Displaying publications 1 - 20 of 29 in total

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  1. [Asian Harmonization Working Party (AHWP) report]
    Takahashi S
    Nihon Hoshasen Gijutsu Gakkai Zasshi, 2014 Apr;70(4):416-7.
    PMID: 24759223
    Matched MeSH terms: Equipment and Supplies/standards*
  2. Evaluating applied security controls for safeguarding medical device-integrated electronic medical records
    Alhammad A, Yusof MM, Jambari DI
    J Eval Clin Pract, 2025 Feb;31(1):e14140.
    PMID: 39297411 DOI: 10.1111/jep.14140
    RATIONALE, AIMS, AND OBJECTIVES: Medical device-integrated electronic medical records (MDI-EMR) pose significant challenges in ensuring effective usage, data security and patient safety. The complexities of MDI-EMR necessitate applying various security mechanisms to safeguard against cyber threats. Therefore, we evaluated cyber threats to MDI-EMR and the effectiveness of applied security controls using a proposed framework from sociotechnical and risk assessment perspectives.

    METHOD: We conducted a qualitative case study evaluation in a general hospital in Saudi Arabia using interviews, observation, and document analysis from the perspectives of major MDI-EMR stakeholders, including healthcare providers, IT professionals and cybersecurity specialists.

    RESULTS: The results showed the interplay among physical, technical and administrative security controls that maintained a secure posture of MDI-EMR. The effectiveness of security controls is highly influenced by the staff's cybersecurity awareness and training. The perceived effectiveness of security controls varied among users, with some expressing satisfaction with the ease of use and reliability, while others highlighting challenges such as password complexity and access procedures. Understanding these diverse perspectives is crucial for tailoring security measures to meet the needs of different stakeholders effectively.

    CONCLUSION: Collaboration among the key stakeholders is crucial for implementing security controls for MDI-EMR. Balancing security measures with usability concerns is essential, as highlighted by challenges in implementing technical controls. A comprehensive approach encompassing physical, technical and administrative controls, continuous education and awareness initiatives are significant to empower staff in recognising and mitigating cyber threats effectively to safeguard medical data and ensure the integrity of healthcare systems.

    Matched MeSH terms: Equipment and Supplies/standards
  3. Fulltext The application study of harmonization code in medical device adverse event reporting
    Choi SJ, Choi S, Park S, Nam KC, Jang HJ, Kim JK, et al.
    BMC Health Serv Res, 2024 Nov 14;24(1):1402.
    PMID: 39543640 DOI: 10.1186/s12913-024-11885-1
    BACKGROUND: The reporting of adverse events in medical devices (MD) is a starting point of post-market surveillance and the most common source of initial safety signals. Because MD adverse events (AE) occur globally and involve high-profile international public health crises, international regulators implanted standard codes for MDAE reporting. This study aimed to assess the application of MDAE terminology and codes by providing examples of virtual events.

    METHODS: An online survey was conducted among participants of the MD Training Program for Regulatory Authorities which provide International Medical Device Regulators Forum (IMDRF) adverse event terminology and codes, and six virtual MDAE cases.

    RESULTS: All 29 of the 72 participants were regulators. In all cases, most participants selected the broad (level 1) codes rather than the detailed (level 2 or level 3) codes. While responders selected a variety of codes for all annexes in case 1, over 50% of responders selected the intended codes in case 6. The codes for cause investigation were chosen more frequently than other annexes for device problem, components, and health effect. No differences were observed in code selection amongst different stakeholders.

    CONCLUSIONS: We identified the diversification in terminology and code selection for reporting MDAEs.

