Single-use Devices Research Articles

Reprocessing and reuse of single-use medical devices: perceptions and concerns of relevant stakeholders toward current practices.

Research and history have largely shown the covert billion-dollar global market of single-use medical device (SUD) reprocessing and reuse to be a safe endeavor, but awareness and perceptions of the practice both within and outside of healthcare have received limited attention. Responses for patients, physicians, and medical practitioners were attained on both online and article-based surveys, in which attitudes and perceptions of SUD reprocessing and reuse were expressed in an assortment of closed-ended questions and partially closed-ended questions. Of the 214 participants, a collective 77% were unaware that the Food and Drug Administration allows SUD reprocessing and reuse. This included 65% of physicians and 84% of patients, which were significantly different proportions (P = 0.005). A significantly greater proportion of patients than physicians (92 vs. 68%) also felt that hospitals bear the responsibility of informing patients of the practice as part of their care (P < 0.001). There is a profound lack of awareness of SUD reprocessing and reuse among all relevant stakeholders. In addition, the overwhelming desire for transparency among patients further forces the debate of whether current, covert methods should be altered, in addition to the question of who bears this responsibility. Despite research and history having shown the practice to be safe, apprehension and misconceptions remain. Survey results suggest that education may be able to subdue such patient concerns.

ACOG Committee Opinion No. 769: Reprocessed Single-Use Devices.

The reprocessing and reuse of single-use instruments has become increasingly common. Although there are limited data on reprocessed single-use devices, existing studies have found a significant rate of physical defects, performance issues, or improper decontamination. There are currently no data in the medical literature of studies evaluating the cost-effectiveness of reprocessed single-use devices in gynecologic surgery. The use of a reprocessed single-use device provides no direct benefit to an individual patient or her physician. It is the operating surgeon's ethical responsibility to make a good faith effort to know whether reprocessed single-use devices are to be used, and to not use instruments if he or she has concerns about the quality or safety of the instrument(s). Studies on the safety, quality, and cost-effectiveness of reprocessed single-use devices in gynecologic surgery are needed. Physicians should be informed whether the instruments used in surgery are original or reprocessed, and adverse events should be reported to improve the safety information about reprocessed single-use devices. Obstetrician-gynecologists are encouraged to report adverse events and outcomes associated with medical devices to the U.S. Food and Drug Administration's Manufacturer and User Facility Device Experience (MAUDE) database.

ACOG Committee Opinion No. 769 Summary: Reprocessed Single-Use Devices.

The reprocessing and reuse of single-use instruments has become increasingly common. Although there are limited data on reprocessed single-use devices, existing studies have found a significant rate of physical defects, performance issues, or improper decontamination. There are currently no data in the medical literature of studies evaluating the cost-effectiveness of reprocessed single-use devices in gynecologic surgery. The use of a reprocessed single-use device provides no direct benefit to an individual patient or her physician. It is the operating surgeon's ethical responsibility to make a good faith effort to know whether reprocessed single-use devices are to be used, and to not use instruments if he or she has concerns about the quality or safety of the instrument(s). Studies on the safety, quality, and cost-effectiveness of reprocessed single-use devices in gynecologic surgery are needed. Physicians should be informed whether the instruments used in surgery are original or reprocessed, and adverse events should be reported to improve the safety information about reprocessed single-use devices. Obstetrician-gynecologists are encouraged to report adverse events and outcomes associated with medical devices to the U.S. Food and Drug Administration's Manufacturer and User Facility Device Experience (MAUDE) database.

Comparative Efficiency of the Equations of Conditional Distributions for Estimation of the Reliability Factor of Highly Reliable Unmaintainable Single-Use Devices

In this study an estimation of the reliability factors of an unmaintainable single-use device with the probability of failure-free operation of 0.94 and higher with small statistical sample is made. Methods of unification of failure-free test results with prior information are analyzed as the first step of systematization of the initial information [1] in conditions of an insufficient size of the required sample, which is defined for instance in [2]. The issue of comparison of samples for the purpose of unification is considered in [3]. The originality of the results obtained is defined by generalization of the comparative efficiency of the equations of conditional distributions as applied to estimates of the reliability factor in highly reliable unmaintainable single-use devices. Estimation of the reliability of a highly reliable unmaintainable single-use device may be one application area of the results.

