PDF Price
$209.00
ADD TO CART
Essential Information for Healthcare Providers Managing Medical IT-Networks
Specifies consensus terms relating to medical device servicing and repair.
This document is directed toward those who are responsible for electrical safety in healthcare facilities.
Covers the reprocessing of hemodialyzers, including a brief history, the monitoring of patients and dialyzers, anticoagulation strategies, effects of reprocessing on solute clearances, personnel qualifications and training, the monitoring and prevention of disease transmission in reuse facilities, common pitfalls of reuse programs, continuous quality improvement, and Health Care Financing Administration regulation.
Covers the reprocessing of hemodialyzers, including a brief history, the monitoring of patients and dialyzers, anticoagulation strategies, effects of reprocessing on solute clearances, personnel qualifications and training, the monitoring and prevention of disease transmission in reuse facilities, common pitfalls of reuse programs, continuous quality improvement, and Health Care Financing Administration regulation.
The purpose of this recommended practice is to provide ergonomic information and human factors engineering guidance so that optimum user and patient safety, system safety and performance, and operator effectiveness will be reflected in medical device design.
The purpose of this recommended practice is to provide ergonomic information and human factors engineering guidance so that optimum user and patient safety, system safety and performance, and operator effectiveness will be reflected in medical device design.
Identifies the fundamental concepts and principles for creating, integrating, and implementing health IT software and health IT systems to maintain safety and effectiveness. (Provisional Standard)
This standard establishes labeling, safety, and performance requirements and referee tests for transcutaneous electrical nerve stimulators intended for use in the treatment of pain syndrome; also covered are labeling requirements for patient leads and electrodes. The standard includes an appendix providing labeling/user guidelines for TENS devices and an appendix providing the rationale for the provisions of the standard.
This standard establishes labeling, safety, and performance requirements and referee tests for transcutaneous electrical nerve stimulators (TENS) intended for use in the treatment of pain syndrome.
This standard establishes labeling, safety, and performance requirements and referee tests for transcutaneous electrical nerve stimulators intended for use in the treatment of pain syndrome; also covered are labeling requirements for patient leads and electrodes. The standard includes an appendix providing labeling/user guidelines for TENS devices and an appendix providing the rationale for the provisions of the standard.
This standard defines specific patient safety features that can be made available in compliant radiotherapy equipment, if and as applicable to that equipment. It provides a mechanism by which manufacturers can provide information to operators, responsible organizations, and regulators detailing how the specific features of the products that they offer comply with this standard or rationale as to why a specific provision might not apply to a particular product.
This standard defines a standard XML format for publishing and reporting the physical parameters of a C-Arm Radiation Therapy Linear Accelerator or the physical parameters in a software model of such a device.
The purpose of this guidance document is to help healthcare professionals prepare for an accrediting agency survey as it relates to the reprocessing of surgical instruments, endoscopes, and other reusable medical devices in any healthcare setting.
Introduces the reader to the basic principles of disinfection and sterilization science and then shows how this science is applied to develop and validate cleaning, disinfection, and sterilization processes.
This technical information report (TIR) covers the selection and use of protective apparel and surgical drapes. It includes information on types of protective materials, safety and performance characteristics of protective materials, product evaluation and selection, levels of barrier performance, and care of protective apparel and drapes. Definitions of terms and informative annexes are also provided.
This technical information report (TIR) covers the selection and use of protective apparel and surgical drapes. It includes information on types of protective materials, safety and performance characteristics of protective materials, product evaluation and selection, levels of barrier performance, and care of protective apparel and drapes. Definitions of terms and informative annexes are also provided.
This technical information report (TIR) is intended to assist health care personnel in the selection of protective apparel and drapes that are listed by and have received marketing clearance from the Food and Drug Administration (FDA). These products are classified as medical devices and are subject to FDA’s labeling, premarket notification (510[k]),1 and medical device reporting (MDR) regulations. In addition, under FDA’s quality system regulation (QSR), good manufacturing practices (GMPs) must be used in the manufacture and commercial reprocessing of these devices
Covers design considerations that medical device manufacturers should take into account to help ensure that their products can be safely and effectively reprocessed.
Includes the following topics : Design considerations: Assurance that a device can be safely and effectively reprocessed begins with the design of the device. Section 3 of the TIR describes categories of medical devices and the materials and other design characteristics that affect the ability of health care personnel to clean, disinfect, and/or sterilize devices adequately; Decontamination: A device cannot be disinfected adequately or sterilized to an adequate sterility assurance level (SAL) if it cannot be cleaned thoroughly. Section 4 addresses variables associated with cleaning and other decontamination processes used in health care facilities, as well as the minimum information that the device manufacturer should supply to health care personnel; Disinfection: Section 5 describes the levels of disinfection, the criteria for selecting chemical disinfectants, and the testing that device manufacturers should perform to establish the effectiveness of the disinfection processes recommended for their products; Sterilization: Section 6 describes the sterilization processes commonly used in health care facilities, the minimum information that device manufacturers should provide with their products, and the procedures that device manufacturers should use to qualify the sterilization parameters that they recommend
The AAMI TIR12 / ANSI/AAMI ST81 Set provides guidelines for designing, testing, and labeling reusable medical devices for reprocessing in health care facilities: A guide for device manufacturers and ANSI/AAMI/ISO ST81:2004/(R)2010, Sterilization of medical devices-Information to be provided by the manufacturer for the processing of resterilizable medical devices. AAMI TIR12 / ANSI/AAMI ST81 Set includes: AAMI TIR12:2010 ANSI/AAMI ST81:2004 (R2010)
This technical information report (TIR) covers design considerations that medical device manufacturers should take into account to help ensure that their products can be safely and effectively reprocessed. It also provides information on decontamination, cleaning, disinfection, and sterilization processes commonly used in health care facilities so that manufacturers can validate reprocessing procedures that can be recommended to and performed adequately in health care facilities. Labeling recommendations and information on applicable regulations are also provided in the TIR, as well as a bibliography and other informative annex. Redline version notes changes from 2004 edition.