, presented with complex anatomic features based on the MitraClip instructions for use, and were deemed suitable for the PASCAL system by a central screening committee. Enrolled patients were treated with the PASCAL system. Safety, effectiveness, and functional and quality-of-life outcomes were assessed. Study oversight also included an echocardiographic core laboratory and clinical events committee. ResultsThe study enrolled 98 patients (37.2% ≥2 independent significant jets, 15.0% severe bileaflet/multi scallop prolapse, 13.3% mitral valve orifice area <4.0 cm2, and 10.6% large flail gap and/or large flail width). The implant success rate was 92.9%. The 30-day composite major adverse event rate was 11.2%. At 6 months, 92.4% patients achieved MR ≤2+ and 56.1% achieved MR ≤1+ (P < 0.001 vs baseline). The Kaplan-Meier estimates for survival, freedom from major adverse events, and heart failure hospitalization at 6 months were 93.7%, 85.6%, and 92.6%, respectively. Patients experienced significant symptomatic improvement compared with baseline (P < 0.001). ConclusionsThe outcomes of the PASCAL IID registry establish the PASCAL system as a useful therapy for prohibitive surgical risk DMR patients with complex mitral valve anatomy. (PASCAL IID Registry within the Edwards PASCAL TrAnScatheter Valve RePair System Pivotal Clinical Trial [CLASP IID] NCT03706833)

An evaluation of the effect of haemolysis on the Roche lactate dehydrogenase assay

Elevated lactate dehydrogenase is an important indicator of liver disease, however, it also increases in in vitro haemolysis, causing significant interference. The Roche Lactate Dehydrogenase (LDH) assay instructions for use indicate a cut off of 15 mg/dL for haemolysis, which excluded 1060 results in our laboratory in 2021.

Additional Aortic Coverage With an Off The Shelf, Multibranched Endograft Compared With Custom Made Devices For Endovascular Repair of Pararenal Abdominal Aortic Aneurysms

Pararenal abdominal aortic aneurysms (p-AAA) require complex endovascular aortic repair or open surgical repair with suprarenal clamping. Custom made devices (CMD), including fenestrated/branched endovascular aortic repair (F/B-EVAR) or off the shelf (OTS) multibranched devices, are available treatment options. The aim of this study is to determine the additional healthy aortic coverage using an OTS multibranched endograft versus CMD for the treatment of p-AAAs. This was a retrospective single centre analysis of prospectively collected data. Consecutive patients with p-AAAs requiring a proximal landing zone above the coeliac artery (CA), planned and treated with CMDs (Zenith Fenestrated) between January 2017 and December 2021 were included in this study. Treatment with supracoeliac coverage using available OTS multibranched devices was simulated using available pre-operative images: T-Branch; E-nside; and TAMBE. Study endpoints included the need for additional proximal aortic coverage, and the number of the segmental arteries additionally covered from the CA for OTS devices compared with CMDs. Eighty three patients with p-AAAs were treated with CMDs (all FEVAR), including juxtarenal AAAs (n = 46; 56%), suprarenal AAAs (n = 20; 24%), and short neck AAAs (n = 17; 20%). In this study, treatment with 249 (3 × 83) OTS endografts was simulated. When compared with CMDs, OTS devices required a mean of 74 ± 19 mm of additional proximal healthy aortic coverage from the CA (CMD: 33 ± 19 mm vs. OTS: 108 ± 6 mm; p ≤ .001), as well as an average sacrifice of 2.5 additional segmental arteries (CMD: 1.3 ± 0.8 vs. OTS: 3.8 ± 0.9; p ≤ .001). In 94% of patients, at least one of the available multibranched endografts could have been implanted in accordance with instructions for use. Despite not requiring customisation time, OTS endografts for the treatment of p-AAA lead to a more extensive healthy aortic coverage, as well as an average sacrifice of 2.5 additional segmental arteries, in comparison with CMDs. When compared with OTS devices, CMDs appear to limit the extent of unnecessary aortic coverage and the theoretical subsequent risk of spinal cord ischaemia.

Zeroing a Transducer on an External Ventricular Drain.