Innovative paper-based Al-air batteries as a low-cost and green energy technology for the miniwatt market

This work demonstrates an innovative Al-air battery made of paper, which can inhibit Al corrosion, simplify battery system and reduce electrolyte storage. One major advantage of it is its minimum cost of fabrication. The corrosion inhibition effect originates from the high porosity and tortuosity of paper, which restricts the diffusive transport of hydroxyl ions to the Al surface. In this manner, low-grade Al can be directly utilized. Targeted for different application fields, three battery subtypes are proposed. The mechanically-rechargeable battery can be used repeatedly by refreshing its Al anode, providing relatively high power for charging portable electronics. The flexible battery employs embedded Al inside paper as anode and oxygen reduction ink as cathode, which is suitable for various single-use and flexible devices. Lastly, a printable battery is proposed by developing a successful Al ink for anode fabrication. Combined with existing printing techniques, this design may lead to a much smarter and more economic battery application in the future.

A new second-generation supraglottic airway device (Ambu® AuraGain•) versus intubating laryngeal mask airway as conduits for blind intubation - A prospective, randomised trial.

Background and Aims:The Ambu® AuraGain• is a new single-use supraglottic airway device with gastric channel, designed to facilitate intubation. The study aimed to assess the success rates of proper placement and intubation using Ambu® AuraGain• compared with intubating laryngeal mask airway (ILMA).Methods:One hundred and twenty patients (18–60 years) were enrolled into this prospective, randomised, comparative study. After inducing general anaesthesia, appropriate size ILMA (group I)/Ambu® AuraGain• (group A) was placed as per the manufacturer's recommendations and correct placement was confirmed. Appropriate size endotracheal tube was passed through the device. The success rate of insertion and intubation, number of attempts, Cormack–Lehane grading before insertion and haemodynamics were recorded. Data were analysed using Mantel–Haenszel Chi-square test, Student's t-test and Fisher's exact test.Results:Demographic and airway parameters were uniformly distributed in both the groups. The success rate for insertion was 100% in both devices. The success rate for intubation was 96.6% (58/60) in group I and 36.6% in group A (P < 0.001). In group I, patients with mean thyromental distance >7.62 ± 0.75 cm had higher successful intubation compared with patients with mean thyromental distance <5.25 ± 0.35 cm (P = 0.014). Cormack–Lehane grading did not correlate with intubation attempts or success rate in group I (P = 0.45), whereas in group A the rate of successful blind intubation with Cormack–Lehane grade 1 was 50% (19/38).Conclusion:Both devices have 100% insertion success, though Ambu® AuraGain• has lower success rate for facilitating intubation compared with ILMA.

A Look Back at 2018

A Look Back at 2018

Remanufactured circular mapping catheters: safety, effectiveness and cost

BackgroundThe use of remanufactured single-use devices (SUDs), including cardiac electrophysiology catheters, has become established in the USA and other health care systems but without much published scientific evaluation on the relative safety or efficacy of these devices. In the United Kingdom (UK), the use of remanufactured SUDs has not been routine. We performed a structured evaluation of the safety and efficacy of a remanufactured circular mapping catheter (Stryker® remanufactured Lasso NAV 2515) during its introduction in our centre.MethodsWe prospectively evaluated the performance of a remanufactured circular mapping catheter in 100 consecutive patients undergoing an AF ablation. Operator feedback was obtained, assessing the device appearance, ease of use and function. As an indirect measurement of efficacy, acute procedure metrics were compared to those in 100 propensity-matched cases performed by the same operators using a new device. Cost savings were calculated.ResultsNo complication occurred in association with the remanufactured device. There was one reported failure of device malfunction—the flexion-extension mechanism of a remanufactured catheter and none in the matched-control group. There was satisfactory communication with the electro-anatomic mapping system. Ease of use of the remanufactured catheter was reported to be similar to a newly manufactured device. Procedural duration was similar with remanufactured devices and matched controls. With 100 cases using the remanufactured device, cost savings amounted to £30,444.ConclusionsThe use of remanufactured circular mapping catheters is safe, efficient and reliable. Widespread use of remanufactured SUDs offers the possibility of significant economic benefit.

Supraglottic airway devices as a strategy for unassisted tracheal intubation: A network meta-analysis.

