1) Can expiring items in a USCG-approved or USCG-accepted First Aid Kit be replaced individually, rather than replacing the kit in its entirety?
Short answer: A first aid kit, whether a prior CG-approved kit or a newer self-certified to ISO standard kit, does NOT have to be in an unopened condition (i.e., sealed outer wrapper) AND items with expirations can be replaced individually. Read on for more information.
The U.S. Coast Guard published a change in type approval requirements for survival craft equipment as a "final rule" in the Federal Register (FR) via 87 FR 68270 on November 14, 2022, with the rule becoming effective on December 14, 2022. The final rule removed CG type approval requirements for nine types of survival craft equipment, including first aid kits, and replaced them with the requirement that the manufacturer self-certify that the equipment complies with a consensus standard. The Office of Design and Engineering Standards (CG-ENG) summarized the changes via Marine Safety Information Bulletin (MSIB) 07-22, dated November 14, 2022.
First aid kits that were previously required to comply with the type approval requirements of 46 CFR 160.041 now have to comply with ISO 18813:2006, Ships and marine technology - Survival equipment for survival craft and rescue boats. First, we will address first aid kits complying with the referenced ISO standard, and then we will address existing CG-approved kits.
First Aid Kits complying with ISO 18813:2006
ISO 18813:2006, nor USCG regulations related to first aid kits, require the entire kit to be "unopened". As shown in 4.12.1 of the standard, the first aid kit must be packed in a waterproof case that can be "closed tightly after use". 4.12.2 deals with the expirations and how they must be marked on the container or visible through the container.
“4.12.1 The first-aid outfit shall be packed in a waterproof case capable of being closed tightly after use, and the contents shall be approved by the Administration to the appropriate national requirements for the craft in which it is carried. The first-aid outfit shall include the following items, plus any other items required by the Administration:
a. waterproof container;
b. first-aid instructions;
c. analgesic medication - 48 doses minimum;
d. antiseptic preparations - suitable for at least 10 applications;
e. burn preparations - suitable for at least 12 applications;
f. adhesive plasters - 20 minimum in assorted sizes;
g. sterile compression bandage - 10 minimum in assorted sizes;
h. adhesive elastic bandages - 4 m minimum;
i. sterile gauze compresses - 2 minimum;
j. triangular bandages - 2 minimum.
4.12.2 If the first-aid outfit contains expiry-dated items, the date of expiry shall be marked on the outside of the waterproof container, or visible through the container.”
Replacement of individual, expired items is not mentioned in the body of the standard, but it is addressed in Annex A (informative) to the standard: "Maintenance and periodic inspection guidelines". A.2.7 addresses the first aid kit items. Note that A.2.7.1 states that each unit carton within the first aid kit should be in an "intact waterproof package" and A.2.7.2 provides for the individual replacement of expired items.
“A.2.7.1 During periodic shipboard inspections, first-aid outfits not packed in inflatable liferafts should be examined to ensure that they contain all of the items listed in the provided instructions. Each unit carton should be in an intact waterproof package. If it is not, it should be replaced with an equivalent waterproof unit from a supplier of approved first-aid outfits.
NOTE Standard cellophane-wrapped unit cartons are not waterproof.
A.2.7.2 Any dated medications in the outfit should be replaced during periodic stripping and cleaning of the lifeboat, rescue boat, or rigid liferaft if their expiry date has passed.
NOTE First-aid outfits packed in inflatable liferafts are inspected during required servicing of the liferaft by an approved service station.”
Existing USCG-Approved First Aid Kits
As stated in the notice of the final rule for the changes to type approval (87 FR 68270), "The Coast Guard is not requiring existing vessels to replace their current kits; however, existing vessels must replace medication and ointments within the kits by their expiration date." (See https://www.federalregister.gov/d/2022-23666/p-186)
Replacement of individual, expired components have been acceptable to maintaining the kit as evidenced by previous information promulgated by the Office of Commercial Vessel Compliance (CG-CVC) in the Top 10 Small Passenger Vessels (Subchapter T) Deficiencies report on their website (excerpt pasted below; see last sentence).
The last publishing of the CG type approval requirements for CG-approved first aid kits can be viewed in the 2022 annual edition of the CFR at 46 CFR Part 160, Subpart 160.041. These previous regulations did not have any specific expiration marking requirements but did specify that individual cartons "shall contain all information required by Federal and State laws" (46 CFR §160.041–4). Separate regulations, such as those in Title 21, Code of Federal Regulations, would stipulate the expiration dates to be marked for medications that are determined by drug product stability testing.
Safety distributors have seen a recent change in the expiration of first aid kit items where some expirations have decreased from 3 years to 1 year. The CG mentioned varied expirations in the FR notice where "The expiration date of OTC [over the counter] medications is typically between one and five years after manufacture." (See https://www.federalregister.gov/d/2022-23666/p-81).
As mentioned in the final rule, and should have been common practice, these previously approved kits can continue to be used if expired items and opened/used cartons are replaced to maintain the kit in 'good condition' and ready to serve the intended purpose.
NOTE: While the FR did not specifically update the First Aid kit verbiage in 33 CFR 144.01-30, CG-ENG is aware and has noted that all of the same guidance applies to units subject to the Lifesaving requirements of 33 CFR Subchapter N, Part 144, Subpart 144.01. First aid kits will no longer be marked as CG-approved after a manufacturer’s “Certificate of Approval” (which provides for the marking of a CG type approval number to a tested and approved product) issued by the CG expires.
Published 19Mar2024.