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Biomedical Instrumentation & Technology 2023Cleaning is essential to ensuring the safe processing of reusable medical devices, and most manufacturers' instructions for use (IFUs) specify that clinical soil should...
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. 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. 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. 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? 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.
Topics: Equipment Reuse; Disinfection; Equipment and Supplies
PubMed: 37343068
DOI: 10.2345/0899-8205-57.2.44 -
International Journal of Radiation... Jun 2017To analyze all recalls involving radiation oncology devices (RODs) from the US Food and Drug Administration (FDA)'s recall database, comparing these with non-radiation...
PURPOSE
To analyze all recalls involving radiation oncology devices (RODs) from the US Food and Drug Administration (FDA)'s recall database, comparing these with non-radiation oncology device recalls to identify discipline-specific trends that may inform improvements in device safety.
METHODS AND MATERIALS
Recall data on RODs from 2002 to 2015 were sorted into 4 product categories (external beam, brachytherapy, planning systems, and simulation systems). Outcomes included determined cause of recall, recall class (severity), quantity in commerce, time until recall termination (date FDA determines recall is complete), and time since 510(k) approval. Descriptive statistics were performed with linear regression of time-series data. Results for RODs were compared with those for other devices by Pearson χ test for categorical data and 2-sample Kolmogorov-Smirnov test for distributions.
RESULTS
There were 502 ROD recalls and 9534 other class II device recalls during 2002 to 2015. Most recalls were for external beam devices (66.7%) and planning systems (22.9%), and recall events peaked in 2011. Radiation oncology devices differed significantly from other devices in all recall outcomes (P≤.04). Recall cause was commonly software related (49% vs 10% for other devices). Recall severity was more often moderate among RODs (97.6% vs 87.2%) instead of severe (0.2% vs 4.4%; P<.001). Time from 510(k) market approval to recall was shorter among RODs (P<.001) and progressively shortened over time. Radiation oncology devices had fewer recalled devices in commerce than other devices (P<.001).
CONCLUSIONS
Compared with other class II devices, RODs experience recalls sooner after market approval and are trending sooner still. Most of these recalls were moderate in severity, and software issues are prevalent. Comprehensive analysis of recall data can identify areas for device improvement, such as better system design among RODs.
Topics: Brachytherapy; Chi-Square Distribution; Databases, Factual; Equipment and Supplies; Linear Models; Medical Device Recalls; Product Surveillance, Postmarketing; Radiation Oncology; Radiotherapy Planning, Computer-Assisted; Software; Statistics, Nonparametric; Time Factors; United States; United States Food and Drug Administration
PubMed: 28463163
DOI: 10.1016/j.ijrobp.2017.02.006 -
Missouri Medicine 2017
Comparative Study Review
Topics: Device Approval; Equipment and Supplies; Europe; Government Regulation; Health Care Sector; Health Services Accessibility; History, 20th Century; Humans; Medical Device Legislation; Patient Advocacy; Patient Care; Physicians; United States
PubMed: 30228612
DOI: No ID Found -
Bulletin of the World Health... Mar 2020Rapid growth in the use of medical devices has drawn attention to gaps in the systematic monitoring of medical device-associated adverse events in India.
PROBLEM
Rapid growth in the use of medical devices has drawn attention to gaps in the systematic monitoring of medical device-associated adverse events in India.
APPROACH
Implementation of national regulations on medical devices started in January 2018. Supported by a nationwide network of monitoring centres, the Indian Pharmacopoeia Commission coordinates adverse event reports from manufacturers, legal representatives and patients or users. The commission follows-up and reviews reports with subject expert groups and sends recommendations on necessary action to the national regulatory authority.
LOCAL SETTING
Before 2015, no systematic structure was in place to collate adverse events associated with medical devices. Several reports of deaths and hospitalization due to faulty hip implants, cardiac stents and poor-quality devices prompted the health ministry to launch the materiovigilance programme.
RELEVANT CHANGES
From July 2015 to October 2019, the commission received 1931 adverse event reports, mostly from marketing authorization holders; 1277 were serious events. Reporting increased markedly after 2017. Cardiac stents were the most reported device (926 events; 47.95%). To encourage a culture of reporting, the commission has raised awareness about the programme among stakeholders, developed user-friendly reporting tools and guidelines, and conducted training for hospital personnel on medical device adverse event reporting.
