| (iii) for collateral radiation in excess of the emission limits as described in Title 21, CFR, §1040.10, "CAUTION - HAZARDOUS ELECTROMAGNETIC RADIATION WHEN OPEN" and "CAUTION - HAZARDOUS X-RAY RADIATION" as applicable. (G) For protective housing or enclosures that provide a defeatable interlock, the words "and interlock defeated" shall be included in the labels specified in subparagraph (F)(i) and (ii) of this paragraph. (H) Other required information. (i) The word "invisible" shall immediately precede the word "radiation" on labels and signs required by this subparagraph for wavelengths of laser and collateral radiation that are outside of the range of 400 to 700 nm. (ii) The words "visible and invisible" shall immediately precede the word "radiation" on labels and signs required by this subparagraph for wavelengths of laser and collateral radiation that are both within and outside the range of 400 to 700 nm. (I) Labels required by this subparagraph shall be clearly visible, legible, and permanently attached to the laser or facility. Signs required by this subparagraph shall be clearly visible, legible, and securely attached to the facility. (4) In lieu of the requirements in paragraphs (1) - (3) of this subsection and subsection (dd) of this section, the agency will accept labeling and signage designated by the following: (A) Title 21, CFR, §1040.10; (B) ANSI Z136.1-2000, Safe Use of Lasers; and (C) IEC standards 60825-1 and 60601-2-22. (w) Surveys. Each registrant shall make or cause to be made such surveys as may be necessary to comply with this section and maintain records of the surveys in accordance with subsection (ee) of this section for inspection by the agency. Surveys shall be performed at intervals not to exceed 12 months, to include but not be limited to the following: (1) a determination that all laser and IPL protective devices are labeled correctly, functioning within the design specifications, and properly chosen for lasers and IPL devices in use; (2) a determination that all warning devices are functioning within their design specifications; (3) a determination that the controlled area is properly controlled and posted with accurate warning signs in accordance with subsection (v) of this section; (4) a re-evaluation of potential hazards from surfaces that may be associated with beam paths; and (5) additional surveys that may be required to evaluate the primary and collateral radiation hazard incident to the use of lasers and IPL devices. (x) Records/documents. Each registrant shall maintain current records/documents required by this subsection in accordance with subsection (ee) of this section for inspection by the agency. (y) Measurements and instrumentation. Each determination requiring a measurement for compliance with this section shall use instrumentation that is calibrated and designed for use with the laser or IPL device that is to be tested. (z) Notification of injury other than a medical event. (1) Each registrant of Class 3b or 4 lasers or user of an IPL device shall immediately seek appropriate medical attention for the individual and notify the agency by telephone of any injury involving a laser possessed by the registrant or an IPL device, other than intentional exposure of patients for medical purposes, that has or may have caused: (A) an injury to an individual that involves the partial or total loss of sight in either eye; or (B) an injury to an individual that involves intentional perforation of the skin or other serious injury exclusive of eye injury. (2) Each registrant of Class 3b or 4 lasers or user of an IPL device shall, within 24 hours of discovery of an injury, report to the agency each injury involving any laser possessed by the registrant or IPL device possessed by a user, as applicable, other than intentional exposure of patients for medical purposes, that may have caused, or threatens to cause, an exposure to an individual with second or third-degree burns to the skin or potential injury and partial loss of sight. (aa) Reports of injuries. (1) Each registrant of Class 3b or 4 lasers or user of an IPL device shall make a report in writing, or by electronic transmittal, within 30 days to the agency of any injury required to be reported in accordance with subsection (z) of this section. (2) Each report shall describe the following: (A) the extent of injury to individuals from radiation from lasers or IPL devices; (B) power output of laser or IPL device involved; (C) the cause of the injury; and (D) corrective steps taken or planned to be taken to prevent a recurrence. (3) Any report filed with the agency in accordance with this subsection shall include the full name of each individual injured and a description of the injury. The report shall be prepared so that this information is stated in a separate part of the report. (4) When a registrant or user of an IPL device is required in accordance with paragraphs (1) - (3) of this subsection to report to the agency any injury of an individual from radiation from lasers or IPL devices, the registrant or user of an IPL device shall also notify the individual. Such notice shall be transmitted to the individual at a time not later than the transmittal to the agency. (bb) Medical event. (1) The registrant of Class 3b or 4 lasers or user of an IPL device shall notify the agency, by telephone or electronic transmittal, within 24 hours of discovery of a medical event or of any injury to or death of a patient. Within 30 days after a 24 hour notification is made, the registrant of Class 3b or 4 lasers or user of an IPL device shall submit a written report to the agency of the event. (2) The written report shall include the following: (A) the registrant's or user's name; (B) a brief description of the event; (C) the effect on the patient; (D) the action taken to prevent recurrence; and (E) whether the registrant or user informed the patient or the patient's responsible relative or guardian. (3) When a medical event occurs, the registrant or user shall promptly investigate its cause, make a record for agency review, and retain the records as stated in subsection (ee) of this section. (cc) Reports of stolen, lost, or missing Class 3b or 4 lasers and IPL devices. (1) Each registrant of Class 3b or 4 lasers or user of an IPL device shall report to the agency by telephone a stolen, lost, or missing laser or IPL device within 24 hours after its occurrence becomes known to the registrant or IPL device user. (2) Each person required to make a report in accordance with paragraph (1) of this subsection shall, within 30 days after making the telephone report, make a written report to the agency that includes the following information: (A) a description of the laser or IPL device involved, including the manufacturer, model, serial number, and class; (B) a description of the circumstances under which the loss or theft occurred; (C) a statement of disposition, or probable disposition, of the laser or IPL device involved; (D) actions that have been taken, or will be taken, to recover the laser or IPL device; and (E) procedures or measures that have been taken to prevent a recurrence of the loss or theft of lasers or IPL devices. (dd) Caution and danger signs. The following contains signs required in accordance with subsection (v)(3) of this section. (1) This sign shall be used with all Class 2 lasers and Class 3a lasers that do not exceed the appropriate MPE, as designated in ANSI Z.136-2000, Safe Use of Lasers. Attached Graphic (2) This sign shall be used with all Class 3a lasers that exceed the appropriate MPE, as designated in ANSI Z.136-2000, Safe Use of Lasers, and all Class 3b and Class 4 lasers. Attached Graphic (ee) Keeping records/documents. The following chart contains time requirements for keeping records/documents: Attached Graphic |
