Source: http://www.amdr.org/industry-info/myths-and-facts/
Timestamp: 2016-10-22 23:29:49
Document Index: 224464116

Matched Legal Cases: ['§ 360', '§ 360', '§ 360', '§ 360', '§ 360', '§ 360', 'art 807', '§ 360', 'art 803', '§ 360', 'art 821', '§ 360', 'art 806', '§ 360', 'art 820', '§ 352', 'art 801']

Myths and Facts « Association of Medical Device Reprocessors
Myth: Manufacturers are required to label some medical devices for “single use” because these devices are unsafe for more than one use. Fact: The “single use” label is not a regulatory requirement, but chosen at the manufacturer’s discretion. In the U.S., Canada and Europe, the “single use” label is a designation chosen by medical device manufacturers, not FDA or any competent authority. Indeed, FDA does not require any device to carry a single use label. Rather, when a manufacturer designs and develops a product, it is the company’s prerogative to determine the materials used and how the device is labeled [1]. In the U.S., to market a device as “reusable,” a manufacturer must invest the resources necessary to demonstrate to FDA that the product can be safely reprocessed at the hospital level [2]. Thus, there is a regulatory incentive to label [3] devices as “single-use” due to increased data requirements for devices to be labeled as “reusable.”
The single-use label does not automatically mean that a device is incapable of being safely reused under certain circumstances. The label means simply, as noted above, that the manufacturer has chosen not to conduct the studies necessary to demonstrate that the product can be labeled as reusable and, thereby, reprocessed at the hospital level.
Fact: The single-use label may often be chosen by manufacturers for economic reasons, not patient safety reasons.
In addition to the regulatory incentive to label devices for “single-use,” manufactures have an economic incentive as well (selling more devices). Approximately three decades ago, some original equipment manufacturers (OEMs) began to change the labels on some medical devices from “reusable” to “single use.” While some of these changes were in response to the HIV/AIDS epidemic of the 1980s, there is OEM documentation from this time-period demonstrating that in some instances, device labeling was changed from “reusable” to “single use” without design, performance or material changes to the devices that would preclude safe reuse by hospitals [4]. This change in labeling was perceived by many hospitals as a marketing strategy aimed at increasing sales of new products. It was clear that certain devices designated by some OEMs as “single use” could be safely reused. Hospital skepticism of the single use label was also noted in a 2000 GAO Report. According to the report, health care personnel “distrust the single-use label for some devices” due to, among other things, their perception that “manufacturers have an economic incentive to market devices as single-use that could just as well be sold as reusable” [5].
By the late 1990s, not only were hospitals and third-parties reprocessing SUDs, but some manufacturers themselves began to offer their own recycling or reprocessing programs [6], further evidence to many hospitals that “single use” is not always a meaningful designation. The American Hospital Association (AHA) [7], the American Association of Orthopedic Surgeons [8], and statements in the Government Accountability Office (GAO) reports have all publicly criticized OEM misuse of the “single use” label [9].
Myth: Tracheal tubes, urinary catheters, cardiac ablative catheters and pacemakers are examples of typically reprocessed “single-use” devices (SUDs). Fact: These products are not reprocessed by AMDR members. In the U.S., all manufacturers (including “single-use” device (SUD) reprocessors) must register their manufacturing facilities and list all products they manufacturer (in addition to other regulatory requirements). A search of FDA’s listing database can confirm the devices that are, and are not reprocessed [10].
In an effort to instill fear and doubt about SUD reprocessing, some OEMs and/or their trade association may be misleading people as to what is actually reprocessed. In order to have an informed discussion about reprocessing, AMDR urges these associations to offer evidence of the companies that are reprocessing devices not under FDA authority.
Myth: In-house (in-hospital) device reuse and third-party (manufacturer) reprocessing are the same and can be referenced interchangeably. Fact: These two are distinctly different activities with different regulatory requirements.
