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OSHA requirements are set by statute, standards and regulations. Our interpretation letters explain these requirements and how they apply to particular circumstances, but they cannot create additional employer obligations. This letter constitutes OSHA's interpretation of the requirements discussed. Note that our enforcement guidance may be affected by changes to OSHA rules. Also, from time to time we update our guidance in response to new information. To keep apprised of such developments, you can consult OSHA's website at https://www.osha.gov.
October 9, 2019
Ascension Employer Solutions
1901 Westwood Center Blvd.
Wausau, WI 54401
Dear Ms. Frank:
Thank you for your letter to the Occupational Safety and Health Administration (OSHA) regarding the recordkeeping regulation contained in 29 CFR Part 1904 - Recording and Reporting Occupational Injuries and Illnesses. You asked whether the use of novel wound closure devices such as Clozex and ZipStitch for the treatment of minor lacerations is considered medical treatment beyond first aid for OSHA recordkeeping purposes.
In your letter, you state that OSHA’s recordkeeping regulation at section 1904.7(b)(5)(ii)(D) provides that Steri-Strips™ and butterfly bandages are considered first aid for recordkeeping purposes while sutures and staples are considered medical treatment. You note that wound care technologies have advanced since OSHA revised its recordkeeping regulation in 2001. Some of the more recent wound closure devices, which are not specifically addressed in the current regulation, are noninvasive and easier to use than Steri-Strips™ or butterfly bandages. Also, you state the Clozex device is marketed as a surgical skin closure and the ZipStitch device is marketed for home use with surgical quality. Both devices are available over-the-counter and do not require specialized training to apply.
Is the use of Clozex or ZipStitch to treat minor lacerations considered first aid or medical treatment for recordkeeping purposes?
OSHA’s recordkeeping regulation at section 1904.7(b)(5)(ii)(D) defines first aid in part as “Using wound coverings such as bandages, Band-Aids™, gauze pads, etc.; or using butterfly bandages or Steri-Strips™ (other wound closing devices such as sutures, stitches, etc. are considered medical treatment).”
Steri-Strips™ are a product of the 3M Company, which advertises them as a comfortable adhesive strip used to secure, close and support small cuts, wounds, and surgical incisions. “Butterfly bandage” is a generic term used for similar adhesive strips designed for small wounds. In response to commenters’ suggestions, both Steri-Strips™ and butterfly bandages were added to the first aid list during the 2001 rulemaking that revised OSHA’s recordkeeping regulation. In the preamble to the final rule, OSHA stated: “Steri-Strips™ and butterfly bandages are relatively simple and require little or no training to apply, and thus are appropriately considered first aid.” See, 66 Fed. Reg. 5989.
OSHA also stated in the 2001 final rule preamble that other wound closing devices such as sutures, stitches, staples, tapes, and glues are medical treatment. Performing these procedures requires substantial medical training, and they are used only for more serious wounds and are generally considered to go beyond first aid. Id. See also, OSHA’s August 26, 2004, Letter of Interpretation to Ronald Bjork.
The list of first aid treatments in section 1904.5(b)(ii) is comprehensive, i.e., any treatment not included on the list is not considered first aid for purposes of OSHA recordkeeping. See, 66 Fed. Reg. 5984. Section 1904.5(b)(5)(ii)(D) specifically states that wound closing devices are considered medical treatment. The regulation also provides that only two wound closing devices, Steri-Strips™ and butterfly bandages, are considered first aid treatments. Accordingly, since ZipStitch and Clozex are wound closing devices and are not included on the first aid list, they are considered medical treatment for OSHA record keeping. Also, please know that OSHA developed the first aid list in section 1904.5(b)(5)(ii) during the 2001 rulemaking that revised the agency’s recordkeeping regulation. Any addition or modification to the first aid list would need to be accomplished through notice and comment rulemaking.
We hope you find this information helpful. OSHA requirements are set by statute, standards, and regulations. Our interpretation letters explain these requirements and how they apply to particular circumstances, but they cannot create additional employer obligations. This letter constitutes OSHA's interpretation of the requirements discussed. Note that our enforcement guidance may be affected by changes to OSHA rules. Also, from time to time we update our guidance in responses to new information. To keep appraised of such developments, you can consult OSHA's website at http://www.osha.gov.
Lee Anne Jillings, Acting Director
Directorate of Technical Support and Emergency Management