[Study on risk prediction model of neck work-related musculoskeletal disorders among automobile manufacturing enterprise workers].

Objective: To explore the risk factors of neck work-related musculoskeletal disorders (WMSDs) among automobile manufacturing enterprise workers, and construct the risk prediction model. Methods: In May 2022, a cluster convenience sampling method was used to selet all front-line workers from an automobile manufacturing factory in Xiangyang City as the research objects. And a questionnaire survey was conducted using the modified Musculoskeletal Disorders Questionnaire to analyze the occurrence and exposure to risk factors of neck WMSDs. Logistic regression was used to analyze the influencing factors of workers' neck WMSDs symptoms, and Nomogram column charts was used to construct the risk prediction model. The accuracy of the model was evaluated by the receiver operating characteristic (ROC) curve, the Bootstrap resampling method was used to verify the model, Hosmer-Lemeshow goodness of fit test was used to evaluate the model, and the Calibration curve was drawn. Results: A total of 1783 workers were surveyed, and the incidence of neck WMSDs symptoms was 24.8% (442/1783). Univariate logistic regression showed that age, female, smoking, working in uncomfortable postures, repetitive head movement, feeling constantly stressed at work, and completing conflicting tasks in work could increase the risk of neck WMSDs symptoms in automobile manufacturing enterprise workers (OR=1.37, 95%CI: 1.16-1.62; OR=2.85, 95%CI: 1.56-5.20; OR=1.50, 95%CI: 1.18-1.91; OR=1.18, 95%CI: 1.02-1.37; OR=1.34, 95%CI: 1.04-1.72; OR=1.62, 95%CI: 1.21-2.17; OR=1.48, 95%CI: 1.13-1.92; P<0.05). While adequate rest time could reduce the risk of neck WMSDs symptoms (OR=0.56, 95%CI: 0.52-0.86, P<0.05). The risk prediction model of neck WMSDs of workers in automobile manutacturing factory had good prediction efficiency, and the area under the ROC curve was 0.72 (95%CI: 0.70-0.75, P<0.001) . Conclusion: The occurrence of neck WMSDs symptoms of workers in automobile manufacturing factory is relatively high. The risk prediction model constructed in this study can play a certain auxiliary role in predicting neck WMSDs symptoms of workers in automobile manufacturing enterprise workers.

On the motivation for pharmaceutical manufacturer coupons: Brand loyalty or customer acquisition?

OBJECTIVE: To generate evidence regarding the offensive (customer acquisition) versus defensive (customer retention) motivation for pharmaceutical manufacturer coupons. DATA SOURCES AND STUDY SETTING: Retail prescriptions from IQVIA's Formulary Impact Analyzer data between 2017 and 2019. STUDY DESIGN: Ordinary least squares regression models with person, therapeutic class, drug, and time-fixed effects to measure the association between switching medications and coupon usage as well as the association between patient out-of-pocket spending and switching to a drug and using a coupon. To study switching type heterogeneity, reanalysis of associations for any type of switch, generic-brand switches, and brand-brand switches. Reestimation of baseline analyses for sodium-glucose cotransporter-2 inhibitors, anticoagulants, and inhaled corticosteroids/long-acting beta2-agonists to assess heterogeneity by drug class and market maturity. DATA COLLECTION: 1,167,132 privately insured patients that utilized at least one coupon between 2017 and 2019 for one or more prescriptions. PRINCIPAL FINDINGS: Coupon usage was associated with a 1.0 percentage point reduction in any kind of drug switch in the full sample and by 0.65-2.9 percentage points for the drug class subgroups. However, these estimates are governed by market dynamics; the probability of switching increased by 40% on the first coupon usage before declining by more than 50% on subsequent coupons. Switching after the first coupon use may be explained by systematic savings implied by coupon use; we find coupons reduced patient out-of-pocket spending by $45.00 (i.e., the majority of patient out-of-pocket costs). In subgroup analyses, coupon savings were $6.43 larger than average for anticoagulants, characterized by the highest levels of brand and generic competition among the considered therapeutic classes. CONCLUSIONS: Pharmaceutical manufacturers may be using coupons to acquire customers and then build brand loyalty, especially in markets with more generic competition. Antitrust authorities and other regulators should scrutinize the impact of coupons on market competitiveness and drug spending.

