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 RISKS 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 comprehensive report to Congress regarding the reprocessed single-use medical device market in the United States. In that report, GAO stated that hospitals using reprocessed single-use devices “believed that reprocessing provides substantial cost savings.”[8]
Additionally, and perhaps more importantly in today’s world, there is a widespread belief that the use of reprocessed devices greatly benefits the climate by reducing medical waste and lowering greenhouse emissions.[9]
But do these benefits outweigh any potential risks? The publicly available information is unclear. In the 2008 congressional report, GAO analyzed adverse event data and medical publications and determined that “[n]either existing FDA data nor studies performed by others are sufficient to draw definitive conclusions about the safety of reprocessed SUDs compared to similar original devices.”[10] And, at the time, it did not seem to be a high priority to find out: “FDA officials have concluded that the cost of conducting rigorous testing would not be an efficient use of resources, especially given that the available data, while limited, do not indicate that reprocessed SUDs present an elevated health risk.”[11]
Some recent publications reach the opposite conclusion. In 2017, an organization named Joint Commission International (JCI) published a white paper that greatly criticized the use of reprocessed single-use devices. In summarizing the paper, JCI stated that the practice of “attempting to clean and reuse . . . single-use medical devices and supplies for other patients” “carries a significant risk to the patient.”[12] The FDA’s website indeed discusses the significant risks associated with inadequate reprocessing procedures:
Inadequate reprocessing between patient uses can result in the retention of blood, tissue and other biological debris (soil) in certain types of reusable medical devices. This debris can allow microbes to survive the disinfection or sterilization process, which could then lead to Healthcare-Associated Infections (HAIs). Inadequate reprocessing can also result in other adverse patient outcomes, such as tissue irritation from residual reprocessing materials, such as chemical disinfectants.[13]
Further, in 2019, the American College of Obstetricians and Gynecologists (ACOG) published a committee opinion stating, among other things, that physicians have an “ethical responsibility to make a good faith effort to know whether reprocessed single-use devices are to be used” and that adverse events should be reported to the FDA’s MAUDE database to improve the safety information related to these reprocessed devices.[14] According to ACOG, there are “limited data on reprocessed single-use devices, [but] existing studies have found a significant rate of physical defects, performance issues, or improper decontamination.”
To better understand the debate surrounding these medical devices, we need to look at what the FDA requires.
Legal Issues and Regulatory Framework
Before 1970, most medical devices were made of materials that were easily cleaned and sterilized, like rubber, glass or metal, so most medical devices at that time were considered to be reusable.[15] In the early 1970s, however, manufacturers began designating certain devices as single-use devices “due to demand by health care organizations, the complexity of newly designed devices, and the introduction of ethylene oxide sterilization.”[16] Predictably, it was not long before providers, in an effort to cut costs, began reprocessing and reusing these single-use devices.[17]
In November 1977, the FDA issued Compliance Policy Guide 300.500 that described the current regulatory responsibility for hospitals that were reprocessing single-use medical devices: Hospitals were simply to assume full liability and responsibility for the reprocessed devices.[18] There were no regulations applicable to the hospital’s actual reprocessing procedures, and there was no mention of third-party reprocessors.
At the turn of the century, things changed. In August 2000, the FDA released its first guidance document regarding single-use devices reprocessed by third parties or hospitals. Under this new guidance, “[t]hird party and hospital reprocessors of single-use devices are subject to all the regulatory requirements currently applicable to original equipment manufacturers, including premarket submission requirements.”[19] Although not specific to reprocessed single-use devices, reprocessors were now subject to the following regulatory requirements under the Federal Food, Drug, and Cosmetic Act:
- Registration and Listing (Section 510 of the Act; 21 CFR Part 807);
- Medical Device Reporting (Sections 519(a)(b) and (c) of the Act; 21 CFR Part 803);
- Medical Device Tracking (Section 519(e) of the Act; 21 CFR Part 821);
- Medical Device Corrections and Removals (Section 519(f) of the Act; 21 CFR Part 806);
- Quality System Regulation (Section 520(f) of the Act; 21 CFR Part 820);
- Labeling (Section 502 of the Act; 21 CFR Part 801); and
- Premarket Requirements (Sections 513 and 515 of the Act; 21 CFR Parts 807 and 814).[20]
None of the requirements above, however, specifically accounted for the unique issues present in single-use reprocessing.
In 2002, Congress stepped in and passed the Medical Device User Fee and Modernization Act of 2002 (MDUFMA), which remains the law of the land today. Under the MDUFMA, the labeling on all reprocessed single-use devices must now “specifically state that they are reprocessed . . . as well as identify the reprocessor.”[21] Additionally, the MDUFMA imposed several requirements on the FDA. First, the FDA was required to modify its device-related adverse event reporting forms to indicate whether a reprocessed single-use device was involved in the adverse event.[22] Second, the FDA was required to increase oversight by identifying the reprocessed devices that should not be used without first determining “effective cleaning, sterilization, and functional performance.”[23] In performing this increased oversight role, the FDA identified nearly 75 different types of reprocessed single-use devices that now must undergo additional premarket requirements.[24]
Given the abundance of federal laws and regulations now applicable to reprocessors of single-use medical devices, there are a variety of interesting legal issues that have recently been litigated—a few of which are briefly addressed below.
