Under the precondition of ensuring safety and effectiveness, whether to reuse reprocessed medical devices to reduce the medical expenses has become the focus of the relevant regulatory authorities in our country. In this paper, we studied the regulatory policy for reprocessed medical devices in major international economies, such as United States, Japan, European Union and so on. From the regulatory and technical level, we thought about the risks of supervising reprocessed medical devices, and analyzed the ideas and risk concerns of supervising reprocessed medical devices to provide reference for regulation of such devices in our country.
Equipment Reuse ; Equipment Safety ; United States

Some single-use medical devices are reprocessed and reused in some countries in the world, but the regulatory approach is different, and in some countries it isn't regulated yet. In this article, the regulatory status quo of single-use medical devices is reviewed. The regulatory development, important regulatory documents and regulatory approaches of single-use medical device reprocessing in the United States, Germany and the UK are introduced. And how to perform scientific risk assessment and effective risk control is discussed. The information is useful to establish China-specific regulations, and to develop relevant standards, guidelines or specifications and the risk control strategies.
China ; Equipment Reuse ; Equipment Safety ; Equipment and Supplies ; Risk Assessment ; United States

Adult ; Catheters, Indwelling ; Equipment Failure ; Equipment Reuse ; Female ; Humans ; Peritoneal Cavity ; Peritoneal Dialysis, Continuous Ambulatory ; instrumentation

It has become a common consensus that resource conservation and intensive recycling for improving resource utilization efficiency is an important way to achieve carbon peak and carbon neutrality(dual carbon). Traditonal Chinese medicine(TCM)resources as national strategic resources are the material basis and fundamental guarantee for the development of TCM industry and health services. However, the rapid growth of China's TCM industry and the continuous expansion and extension of the industrial chain have exposed the low efficiency of TCM resources. Resource waste and environmental pollution caused by the treatment and discharge of TCM waste have emerged as major problems faced by the development of the industry, which has aroused wide concern. Considering the dual carbon goals, this paper expounds the role and potential of TCM resource recycling and circular economy industry development. Taking the typical model of TCM resource recycling as the case of circular economy industry in reducing carbon source and increasing carbon sink, this paper puts forward the suggestions for the TCM circular economy industry serving the double carbon goals. The suggestions mainly include strengthening the policy and strategic leading role of the double carbon goals, building an objective evaluation system of low-carbon emission reduction in the whole industrial chain of TCM resources, building an industrial demonstration park for the recycling of TCM resources, and promoting the establishment of a circular economy system of the whole industrial chain of TCM resources. These measures are expected to guide the green transformation of TCM resource industry from linear economic model to circular economy model, provide support for improving the utilization efficiency and sustainable development of TCM resources, and facilitate the low-carbon and efficient development of TCM resource industry and the achievement of the double carbon goals.
Medicine, Chinese Traditional ; Equipment Reuse ; Goals ; Environmental Pollution ; Economic Development ; Carbon ; China

A series of studies were reviewed to determine the safety and efficacy of reusing single-use coronary balloon catheters. The coronary balloon catheter is marketed as a single-use device. However, due to its high expense and the demands for containment of health care costs many medical institutions in various countries of the world are cleaning and resterilizing it for reuse. The US FDA does not prohibit reuse, but does place the burden on the physician and hospital to demonstrate that the balloon catheter is properly cleaned and sterilized, retains the physical characteristics of the original, and is safe and effective. The major concerns in the reuse of single-use balloon catheters regard the various potential risks to patients, in comparison with new balloon catheters, such as infection, toxicity, contamination, biologic incompatibility, decreased mechanical performance, device breakage, and poor clinical outcomes. To date, the risks for patients have beenwere considered acceptable as long as the rigorous procedures related to cleaning, sterilization, and quality controls were well established. However, it is considered that further. The large sample sized, randomized, prospective, multicenter, multinational clinical trials need to be conducted to establish a rigorous, well-defined protocol for the validation of cleaning, sterilization, and quality control, in order to guarantee the safer reuse of coronary balloon catheters. Furthermore, the establishment of new, open door, standardized guidelines for the reuse of balloon catheters is urgently needed in Korea.
Angioplasty, Balloon ; Cardiac Catheterization ; Catheters* ; Containment of Biohazards ; Equipment Reuse ; Health Care Costs ; Humans ; Korea ; Quality Control ; Sterilization

Disposable Equipment ; statistics & numerical data ; Equipment Reuse ; statistics & numerical data ; Humans ; Injections ; adverse effects ; statistics & numerical data ; Risk Factors ; Safety ; Surveys and Questionnaires ; Syringes