Total ankle replacement: Implant Manufacturer's guidelines for post-operative rehabilitation: A review of literature.

Introduction: Total ankle replacements (TARs) is emerging as a successful alternate treatment option to arthrodesis for surgical treatment of end stage ankle arthritis. This has led to manufacturers producing a selection of implants. There is wide variations in post-operative rehab protocols being adopted for treatment following TAR surgery. This depends on choice of implants and manufacturer recommendations too. Following the author's investigation, a lack of standardisation between manufacturer post-operative protocols was identified. The aim of this project was to analyse similarities and differences in guidelines for: choice of immobilisation, weight-bearing (WB) status, of range of movement (ROM) exercises and Physiotherapy. Method: Current commonly used TAR implants in the UK were identified using National Joint Registry's 2020 Annual Report. Additional implants were included after accessing data regarding the TAR market. Individual company websites were researched for information available on public domain for post op management guidelines and the results were summarised. Results: Only 7 implants were reviewed as 6 companies either did not provide post-operative protocols or recommended a surgeon guided rehabilitation process. Different manufacturers allow partial WB by week 2, week 3 and week 7. One protocol suggested full WB from week 4 whereas two others suggested it from week 6. Choices of immobilisation varied as one company suggested casting alone for 6 weeks, two suggest casting followed by a period in a boot, one suggests splinting and a boot and one uses all 3 types of immobilisations. ROM exercises were mentioned by three manufacturers and were encouraged from week 2 and 3. Physiotherapy was mentioned in four protocols, two of which suggest intervention from week 6, one from week 7 and the other mentions the importance of therapy rather than specific timelines. Conclusion: There are differences between post op TAR guidelines from the implant manufacturers regarding the categories analysed. The variation in the data collected makes it challenging to suggest a singular protocol to be followed after TAR surgery.

Regulatory landscape, risks, and solutions for refurbished medical devices: a comparative analysis in the US, EU, Malaysia, and Ghana.

INTRODUCTION: Refurbished medical devices are previously owned equipment that undergo a process of restoration to ensure they meet quality standards and function effectively. The utilization of refurbished medical devices, coupled with the integration of software, poses intricate challenges in terms of regulatory compliance, risk management, and patient safety. AREAS COVERED: This article explores the regulatory frameworks governing refurbished medical devices in the United States (US), the European Union (EU), Malaysia, and Ghana. Included information from a range of primary and secondary sources. Additionally, it aims to identify and analyze the risks associated with refurbished medical devices, with a specific focus on the implications of software integration, and recommend practical solutions for mitigating these risks. EXPERT OPINION: The landscape of refurbished medical devices presents challenges in terms of regulatory compliance, risk management, and patient safety. Addressing these challenges requires careful consideration and strategies to ensure that refurbished devices meet stringent quality standards. By focusing on these areas, policymakers and healthcare professionals can enhance the safe utilization of refurbished medical devices, thereby improving access to quality healthcare, particularly in underserved regions.

Ceramic Heads With 12/14 Titanium Sleeves Used on Manufacturer-Non-Compatible Retained Femoral Components Do Not Lead to Implant Failure in Revision Hip Arthroplasty.

BACKGROUND: Ceramic femoral heads with titanium sleeves are commonly used in revision total hip arthroplasty (rTHA). Companies advise against combination with a retained femoral component from another manufacturer. However, no data are available. The aim of this study was to evaluate and compare the implant failure and revision rates of ceramic heads with a 12/14 titanium sleeve used on manufacturer-compatible versus noncompatible retained femoral components. METHODS: A retrospective single-center cohort analysis was performed using a prospectively maintained institutional arthroplasty registry. We identified 439 patients who received a titanium 12/14 ceramic head during rTHA between January 1, 2007, and December 31, 2022. There were 229 manufacturer-compatible and 210 manufacturer-noncompatible retained femoral stems, according to the company's official product compatibility list. Implant failure and rerevision rates were evaluated. RESULTS: After a median follow-up of 6.6 years (IQR (interquartile range): 4.5 to 9.3), there was no significant difference (P = 0.770) in the rerevision rate between the manufacturer-compatible group (17.0%) and the noncompatible group (18.1%). Revision-free survival after rTHA was 81.2% in the manufacturer-compatible group and 78.9% in the manufacturer-noncompatible group after 15 years (P = 0.653). Most rerevisions occurred in the first year after rTHA, with 29 of 229 (12.7%) in the manufacturer-compatible group and 24 of 210 (11.4%) in the manufacturer-noncompatible group (P = 0.705). We observed only one implant failure in the manufacturer-noncompatible group, but this was not related to a mismatch problem. CONCLUSIONS: Although legal uncertainties remain, this study showed no increased risk of implant failure or revision rates when a ceramic femoral head, with a 12/14 titanium sleeve, was used on a noncompatible femoral stem from a manufacturer.