Original Manufacturer Duty to Warn of Reprocessors?
One issue that has arisen in litigation is whether the original manufacturer of a single-use device has a duty to warn that its devices are also being reprocessed for reuse by third parties. For instance, in Kapps v. Biosense Webster, a single-use “mapping” cardiac catheter manufactured by Biosense was used in a patient at Mayo Clinic.[25] After use, Mayo Clinic shipped the catheter to a third party, Ascent, for reprocessing (inspection, cleaning, sterilization and repackaging).[26] As part of the repackaging reprocess, Ascent included its own warranty and instructions for use (IFU).[27] Ascent shipped the reprocessed catheter back to Mayo Clinic, who used it with a second patient.[28] That second patient experienced complications and filed products liability claims against Biosense and Ascent.[29]
The plaintiff and his expert witness argued that Biosense, the original manufacturer, should have included warnings in its IFU that Ascent was reprocessing its catheters and the alleged dangers associated with the same.[30] In rejecting this argument at the summary judgment stage, the U.S. District Court for the District of Minnesota stated that, in addition to Biosense’s original warnings, “it is fanciful to suggest that Biosense has a further duty to tell doctors, in effect:
Our catheters are labeled for a single use. We really mean it. Some companies will offer to reprocess our catheters. Those companies will tell you that the reprocessed catheters are safe. Don’t believe them.”[31]
The District Court granted summary judgment on all of Plaintiff’s claims against the original manufacturer, Biosense.[32]
Impossible for Reprocessor to Change the Label?
When thinking about the legal relationship between a third-party reprocessor and the original manufacturer, it seems analogous to that of a generic drug manufacturer and a name-brand manufacturer. As most know, a generic drug label must be identical to the name-brand’s label, so generic drug manufacturers enjoy an “impossibility” preemption defense against claims seeking warnings different from those given by the name-brand manufacturer.[33]
What about reprocessors of single-use devices—can they provide warnings different from the original manufacturer? Apparently, there are no laws or regulations that preclude it. In In re Stryker LFIT V40 Femoral Head, the defendants argued that since the distributor/reprocessor was not the original manufacturer of the device, the distributor/reprocessor was “prohibited from altering the design, labeling, packaging, instructions for use, or warnings” of the original device.[34]
The U.S. District Court for the District of Massachusetts rejected this argument.[35] In doing so, the District Court looked to the text of 21 C.F.R. § 807.20 (medical device establishment registration requirements) and stated:
[O]n its plain language, this section does not appear to prohibit [the distributor/reprocessor] from altering the labeling and packaging of FDA-regulated medical devices, but does require that [the distributor/reprocessor], like the [the original manufacturer], would need to register and submit premarket notification submission . . . if it repackages or relabels the device.[36]
In other words, it was “not obvious that impossibility preemption would apply to a medical device” distributor/reprocessor.[37]
The Prometheus Case
Earlier this year, the United States filed a False Claims Act case against The Prometheus Group regarding its single-use rectal pressure sensors and anorectal catheters that were allegedly improperly reused with multiple patients.[38] The lawsuit, filed in the U.S. District Court for the Western District of Michigan, seeks to recover Medicare payments for vulnerable patients who were exposed to excess risks of bacterial, viral and fungal infections.[39]
The FDA cleared Prometheus’s rectal pressure sensor and anorectal catheter as single-use devices with labeling that contains phrases like “a potential bio-hazard,” “[t]his sensor is restricted for single person use only[ and u]se by another person is strictly prohibited by Federal Regulations.”[40] Nevertheless, according to the complaint, Prometheus “encouraged and instructed health care providers to reuse [these devices] on multiple patients, using a glove or condom to cover the probes, as a way to reduce the overhead costs” associated with the devices.[41] Additionally, and most relevant to this article, the complaint alleges that Prometheus “made no attempt to determine if the probes worked effectively when re-used under those conditions.”[42] In other words, although the healthcare providers were taking measures to reprocess these devices before reuse, those reprocessing measures were not submitted and blessed by the FDA in accordance with the regulations discussed above.
Conclusion
Reprocessed single-use medical devices have been subject to evolving federal laws and regulations for two decades. In 2019, the reprocessing market was estimated to earn around $40 million annually,[43] but given the constant pressure to reduce costs and the growing focus on greenhouse emissions and climate change, we should only expect the reprocessing market to continue to grow. As it does, hopefully more fulsome data is available regarding the risks and benefits of reprocessing single-use medical devices.
