Response: The department disagrees with the commenter and believes that the language is appropriate to clarify the department's authority to remove distressed devices from commerce when necessary and to clarify the salvager's responsibilities with respect to the disposition of nonsalvageable devices. No changes were made as a result of the comment.

Comment: Concerning §229.611(a), one commenter suggested that the subsection be deleted in its entirety based on the belief that devices in need of routine servicing are not "distressed devices."

Response: The department disagrees with the commenter and believes that the language is necessary in order to ensure that salvageable devices are reconditioned prior to sale or distribution, unless such devices are sold or distributed to a person licensed under these sections or such sale or distribution is conducted pursuant to §229.611(o). No changes were made as a result of the comment.

Comment: Concerning §229.611(e), one commenter questioned the purpose of the subsection and suggested that it be deleted in its entirety.

Response: The department disagrees with the commenter and believes that the language is necessary in order to conform to statutory requirements in Health and Safety Code, Chapter 432. No changes were made as a result of the comment.

Comment: Concerning §229.611(f), one commenter believed the language "sufficient personnel with necessary education" was too subjective and suggested that the subsection be deleted in its entirety.

Response: The department disagrees with the commenter and believes that the language is appropriate to recognize the importance of having adequate personnel to perform reconditioning activities. In addition, the language is broadly written to recognize the diversity that exists in staffing levels as well as employee education and experience. No changes were made as a result of the comment.

Comment: Concerning §229.611(g), one commenter believed that the subsection was unnecessary and suggested that the subsection be deleted in its entirety.

Response: The department disagrees with the commenter and believes that basic operating procedures are necessary for salvage businesses to ensure that devices are properly identified during various stages of receipt, reconditioning, and distribution in order to prevent errors that could potentially result in the release of any distressed devices to consumers. No changes were made as a result of the comment.

Comment: Concerning §§229.611(h), 229.611(i), 229.611(j), 229.611(k), 229.611(l), and 229.611(m), one commenter believed that these subsections as they relate to inspection, measuring, and test equipment, device history records, device master records, complaint files, internal audits, and corrective and preventative action should be deleted in their entirety since they are derived from federal requirements that apply to device manufacturers and not device salvagers.

Response: The department disagrees with the commenter and believes that the subsections as proposed are appropriate and necessary in order to establish minimum standards for the reconditioning of distressed devices by salvage establishments. The department has taken into consideration the classification of the devices being reconditioned in determining the standards appropriate for the specific reconditioning process. No changes were made as a result of the comment.

Comment: Concerning §229.611(m), one commenter believed the language to be unclear and suggested the subsection should be deleted in its entirety.

Response: The department disagrees with the commenter and believes that the subsection as proposed can be reasonably understood and is an appropriate standard for reconditioning distressed class II and class III devices. No changes were made as a result of the comment.

Comment: Concerning §229.611(n), one commenter believed that this subsection as it pertains to device remanufacturers was unfair and should be deleted in its entirety.

Response: The department disagrees with the commenter and believes that the subsection is consistent with the existing rule requirements for remanufacturers as promulgated under Health and Safety Code, Chapter 431. No changes were made as a result of the comment.

Comment: Concerning §229.612, one commenter believed that the section was unnecessary and should be deleted in its entirety.

Response: The department disagrees with the commenter and believes that minimum record keeping requirements, including the requirement to maintain inventory records, are necessary to ensure that distressed devices are received, reconditioned, distributed and/or disposed of in a manner that is considered acceptable under the rules. No changes were made as a result of the comment.

Comment: Concerning §229.613, one commenter believed that the section should be amended to require that the department must provide 24-hour notice to a salvage establishment or broker prior to conducting inspections of a place of business.

Response: The department disagrees with the commenter and believes that it is essential for the agency to have the ability to conduct inspections at any reasonable time in order to determine compliance with the applicable statutes and rules. No changes were made as a result of the comment.

Comment: Concerning §229.613(e), one commenter believed that the subsection should be amended to delete the following language which the commenter thought was too subjective: "unless the commissioner or authorized agent finds or has probable cause to believe that the device cannot be adequately reconditioned in accordance with the chapter and these sections."

Response: The department disagrees with the commenter and believes that the language is consistent with the statutory language in Health and Safety Code, Chapter 432. No changes were made as a result of the comment.

Comment: Concerning §229.614(i)(1), one commenter believed that the paragraph should be amended to reflect that an administrative penalty may not exceed $1,000 for each violation of the rules and that the total penalty may not exceed $5,000.

Response: The department disagrees with the commenter and believes that the penalty amounts as proposed are consistent with the amounts provided for in Health and Safety Code, Chapter 432. No changes were made as a result of the comment.

The comments on the proposed rules received by the department during the comment period were submitted by: Lone Star Medical Equipment, Medical X-Change, Shattuck and Associates, Association of Texas Medical Equipment Dealers, Beacon Medical Specialties, Alpha Omega, Inc., Medical Resource USA, North Runnels Hospital, Knox County Hospital District, El Campo Memorial Hospital, Nocona General Hospital, Lillian Hudspeth Memorial Hospital, Frio Regional Hospital, Seton Edgar B. Davis Hospital, Yoakum Community Hospital, Cuero Community Hospital, Hamilton Healthcare System, Ballinger Memorial Hospital District, Llano Memorial Healthcare System, Texas Organization of Rural and Community Hospitals, Texas Hospital Association, T Medical Systems, Georgetown Healthcare System, Stockyard Medical, Inc., Coleman County Medical Center, Representative Lon Burnam, Hill Country Memorial Hospital, East Texas Medical Center - Athens, East Texas Medical Center - Fairfield, Intellamed, Christus Health, Texas Medical, and United Regional Health Care System. In addition, one individual commented. The commenters representing North Runnels Hospital, Knox County Hospital District, Nocona General Hospital, Lillian Hudspeth Memorial Hospital, Frio Regional Hospital, Seton Edgar B. Davis Hospital, Yoakum Community Hospital, Cuero Community Hospital, Hamilton Healthcare System, Llano Memorial Healthcare System, Texas Organization of Rural and Community Hospitals, Coleman County Medical Center, Hill Country Memorial Hospital, East Texas Medical Center - Athens, East Texas Medical Center - Fairfield, Christus Health, and United Regional Health Care System were generally in favor of the rules, but had questions or specific concerns and/or suggestions for changes to the new sections. Commenters representing El Campo Memorial Hospital, Ballinger Memorial Hospital District, the Texas Hospital Association, and Georgetown Healthcare System were generally opposed to the new sections unless hospitals that buy and sell distressed devices were exempt from the rules. The individual commenter and commenters representing Medical X-Change, Shattuck & Associates, Association of Texas Medical Equipment Dealers, Alpha Omega, Inc., Medical Resource USA, T Medical Systems, Stockyard Medical, Representative Lon Burnam, Intellamed, Texus Medical, and Beacon Medical Specialties, were generally opposed to the new sections in their entirety.

The new sections are adopted under Health and Safety Code, §432.011, which provides the department with the authority to adopt necessary regulations pursuant to the enforcement of Chapter 432; and §12.001, which provides the Texas Board of Health (board) with the authority to adopt rules for the performance of every duty imposed by law on the board, the department, and the commissioner of health.