    Matched MeSH terms: Equipment and Supplies/adverse effects; Equipment and Supplies/standards
  4. Fulltext Energy harvesting for the implantable biomedical devices: issues and challenges
    Hannan MA, Mutashar S, Samad SA, Hussain A
    Biomed Eng Online, 2014;13:79.
    PMID: 24950601 DOI: 10.1186/1475-925X-13-79
    The development of implanted devices is essential because of their direct effect on the lives and safety of humanity. This paper presents the current issues and challenges related to all methods used to harvest energy for implantable biomedical devices. The advantages, disadvantages, and future trends of each method are discussed. The concept of harvesting energy from environmental sources and human body motion for implantable devices has gained a new relevance. In this review, the harvesting kinetic, electromagnetic, thermal and infrared radiant energies are discussed. Current issues and challenges related to the typical applications of these methods for energy harvesting are illustrated. Suggestions and discussion of the progress of research on implantable devices are also provided. This review is expected to increase research efforts to develop the battery-less implantable devices with reduced over hole size, low power, high efficiency, high data rate, and improved reliability and feasibility. Based on current literature, we believe that the inductive coupling link is the suitable method to be used to power the battery-less devices. Therefore, in this study, the power efficiency of the inductive coupling method is validated by MATLAB based on suggested values. By further researching and improvements, in the future the implantable and portable medical devices are expected to be free of batteries.
    Matched MeSH terms: Equipment and Supplies*
  5. Fulltext The urine bag used in pneumothorax
    Kuan YC, How SH, Yudisthra G, Ng TH, Fauzi M, Sapari S
    Med J Malaysia, 2008 Mar;63(1):79-80.
    PMID: 18935746 MyJurnal
    Pneumothorax is the presence of air in the pleural cavity. It can be classified into spontaneous, traumatic or iatrogenic. The majority of pneumothorax cases are spontaneous, which can be further classified into primary spontaneous pneumothorax (PSP) or secondary spontaneous pneumothorax (SSP), defined by the absence or presence of obvious underlying lung disease respectively. The treatment of spontaneous pneumothorax includes simple aspiration, intercostal tube drainage or surgical intervention. When intercostal tube drainage is used, it is usually attached to an underwater-seal system. Mobile chest drains, such as the Heimlich valve, replace the underwater-seal and allow outpatient management of spontaneous pneumothoraces. The Heimlich valve however, is costly and not readily available in many local hospitals. Cheaper and easily obtainable alternatives which are also safe are being sought. This is a case report describing the use of the urine bag in the management of a patient with spontaneous pneumothrax.
    Study site: Hospital Tengku Ampuan Afzan, Kuantan, Pahang, Malaysia.
    Matched MeSH terms: Equipment and Supplies, Hospital*
  6. Fulltext Order batching in warehouses by minimizing total tardiness: a hybrid approach of weighted association rule mining and genetic algorithms
    Azadnia AH, Taheri S, Ghadimi P, Saman MZ, Wong KY
    ScientificWorldJournal, 2013;2013:246578.
    PMID: 23864823 DOI: 10.1155/2013/246578
    One of the cost-intensive issues in managing warehouses is the order picking problem which deals with the retrieval of items from their storage locations in order to meet customer requests. Many solution approaches have been proposed in order to minimize traveling distance in the process of order picking. However, in practice, customer orders have to be completed by certain due dates in order to avoid tardiness which is neglected in most of the related scientific papers. Consequently, we proposed a novel solution approach in order to minimize tardiness which consists of four phases. First of all, weighted association rule mining has been used to calculate associations between orders with respect to their due date. Next, a batching model based on binary integer programming has been formulated to maximize the associations between orders within each batch. Subsequently, the order picking phase will come up which used a Genetic Algorithm integrated with the Traveling Salesman Problem in order to identify the most suitable travel path. Finally, the Genetic Algorithm has been applied for sequencing the constructed batches in order to minimize tardiness. Illustrative examples and comparisons are presented to demonstrate the proficiency and solution quality of the proposed approach.