[1] Ctrs. for Disease Control and Prevention, Reuse of Single-Use Med. Devices, Guideline for Disinfection and Sterilization in Healthcare Facilities, (2008), https://www.cdc.gov/infectioncontrol/guidelines/disinfection/reuse-of-devices.html#:~:text=The%20options%20for%20hospitals%20are,other%20than%20acute%2Dcare%20hospitals.
[2] U.S. Gov’t. Accountability Office, REPROCESSED SINGLE-USE MED. DEVICES, FDA Oversight Has Increased, and Available Information Does Not Indicate That Use Presents an Elevated Health Risk, (Jan. 2008), at p. 1., https://www.gao.gov/assets/gao-08-147.pdf.
[3] Id. (emphasis added).
[4] 21 U.S.C. § 321 (ll)(1).
[5] Id. at (ll)(2)(A).
[6] U.S. Dep’t. of Health and Human Servs., U.S. Food and Drug Admin., Labeling Recommendations for Single-Use Devices Reprocessed by Third Parties and Hosps.; Final Guidance for Indus. and FDA, (July 30, 2001), at p. 3, https://www.gao.gov/assets/gao-08-147.pdf.
[7] U.S. Gov’t. Accountability Report, at p. 11.
[8] Id. at p. 13.
[9] Ass’n of Med. Device Reprocessors, Global Regulatory Standards for Single-Use Device Reprocessing/Remanufacturing, (May 21, 2022), at pp. 3-5, http://amdr.org/amdr-document-signup-form/.
[10] U.S. Gov’t. Accountability Report, at p. 6.
[11] Id.
[12] Joint Comm’n Int’l, Reuse of Single-Use Devices: Understanding Risks and Strategies for Decision-Making for Health Care Orgs., (2017), at p. 3, https://www.jointcommissioninternational.org/-/media/jci/jci-documents/offerings/other-resources/white-papers/jci_white_paper_reuse_of_single_use_devices.pdf.
[13] U.S. Food and Drug Admin., Working Together to Improve Reusable Med. Device Reprocessing, https://www.fda.gov/medical-devices/reprocessing-reusable-medical-devices/working-together-improve-reusable-medical-device-reprocessing (last visited August 29, 2022).
[14] Am. Coll. of Obstetrics and Gynecology, Comm. Op. No. 769, Reprocessed Single-Use Devices, Vol. 133, No. 3, (March 2019), at p. 1, https://www.acog.org/-/media/project/acog/acogorg/clinical/files/committee-opinion/articles/2019/03/reprocessed-single-use-devices.pdf.
[15] Joint Comm’n Int’l, at p. 1.
[16] Id.
[17] Ctrs. for Disease Control and Prevention, Reuse of Single-Use Med. Devices, Guideline for Disinfection and Sterilization in Healthcare Facilities, (2008), https://www.cdc.gov/infectioncontrol/guidelines/disinfection/reuse-of-devices.html#:~:text=The%20options%20for%20hospitals%20are,other%20than%20acute%2Dcare%20hospitals.
[18] Am. Coll. of Obstetrics and Gynecology, Comm. Op. No. 769, at p. 1; see also Med. Device Online, FDA Issues Strategy on Reuse of Single-Use Devices, (Nov. 1, 1999), https://www.meddeviceonline.com/doc/fda-issues-strategy-on-reuse-of-single-use-de-0001#fda.
[19] U.S. Dep’t. of Health and Human Servs., U.S. Food and Drug Admin., Enforcement Priorities for Single-Use Devices Reprocessed by Third Parties and Hosp., (August 14, 2000), at p.1, http://amdr.org/wp-content/uploads/2021/03/1168-.pdf (emphasis added).
[20] Id. at p. 13.
[21] U.S. Gov’t. Accountability Report, at p. 2.
[22] Id. at p. 6.
[23] Id. at pp. 2-3.
[24] Id. at p. 5.
[25] 813 F. Supp.2d 1128, 1134 (D. Minn. Sept. 27, 2013).
[26] Id.
[27] Id. at 1134-35.
[29] Id.
[30] Id. at 1158.
[31] Id. at 1158-59.
[32] Id. at 1167.
[33] See PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011).
[34] MDL No. 17-md-2768-IT, 2017 WL 3815937, at *3 (D. Mass. Aug. 31, 2017).
[35] Id. at *3-4.
[36] Id. at *3.
[37] Id. at *4.
[38] U.S. Dep’t of J., Justice Department Files False Claims Act Complaint Against Medical Device Manufacturer and its Owner for Training Providers to Improperly Reuse Disposable Items, (May 17, 2022), https://www.justice.gov/opa/pr/justice-department-files-false-claims-act-complaint-against-medical-device-manufacturer-and.
[39] Id.
[40] Id.
[41] Id.
[42] Id
[43] Am. Coll. of Obstetrics and Gynecology, Comm. Op. No. 769, at p. 1.
Finis
