121 STAT. 858 Audits.
PUBLIC LAW 110–85—SEPT. 27, 2007
‘‘(F) For the purpose of setting risk-based inspectional priorities, the Secretary shall accept voluntary submissions of reports of audits assessing conformance with appropriate quality systems standards set by the International Organization for Standardization (ISO) and identified by the Secretary in public notice. If the owner or operator of an establishment elects to submit audit reports under this subparagraph, the owner or operator shall submit all such audit reports with respect to the establishment during the preceding 2-year periods.’’; and (6) in paragraph (10)(C)(iii), by striking ‘‘based’’ and inserting ‘‘base’’. SEC. 229. STUDY OF NOSOCOMIAL INFECTIONS RELATING TO MEDICAL DEVICES.
(a) IN GENERAL.—The Comptroller General of the United States shall conduct a study on— (1) the number of nosocomial infections attributable to new and reused medical devices; and (2) the causes of such nosocomial infections, including the following: (A) Reprocessed single-use devices. (B) Handling of sterilized medical devices. (C) In-hospital sterilization of medical devices. (D) Health care professionals’ practices for patient examination and treatment. (E) Hospital-based policies and procedures for infection control and prevention. (F) Hospital-based practices for handling of medical waste. (G) Other causes. (b) REPORT.—Not later than 1 year after the date of the enactment of this Act, the Comptroller General shall complete the study under subsection (a) and submit to the Congress a report on the results of such study. (c) DEFINITION.—In this section, the term ‘‘nosocomial infection’’ means an infection that is acquired while an individual is a patient at a hospital and was neither present nor incubating in the patient prior to receiving services in the hospital. SEC. 230. REPORT BY THE FOOD AND DRUG ADMINISTRATION REGARDING LABELING INFORMATION ON THE RELATIONSHIP BETWEEN THE USE OF INDOOR TANNING DEVICES AND DEVELOPMENT OF SKIN CANCER OR OTHER SKIN DAMAGE.
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(a) IN GENERAL.—The Secretary of Health and Human Services (referred to in this section as the ‘‘Secretary’’), acting through the Commissioner of Food and Drugs, shall determine— (1) whether the labeling requirements for indoor tanning devices, including the positioning requirements, provide sufficient information to consumers regarding the risks that the use of such devices pose for the development of irreversible damage to the eyes and skin, including skin cancer; and (2)(A) whether modifying the warning label required on tanning beds to read, ‘‘Ultraviolet radiation can cause skin cancer’’, or any other additional warning, would communicate the risks of indoor tanning more effectively; or (B) whether there is no warning that would be capable of adequately communicating such risks.
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