    Matched MeSH terms: Equipment and Supplies*
  7. New Device for Intrinsic Hand Muscle Strength Measurement: An Alternative to Strain Gauge Handheld Dynamometer
    Madhanagopal J, Singh OP, Mohan V, Sathasivam KV, Omar AH, Abdul Kadir MR
    Eval Health Prof, 2019 03;42(1):103-113.
    PMID: 28868907 DOI: 10.1177/0163278717727568
    An accurate measurement of intrinsic hand muscle strength (IHMS) is required by clinicians for effective clinical decision-making, diagnosis of certain diseases, and evaluation of the outcome of treatment. In practice, the clinicians use Intrins-o-meter and Rotterdam Intrinsic Hand Myometer for IHMS measurement. These are quite bulky, expensive, and possess poor interobserver reliability (37-52%) and sensitivity. The purpose of this study was to develop an alternative lightweight, accurate, cost-effective force measurement device with a simple electronic circuit and test its suitability for IHMS measurement. The device was constructed with ketjenblack/deproteinized natural rubber sensor, 1-MΩ potential divider, and Arduino Uno through the custom-written software. Then, the device was calibrated and tested for accuracy and repeatability within the force range of finger muscles (100 N). The 95% limit of agreement in accuracy from -1.95 N to 2.06 N for 10 to 100 N applied load and repeatability coefficient of ±1.91 N or 6.2% was achieved. Furthermore, the expenditure for the device construction was around US$ 53. For a practical demonstration, the device was tested among 16 participants for isometric strength measurement of the ulnar abductor and dorsal interossei. The results revealed that the performance of the device was suitable for IHMS measurement.
    Matched MeSH terms: Equipment and Supplies/economics
  8. Preparation of emulsions by rotor-stator homogenizer and ultrasonic cavitation for the cosmeceutical industry
    Han NS, Basri M, Abd Rahman MB, Abd Rahman RN, Salleh AB, Ismail Z
    J Cosmet Sci, 2012 Sep-Oct;63(5):333-44.
    PMID: 23089355
    Oil-in-water (O/W) nanoemulsions play an important key role in transporting bioactive compounds into a range of cosmeceutical products to the skin. Small droplet sizes have an inherent stability against creaming, sedimentation, flocculation, and coalescence. O/W emulsions varying in manufacturing process were prepared. The preparation and characterization of O/W nanoemulsions with average diameters of as low as 62.99 nm from palm oil esters were carried out. This was achieved using rotor-stator homogenizer and ultrasonic cavitation. Ultrasonic cell was utilized for the emulsification of palm oil esters and water in the presence of mixed surfactants, Tween 80 and Span 80 emulsions with a mean droplet size of 62.99 nm and zeta potential value at -37.8 mV. Results were comparable with emulsions prepared with rotor-stator homogenizer operated at 6000 rpm for 5 min. The stability of the emulsions was evaluated through rheology measurement properties. This included non-Newtonian viscosity, elastic modulus G', and loss modulus G″. A highly stable emulsion was prepared using ultrasonic cavitation comprising a very small particle size with higher zeta potential value and G' > G″ demonstrating gel-like behavior.
    Matched MeSH terms: Equipment and Supplies
  9. An intensive care unit in a rural area
    Krishna SR
    Anaesth Intensive Care, 1975 May;3(2):122-6.
    PMID: 1155754
    Factors that governed the setting up of a multipurpose, temporary Intensive Care Unit of six beds, in a remote area of Malaysia and the experience of operating it for more than two and a half years are outlined.
    Matched MeSH terms: Equipment and Supplies, Hospital
  10. Fulltext Microwave bio-sensor based on symmetrical split ring resonator with spurline filters for therapeutic goods detection
    Alahnomi RA, Zakaria Z, Ruslan E, Ab Rashid SR, Mohd Bahar AA, Shaaban A
    PLoS One, 2017;12(9):e0185122.
    PMID: 28934301 DOI: 10.1371/journal.pone.0185122