BACKGROUND: External ventricular drains (EVDs) are commonly used in severely brain-injured patients to diagnose intracranial hypertension. The accuracy of the intracranial pressure reading is dependent on zeroing the external transducer to air. Recent concern about zeroing techniques has been identified in the neuroscience community. The open method requires removing the nonvented cap, and the closed method requires zeroing through the filter at the top of the burette. This critical appraisal seeks to explore whether zeroing a transducer on an EVD through the filter of the burette provides the same baseline zero as opening the transducer to air. METHODS: Independent searches in CINAHL, PubMed, and Web of Science were conducted using "external ventricular drain* OR EVD AND transducer"; secondary search terms included "zero AND transducer" AND "ventric." RESULTS: Database search produced 1 single observation study and 2 clinical practice guidelines from neuroscience professional organizations. The single observation study provided no evidence of equivalence between the 2 zeroing methods; the 2 clinical practice guidelines reference the open method. The transducer manufacturer's instructions for use direct the clinician to open the transducer to air by removing the nonvented cap. CONCLUSION: The question "Does zeroing the transducer on an EVD through the filter of the burette provide the same baseline zero as opening the transducer to air?" cannot be answered with the results of this appraisal. However, evidence found in the literature does suggest an open method to ensure the most accurate physiological value for treatment decisions.

Which caval diameter? Clarification manufacturer's instructions for inferior vena cava filter use and implications for practice

To clarify manufacturer's instructions for inferior vena cava (IVC) filter use and implications for practice. Three vendors of IVC filters were contacted for clarification, with all stating that caval diameter limits are to be true maximum and true minimum cross-sectional diameters. To determine the implications of this, measurements were performed on 302 abdominal computed tomography studies in four transaxial dimensions perpendicular to the long axis including true maximum and minimum diameters, and measurements reflecting those typically taken on fluoroscopic cavography. Based on the true maximum and true minimum caval diameter limits as clarified by vendors, 22% of patients who would typically be considered suitable for IVC filter insertion based on frontal and lateral fluoroscopic cavography would be contraindicated, and 40% of patients who would typically be considered suitable for IVC filter insertion based on only frontal fluoroscopic cavography (as lateral projection is often not performed) would be contraindicated. There is a marked discordance between the vendor-clarified caval diameter limits of three common IVC filter devices and real-world caval geometry. Given the rarity of complications, this suggests a pressing need for revision of manufacturers' instructions for use statements to better reflect current safe routine clinical use, particularly from a medicolegal perspective.

Endurant Stent Graft in Patients with Challenging Neck Anatomy “One Step Outside Instructions for Use”: Early and Midterm Results from the EAGLE Registry

The aim of the Endurant for Challenging Anatomy: Global Experience (EAGLE) registry is to evaluate prospectively the technical and clinical success rate of a stentgraft used in patients with challenging neck anatomy outside the instructions for use (IFU) but within objective anatomical limits.

Pengembangan Modul Berbentuk Scrapbook pada Materi Sistem Saraf untuk Meningkatkan Hasil Belajar Siswa SMA Kelas XI

Nervous system material has a broad scope and is abstract, causing students to have difficulty understanding. One effort that can be made to improve student learning outcomes is to develop learning modules. This research is development research according to Borg and Gall to create a scrapbook module on the nervous system material. The products developed are focused on improving student learning outcomes with data collection procedures including appropriateness tests by material experts and media experts, practicality tests by teachers, and readability tests by students using assessment questionnaires. Items tested include the presentation of the material, conformity with student character, instructions for use, module quality, concept correctness, and student responses. The product validation data obtained is converted to obtain the eligibility category according to Widiyoko. The results of the due diligence by material experts obtained X = 3.8 in the good category, and the due diligence by media experts obtained X = 4.2 in the very good category. While the results of the practicality assessment by the biology teacher obtained X = 4.4 with a very good category and the assessment by students obtained X = 4.3 with a very good category. Based on the results of the feasibility and practicality assessments that were analyzed the scrapbook module was feasible and ready to be used in learning biology specifically on the nervous system material because it met the development requirements

AIUM Official Statement: Guidelines for Cleaning and Preparing External- and Internal-Use Ultrasound Transducers and Equipment Between Patients as Well as Safe Handling and Use of Ultrasound Coupling Gel.

AIUM Official Statement: Guidelines for Cleaning and Preparing External- and Internal-Use Ultrasound Transducers and Equipment Between Patients as Well as Safe Handling and Use of Ultrasound Coupling Gel.

Off-label use of an iliac branch device and a reversed iliac limb for a patient with a unilateral common iliac artery aneurysm and a narrow distal aorta: A case report.

Current bifurcated aortic endografts are unsuitable for patients with a narrow distal aorta except AFX2, which is unavailable in South Korea. An iliac branch device (IBD) was introduced to exclude iliac aneurysms while preserving the pelvic circulation. With advancements in endovascular techniques, various attempts for outside instructions for use have been reported to be practicable in certain patients. A 58-year-old man was referred to our emergency room with an incidentally found left common iliac artery aneurysm (CIAA) in a general checkup. Computed tomography angiogram showed a narrow distal aorta that tapered from 20 mm just below the renal artery to 13 mm at aortic bifurcation and a left isolated CIAA with a maximal diameter of 40 mm and 70 mm in length. After left hypogastric artery embolization, the Cook IBD was placed at the aortic bifurcation, and the Bard Covera Plus stent-graft was deployed from the IBD cuff to the left external iliac artery. Then, a reversed Medtronic Endurant iliac limb was implanted into the infrarenal aorta down to the proximal IBD. The stent grafts were patent without endoleak at the 6-month follow-up. In selected patients with an isolated CIAA with a narrow distal aorta, IBD can be used as a main body at the aortic bifurcation for successful aneurysm exclusion. However, considering the application of outside instructions for use, special attention and careful planning must be taken before the procedure.