In the case of devices which are reused within the hospital, central sterile departments in hospitals clean and sterilize devices that are labeled as “reusable” (and in Canada, some Provinces allow the reuse of non-critical SUDS). In the case of reprocessed devices, third-party reprocessors clean, repair and sterilize SUDs, bringing them back to original specifications. Unlike hospitals’ central sterile activities, commercial reprocessing is performed under FDA’s stringent oversight and pursuant to rigorously validated protocols. While both activities involve the re-use of medical devices, any safety problems associated with cleaning and sterilization activities by in-house central sterile departments have no bearing on the safety of commercial, FDA-regulated reprocessing of SUDs, and should not be confused.
Myth: Items that come into contact with the central nervous system, including the brain and spine, are reprocessed and therefore may transmit Creutzfeldt-Jakob Disease (CJD).
Fact: FDA’s publicly available database shows that no companies reprocess any neurological devices, or any devices that potentially pose a risk of CJD transmission.
AMDR members have agreed not to reprocess these devices [11].
Myth: Reprocessed medical devices fail more often than original devices, leading to increased patient harm (or an increased risk to patients).
Fact: “FDA believes that reprocessed SUDs that meet FDA’s regulatory requirements are as safe and effective as a new device” [12].
The 2008 GAO Report concurs with FDA’s assessment and concludes that:
After reviewing the available evidence – including FDA’s process for identifying and investigating device-related adverse events reported to involve reprocessed SUDs, peer-reviewed studies published since 2000, and the results of our and FDA’s consultations with hospital representatives – we found no reason to question FDA’s analysis indicating that no causative link has been established between reported injuries or deaths and reprocessed SUDs [13].
Fact: All Evidence Indicates That SUDs Reprocessed in Accordance with FDA’s Requirements Are Safe and Effective.
In a letter from FDA to Congressman Tom Davis and Harry Waxman dated January 23, 2006, FDA indicated that a total of 65,325 reports have been filed between 2003 and 2006 for the malfunction or injury associated with the first use of devices labeled for “single use.” The same search produced 176 cases of apparent malfunction or injury associated with reprocessed devices. Upon analysis of the latter reports, FDA determined that these adverse events were not related to the reprocessing of the “single use” device (SUD) [14].
Myth: Reprocessing is inadequately regulated.
Fact: FDA rigorously regulates the reprocessing industry. In fact, reprocessing must meet the same regulations as OEMs and then some.
Pursuant to the Federal Food Drug and Cosmetics Act (FDCA), FDA requires reprocessors to comply with all device manufacturing requirements that apply to OEMs [15], as well as some additional requirements that apply only to reprocessors (Please see appendix for FDA premarket review requirements)
Myth: Cleaning detergents and other residue cannot be eliminated from certain devices that are reprocessed.
Fact: Reprocessors must document through their Quality System that its manufacturing processes successfully clean, sterilize, and is functional, to the same, if not greater degree, as the original device before it is allowed to be commercially reprocessed. Extensive data must be submitted to the FDA before the agency clears a particular device for reprocessing. If a device cannot meet the same requirements as an original device, it does not receive FDA’s clearance for reprocessing [16].
Myth: Because reprocessed devices are riskier, patients should have to sign informed consent papers authorizing their use.
Fact: Reprocessed SUDs are not investigational or experimental devices and therefore, there is no legal, medical or ethical basis for imposing a requirement to seek informed consent for the use of reprocessed devices but not for the use of original devices.
Indeed, SUD reprocessing has been regulated by FDA for over a decade, and all sources indicate no increased risk to patients. Comparing a reprocessed device to an original device is similar to comparing generic drugs to brand name drugs. Both are equivalent in the eyes of FDA and both must meet the same strict regulatory requirements. Reprocessed devices are as safe and effective as original equipment, and there is no evidence that the use of reprocessed devices increases the risks associated with a medical procedure. Obtaining informed consent from patients for the use of reprocessed “single use” devices does nothing to increase patient safety nor does it provide patients with any meaningful information about the actual risks and benefits of the medical procedures they are about to undergo. Reprocessed devices are legally marketable devices that are subject to stringent regulation by FDA. These regulations compel reprocessors to comply with all of the requirements applicable to original devices, including premarket clearance and approval requirements, along with some additional requirements applicable only to reprocessors.
Myth: Reprocessing provides no benefits to patients.