    A novel symmetrical split ring resonator (SSRR) based microwave sensor with spurline filters for detecting and characterizing the properties of solid materials has been developed. Due to the weak perturbation in the interaction of material under test (MUT) and planar microwave sensor, spurline filters were embedded to the SSRR microwave sensor which effectively enhanced Q-factor with suppressing the undesired harmonic frequency. The spurline filter structures force the presented sensor to resonate at a fundamental frequency of 2.2 GHz with the capabilities of suppressing rejected harmonic frequency and miniaturization in circuit size. A wide bandwidth rejection is achieved by using double spurlines filters with high Q-factor achievement (up to 652.94) compared to single spurline filter. The new SSRR sensor with spurline filters displayed desired properties such as high sensitivity, accuracy, and performance with a 1.3% typical percentage error in the measurement results. Furthermore, the sensor has been successfully applied for detecting and characterizing solid materials (such as Roger 5880, Roger 4350, and FR4) and evidently demonstrated that it can suppress the harmonic frequency effectively. This novel design with harmonic suppression is useful for various applications such as food industry (meat, fruit, vegetables), biological medicine (derived from proteins and other substances produced by the body), and Therapeutic goods (antiseptics, vitamins, anti-psychotics, and other medicines).
    Matched MeSH terms: Electrical Equipment and Supplies
  11. Fulltext Prebiopsy localisation of impalpable breast lesions
    Hisham AN, Harjit K, Fatimah O, Yun SI
    Med J Malaysia, 2004 Aug;59(3):402-5.
    PMID: 15727388
    Prebiopsy localization of impalpable breast lesions (IBL) assures removal of suspicious mammographically detected lesions. Specimen radiograph of the excised specimen is mandatory to confirm complete excision. The aim of this study was to audit our series of percutaneous hookwire localization and to determine the positive biopsy rate of the mammographically detected impalpable breast lesion in our center. Thirty-eight patients with suspicious IBL underwent excision biopsy under mammographic localization in our unit from late February 1998 to May 2003. The excised specimen is immobilized and compressed within the Transpec device. This device incorporates a reference grid visible in the specimen radiograph. Hence, the target lesion marked in the reference grid of the specimen radiograph will allow precise examination and exact localization of the suspicious lesion by the pathologist. The positive biopsy rate for malignant lesion was 26.3%, the majority fall in the range of 40-59 age group. Thirty-two (84.2%) of the patients had clustered micro-calcifications, 4 (10.5%) had impalpable mass lesions and in 2 (5.3%) spiculated lesions were seen on the preoperative mammogram. Mammographic feature of clustered micro-calcification accounts for all the malignant lesions in our series. Utilization of Transpec device has shown to be practical, reliable and cost effective in the management of IBL. Nonetheless, it should be emphasized that optimal specimen radiography and pathological correlation requires close cooperation between radiologist, surgeon and pathologist.
    Matched MeSH terms: Equipment and Supplies/standards*
  12. The fundamentals of tissue engineering: new scaffolds
    Di Silvio L, Gurav N, Sambrook R
    Med J Malaysia, 2004 May;59 Suppl B:89-90.
    PMID: 15468832
    The ability to regenerate new bone for skeletal use is a major clinical need. In this study, two novel porous calcium phosphate materials pure HA and biphasic HA/beta-Tricalcium phosphate (HA/beta -TCP) were evaluated as potential scaffolds for cell-seeded bone substitutes using human osteoblast-like cells (HOS) and primary human mesenchymal stem cells (hMSCs). A high rate of proliferation was observed on both scaffolds. A greater increase in alkaline phosphatase (ALP- an indicator of osteoblast differentiation) was observed on HA/beta -TCP compared to HA. This observation indicates that HA/TCP may play a role in inducing osteoblastic differentiation. Although further evaluation is required both materials show potential as innovative synthetic substitutes for tissue engineered scaffolds.
    Matched MeSH terms: Equipment and Supplies/standards
  13. Testing the agreement of medical instruments: overestimation of bias in the Bland-Altman analysis
    Zaki R, Bulgiba A, Ismail NA
    Prev Med, 2013;57 Suppl:S80-2.
    PMID: 23313586 DOI: 10.1016/j.ypmed.2013.01.003