Older adults' needs and requirements for a comprehensive exergame-based telerehabilitation system: A focus group study.

Telerehabilitation in older adults using information and communication technologies (ICTs) provides therapy, which is potentially equally effective as traditional rehabilitation, yet more accessible. This study aimed to analyze the needs and requirements of older adults (OA) and healthcare-professionals (HP) toward ICTs and telerehabilitation in general as well as toward a specific novel exergame-based telerehabilitation system (COCARE system, Dividat). The COCARE telerehabilitation system enables individual training based on exergames, as well as an assessment system and a digital centralized case management. Six focus groups with in total 34 participants were conducted. A mixed-methods approach was used comprising questionnaires and semi-structured interviews. Both OA and HP would engage to an exergame-based telerehabilitation program. Major motivating factors are the relevance of such a training for health and the entertainment component of exergames. Main requirements are simplification of the system, variety, a personalized training, a constantly available contact person, and comprehensive instructions for use. Besides, HP praised the system's motivational effect, but remained concerned about risk of falls and social isolation. ICTs for telerehabilitation are accepted by OA and HP but should be adapted hardware- and software-wise to address OA' age-stemming vulnerabilities (e.g., risk of falls) and low ICT literacy.

Description the completeness of prescriptions for inpatients at the Pharmacy Installation HKBP Balige General Hospital period of July 2020

Prescription is a written request from a doctor to a pharmacist to provide drugs for patients written in the prescription. For in accordance with applicable laws and regulations to minimize irrational use of drugs and preventmedication errors for patient safety purposes. The purpose of this study was to describe Description the completeness of prescriptions for inpatients at the Pharmacy Installation HKBP Balige General Hospital period of July 2020. The design of this study was descriptive, with a sample of 186 prescriptions, using a cluster random sampling technique. The results showed that 46.2% of prescriptions at the Balige HKBP RSU for the July 2020 period were complete and 53.8% incomplete. Of the total 186 prescription sheets, the information on the doctor's name (27.4%), the doctor's initial (5.9%), the patient's name (0.5%), the patient's address (36.6%), the instructions for use (10,2%). This shows that the completeness of the recipe at RSU HKBP Balige is not complete. Incomplete prescriptions occur because many visiting patients increase the busyness of the prescriber, so doctors do not have time to write a complete prescription. It is recommended to the management of RSU HKBP Balige to put more emphasis on doctors to complete prescriptions, so that TTK does not find incomplete prescriptions anymore.

Development of Word Root-Based Digital Dictionary for Shorof Mastery

The goal of this research was to explain how to develop a word root-based digital dictionary for shorof mastery to make it easier for language learners in recognizing word root and meaning in the use of dictionaries as well as to find meaning of each or some vocabularies in the text. The research method used in this study was Research and Development, using the ADDIE model which includes five stages, namely (1) analysis, (2) design, (3) development, (4) implementation, and (5) evaluation. The subjects were college students and students of Al-Khoirot Islamic Boarding School Malang. The data collection techniques were observation, interview, and questionnaire. This development research data analysis technique used two data analysis techniques, namely qualitative descriptive analysis and quantitative descriptive analysis. The qualitative data is in the form of data identification, data grouping, data presentation and explanation, and conclusion. While the quantitative data is a percentage analysis technique in analyzing quantitative data. The results of this development were in the form of a word root-based digital dictionary for shorof mastery that has six displays, which are preface, instructions for use, dictionary, exercises, references, and developers. The assessment by students and college students reached an average score of 94.7% which is valid category. Hence, it can be concluded that this digital dictionary is feasible to use at any time in learning Arabic and students are able to learn independently wherever they are.

Cleaning Challenges: Can Extended Soil Dry Times Be Reversed?

