Single-use Medical Devices Research Articles

SURFACE CHARACTERIZATION OF REPROCESSED SINGLE-USE MEDICAL CATHETERS BY FRACTAL MASS DIMENSION

Reprocessing of single-use medical devices is an issue of concern and discussion due to infection risk and operation failure. Cleaning procedures and sterilization processes can produce structural changes and relevant topographical alteration of the biomedical device surfaces which may activate mechanisms able to cause unwanted biological response. Atomic Force Microscopy analysis (AFM) to measure Poly(vinyl chloride) (PVC) catheters surface roughness variation along successive sterilization cycles was applied. In this work, the relation between the number of reprocessing cycles and the fractal mass dimension of reprocessed catheter surface microscopic images is studied.

Single-use devices (SUDs): How often are they reused in sterile sites in Australia?

The objectives of the study were threefold: to determine in Australian hospitals the extent that medical devices are reused in sterile sites when labelled ’single use only’, to assess the adequacy of cleaning and sterilising procedures before reuse and to estimate the possible incidence of cross-infection if these devices are reused. The setting consisted of all Australian hospitals with more than 45 beds and undertaking medical and surgical procedures (461 hospitals). A self-administered questionnaire survey was used to collect results. Questionnaires were sent to hospital infection control practitioners in 2001 requesting information about reuse in sterile sites of single-use medical devices (SUDs), the extent of reuse, the cleaning and sterilising processes involved, and the reasons for reuse.Responses were received from 189 hospitals (41%). Reuse occurred in 28 (15%) either at the time of the survey or within the previous 12 months (CI=10-21%). More reuse occurred in the larger hospitals (50% if >300 beds) than in smaller hospitals (13% if 100-300 beds). Diathermy pencils, even though relatively inexpensive, were the most frequently reused devices (10 hospitals). The main reason given for reuse was cost saving. No cross infections were reported.Reuse of medical devices labelled ’single use only’ and used in sterile sites remains common in Australian hospitals but this use has decreased since 1994 (a fall of reuse from 68% to 15%). Most devices appear to be unsuitable for reuse. There are now many studies that show these devices cannot be adequately cleaned and/or sterilised. We strongly advise against further reuse of these items.

The Food and Drug Administration and Reprocessing of Single-Use Medical Devices: A Revised Policy and New Questions

THE past three decades have seen an explosion in the use of single-use medical devices, stemming from a desire to improve product performance and minimize the potential for disease transmission, and enabled by advances in fabrication techniques. Conversely, single-use devices are typically more expensive on a per-use basis, which has led to renewed interest in at least limited reprocessing and reuse of these devices. The U.S. Food and Drug Administration (FDA) has long been aware of device reuse and has traditionally held reprocessors of single-use devices to fewer regulatory requirements than original equipment manufacturers.

Reprocessing Single-use Medical Devices

Health care providers today often can choose between reprocessed single-use devices (SUDs) or SUDs from original equipment manufacturers. The concern about whether reprocessing is safe and should continue was reflected in the US Food and Drug Administration's draft regulations regarding reprocessing and reuse of SUDs; the Government Accounting Office study on SUDs; legislation introduced at both the federal and state levels; and Congressional hearings by the US House of Representatives and the US Senate. This article offers a review of these activities.

The risks of reuse: legal implications for hospitals of reusing single-use medical devices.

There is no doubt that the practice of reuse in hospitals is a reaction to the budgetary constraints under which hospitals are operating. However, the costs of appropriately monitoring and sterilizing reused equipment as well as the significant risk of patient harm and potential liability raise the unavoidable question of whether this practice is an advisable one. These costs and risk should be carefully examined before a decision about whether to reuse single-use devices is made.

Contribution méthodologique aux pratiques de matériovigilance en transfusion sanguine

To reduce seriousness and frequency of iatriogenic risk implies prevention policies and efficient operational systems for vigilance. This risk management implies definition of precise organizations and procedures able to locate and to notify quickly undesirable events. This is the case about single use medical devices (SUMD) used in blood transfusion. This article is a contribution to the organisation of the implemented material vigilance in blood transfusion, collectively carried out with actors concerned (users, manufacturers, National Commission for Material Vigilance). It presents a lot of tools and methods to favour practices harmonization, as well as preventive a curative (specifications before purchase, main part of the quality contract between customer and supplier; internal control plan; index for medical device used in transfusion; illustrated glossaries for three main families of medical devices; index about symptomatic events; definitions of seriousness levels with their operational consequences; methods to manage a single use medical device judged as defective; tool for the review of incidents according to reference and batch). Then, the management of incidents about SUMD is presented within a material vigilance system integrated into the quality system of the institution, for user as for manufacturer. This is done in a chronological order with successively description of the incident, the assessment of the impact, the management of the associated risk, the periodical review of incidents and management of matters in dispute.