First report on liquid crystal monomers in tree barks surrounding a display manufacturer: Insights for atmospheric transport and establishment of priority list.

Tree bark has been proven as an effective passive air sampler, particularly where access to active sampling methods is limited. In this study, 60 target liquid crystal monomers (LCMs; comprising 10 cyanobiphenyl and analogs (CBAs), 13 biphenyl and analogs (BAs), and 37 fluorinated biphenyl and analogs (FBAs)) were analyzed in 34 tree barks collected from the vicinity of a liquid crystal display (LCD) manufacturer situated in the Pearl River Delta, South China. The concentrations of LCMs in tree barks ranged from 1400 to 16000 ng/g lipid weight, with an average of 5900 ng/g lipid weight. Generally, bark levels of BAs exponentially decreased within 5 km of the LCD manufacturer. The profiles of LCMs in tree barks are similar to previously reported patterns in gaseous phase, suggesting bark's efficacy as a sampler for gaseous LCMs. The inclusion of different congeners in existing studies on the environmental occurrence of LCMs has hindered the horizontal comparisons. Therefore, this study established a list of priority LCMs based on environmental monitoring data and the publicly accessible production data. This list comprised 146 LCMs, including 63 REACH registered LCMs that haven't been analyzed in any study and 56 belonging to 4 types of mainstream LCMs.

Characterizing the safety profile of vagus nerve stimulation devices for epilepsy from 21,448 manufacturer and user reports.

OBJECTIVE: This study summarizes medical device reports (MDRs) associated with adverse events for vagus nerve stimulation (VNS) devices indicated for epilepsy as reported by the Manufacturer and User Facility Device Experience (MAUDE) database of the US Food and Drug Administration. METHODS: The MAUDE database was surveyed for MDRs from November 2013 to September 2022 regarding VNS devices for epilepsy. Event descriptions, device problems, correlated patient consequences, and device models were grouped and analyzed in Python. Based on event description, revision surgeries and other unique events were identified. Revenue from VNS device sales was used to approximate growth in their use over time. RESULTS: A total of 21,448 MDRs met the inclusion criteria. High VNS impedance, the most prevalent device malfunction overall (17.0% of MDRs), was the most common factor for 18 of the 102 encountered patient problems and led to 1001 revision surgeries (3371 total revisions). Included in those 18 device malfunctions were 3 of the top 6 occurring patient problems: seizure recurrence (9.9% associated with high impedance; encompassed focal, absence, and grand mal subtypes), death (1.3%), and generalized pain (7.9%). The next 4 top cited device malfunctions-lead fracture (13.7% of MDRs), operational issue (6.6%), battery problem holding charge (4.2%), and premature end-of-life indicator (2.9%)-differed widely in their percentage of cases that did not impact patients (77.4%, 57.3%, 48.9%, and 92.2%, respectively), highlighting differing malfunction severities. Seizure recurrence, the most prevalent patient impact, was the outcome most associated with 32 of the 68 encountered device problems, including high impedance (12.8%), lead fracture (12.2%), operational issue (18.4%), battery problem holding charge (31.2%), and premature end-of-life indicator (8.9%), which comprised the top 5 occurring device problems. In general, MDRs spanned a diverse range including device age, hardware, software, and surgeon or manufacturer error. Trends were seen over time with declining annual MDRs coupled with a rise in the use of VNS devices as gauged by revenue growth. Shifting device and patient problem profiles were also seen in successive models, reflecting engineering updates. CONCLUSIONS: This study characterizes the most common and consequential side effects of VNS devices for epilepsy while clarifying likely causes. In addition, the outcomes of 68 distinct device malfunctions were identified, including many not ubiquitously present in literature, lending critical perspective to clinical practice.