Background: Cleaning is essential to ensuring the safe processing of reusable medical devices, and most manufacturers' instructions for use (IFUs) specify that clinical soil should not be allowed to dry on devices. If soil is allowed to dry, the cleaning challenge could be increased due to change in soil solubility. As a result, an additional step could be needed to reverse the chemical changes and return a device to a state where cleaning instructions are appropriate. Methods: Using a solubility test method and surrogate medical devices, the experiment described in this article challenged eight remediation conditions to which a reusable medical device might be exposed if soil is dried on a device. These conditions included soaking with water or neutral pH, enzymatic, or alkaline detergent cleaning agents, as well as conditioning with an enzymatic humectant foam spray. Results: The results demonstrated that only the alkaline cleaning agent was able to solubilize the extensively dried soil as effectively as the control, with a 15-minute soak being as effective as a 60-minute soak. Discussion: Although opinions vary, the overall data demonstrating the risk and chemical changes that occur when soil dries on medical devices are limited. Further, in cases in which soil is allowed to dry on devices for an extended time outside of the guidance from leading practices and manufacturers' IFUs, what additional steps or processes may be necessary to ensure that cleaning can be effective? Conclusion: This experiment demonstrated the effectiveness of a soaking step with an alkaline cleaning agent as an additional step if soil is dried on reusable medical devices, thus reversing the effect of an extended soil dry time.

Endovascular aneurysm repair using the Gore Excluder Conformable Abdominal Aortic Aneurysm Endoprosthesis with active control system in octogenarians with highly angulated aneurysm neck: a UK single-centre experience

Objective: Abdominal aortic aneurysm (AAA) with highly angulated neck (&gt;60°) in octogenarians represents a challenge to treatment with endovascular aneurysm repair (EVAR). In such cases, EVAR may be used outside the manufacturer’s Instructions for Use and attendant higher risk of failure. The new device Gore Excluder Conformable AAA Endoprosthesis with active control (CEXC) system has been designed to achieve optimal aortic wall apposition and seal in these more challenging geometries. This study reports the initial results and technical success of this device in octogenarians with highly angulated aneurysm necks (&gt;60°). Methods: All patients aged &gt;80 years who had AAAs treated with the CEXC device at a single UK centre between January 2020 and July 2023 were analysed. The primary endpoint was technical success, which was defined as successful introduction and deployment of the device in the absence of surgical conversion or mortality, type I or III endoleaks or graft limb obstruction. The secondary outcomes included 30-day morbidity, mortality, endoleak and re-intervention rates. Results: Twenty patients were included (17 (75%) males) of median age 81 (range 80–84) years. The median AAA diameter was 60 (57–63) mm and the median infrarenal neck angulation was 80 (70–89)°. The active control system was used in six cases. The median procedural time was 277 (254–316) minutes. The immediate technical success rate was 95%, with one type Ia endoleak (5%). In the 30-day postoperative period, four complications were reported. On the 30-day follow-up CT scan, five type II endoleaks were observed and one initial type Ia endoleak had persisted at 30 days. No re-intervention was required during the first 30-day postoperative period. One hospital death occurred during the coronavirus disease 2019 pandemic; however, the death was unrelated to the surgery. Conclusions: EVAR with the CEXC device in octogenarians with hostile aortic neck anatomy is feasible inside the Instructions for Use, and shows satisfactory initial results.

Effects of Time, Temperature, and Humidity on Soil Drying on Medical Devices.

In the healthcare environment, delays can occur that prevent reusable devices from being processed within the specified time outlined in manufacturers' instructions for use. It has been suggested in the literature and industry standards that residual soil components, such as proteins, may undergo a chemical change when they are exposed to heat or experience prolonged drying times under ambient conditions. However, little experimental data are available in the literature to document this change or how is may be addressed for cleaning efficacy. This study presents the effects of time and environmental conditions on contaminated instrumentation from the point of use until the cleaning process begins. It demonstrates that soil drying after a period of eight hours changes the solubility of the soil complex, with a significant change occurring after 72 hours. Temperature also contributes to chemical changes in protein. Although no significant difference occurred between 4°C and 22°C, temperatures greater than 22°C demonstrated a decrease in soil solubility in water. An increase in humidity prevented the soil from completely drying and prevented the chemical changes affecting solubility from occurring.

Requirements for human mesenchymal stem cell‐derived small extracellular vesicles

Abstract“Requirements for human mesenchymal stem cell‐derived small extracellular vesicles” is the first set of guidelines on human mesenchymal stem cell‐derived small extracellular vesicles (hMSC‐sEVs) in China, jointly drafted and agreed upon by experts from the Chinese Society for Extracellular Vesicles. It was released by the Chinese Research Hospital Association on 28 December 2021 and came into effect on 1 January 2022. This standard specifies the technical requirements, test methods and regulations, packaging, instructions for use, labeling, storage, transportation, and waste handling for hMSC‐sEVs, which apply to the production and quality control of hMSC‐sEVs. We hope that the publication of these guidelines will promote consensus on the research and application of human mesenchymal stem cell‐derived small extracellular vesicles and accelerate its international standardization.