We aimed to compare the effectiveness of supraglottic airway devices as a strategy for unassisted tracheal intubation. Accordingly, we searched the OVID-MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials, KoreaMed, and Google Scholar databases to identify all relevant randomized controlled trials (RCTs) on supraglottic airway devices as a strategy for tracheal intubation published until May 2017. The primary outcome was the overall success rate of intubation by the intention to treat (ITT) strategy. The secondary outcomes of the study were the overall success rate of tracheal intubation by the per protocol (PP) strategy and the success rate of tracheal intubation at first attempt by ITT and PP. We conducted a network meta-analysis with a mixed-treatment comparison method to combine direct and indirect comparisons among supraglottic airway devices. Of 1396 identified references, 16 RCTs (2014 patients) evaluated unassisted intubation with supraglottic airway devices. Patients were grouped according to the type of device used: LMA-CTrach, LMA-Fastrach, Air-Q, i-gel, CobraPLA, Ambu-Aura, or single-use LMA devices. Based on the surface under the cumulative ranking curve, the three best supraglottic airway devices for use as a strategy for unassisted tracheal intubation were LMA-CTrach (which included video-assisted tracheal tube guidance), single-use LMA-Fastrach, and LMA-Fastrach. LMA-Fastrach showed a higher success rate of intubation than did i-gel, CobraPLA, Air-Q, and Ambu-Aura. However, this study was limited by the small number of eligible RCTs. Therefore, well-designed RCTs performed on large patient populations are required to increase the confidence of the results.

Safety profile of subcutaneous trastuzumab for the treatment of patients with HER2-positive early or locally advanced breast cancer: primary analysis of the SCHEARLY study

BackgroundSubcutaneous trastuzumab (H SC) is a valuable alternative to the intravenous formulation. This study assessed H SC safety and tolerability in human epidermal growth factor receptor 2 (HER2)+ early/locally advanced breast cancer (EBC/LABC). MethodsSCHEARLY is a prospective, two-cohort, non-randomised, multicentre Italian trial included in the umbrella study UmbHER1, planning a 1-year treatment with H SC 600 mg in HER2+ EBC/LABC. Patients were sequentially assigned to cohort A (N = 121) and B (N = 119) to receive H SC via a handheld syringe and a single-use injection device, respectively. Adjuvant or neoadjuvant treatment included anthracycline-containing regimens followed by H SC plus taxanes and then alone for 18 cycles totally. ResultsTwo hundred forty patients were enrolled (adjuvant therapy: 81.7%; neoadjuvant therapy: 18.3%), and 201 completed the treatment (early discontinuation was mainly due to intercurrent adverse events [AEs], 7.5%). Overall, the two cohorts displayed similar safety profiles. From H SC start, the rate of treatment-related AEs in the safety population (N = 228) was 3.9% for grade ≥3 AEs; 0.9% for serious AEs (one pleuropericarditis and one anaphylactic shock, both resolved) and 14.5% for cardiac AEs, the most common being the decreased left ventricular ejection fraction (7.9%; mean reduction from the screening to the follow-up visit was 2.9%). No cases of congestive heart failure occurred. The rate of systemic administration-related reactions and local injection site reactions was 68.0% and 21.9%, respectively, mostly of grade 1–2. ConclusionsH SC 600 mg confirmed to be a safe and tolerable option as adjuvant/neoadjuvant therapy in patients with HER2+ EBC and LABC. ClinicalTrials.gov IdentifierNCT01940497.

Reuse of catheters and devices labelled for single use: evidence, recommendations and oversight

Cardiovascular disease has become the most common cause of death and morbidity throughout the world, not just the affluent societies. In 2015, there were 422 million prevalent cases of cardiovascular...

Single-use medical devices: economic issues

Evaluate MedTech estimated that worldwide sales of medical devices in 2017 were US$386.8 billion. Cardiology was among the largest groups, with $44.6 billion in sales.1 The Emergo Group estimated US...

Acceptability, effectiveness and safety of a Renew® anal insert in patients who have undergone restorative proctocolectomy with ileal pouch-anal anastomosis.

Restorative proctocolectomy has gained acceptance in the surgical management of medically refractive ulcerative colitis and cancer prevention in familial adenomatous polyposis. Incontinence following restorative proctocolectomy occurs in up to 25% of patients overnight. The Renew® insert is an inert single-use device which acts as an anal plug. The aim of this study was to assess the acceptability, effectiveness and safety of the Renew® insert in patients who have undergone restorative proctocolectomy. The device has yet to be assessed in patients who have undergone restorative proctocolectomy. This was a prospective study exploring the acceptability, effectiveness and safety of the Renew® insert in improving incontinence in patients who had undergone restorative proctocolectomy. A total of 15 patients with incontinence were asked to use the Renew® insert for 14days following their standard care. The Incontinence Questionnaire-Bowels was used pre- and posttreatment to assess response and patients were asked to report the perceived acceptability, effectiveness and safety of the device at the end of the trial. The device was acceptable to 8/15 (53%) of patients and was effective in 6/15 (40%). Only 2/15 (13%) of patients raised any safety concerns, and these were minor. The device was associated with a significant reduction in night seepage (P=0.034). In a small study, the Renew® insert can be both acceptable and effective and is also associated with few safety concerns. It is also associated with significant reductions in night-time seepage.

