Fact Sheet Global Atlas of medical devices
MINISTERIAL ORDER Nº 002/17/10/TC OF 27/10/2017 DETERMINING THE FEES FOR REGISTRATION OF PHARMACEUTICAL PRODUCTS, MEDICAL DEVICES AND OTHER RELATED SERVICES | Official Gazette nº 46 of 13/11/2017
Decontamination of medical devices plays an important role in the prevention of health care-associated infections. It includes cleaning, disinfection and/or sterilization. The processes involved in decontamination are complex, require specific infrastructure and equipment, and involve several sequen...tial steps that need to be performed correctly – from device collection and receipt by the decontamination unit to processing, storage and distribution throughout the facility. Quality control procedures (such as validation) at each step of the decontamination process are of the utmost importance to ensure the correct functioning of the equipment and processes. This aide-memoire presents a concise overview of important advice and key elements at a glance.
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This guideline aims to improve the quality of donations and the management thereof and serve as the basis for policies of the State and other organizations in the giving and receiving of donations of medicines, medical devices and IVDs.
Over the last three or four decades, there has been an enorm...ous increase in scientific knowledge about the mode of action, effects and side effects of medicines, medical devices and IVDs. It is important for all
stakeholders to understand that these products have both benefits and risks, that they have to be used carefully and appropriately and that some can do more harm than good.
There are many different scenarios for the donation of medicines, medical devices and IVDs. Donations may take place in acute emergencies or as part of development aid in non-emergency situations. They may involve donations (i.e. direct or through private voluntary organizations), aid by governments or persons authorized to sell medicines, medical devices and/or IVDs.
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The decontamination of instruments and medical devices plays a very important role in the prevention of health care-associated infections (HAIs). Indeed, improper decontamination of surgical instruments, endoscopic devices, respiratory care devices and reusable haemodialysis devices still occurs in ...many settings, leading to HAIs. This course is based on the WHO manual on decontamination and reprocessing of medical devices for health care facilities, as well as in collaboration with the US CDC.
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Globally, 311,000 women die of cervical cancer every year, 85 percent of them
in resource limited regions of the world. To address this grave threat to women,
the WHO made a call to action in 2018, resulting in accelerated plans to improve
cervical cancer control under the elimination threshold w...ith respect to cervical
cancer incidence. As part of WHO’s approach to cervical cancer control, availability of high quality,
affordable medical devices for HPV screening, and treatment of precancerous
lesions in low resource settings is indispensable.
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Document No. : FDA/SMC/CTD/GL-CCT/2013/01
Successful detonation of an improvised nuclear device (IND) would be a catastrophic event, causing an unprecedented number of injuries and lives lost, as well as economic, political, and social disruption. However, an effective medical response and an infrastructure prepared to protect itself from f...allout could save tens of thousands of lives. Since 2001, all levels of government, academic institutions, and professional organizations have done significant work to enhance our ability to prepare for and respond to a nuclear detonation. The following manual is intended to simplify and translate the necessary protective actions and medical response modalities in order to make them more accessible and easier to translate into practice. The approach of this manual is to provide a common baseline application for various allied response disciplines (to include senior operational responders, emergency managers, public health advisors, and municipal, State, and Federal executives and elected officials). This manual will enhance mutual understanding of the basics of nuclear response.
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This collection of posters are intended for health care workers, biomedical engineers and staff of health facilities in charge of caring, cleaning, decontaminating and sterilizing respiratory medical equipment in hospitals and health facilities. They include checklists to ensure the optimal infectio...n prevention and control during their use and between patients.
They describe the procedures to follow (Checklists) to clean, decontaminate and sterilize different respiratory devices:
Oxygen concentrators,
Non-invasive mechanical ventilation equipment: High flow nasal cannula, BiPAP/CPAP,
Mechanical ventilators,
Pulse oximeters and monitors.