LESSONS LEARNT
Regular training to stakeholders develops a sense of responsibility towards reporting medical device adverse events and ensures quality data reporting. Reporters must be assured that reporting adverse events does not have any legal implications for them and given acknowledgement of their role in high-quality device associated adverse event reporting.
Topics: Equipment Safety; Equipment and Supplies; Humans; India; Mandatory Reporting; Product Surveillance, Postmarketing; Registries; Safety Management
PubMed: 32132755
DOI: 10.2471/BLT.19.232785 -
CMAJ : Canadian Medical Association... Jun 2021
Topics: Defibrillators, Implantable; Equipment and Supplies Utilization; Humans
PubMed: 34099469
DOI: 10.1503/cmaj.210327 -
Applied Psychophysiology and Biofeedback Mar 2019Neurofeedback is a well-investigated treatment for ADHD and epilepsy, especially when restricted to standard protocols such as theta/beta, slow cortical potentials and... (Review)
Review
Neurofeedback is a well-investigated treatment for ADHD and epilepsy, especially when restricted to standard protocols such as theta/beta, slow cortical potentials and sensori-motor rhythm neurofeedback. Advances in any field are welcome and other techniques are being pursued. Manufacturers and clinicians are marketing 'superior' neurofeedback approaches including 19 channel Z-score neurofeedback (ZNFB) and 3-D LORETA neurofeedback (with or without Z-scores; LNFB). We conducted a review of the empirical literature to determine if such claims were warranted. This review included the above search terms in Pubmed, Google scholar and any references that met our criteria from the ZNFB publication list and was restricted to group based studies examining improvement in a clinical population that underwent peer review (book chapters, magazine articles or conference presentations are not included since these are not peer reviewed). Fifteen relevant studies emerged with only six meeting our criterion. Based on review of these studies it was concluded that empirical validation of these approaches is sorely lacking. There is no empirical data that supports the notion that 19-channel z-score neurofeedback is effective or superior. The quality of studies for LNFB was better compared to ZNFB and some suggestion for efficacy was demonstrated for ADHD and Tinnitus distress. However, these findings need to be replicated, extended to other populations and have yet to show any "superiority." Our conclusions continue to emphasize the pervasive lack of evidence supporting these approaches to neurofeedback and the implications of this are discussed.
Topics: Attention Deficit Disorder with Hyperactivity; Electroencephalography; Equipment and Supplies; Evidence-Based Medicine; Humans; Neurofeedback
PubMed: 30255461
DOI: 10.1007/s10484-018-9420-6 -
Clinical Pharmacology and Therapeutics Apr 2020A wide range of analytic and data sharing options are available in nonexperimental multidatabase studies designed to assess the real-world benefits and risks of medical... (Comparative Study)
Comparative Study Review
A wide range of analytic and data sharing options are available in nonexperimental multidatabase studies designed to assess the real-world benefits and risks of medical products. Researchers often consider six scientific domains when choosing among these options-study design, exposure type, outcome type, covariate summarization technique, covariate adjustment method, and data sharing approach. This article reviews available analytic and data sharing options and discusses key scientific and practical considerations when choosing among these options in multidatabase studies of comparative effectiveness and safety of medical products. The scientific considerations must be balanced against what the data-contributing sites are able or willing to share. While pooling of person-level data sets remains the most familiar and analytically flexible approach, newer analytic and data sharing approaches that share less granular summary-level information may be equally valid and preferred in some multidatabase studies, especially when sharing of person-level data is challenging or infeasible.
Topics: Data Collection; Data Interpretation, Statistical; Databases, Factual; Equipment and Supplies; Humans; Information Dissemination; Treatment Outcome
PubMed: 31869442
DOI: 10.1002/cpt.1754 -
Value in Health : the Journal of the... Jan 2022For medical devices, a usability assessment is mandatory for market access; the objective is to detect potentially harmful use errors that stem from the device's design....
OBJECTIVES
For medical devices, a usability assessment is mandatory for market access; the objective is to detect potentially harmful use errors that stem from the device's design. The manufacturer assesses the final version of the device and determines the risk-benefit ratio for remaining errors. Nevertheless, the decision rule currently used to determine the sample size for this testing has statistical limitations and the lack of a clear decision-making perspective.