GAO Issues Report on Reuse of Single-Use Medical Devices

GAO Issues Report on Reuse of Single-Use Medical Devices

Microbiological, microstructure, and material science examinations of reprocessed Combitubes after multiple reuse.

Reprocessing (repeated cleaning, disinfection, and sterilization) and reuse of single-use medical devices has been performed safely with some devices. The aim of our study was to analyze whether reprocessing of the Combitubes (Kendall-Sheridan, Argyll, NY) airway device, used for emergency endotracheal intubation and difficult airway management, is possible and can be performed appropriately and safely. Microbiological, microstructure, and material science examinations were performed with unused, as well as multiple reused and reprocessed Combitubes. The reprocessing procedure consisted of a cleaning, a disinfection, a final inspection, and a sterilization. Microbiological examinations of multiple reused and reprocessed Combitubes found no test organisms in quantitative cultures. A microbial reduction between four and five log levels compared with nonreprocessed tubes was found. Microstructure analysis for the examination of topographical alterations and changes in the chemical composition of the surface demonstrated nonsignificant alterations between new and reprocessed medical devices. In material science examinations, cuff burst pressures were not different between unused and multiple reprocessed Combitubes. The results of all examinations proved that the decontamination process is adequately effective, and that no significant superficial alterations are generated by the multiple reuse and reprocessing of the Combitubes. To assure uniformly good results, a quality management system must be established and only validated methods should be used. Reprocessing of single-use medical devices offers the opportunity of significant savings and is already performed with some devices. Microbiological, microstructure, and material science examinations proved that reprocessing of multiple reused Combitubes (Kendall-Sheridan, Argyll, NY), mainly used for emergency airway management, is possible and safe.

Risk management issues in the reuse of single-use medical devices

The future of the practice of reusing single-use medical devices is currently uncertain because the U.S. Food and Drug Administration is poised to promulgate regulations on the subject. This article deals with the risk issues associated with contracting with an external vendor to perform this function under current FDA regulations and provides guidance for minimizing these risks.

U.S. Senate Sets Aside Fund to Track Reprocessed Single-Use Medical Devices

U.S. Senate Sets Aside Fund to Track Reprocessed Single-Use Medical Devices

The dilemma over reprocessing single-use medical devices.

Making informed decisions about the reuse of single-use medical devices requires considerable analysis, study and management buy-in. This article addresses such issues as the prevalence of the practice, the changing standards and guidelines, institutional responsibilities, risk and insurance concerns and the ethical issues posed by the concept of reuse.

Technical and economic feasibility of reusing disposable perfusion cannulas

Objective(s): The reuse of disposable devices is a potential source of significant cost savings to hospitals. Venous and arterial perfusion cannulas under new and reused conditions were selected to identify the clinical, safety, technical, logistic, and economic issues that must be addressed to realize these savings. Methods: Single- and dual-stage venous and arterial cannulas from two manufacturers were tested when new, after initial clinical use, and after a single clinical use plus up to nine simulated reuses. Reuse was simulated by end-to-end bending, coupling and uncoupling of the connectors, and by two 1-hour soaks in plasma at 4° and 40° C, respectively. Cannulas were decontaminated and then processed by a peracetic acid-based liquid chemical sterilization system after each use/reuse. Sterilization was validated by eliminating Bacillus subtilis spores from the cannulas on each of five consecutive cycles. Cannulas were tested for physical changes, functional integrity, biocompatibility, and in vivo performance in sheep. A cost analysis was also performed. Results: Sterilization was successfully achieved. Mechanical changes were less than 20% on all variables studied and were undetectable by experienced cardiac surgeons in selective evaluation. No clinically important differences were found between new and reused cannulas, even after nine simulated reuses. Reusing cannulas four times would reduce the cost per procedure from $53 to $19 (64%). Conclusions: Preliminary data suggest that the perfusion cannulas tested can be safely and efficaciously used five times. Limited reuse of these disposable cannulas is technically feasible and cost-effective. Cannula reuse would result in a small incremental savings; however, with more expensive devices and higher-volume sterilization procedures, the savings could be considerably greater. This program provides a model for evaluation of other single-use medical devices for reuse. (J Thorac Cardiovasc Surg 1997;114:448-60)

OR expansions; reuse of single-use medical devices; universal, standard, and transmission-based precautions

OR expansions; reuse of single-use medical devices; universal, standard, and transmission-based precautions

Biologic test indicators; classification of medical devices; scope disinfection; reused single-use medical devices

Biologic test indicators; classification of medical devices; scope disinfection; reused single-use medical devices

Reuse in sterile sites of single-use medical devices: how common is this in Australia?