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Following a radiation incident such as an improvised nuclear device (IND) detonation, state and local response authorities will need to establish one or more population monitoring and decontamination facilities to assess
people for radioactive exposure, contamination, and the need for
decontamin...ation or other medical follow-up. These facilities are known as community reception centers (CRCs). The basic services offered at a CRC include the following: screening people for radioactive contamination, assisting people with washing or decontamination, registering people for subsequent follow-up, and prioritizing people for further care. This guide
describes the function of each station of a CRC and provides a question bank and other information to guide data collection at each station. A question bank format was chosen to provide the user the ability to tai
lor the data collection tool to fit a particular incident and/or locality.
The CRC data collection tool is designed for CRC staff to fill out the information collected from the individual being assessed.
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This collection of posters are intended for health care workers, biomedical engineers and staff of health facilities in charge of caring, cleaning, decontaminating and sterilizing respiratory medical equipment in hospitals and health facilities. They include checklists to ensure the optimal infectio...n prevention and control during their use and between patients.
They describe the procedures to follow (Checklists) to clean, decontaminate and sterilize different respiratory devices:
Oxygen concentrators,
Non-invasive mechanical ventilation equipment: High flow nasal cannula, BiPAP/CPAP,
Mechanical ventilators,
Pulse oximeters and monitors.
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MedPPE emphasizes the role and timing of health workers jobs and offers specific information to prevent the spread of COVID-19. The guidelines are aimed at all personnel working in health facilities, including security guards, administrative and cleaning personnel, transfer assistants, nurses, biome...dical and imaging technicians, surgeons, and physicians, among others.
MedPPE provides guidance for the use of PPE according to workers’ function, the level of care they provide, and the multiple environments of primary health care and hospitals. The tool also clarifies the type of PPE needed when performing aerosol-generating procedures and other activities related to the care of patients infected or suspected of being infected with COVID-19.
However, use of PPE alone is not enough to protect against COVID-19. Hand hygiene and proper PPE dressing and undressing procedures must also be followed, along with the proper disposal and management of waste.
MedPPE is available in Spanish, English, Portuguese and French for iOS and Android devices.
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A pulse oximeter is a small device that can typically be clipped on a finger (toe or earlobe is also possible) to measure oxygen levels in the blood.
This works completely painless and will give you a reading within a few seconds.
Asthma is the most common chronic illness of childhood. The prevalence is rising and the mortality and morbidity from asthma are unacceptably high in South Africa. This article emphasizes the importance to make a correct diagnosis based, most importantly, on the clinical history and supported by inv...estigations. Further, the appropriate drug and device must be chosen to achieve good asthma control. It explains that patients must be followed up regularly and their asthma control must be assessed so that the treatment can then be adjusted according to the level of control. Additionally, Asthma education and adherence are important components of management of the condition.
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Asthma is a heterogeneous condition characterised by chronic inflammation and variable expiratory airflow limitation, with airway reversibility. Management of chronic inflammation with anti-asthma medication improves asthma control and quality of life. The aim of this journal is to provide an eviden...ce-based approach for chronic asthma management in young children and adolescents and provide guidance on the use of new asthma drugs in children.
For that, the South African Childhood Asthma Working Group (SACAWG) convened in January 2017. The asthma treatment task group reviewed the available scientific literature and international asthma treatment guidelines. The evidence was then graded according to the Grades of Recommendation Assessment, Development and Evaluation (GRADE) system and recommendations were made based on scientific evidence and local context. Asthma management recommendations were made for children ˂6 years of age and older children and adolescents, as well as for stepping up and stepping down of therapy. This review does not include biologics or novel asthma drugs, which are covered in another CME article in this edition of SAMJ.
The final conclusions are that it is important to ensure good response, treatment and adherence, type of medication, device and checking of technique are all critical. Stepping up of therapy should be done only after ensuring good adherence and technique. Once therapeutic response is achieved, medication administration has to be stepped down to improve ease of use and avoid unnecessary side-effects.
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