How to verify the analytical and clinical performance of ELISA immunoanalysis in the real laboratory practice. PCSK9 as an example.

BACKGROUND: Manufacturers and diagnostic companies often recommend on-site verification of analytical performance in the clinical laboratory. The validation process used by manufacturers is rarely described in detail, and certain information on analytical performance is missing from the product sheet, especially for immunoanalytical methods. We describe an approach to the detailed validation of an ELISA method for the measurement of proprotein convertase subtilisin/kexin type 9 (PCSK9) plasma concentrations. We compared manufacturers' claims of analytical performance with data obtained in the field laboratory using several approaches. METHODS: We used the Human Proprotein Convertase 9/PCSK9 Quantikine ELISA diagnostic kit (R&D systems, Bio-Techne Ltd., Abingdon Science Park, Abingdon, UK) and three levels of quality control solution Quantikine Immunoassay Control Group 235 (R&D systems, Bio-Techne Ltd., Abingdon Science Park, Abingdon, UK) to verify precision. We measured the concentration of PCSK9 using the DS2 ELISA Reader (Dynex Technologies GmbH, Denkendorf, Germany). We used analysis of variance (ANOVA) and the R statistical package (R core team, version 1.4.5). Statistical analysis and terminology were performed according to protocol CLSI EP15-A3, and the reference interval was checked according to CLSI/IFCC C28-A3c. RESULTS: We found a significant difference between the manufacturer's claims of analytical performance and real data measured in the routine clinical laboratory. The calculated CV (%) for repeatability (calculated by simple estimation of the mean and SD, as used by the manufacturer) was between 5.5% and 7.4%, but the manufacturer's claim was between 4.1% and 6.5%. Using ANOVA, the true repeatability was between 5.0% and 6.9%. Similarly, ANOVA revealed values of CV (%) for within-laboratory imprecision between 6.5% and 9.1%, while the manufacturer's claims were between 4.1% and 5.9%. The recovery ranged from 105.5% to 121.8%. The manufacturer's recommended reference interval was checked and we didn't find any significant difference between men and women. CONCLUSIONS: We describe a comprehensive approach to verify the analytical performance of an ELISA method using the measurement of PCSK9 plasma concentration as an example. We found differences between the results of this approach based on the CLSI EP15-A3 protocol and data provided by the manufacturer. We recommend the verification of analytical performance by more complex statistical tools in laboratory practice.

Revision Cochlear Implantation With Device Manufacturer Conversion: Surgical Outcomes and Speech Perception Performance.

OBJECTIVE: Describe the clinical profile of revision cochlear implantation (RCI) cases involving device manufacturer conversion (RCImc+), compare them to cases without manufacturer conversion (RCImc-), and classify the reasons for manufacturer conversion (MC). STUDY DESIGN: Retrospective case review. SETTING: Tertiary academic center. METHODS: Data on demographics, RCI indications, medical background, surgical details, and the reasons for MC were collected for all RCIs from 1989 to 2020. Post-RCI speech perception performance was categorized as unchanged, improved, or declined, according to clinically based criteria. RESULTS: Of 185 RCIs, 39 (21%) involved MC, mostly in pediatric patients (67%). The leading RCImc+ indications were device-related (59%) and medical (31%) failures. Initial implant manufacturers were Advanced Bionics (49%), Cochlear (25.5%), or Medel (25.5%). Most MC reasons were patient-driven (64%) versus CI team recommendations (36%). The RCImc+ group demonstrated a 3-fold higher rate of medical indications than RCImc- (31% vs 11.5%, P = .007). The time interval from symptom onset to RCI was longer in RCImc+ (43 vs 20.3 months, P = .001), and the rate of multiple revisions in the same ear was higher (25.6% vs 8.2%, P = .009). Complete reinsertion rates were high in both RCImc+ and RCImc- (94.8% vs 94.5%, P = 1) without any complications. Speech perception improved or remained unchanged in most (84%) cases, with no significant difference between the groups (P = .183). CONCLUSION: This retrospective study showed that RCI involving MC is safe and beneficial. Although RCImc+ patients exhibited distinct clinical characteristics, MC did not impact surgical or speech perception outcomes. This provides evidence-based data to support informed decision-making by CI teams and patients.