This is a research project aimed at investigating the clinical efficiency of W-F168-B, a dialyzer reprocessing machine made by Weilisheng Biological Material Company in Chengdu, evaluating its effects on total cell volume (TCV) and dialysis sufficiency, and assessing its disinfection efficacy. All subjects were randomly divided into two groups, whose dialyzers were reprocessed by W-F168-B (made in Chengdu) and RENATRON II (made by MINNTECH Company in the United States) respectively. We detected TCV of the dialyzer before and after reusing and calculated their diversity. We also calculated all subjects' Kt/V. The values of TCV diversities of two groups were 5.5 +/- 4.15 (experimental group) and 4.5 +/- 2.56 (control group) respectively, P > 0.05. The levels of Kt/V of experimental group and control group were 1.25 +/- 0.26 and 1.24 +/- 0.19, P > 0.05. T-test showed that there was no statistically significance difference between the two groups. The result of every hemoculture is negative. In conclusion, these two dialyzer reprocessing machines are similar in the effect of the dialyzer's performance and the subject's dialysis sufficiency. The reused dialyzers reprocessed by these two machines are safe for use.
Adult ; Aged ; Equipment Contamination ; Equipment Reuse ; Evaluation Studies as Topic ; Female ; Humans ; Male ; Middle Aged ; Renal Dialysis ; adverse effects ; instrumentation ; Safety ; Urea ; blood

Selecting reused polysulfone membrane (PSM) dialyzers as research objects, we mainly analyzed quantitatively the adhesion ingredients which obstructed the passage through the membrane, and we investigated the differences of residual contaminants on the surface of PSM in the cases of various reuse times. The results illustrated that after the completion of dialysis, the dialyzer was first cleaned by reverse osmosis (RO) water to remove the protein adsorpted. Then we used 2% sodium hypochlorite (NaClO) solution to soak it, and the glucose, cholesterol and triglyceride adsorpted were dissolved off. Meanwhile, the quantity of most of adsorption gradually increased with the increase of reuse times.
Adsorption ; Adult ; Cholesterol ; analysis ; Equipment Reuse ; Female ; Glucose ; analysis ; Humans ; Male ; Membranes, Artificial ; Middle Aged ; Polymers ; Proteins ; analysis ; Renal Dialysis ; adverse effects ; instrumentation ; Sulfones ; Triglycerides ; analysis

The aim of this study was to systemically analyze the proteins that adsorbed on the surface of hemodialysis membrane. The Fresenius F6 reused polysulfone dialyzers were selected as the research objects. The methodology we used encompassed the digestion of protein in rinsed solution and the separation of peptide mixture in virtue of RP-HPLC followed by ESI-MS/MS identification in orde to get their adsorption behavior, species and characteristics. The results illustrated that, after being rinsed by reverse osmosis (RO) water, 179 species of the protein adsorbed on the hemodialysis membrane, most of which were acidulous and middle or small weight protein molecules. The data from counting the numbers of peptides showed there were 5 species of high-abundant proteins (the contents being above 5% each), namely Ficolin-2 precursor, Complement C3 precursor (Fragment), Mannan-binding lectin serine protease 1 isoform 2 precursor, Complement-activating component of Ra-reactive factor precursor, and Mannan-binding lectin serine protease 1 isoform 3. These proteins are in close relationship with human immune system; moreover, they are of great significance to the clinical mechanism for cleaning reuse hemodialyzers and to the development of new hemodialysis materials.
Adsorption ; Complement C3 ; analysis ; Equipment Reuse ; Humans ; Lectins ; analysis ; Mannose-Binding Protein-Associated Serine Proteases ; analysis ; Membranes, Artificial ; Renal Dialysis ; instrumentation

OBJECTIVE: To establish reuse process of positive pressure powered air-filter protective hoods during coronavirus disease 2019 (COVID-19) epidemic. METHODS: The procedure of pretreatment, storage, recovery, cleaning, disinfection and sterilization process of positive pressure powered air-filter protective hoods, which were used in the treatment of COVID-19 infection patients was established in Central Sterile Supply Department of the hospital. The cleaning and disinfection effects of the protective hoods after treatment were examined by magnifying glass method, residual protein detection method, real-time PCR, and agar pour plate method. RESULTS: Twenty five used protective hoods underwent totally 135 times of washing, disinfecting and sterilizing procedures. After washing, all the protein residue tests and COVID-19 nucleic acid tests showed negative results. After sterilizing, all the protective hoods met sterility requirement. All the tested protective hoods were undamaged after reprocessing. CONCLUSIONS The established reuse procedures for used positive pressure powered air-filter protective hoods are safe.
Air Filters/virology* ; Betacoronavirus ; COVID-19 ; Coronavirus Infections/prevention & control* ; Disinfection/standards* ; Equipment Reuse/standards* ; Pandemics/prevention & control* ; Pneumonia, Viral/prevention & control* ; SARS-CoV-2 ; Sterilization/standards*