Communication to Stakeholders
1.1 On 01 June 2017, the President of the Republic of South Africa signed into effect Amendment Act 72 of 2008 (and effectively therefore also Amendment Act 14 of 2015), which broadened the regulatory scope of the Medicines and Related Substances Act, 1965 (Act 101 of 1965; the “Act”), to include the regulation of medical devices.
Man’s earliest attempt to provide lighting for tasks began in prehistoric times with the use of fire for illumination. From burning pine knots to lighting walking paths to using a wick in a Grecian lamp, the technology of illumination progressed slowly. After many injuries and accidents with oil and gas lamps, Thomas Alva Edison developed the first practical incandescent lamp in 1879. Since then, lighting technology using artificial light sources has steadily improved.
Maintaining Sterility During Transport and Storage
Utmost care is taken in the CSSD to clean, check, assemble, pack and sterilize instruments sets, bowl packs, gown packs and linen. It is essential that these items are then transported and stored in such a manner as to maintain sterility. According to Nancy Chobin, sterility maintenance is directly affected by packaging materials, storage methods and conditions, handling practices, and methods of distribution.1
KEN has developed KEN NetCom, an innovative, network-based software that ensures easy and reliable communication between users and technical staff with the machines to which the system is selected. KEN NetCom appears as a website on the online PCs and therefore software must not be installed on the department or institution’s own PCs.
KEN XML Connect
Another option is to get the machine to deliver a continuous data stream to a larger system. More and more large hospitals invest in quality assurance systems where data is gathered from many different types of machines. These machine types can be washing machines, autoclaves, x-ray equipment, scanners, dishwashers, etc.
Such a system, typically consisting of one or more computers connected to a large server, is a solution that accommodates the user’s interest in presenting all the collected data in a particular way. Therefore, KEN has chosen XML standard communication for these major systems.
Reusable surgical instruments are subjected to a decontamination process. Which means they are cleaned, inspected, packaged, sterilized transported and stored after every use on a patient. The purpose of the packaging system is to keep the instruments sterile until they are used, and to allow them to be opened aseptically when they are used. The international standard ISO 11607-1 describes the requirements for sterile barrier systems (packaging), while the ISO 11607-2 standard describes validation of packaging processes. This standard is applicable to the medical industry, to health care facilities (hospitals, doctors and dentists).
Much has been written about the transition of OR lighting away from traditional incandescent technology to LED technology. By now, some of the advantages of LED roll off the tongue; less heat, longer life, better energy efficiency. But these advantages are just the beginning.
If the point of new technology is to provide better patient outcomes, only one of these often stated advantages, less heat, directly applies. LEDs radiate much less heat than incandescent bulbs, so the surgeon and staff are more comfortable important during long cases). And cooler light means less heat in the surgical field, reducing the risk of drying out exposed tissue. There are several other advantages of LED lighting, beyond reducing heat, that have direct clinical benefits.
Healthcare workers in the operating room are exposed to radiation during a multitude of surgical procedures as visualisation may be required in orthopaedics, neurology, urology and cardiothoracic surgery. New technologies and techniques have allowed clinicians to perform complex diagnostic and interventional procedures. Exposure to radiation in the operating room often occurs during the taking of standard x-rays and during fluoroscopy, often incorporating the use of a C-arm. Read more
Medical devices/surgical instruments are used throughout the hospital to perform procedures on patients on a daily basis. These procedures are performed in theatre, the ward, maternity and doctors rooms. Contaminated devices need to be transported safely to the CSSD to be decontaminated. Contaminated devices should be transported in a manner that will ensure the safety of the staff and other patients. For this reason it is best to transport contaminated devices in closed, durable, and easy to decontaminate trolleys. It is not acceptable to transport contaminated items on open trolleys only covered with a piece of linen. Linen is not impermeable and will not contain pathogenic soils and microorganisms. Read more
A needle stick (NSI) injury can be defined as an accidental skin penetration wound caused by a suture needle or a hallow bore needle. A sharps injury (SI) is a skin penetrating wound caused by a sharp device like a scalpel, trocar, scissors, drill bit, broken glass or a saw blade. Blood and body fluid exposure occurs when a splash of these fluids comes into contact with skin or mucous membranes. Operating room nurses are continuously at risk for a needle stick or sharps injuries and blood or body fluid splashes as a result of the nature of the work they do. Read more