Adverse events associated with Vibrant Soundbridge: A MAUDE study.

OBJECTIVE: To summarize adverse events and their root causes reported to the United States Food and Drug Administration (FDA) on Vibrant Soundbridge (VSB) hearing device (Med-El, Innsbruck, Austria), an active middle ear implant for patients with moderate to severe hearing loss. MATERIALS AND METHODS: The FDA's Manufacturer and User Facility Device Experience (MAUDE) database was queried for reports of VSB adverse events from January 1, 2012, to July 27, 2022. RESULTS: Six hundred sixty-three total medical device reports were identified, from which 913 adverse events were extracted. Of these, 498 (54.5 %) were adverse events to patients (AEPs), while 415 (45.5 %) were device malfunctions (DMs). The most common AEPs were hearing performance issues 428 (85.9 %). The most common DMs were compromised conductive link 125 (30.1 %). Root causes identified for DMs were iatrogenic 85 (58.6 %), patient-related 28 (19.3 %), and trauma and external causes 32 (22.1 %). The most common iatrogenic root cause 12 (14.1 %) involved damage to the conductive link during revision surgery. The most common patient-related causes of DMs were excessive middle ear tissue growth 16 (57 %), and abrupt body movements 5 (28.6 %). The most common external cause of DM was cleaning of the ear canal or mastoid cavity 20 (62.5 %). CONCLUSIONS: Despite its well-known limitations, the MAUDE database provides valuable information on possible complications of VSB as it relates to device malfunction or adverse events for patients. Implementation of standardized reports with relevant and well-defined categories could certainly allow for a more meaningful analysis.

Would manufacturing go for renewable energy? Manufacturers' preference towards sustainability.

Malaysia needs to fully utilize its renewable energy resources to meet its goal of installed capacity of 31% of renewable energy in 2025 and 40% in 2035. In order to empower renewable energy sources, the government has established a fund known as the renewable energy fund (RE FUND). In Malaysia, most manufacturing sectors contribute to the RE FUND through their monthly electricity bills due to their electricity consumption exceeding 300kwh per month. As Malaysia's highest electricity consumer, the manufacturing sector needs government investment incentives to switch to renewable energy sources to generate electricity. Therefore, this study was conducted to identify attribute preferences of the manufacturing sector due to investing in renewable energy sources. The Choice Experiment method was employed where the Mixed Logit model was chosen to identify the willingness to pay for the manufacturing sectors based on their preferences among the four attributes: types of renewable energy, project location, annual reduction in GHG emissions, and RE FUND. The study results found that the manufacturing sector places the highest value on the project location, where they prefer to improve the project location from current condition to far location. This study can also help to achieve the Goal 7 in the Sustainable Development Goal (SDG), where investment in renewable energy sources can guarantee that all individuals obtain affordable, reliable, sustainable, and modern electricity in 2030.

Dual Mobility Articulation in Total Hip Arthroplasty: Mixed Femoral and Acetabular Components are a Feasible Option.

BACKGROUND: The utilization of a different manufacturer for the prosthetic femoral head and the polyethylene insert in dual mobility (DM) for total hip arthroplasty (THA) may be necessary, especially in the revision setting. However, there is no data in the literature about this application. This study evaluated the outcomes of mixed manufacturer components, with the hypothesis that there would be no difference in measured outcomes compared to matched components. METHODS: The DM articulations implanted during THA revision were retrospectively reviewed from 2011 to 2017. The study group was then stratified into 2 cohorts: matching components or mixed components. Of 130 hips included in the study with DM articulations with average follow-up of 7 years, 103 had mixed and 27 had matching manufacturer components. Rates of all cause reoperation and revision, intraprosthetic dislocation, dislocation, and aseptic loosening were compared using Chi-squared and Fisher's exact test; survival analysis was also performed. RESULTS: Matched and mixed manufacturer implants had no significant difference between all cause reoperation (33 versus 25.2%), dislocation (14.8 versus 7.7%), and aseptic loosening (3.7 versus 3.9%), respectively. Higher rates of intraprosthetic dislocation (11 versus 0.97%) were observed in the matching component cohort. Survival analysis showed similar outcomes at 2, 5, and 10 years. CONCLUSIONS: Mixed-component DM articulations show similar results compared to matching components. The off-label use of mixed manufacture DM articulation in THA is a feasible and safe option in the correct patient. Furthermore, when encountering a well-fixed femoral stem or acetabular shell, the use of a mixed component DM articulations may reduce the morbidity for the patient and prevent revision of all components.

