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The practice of reusing medical devices labeled for only one use began in hospitals in the late 1970s. [8] After a thorough review by the U.S. FDA in 1999 and 2000, [8] the agency released a guidance document for reprocessed SUDs that began regulating the sale of these reprocessed devices on the market, [9] under the condition that third-party reprocessors would be treated as the manufacturer ...
To date, 1299 hospitals in India have achieved accreditation by NABH. [9] In public hospitals, Gandhinagar General hospital was the first to get NABH accreditation in 2009. Standards↵, ↵The NABH standards 4th edition standards are documented in 10 chapters, which are as follows: Access, Assessment, and Continuity of Care; Care of Patients (COP)
"Comparison of Joint Commission and Healthcare Facilities Accreditation Program (HFAP) Emergency-Related Standards for Hospitals" (PDF). American Health Lawyers Association. Barabas, MC (Sep 2002). "Healthcare facilities accreditation program: the recognized alternative to the joint commission on accreditation of healthcare organizations".
Ministries of health in several sub-Saharan African countries, including Zambia, Uganda, and South African, were reported to have begun planning health system reform including hospital accreditation before 2002. However, most hospitals in Africa are administered by local health ministries or missionary organizations without accreditation programs.
ISO 14644 Standards were first formed from the US Federal Standard 209E Airborne Particulate Cleanliness Classes in Cleanrooms and Clean Zones. The need for a single standard for cleanroom classification and testing was long felt. After ANSI and IEST petitioned to ISO for new standards, the first document of ISO 14644 was published in 1999, ISO ...
Medical device is not to be for a use in supporting or sustaining human life, for a use which is of substantial importance in preventing impairment of human health, and does not present a potential unreasonable risk of illness or injury. Class II - Performance Standards for devices considered as moderate risks for human use.
A number have deeming power for Medicare and Medicaid.. American Association for Accreditation of Ambulatory Surgery Facilities [2] (AAAASF); Accreditation Association for Ambulatory Health Care (AAAHC)
In Division 2, the Knox-Keene Health Care Service Plan Act of 1975 in Division 2. Chapter 2.2., 1340 - 1399.864, [13] which is enforced by the California Department of Managed Health Care and regulates most health insurance in California, although some plans are regulated by the California Department of Insurance (CDI) with sometimes similar "companion" statutes in the California Insurance ...