Fact: Besides being just as safe as original equipment, reprocessing keeps tons of medical waste from filling community landfills, and saves money for local hospitals that they can use to hire more patient care staff, improve technology, or provide care to the indigent. The reprocessing industry has also helped with overall cost-containment in the medical device industry. Through the competition created by third-party reprocesssors, OEMs have significantly lowered their prices on certain devices. For example, Microvasive Endoscopy, a division of Boston Scientific, has entered into agreements with certain hospitals to discount biopsy forceps in exchange for the hospital agreeing to not reprocess those devices [17]. In other instances, OEMs have discounted items so low that it made reprocessing less cost-effective for the hospital. While medical costs continue to spiral out of control, reprocessing is one of the few things the medical community can do to save money without compromising patient safety.
Myth: If a hospital uses reprocessed devices, it is probably providing inferior care.
Fact: A majority of U.S. hospitals reprocess with an AMDR member. AMDR’s members serve America’s finest medical facilities, including 16 of the 17 institutions ranked by U.S. News & World Report as the nation’s “Honor Roll” hospitals [18]. Further, many of the most preeminent physicians and professional health care groups in the country have publicly supported FDA-regulated reprocessed devices as being safe and effective [19].
Myth: OEMs are blamed for reprocessed device malfunctions, are unfairly sued for reprocessing failures, or have otherwise suffered legal consequences due to reprocessing. Fact: To our knowledge, no manufacturer has ever been found liable, nor has any lawsuit ever even been filed against an original equipment manufacturer for the failure of a reprocessed device. Pursuant to federal legislation (MDFMA and MDUFSA) [20], all reprocessed medical devices are marked as such, therefore a doctor or nurse filing an adverse event report for any device would know whether or not it was reprocessed. Further, because all reprocessors have always traced their devices for internal tracing purposes, they always include marking mechanisms to identify the device as reprocessed by their company. AMDR asks that OEMs making such claims demonstrate evidence.
Appendix: FDA Premarket Review & Requirements
FDA designates devices as Class I, Class II, or Class III, depending upon the risk the device poses to the patient or the user, and the level of regulatory control necessary to “provide a reasonable assurance of the safety and effectiveness of the device”[21]. This risk-based approach to regulation is not unlike the device classification scheme in Europe or Canada, though there are differences in terms of how specific devices are classified.
A. Premarket Review Requirements
Like all devices, a reprocessed device is subject to premarket review by FDA, unless the agency has, by regulation, declared the device to be exempt from premarket requirements. Most devices that require premarket review go through the 510(k) clearance process. The 510(k) is a comparative submission: In order to obtain 510(k) clearance to market a device, a 510(k) submitter must demonstrate that its device is “substantially equivalent” (i.e., as safe and effective as) to a legally marketed “predicate” device.
While FDA has subjected reprocessors to the same basic premarket review requirements as OEMs, it also has recognized the inherent differences between the manufacturing activities associated with the design and manufacture of a new device, and the reprocessing activities associated with the cleaning, sterilization and function testing of a reprocessed device. At the outset, it is important to remember that the starting material for a reprocessed device is a device that has already undergone premarket clearance/approval by FDA. Thus, FDA and Congress made the following adjustments to the premarket review requirements:
Requiring premarket review for a whole host of reprocessed devices, while their “new” counterparts are exempt from such review – Pursuant to provisions added to the FDCA in 2002 by the Medical Device User Fee and Modernization Act (“MDUFMA”), FDA withdrew the exemptions from the premarket notification requirement for a significant number of previously exempt reprocessed devices, although the “original” devices remain exempt from premarket review [22].
Requiring premarket validation data to demonstrate that reprocessing results in a device that is substantially equivalent to a new device – Reprocessors must, in many cases, include in their premarket submissions a whole category of data that OEMs are not required to submit [23]. Specifically, reprocessors are, in many cases, required to include “validation data . . . regarding cleaning and sterilization, and functional performance” to show that the reprocessed device “will remain substantially equivalent . . . after the maximum number of times the device is reprocessed as intended” [24].
Establishing a Premarket Report that enables reprocessors to seek approval of reprocessed Class III devices – As part of the 2002 MDUFMA amendments to the FDCA, a new type of application – known as a Premarket Report (PMR) – was created for Class III reprocessed SUDs that otherwise would have been subject to the PMA requirement.