Safely Introducing New Surgical Devices in Minimally Invasive Gynecologic Surgery: An Argument for Use of the IDEAL Framework.

OBJECTIVE: To review the Food and Drug Administration (FDA) premarket regulatory and postmarket surveillance processes for 2 minimally invasive gynecologic surgery case studies-the laparoscopic power morcellator and the Essure permanent birth control device-and to introduce the IDEAL (Idea, Development, Exploration, Assessment, Long-term) framework for safely introducing and monitoring minimally invasive gynecologic surgery devices. DATA SOURCES: News media publications, agency websites, legal articles, and scientific papers. METHODS OF STUDY SELECTION: Articles and papers were selected that described events leading to FDA approval of these devices and subsequent complications. TABULATION, INTEGRATION, AND RESULTS: Based on current FDA premarket regulatory processes, 67% of devices do not currently require premarket review and only 1% are subject to clinical trial requirements. The IDEAL framework delineates 5 phases for safe introduction of medical devices: idea, development, exploration, assessment, and long-term study. CONCLUSION: The laparoscopic power morcellator and Essure cases illustrate possible shortcomings in our device approval system that could be improved upon using the IDEAL framework, which limits device use until safety and efficacy data have been established and recommends postmarket surveillance.

Rapid and green discrimination of bovine milk according to fat content, thermal treatment, brand and manufacturer via colloidal fingerprinting.

Addressing food safety and detecting food fraud while fulfilling greenness requisites for analysis is a challenging but necessary task. The use of sustainable techniques, with limited pretreatment, non-toxic chemicals, high throughput results, is recommended. A combination of Field Flow Fractionation (FFF), working in saline carrier and with minimal preprocessing, and chemometrics was for the first time applied to bovine milk grouping. A set of 47 bovine milk samples was analyzed: a single analysis yielded a characteristic multidimensional colloidal dataset, that once processed with multivariate tools allowed simultaneously for different discriminations: fat content, thermal treatment, brand and manufacturing plant. The analytical methodology is fast, green, simple, and inexpensive and could offer great help in the field of quality control and frauds identification. This work represents also the first attempt to identify milk sub-typologies based on colloidal profiles, and the most complete study concerning multivariate analysis of FFF fingerprint.

IPEM topical report: results of a 2022 UK survey on the use of linac manufacturer integrated quality control (MIQC).

In recent years Radiotherapy linear accelerator (linac) vendors have developed their own integrated quality control (QC) systems. Such manufacturer-integrated-quality-control (MIQC) has the potential to improve both the quality and efficiency of linac QC but is currently being developed and utilised in the absence of specific best-practice guidance. An Institute of Physics and Engineering in Medicine working party was commissioned with a view to develop guidance for the commissioning and implementation of MIQC. This study is based upon a survey of United Kingdom (UK) radiotherapy departments performed by the working party. The survey was distributed to all heads of radiotherapy physics in the UK and investigated availability and uptake, community beliefs and opinions, utilisation, user experience and associated procedures. The survey achieved a 95% response rate and demonstrated strong support (>95%) for its use and further development. MIQC systems are available in 79% of respondents' centres, and are in clinical use in 66%. The most common MIQC system was Varian MPC, in clinical use in 58% of responding centres, with CyberKnife AQA\E2E in 11%, TomoTherapy TQA in 8% and no users of Elekta Machine QA. A majority of users found their MIQC to be easy to use, reliable, and had five or more years of experience. Most users reported occasions of discrepancy in results between MIQC and conventional testing, but the majority considered this acceptable, indicating a false reporting frequency of quarterly or less. MIQC has shown value in preventative maintenance and early detection of machine deviations. There were inconsistent approaches in the utilisation and commissioning tests performed. Fewer than half of users perform QC of MIQC. 45% of responders have modified their QC processes with the introduction of MIQC, via replacement of conventional tests or reduction in their frequency. Future guidance is recommended to assist in the implementation of MIQC.

