Illinois § 16.5

§ 16.5.

Single-use surgical devices. (a) The General Assembly finds that certain surgical devices are designed to be used for only one surgical procedure. Further, the reuse, recycling, and refurbishing of surgical devices intended for single use have been linked to cases of patient infection, chemical injury, and mechanical failure. It is therefore the purpose of this Section to protect the public health and safety by prohibiting the unregulated reuse, recycling, and refurbishing of single-use surgical devices. (b) For purposes of this Section, "single-use surgical device" means a cardiac catheter, angioplasty balloon catheter, arthroscopic knee surgery blade, and any other device marketed or sold as a disposable or single-use device as determined by rule of the Department of Public Health to be designed for use in a single surgical procedure to avoid risk of infection from improper sterilization or risk of mechanical failure posed by subsequent use. (c) No person shall knowingly reuse, recycle or refurbish for reuse, or provide for reuse of a single-use surgical device. However, this Section does not apply to persons who utilize, recycle or reprocess for utilization, or provide for utilization a single-use surgical device that has been reprocessed by an entity or person registered with and regulated by the United States Food and Drug Administration or reprocessed by a hospital licensed under the Hospital Licensing Act or the University of Illinois Hospital Act. A person convicted of violating this subsection is guilty of a business offense and shall be fined not less than $1,000 for the first violation and not less than $2,000 for a second or subsequent violation. (Source: P.A. 90-398, eff. 1-1-98.)