Trust The ReProcess? A Practical And Legal Overview Of Reprocessing Single-Use Medical Devices In The United States

• Published date: 13 December 2022
• Subject Matter: Food, Drugs, Healthcare, Life Sciences, Food and Drugs Law, Biotechnology & Nanotechnology
• Law Firm: Butler Snow LLP
• Author: Mr Adam D. Porter

Allow me to set the stage. Our plaintiff claims he felt a nagging pain in his shoulder for months and finally went to see the local orthopedic surgeon. The surgeon apparently informed him that the tissue and cartilage in his shoulder is in "rough shape!" and needed surgery. So, he underwent a routine informed consent process for laparoscopic shoulder surgery, which describes the procedure as follows:

An incision will be made in my shoulder and the damaged tissue and cartilage will be repaired. Additional procedures, to include arthroscopy, will be done as needed.

MY RISK I understand that there are potential risks, complications and side effects associated with any surgical procedure. Although it is impossible to list all of them, I have been informed of some of the possible risks, which include but are not limited to the following: Bleeding, infection, scar, nerve or blood vessel injury, continued pain, continued weakness, repeat tearing, loss of shoulder motion, the need for further surgery as well as the risk of medical or anesthetic complications.

The plaintiff says he blinked his eyes and it was over. Surgery was a success.

Or so it seemed. Several days after the surgery, the plaintiff reported feeling ill. It was not, however, the typical sinus infection or upset stomach; he believed something was very wrong. Upon returning for additional treatment, the diagnosis was a serious blood infection. Plaintiff's physician suspected that it was caused by a contaminated medical device used during surgery.

The final piece of the plaintiff's story is that the culprit medical device was indicated for single-use only. According to the manufacturer's specification, the device was to be disposed of after using it once. Plaintiff has discovered, however, that the device had been used in a previous surgery with another patient.

"Reuse of single-use devices involves regulatory, ethical, medical, legal and economic issues and has been extremely controversial for more than [three] decades."¹ Indeed, the data shows that healthcare providers frequently and routinely reuse "single-use devices."

How can something this problematic'the reusing of a single-use medical device'happen in the United States? The answer is: so long as the single-use device is "reprocessed" under the pertinent regulations, the FDA allows it to be reused.

The Terminology

For purposes of this article, there are two types of medical devices regulated by the FDA: (1) reusable devices and (2) single-use (or disposable) devices (SDU). For a medical device company to market a reusable medical device, the company must "provide data demonstrating to FDA's satisfaction that the device can be cleaned and sterilized without impairing its function."² In other words, the FDA reviews the cleaning and sterilization (i.e., reprocessing) procedures and post-reprocessing data in approving a reusable device for market.

Single-use devices, on the other hand, can be marketed after the medical device company "demonstrate[es] to FDA that the device is safe and effective if used once."³ It is a device "that is intended for one use, or on a single patient during a single procedure."⁴ Nothing in FDA regulations, however, prohibits a single-use device from being "reprocessed" and reused so long as the requisite hurdles, discussed below, are cleared.

The term "reprocessed" is what this article is about. According to 21 U.S.C. ' 321 (ll)(2)(A), "[t]he term 'reprocessed' . . . means an original device that has previously been used on a patient and has been subjected to additional processing and manufacturing for the purpose of an additional single use on a patient."⁵ "Reprocessing includes all the steps performed to make a contaminated reusable or single-use device ready for patient use. The steps may include cleaning, functional testing, repackaging, relabeling, disinfection or sterilization."⁶

Context and Controversy

In the United States, the scope of reprocessed single-use devices is expansive'ranging from post-operative compression sleeves for blood clot prevention, to surgical blades and drills, to electrophysiology catheters, which are inserted into a patient's heart to measure cardiac rhythm.⁷ These reprocessed devices (and many others like them) are used every day in hospitals all over the country. While it seems that most organizations favor the reuse of these devices, this practice certainly has its critics.

The most powerful argument in support of reprocessed single-use devices is what you may expect: a reduction in costs. In 2008, the U.S. Government Accountability Office (GAO) issued a...