Using the Manufacturer's Instructions for Use and Spaulding Classification System to Assess Disinfection Practices for Ultrasound Transducers in the Perioperative Setting.

Proper use and disinfection of medical devices and instruments is essential to preventing infection and providing safe patient care. Because of an increase in the complexity of medical devices and patient interventions, it has become more difficult for perioperative staff members to ensure that equipment is properly used and disinfected according to the manufacturer's instructions for use and the Spaulding classification system. One type of medical device that may have multiple clinical uses is the ultrasound transducer. In the perioperative setting, ultrasound transducers can be used for surface, percutaneous, and endocavitary procedures. They also may be used at multiple times before, during, and after a procedure, which may make it challenging for perioperative staff members to know the correct disinfection practice. They should use the device's instructions for use and the Spaulding classification system to guide their clinical practice.

Adverse Events and Subsequent Management Associated With Eustachian Tube Balloon Dilation.

Objective: Eustachian tube balloon dilation is a minimally invasive technique used to improve persistent Eustachian tube dysfunction. Currently, the US Food and Drug Administration (FDA) has approved the use of balloon dilation devices produced by three manufacturers, but little is known about associated adverse events and subsequent management. Study Design: Case series. Setting: FDA Manufacturer and User Facility Device Experience (MAUDE) database. Methods: Reports submitted to the FDA using the MAUDE database searched from January 2000 to July 2022 were analyzed for adverse events and management. Results: A total of 13 adverse events were found in the database. Subcutaneous emphysema (n = 8) was the most common event. Other less frequent events included patulous Eustachian tube (n = 2), vascular dissection (n = 1), nasopharyngeal mucocele (n = 1), and tinnitus (n = 1). A majority of patients who experienced subcutaneous emphysema received antibiotics (n = 5) and were admitted to the hospital (n = 4). The patient with a carotid dissection 7 days postprocedure presented with a stroke and fully recovered after stent placement. There was limited preprocedure information in the MAUDE database. There were 2 patients who did not fully recover after a complication. Three patients underwent corrective surgical interventions. No one company had more associated adverse events reported. Conclusion: Subcutaneous emphysema is the most common adverse event after Eustachian tube dilation. Further studies exploring potential balloon dilation adverse events to allow for better patient counseling are warranted.

The Rubik's Cube of Manufacturers' Coupons: Making the Case for Sneetches.

Description Asthma maintenance inhalers are inordinately expensive, inhibiting patients from affording their medication and compromising compliance and adherence and optimal health outcomes. The objective of this article was to examine and highlight the competitive world and challenged opportunity of manufacturers' coupons discounting the inordinate cost of respiratory inhalers and asthma treatment. The cost of asthma treatment, in particular the cost of respiratory medicines, even with health insurance, can be prohibitive (upwards of $700 per month for one inhaler). Medication costs restrict medication access. Compliance and adherence suffer attested by monthly maintenance inhalers being filled less than 50% of the time. Pharmaceutical manufacturers of branded drugs competitively offer and market discount programs designed to help offset out-of-pocket medication (copay or coinsurance) costs. However, these programs vary depending on the manufacturer and are contingent on the parameters of individual insurance plans and their respective pharmacy benefit managers (PBMs). In an attempt to gain market advantage, manufacturers, coupons frequently change criteria making the opportunity of savings for patients and prescribing clinicians difficult to discern, implement and sustain.

The changing landscape of semiconductor manufacturing: why the health sector should care.

As semiconductor devices become increasingly ubiquitous in healthcare, the health sector has in turn grown highly dependent on the semiconductor industry. This relationship is not always symbiotic, and even mild turbulence in the semiconductor industry has the potential to derail patient care. Here, we introduce semiconductor manufacturing and discuss political and economic forces that will shape the industry for years to come. The uncertain outlook for semiconductors underscores the need for stakeholder collaboration to ensure an adequate supply of semiconductor-utilizing medical devices for the patients of today and tomorrow.