Assessing the operational feasibility and acceptability of an inhalable formulation of oxytocin for improving community-based prevention of postpartum haemorrhage in Myanmar: a qualitative inquiry

ObjectiveThis study assessed the potential operational feasibility and acceptability of a heat-stable, inhaled oxytocin (IOT) product for community-based prevention of postpartum haemorrhage in Myanmar.MethodsA qualitative inquiry was conducted between June...

Single-use Medical Devices Re-processing: Risk Assessment and Quality Control Technologies

The reuse of high-cost single-use medical devices (SUD) is permitted in many countries, such as the United States, Germany and the United Kingdom, but strict regulatory requirements must be met. In addition to regulatory policies and regulations, such as market access mode and special requirements on Good Manufacture Practice (GMP), there are strict technical requirements on the potential risk control and quality assurance system. Therefore, effective risk assessment and risk control technology are the keys to ensure effective quality control and safe use of SUDs. In this article, based on analyzing the technological requirements of the national regulatory on SUDs in the United States, Germany and Britain, and combined with the review from latest relevant literature, to discuss the strategies of how to carry out scientific risk assessment. Some risk control technologies on the reuse of SUDs are introduced, which will provide support for the further study on risk control strategies and regulatory decisions for the reuse of SUDs in China.

Wearable and Implantable Epidermal Paper-Based Electronics.

Traditional manufacturing methods and materials used to fabricate epidermal electronics for physiological monitoring, transdermal stimulation, and therapeutics are complex and expensive, preventing their adoption as single-use medical devices. This work describes the fabrication of epidermal, paper-based electronic devices (EPEDs) for wearable and implantable applications by combining the spray-based deposition of silanizing agents, highly conductive nanoparticles, and encapsulating polymers with laser micromachining. EPEDs are inexpensive, stretchable, easy to apply, and disposable by burning. The omniphobic character and fibrous structure of EPEDs make them breathable, mechanically stable upon stretching, and facilitate their use as electrophysiological sensors to record electrocardiograms, electromyograms, and electrooculograms, even under water. EPEDs can also be used to provide thermotherapeutic treatments to joints, map temperature spatially, and as wirelessly powered implantable devices for stimulation and therapeutics. This work makes epidermal electronic devices accessible to high-throughput manufacturing technologies and will enable the fabrication of a variety of wearable medical devices at a low cost.

A Paradigm Shift Toward Terminally Sterilized Devices.

Given the complexity of the sterilization process, and the risk involved in absence of strict adherence to the protocol described by the medical device manufacturers, terminally sterilized devices are emerging and being promoted in the field of medical practices. The characteristics associated with conventional reprocessing are demanding logistics, costs of delay, operations and adverse events, and unacceptable liability. Demanding logistics were a result of decoupled staff between the operating room and sterilize processing department, understaffed and high-volume processing with an additional burden due to inventory management and inefficient training. Other costs arose from upkeep, delay in operating room, and surgical-site infections. Liability arose from the repeatedly use of an unquantifiable process thus adding uncertainties, limited shelf life of the reprocessed implants, contingency of flash sterilization and introduction of newer technology with higher demand on cleaning performances. In contrast, terminally sterilized single-use devices do not carry any of the aforementioned-characteristics, deeming it to be the simplest solution to the current conundrum. This review serves to provide an evaluation of logistics, costs, and potential adverse effects, both directly and indirectly, associated with current practices in the sterile processing department, and also describes as to how the use of terminally sterilized devices can help circumvent those.

Dépenses en dispositifs médicaux stériles dans certains actes de chirurgie hépatobiliaire et digestive : que resterait-il du Groupe Homogène de Séjour ?

Medical devices innovations and associated procedures represent a large part of health facilities budget. The aim of this work was to evaluate the cost of medical devices used during different surgical procedures. This cost was compare with the revenue collected from hospital stay pricing. A prospective analysis of the medical devices used in operating room was carried out for different types of programmed surgeries. For five weeks, references of sterile single-use medical devices used during the interventions were collected. Expenditure on medical devices used during surgical procedures represented 5.7% of the hospitalization value for an inguinal hernia repair, 12% for a cholecystectomy, 9.35% for a colectomy, 14.5% for a hepatectomy and 7% for pancreatectomy, any severity index combined. The most important correlations existed between act duration and patient's level of severity and between operating times and consumables expenditure. Cost optimization opportunities are equivalence of some medical devices ranges, purchases with national groupings and potential decreases in operating times related to the use of innovative medical devices.