    The Bland-Altman method is the most popular method used to assess the agreement of medical instruments. The main concern about this method is the presence of proportional bias. The slope of the regression line fitted to the Bland-Altman plot should be tested to exclude proportional bias. The aim of this study was to determine whether the overestimation of bias in the Bland-Altman analysis is still present even when the proportional bias has been excluded.
    Matched MeSH terms: Equipment and Supplies/standards*
  14. Fulltext Streptomyces sp.-A Treasure Trove of Weapons to Combat Methicillin-Resistant Staphylococcus aureus Biofilm Associated with Biomedical Devices
    Pusparajah P, Letchumanan V, Law JW, Ab Mutalib NS, Ong YS, Goh BH, et al.
    Int J Mol Sci, 2021 Aug 28;22(17).
    PMID: 34502269 DOI: 10.3390/ijms22179360
    Biofilms formed by methicillin-resistant S. aureus (MRSA) are among the most frequent causes of biomedical device-related infection, which are difficult to treat and are often persistent and recurrent. Thus, new and effective antibiofilm agents are urgently needed. In this article, we review the most relevant literature of the recent years reporting on promising anti-MRSA biofilm agents derived from the genus Streptomyces bacteria, and discuss the potential contribution of these newly reported antibiofilm compounds to the current strategies in preventing biofilm formation and eradicating pre-existing biofilms of the clinically important pathogen MRSA. Many efforts are evidenced to address biofilm-related infections, and some novel strategies have been developed and demonstrated encouraging results in preclinical studies. Nevertheless, more in vivo studies with appropriate biofilm models and well-designed multicenter clinical trials are needed to assess the prospects of these strategies.
    Matched MeSH terms: Equipment and Supplies/adverse effects*; Equipment and Supplies/microbiology
  15. Guidelines on maintenance and operation of equipment in a pathology laboratory (version 1/2004)
    College of Pathologists, Academy of Medicine of, Malaysia
    Malays J Pathol, 2005 Jun;27(1):69-70.
    PMID: 16676697
    Matched MeSH terms: Equipment and Supplies
  16. World cup hockey
    Whitney S
    Physiotherapy, 1983 Nov;69(11):390-2.
    PMID: 6665077
    Matched MeSH terms: Equipment and Supplies
  17. Microbial colonization of medical devices and novel preventive strategies
    Shunmugaperumal T
    Recent Pat Drug Deliv Formul, 2010 Jun;4(2):153-73.
    PMID: 20236065
    Upon implantation or insertion into patient's body for exerting the intended purpose like salvage of normal functions of vital organs, the medical devices are unfortunately becoming the sites of competition between host cell integration and microbial adhesion. Moreover, since there is an increased use of implanted medical devices, the incidence of biofilm-and medical devices-related nosocomial infections is also increasing progressively. To control microbial colonization and subsequent biofilm formation of the medical devices, different approaches either to enhance the efficiency of certain antimicrobial agents or to disrupt the basic physiology of the pathogenic microorganisms including novel small molecules and antipathogenic drugs are being explored. In addition, the various lipid-and polymer-based drug delivery carriers are also investigated for applying antibiofilm coating of the medical devices especially over catheters. The main intention of this review is therefore to summarize the major and/breakthrough inventions disclosed in patent literature as well as in research papers related to microbial colonization of medical devices and novel preventive strategies. This review starts with an overview of the preventive strategies followed by a short description about the potential of different lipidic-and polymeric-drug delivery carriers in eradicating the biofilm-associated infections from the medical devices.
    Matched MeSH terms: Equipment and Supplies/microbiology*
  18. WHO partograph cuts complications of labour and childbirth
    Safe Mother, 1994 Jul-Oct;?(15):10.
    PMID: 12345820
    Matched MeSH terms: Equipment and Supplies*
  19. Hysterosalpingography -- a Malaysian experience
    Arumugam K, Ng KB
    Malays J Reprod Health, 1987 Dec;5(2):85-8.
    PMID: 12315186
    Matched MeSH terms: Equipment and Supplies*
  20. Female sterilization using Filshie clip in private practice
    Puraviappan, Hamid Arshat, Jaffar Ali
    Malays J Reprod Health, 1983 Jan;1(1):40-5.
    PMID: 12279888
    Matched MeSH terms: Equipment and Supplies*
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