To determine to what extent Australian hospitals reuse in sterile sites medical devices labelled "single use only"; to assess the adequacy of cleaning and sterilising procedures before reuse; and to estimate the possible incidence of cross-infection and the costs of not reusing these devices. A self-administered questionnaire survey. All Australian hospitals (419) with more than 45 beds and undertaking medical and surgical procedures. Questionnaires were sent to hospital infection control practitioners in 1994 requesting information about reuse in sterile sites of single-use medical devices, the extent of reuse, the cleaning and sterilising processes involved, and the reasons for reuse. Responses were received from 168 hospitals (40%). Reuse occurred in 64 (38%), and another 33 hospitals had been reusing medical devices 12 months before our survey (i.e., 97/168 hospitals [58%] were either reusing them at the time of our survey or had been doing so 12 months previously). More large (> 300 beds) metropolitan public hospitals (9/14; 64%) reported reusing than did smaller (50/143; 41%) or private hospitals (15/47; 32%). At six of the 64 hospitals where reuse occurred, the process of cleaning and/or sterilization of these devices was not satisfactory; from the information we received, both cleaning and sterilization were satisfactory in only 38 hospitals (59%). Examination of the 14 most commonly reuse devices showed that the structure of 13 of these may compromise cleaning (and therefore sterilization). The main reason given for reuse was cost saving. Assuming a 2% prevalence of transmissible infections in blood, and an infection transmission risk of 1/500, we estimate that each year in Australia there may be 40 cases of cross-infection for every one million procedures performed with reused devices (0.004%). Reuse of medical devices labelled "single use only" is common in Australian hospitals. Most devices appear to be unsuitable for reuse. Complete cessation of this practice of reusing single-use medical devices would stop potential cross-infection, but this would cost and estimated $2.5 million or more per case prevented

Infection control brief: dilemma of the decade – re-use of single-use medical devices

Marilyn Leaver RNBNCIC(USA) is Infection Control Consultant at Wakefield Hospital in Adelaide, South Australia. Originally, hospital sterile supply departments were established to provide sterile instruments for surgery. These instruments were relatively simple in construction and sterilised by steam under pressure in autoclaves. Since the advent of ethylene oxide gas, which permits sterilisation of a wide range of heat-labile equipment, pressure has been placed upon sterile supply departments to reprocess for re-use a variety of plastic and other products originally designated by manufacturers as for single use only.

The installation for the single-use medical devices sterilization based on the electron accelerator type ILU.

The possibility of the single-use syringes sterilization inside the standard production packs was tested using the accelerator type ILU-6 with the energy up to 2.5 MeV and the electron beam power up to 20 KW. The syringes were placed vertically (along the beam direction), and the irradiation was made from two sides. The dosimetry measurements were provided using the film dosimeters and the special bacterial cultures. The results show that the dose ununiformity inside the volume of the syringes does not exceeds ±15%. The practical results of these investigations are two installations for the single-use syringes sterilization with the productive rate of 100,000 units per hour. These installations are now under construction. The equipment layout variant and some economical are now of the process are given. The usage of the compact accelerator with the energy up to 5 MeV and the beam power up to 20kW is regarded for the sterilization of the wide scope of the medical devices as another variant.

Recycled RRIM in sandwich panels

Single-use medical devices have been under close scrutiny for several years, especially the choice of plastic materials. Many different requirements such as medical safety, treatment functionality and efficiency, environmental performance, etc. have to be fulfilled. Today, the most commonly used materials for hydrophilic urinary catheters are polyvinylchloride (PVC) and thermoplastic polyurethane (TPU). In this research study, these two materials' environmental performance was evaluated. In light of the knowledge gained in that study a new plastic material for use in urinary catheters was developed. The aim of the development of this new material was to design a high performance material with superior environmental performance. The newly developed plastic material is a polyolefin-based elastomer. The ecological environmental performance of the new material was evaluated and compared to the existing plastic materials. The study focused exclusively on the choice of plastic materials and their ecological environmental performance.The analysis has been performed using a system perspective and a life cycle assessment (LCA) methodology. The functional unit has been set to the treatment of one patient during one year. The results from the LCA models have been presented both in terms of direct inventory data, such as energy use and formed emissions, and in terms of the results from four different impact assessment methods. Analysis of the results based on direct inventory data, i.e. common inventory results such as energy resource uses and emissions of CO2, NOx and SO2 show an overall better environmental performance for the new polyolefin-based elastomer compared to the existing PVC and TPU plastic materials. The normalization and weighting steps in the analyzes have indicated the importance of energy resource uses and global warming as indicator for the environmental performance even if other impact categories also can play a role. In the environmental impact assessment, the polyolefin-based elastomer showed a clearly better environmental performance than the TPU material. Compared to PVC plastic material the new polyolefin-based elastomer showed an almost equivalent environmental performance. This can be mainly explained by the different materials' energy use. The new material has thus also shown to be an environmentally good alternative to PVC if a PVC-free material is requested. Basing the plastic formula, on simple bulk plastics with low energy use in the production of single-use medical devices, has been shown to be a successful method of producing high quality products with superior environmental performance.