Methicillin-resistant Staphylococcus aureus spreading through medical devices used in nursing care: what can we learn from Portugal?

Background: Presently, Portugal faces the third highest level of Staphylococcus aureus in the European Union, leading to burdensome outcomes for health systems, public institutions, patients and their respective families. A significant contamination rate of portable medical devices used by nurses in direct patient care was identified in four medical wards in a large public tertiary hospital. We described the degree of contamination and investigate associated risk factors. Methods & Materials: Descriptive-correlational and cross-sectional study. The target population corresponds to all nurses who provide direct patient care in the referred settings. Medical devices were swabbed and cultured in Mannitol salt agar (MSA). The obtained isolates were subjected to the latex agglutination test in order to investigate the presence of Staph. aureus. Additional information regarding medical devices management by nurses was collected by individual questionnaire. Data were analyzed with IBM SPSS 20. Results: Between April and June 2017, 383 medical devices carried by 50 nurses in their uniform pockets were tested. The most representative devices were tourniquets (68%), adhesive rolls (56%), scissors (26%) and thermometers (20%). Colonies of Staphylococcus coagulase positive (32%) and negative (27%) were identified, ranging from 1.0 × 101 to > 1.5 × 103 CFU/mL. The highest CFU/mL values were observed in reusable tourniquets and axillary thermometers. Overall, and regarding Staphylococcus isolates, 66.6% were positively identified as Methicillin-resistant Staphylococcus aureus (MRSA). Data retrieved from questionnaires evidences that nurses reuse these devices between patients (100%); commonly share these devices with other healthcare professionals such as other nurses, physicians and assistants (92%), are unaware of clinical guidelines regarding medical devices management (82%); lack infection prevention and control training (42%); and don’t properly clean these devices during patient care (32.7%). Conclusion: Fundamental lack of recurrent training, access to specific institutional guidelines and ineffective management of these devices, including lack of cleaning/disinfection, reuse between procedures/patients and sharing them with other professionals were associated with MRSA. The implementation of pathways for medical device management, mandatory staff training and introduction of single-use medical devices in medical wards are recommended to prevent/control future MRSA outbreaks.

Single-use versus reusable flexible ureteroscopes: a comprehensive cost-analysis decision model

Purpose: The significant improvements in flexible ureterorenoscopes have made flexible ureteroscopy the main treatment modality to target upper urinary pathologies. The purpose of this study was to critically evaluate all literature concerning the cost-effectiveness of flexible ureteroscopy comparing single-use with reusable scopes. Methods: A systematic online literature review was performed in PubMed, Embase and Google Scholar databases. Two separate urologists (GSM and FCT) performed the online search and reviewed all papers considered suitable and relevant for this analysis. Because of the paucity of high quality publications, not only prospective assessments but also case control and case series studies were included in the final analysis. All factors potentially affecting surgical costs or clinical outcomes were considered in the analysis. Results: 741 studies with the previously elected terms were found. Of those, 18 were duplicated and 77 were not related to urology procedures and were excluded. Of the remaining 646 studies, 59 published between 2000 and 2018 were considered of relevance to the pre-defined queries and were selected for further analysis. Stone free and complication rates were similar between single-use and reusable scopes. In special, urinary tract infection rate following flexible ureteroscopy is not inferior if a single-use device is used instead of a reusable scope. Operative time was in average 20% shorter if a digital scope was used, single-use or not. There is a suggestion that the learning curve is shorter with single-use devices but this is not consistent in the literature. Surgeon expertise impacts the longevity of the flexible scope. Reusable digital scopes seem to last longer than optic ones, though scope longevity is very variable worldwide. New scopes usually last three to four times more than refurbished ones and single-use ureterorenoscopes have good resilience throughout long cases. Both sterilization method and cleaning process impact scope longevity, the best results being achieved with Cidex and a dedicated nurse to take care of the sterilization process. The main factors that negatively impact device longevity regarding patient and disease are lower pole pathologies, large stone burden and non-use of a ureteral access sheath. Conclusions: The cost-effectiveness of a flexible ureteroscopy program is dependent of several aspects that must be considered when deciding whether to choose between a single-use and a reusable ureterorenoscope. Disposable devices are already a reality and will progressively become the standard as manufacturing price falls significantly.