The Trade Agreements Act of 1979 was passed by Congress to serve several purposes. Firstly, it aims to foster international trade and expand the United States’ ability to engage in trade deals. Secondly, it hopes to further define and better enforce trading rules and regulations. Finally, the act also approved agreements made in a previous act in 1974.
In reference to surgical trays, the part of the Trade Agreements Act (TAA) that is most applicable is the goal of opening international trade deals because it defined various products as compliant if they are manufactured in the United States or in one of the other countries listed in the agreement as a “designated country”. Designated countries include places the United States has an existing free trade agreement with, countries that participate in the World Trade Organization Government Procurement Agreement, “least developed countries”, as well as Caribbean Basin countries.
Due to the requirement put forward by the TAA that all goods and services procured by the federal government (or any government-funded agencies including most hospitals) must be manufactured in either the United States or a designated country, it can be difficult sometimes to insure compliance if there is uncertainty about where products like surgical trays originated or were actually constructed.
On occasion, the TAA will run a compliance check and investigate the origin of an acquired product or service. In these instances, a company or hospital in fact, may have to provide evidence that their surgical trays have been manufactured in the United States or a designated country, or they will be subject to punishment under the rules and regulations of the FAA.
In the specific case of surgical trays, the easiest and most obvious step toward compliance would be simply to make sure that the trays you have purchased originate from one of the countries specified in the list of designated countries. However, surgical trays present a unique issue that may also come up under the FAA: sometimes the customized items contained on surgical trays are new or unavailable from one of the designated countries. CPT Medical, Inc. provides a solution to this issue: “You need to know that the vendors of the tools you’re purchasing have updated the part numbers for their products in the DAPA Management System.” This insures that the part numbers for any pieces on your surgical trays are registered and thus are able to be tracked or investigated by the FAA. CPT Medical, Inc. further has internal procedures that includes verification from manufacturers of place of product production.