METHODS
As an alternative, we developed a value-of-information analysis from the medical device manufacturer's perspective. The consequences of use errors not detected during usability testing and the errors' probability of occurrence were embedded in a loss function. The value of further testing was assessed as a reduction in the expected loss for the manufacturer. The optimal sample size was determined using the expected net benefit of sampling (ENBS) (the difference between the value provided by new participants and the cost of their inclusion).
RESULTS
The value-of-information approach was applied to a real usability test of a needle-free adrenaline autoinjector. The initial estimate (performed on the first n = 20 participants) gave an optimal sample size of 100 participants and an ENBS of €255 453. This estimation was updated iteratively as new participants were included. After the inclusion of 90 participants, the ENBS was null for any sample size; hence, the cost of adding more participants outweighed the expected value of information, and therefore, the study could be stopped.
CONCLUSIONS
On the basis of these results, our method seems to be highly suitable for sample size estimation in the usability testing of medical devices before market access.
Topics: Cost-Benefit Analysis; Equipment and Supplies; Humans; Research Design; Sample Size; Technology Assessment, Biomedical
PubMed: 35031090
DOI: 10.1016/j.jval.2021.07.010 -
Anesthesiology Sep 2020Automated medical technology is becoming an integral part of routine anesthetic practice. Automated technologies can improve patient safety, but may create new workflows... (Review)
Review
Automated medical technology is becoming an integral part of routine anesthetic practice. Automated technologies can improve patient safety, but may create new workflows with potentially surprising adverse consequences and cognitive errors that must be addressed before these technologies are adopted into clinical practice. Industries such as aviation and nuclear power have developed techniques to mitigate the unintended consequences of automation, including automation bias, skill loss, and system failures. In order to maximize the benefits of automated technology, clinicians should receive training in human-system interaction including topics such as vigilance, management of system failures, and maintaining manual skills. Medical device manufacturers now evaluate usability of equipment using the principles of human performance and should be encouraged to develop comprehensive training materials that describe possible system failures. Additional research in human-system interaction can improve the ways in which automated medical devices communicate with clinicians. These steps will ensure that medical practitioners can effectively use these new devices while being ready to assume manual control when necessary and prepare us for a future that includes automated health care.
Topics: Anesthesiology; Automation; Equipment and Supplies; Humans; Medical Records; Operating Rooms; Patient Safety
PubMed: 32472805
DOI: 10.1097/ALN.0000000000003385 -
BMC Medical Education Apr 2020Interactions between pharmaceutical and medical device industries and students can lead to commercial influences on educational messages, with a potential to bias future...
BACKGROUND
Interactions between pharmaceutical and medical device industries and students can lead to commercial influences on educational messages, with a potential to bias future treatment choice. This is the first study in the Baltic countries describing exposure and attitudes of medical, pharmacy and nursing students towards cooperation with industry.
METHODS
A cross-sectional on-line survey of current medical, pharmacy and nursing students (n = 918) in three Baltic countries was carried out.
RESULTS
We found that most students participate in events organized or sponsored by industry and accept a range of gifts and benefits. Students in the Baltic countries consider cooperation with industry important; at the same time, most do not feel that they have sufficient training on how to ethically interact with pharmaceutical and medical device companies and believe that these interactions can influence their prescribing or dispensing patterns. There is a tendency to rationalize cooperation with industry by referring to the current economic situation and patient benefits. Pharmacy students have higher rates of participation and they accept gifts and other benefits more often than nursing or medical students; therefore, they are likely to be more vulnerable to potential industry influence.
CONCLUSIONS
The findings highlight the need to include topics on ethics and conflicts of interests in cooperation with industry in curriculum of health care students in Baltic countries. Without proper training, students continue to be at risk to industry influence and may develop habits for their further practice differing from evidence-based practice in prescribing and dispensing of medicines, as well as use of medical devices.
Topics: Attitude of Health Personnel; Cross-Sectional Studies; Curriculum; Drug Industry; Equipment and Supplies; Estonia; Humans; Interprofessional Relations; Latvia; Lithuania; Students, Health Occupations
PubMed: 32252743
DOI: 10.1186/s12909-020-02008-5