Thus, with the foregoing requirements, FDA and Congress were able to strike a balance between holding reprocessors to the high manufacturing standards necessary to ensure the safe and effective reprocessing of SUDs, while acknowledging that not every OEM requirement can or should apply to reprocessors.
B. Other Manufacturing Requirements Applicable to Reprocessors
In addition to FDA’s premarket requirements, like OEMs, reprocessors are subject to establishment registration and medical device listing [25]; medical device reporting [26]; medical device tracking [27]; reports of corrections and removals [28], the quality system regulation (“QSR”) [29]; and labeling requirements [30]. These requirements were phased in beginning in 2000 with the release of FDA’s guidance document, Enforcement Priorities for Single-Use Devices Reprocessed by Third Parties and Hospitals [31].
[1] In a 2008 report, the U.S. Government Accountability Office (GAO), or Congress’ investigative arm, wrote:
The decision to label a device as single-use or reusable rests with the manufacturer. If a manufacturer intends to label a device as reusable, it must provide data demonstrating to FDA’s satisfaction that the device can be cleaned and sterilized without impairing its function. Thus, a device may be labeled as single-use because the manufacturer believes that it cannot be safely and reliably used more than once, or because the manufacturer chooses not to conduct the studies needed to demonstrate that the device can be labeled as reusable.
In a 2008 report, the U.S. Government Accountability Office (GAO)
U.S. Government Accountability Office, GAO-08-147, Reprocessed Single-Use Medical Devices: FDA Oversight Has Increased, and Available Information Does Not Indicate That Use Presents an Elevated Health Risk (emphasis added) (January 2008), at 1 [hereinafter 2008 GAO Report]; See also, GAO’s 2000 report:
Manufacturers that intend to market a device as reusable must give FDA supporting data demonstrating to the agency’s satisfaction that a device can be cleaned and sterilized without impairing its function. All other devices are intended for single-use. Thus, a device may be marketed for single-use because the manufacturer believes that it cannot be safely and reliably used more than once or because the manufacturer chooses not to conduct the studies needed to prove that the device should be labeled as reusable. In effect, because FDA can only evaluate a device relative to the use intended for it by its manufacturer, its approval of a device as single-use means that a device can be used safely and reliably once, not necessarily that it cannot be used safely and reliably more than once if it is appropriately reprocessed.
Government Accountability Office, GAO/HEHS-00-123, Single-Use Medical Devices: Little Available Evidence of Harm From Reuse, but Oversight Warranted (emphasis added) (June 2000), at 4 [hereinafter 2000 GAO Report].
[2] See, e.g., FDA Draft Guidance for Industry and FDA Staff – Processing/Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling (May 2011) and FDA Reviewer Guidance: Labeling Reusable Medical Devices for Reprocessors in Health Care Facilities (April 1996) which both detail the extensive requirements FDA has of manufacturers to validate the cleaning of a reusable devices; See also, Association for the Advancement of Medical Instrumentation (AAMI), Technical Information Report 30: A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices (10 August 2011).
[4] See Letter from Brian Dowling, Product Manager, USCI Cardiology & Radiology Products (24 July, 1980) (explaining that, although USCI was changing the label on its intracardiac electrodes from “reusable” to “single use,” “our manufacturing processes . . . have not changed. These electrodes are made with the same materials and in the same manner as they have been in the past”);. See also, Letter from Geoffrey M. Allen, Boston Scientific Corp., Microvasive Division (1 May, 1987), at 2 (informing a hospital that its “BICAPâ Hemostatic Probes are recommended for single use only. However, this recommendation does not prohibit reuse under certain specific conditions. . .”).
[5] 2000 GAO Report, supra note 1, at 11.
[6] For example, the orthopedic device manufacturer Synthes offered hospitals the option to purchase previously used external fixation components as part of its own reprocessing program. “The U.S. division of this Swiss firm is reprocessing over a dozen of its fixation devices, including single use devices such as its ‘combination clamp’ and ‘tube to tube clamps,’” see “OEM Moves into Reprocessing,” Medical Design Technology (1 March, 2006); See also FDA 510(k) clearance K033158, “Synthes (USA) Reprocessed External Fixation Devices,” (cleared by FDA on 5 November, 2003); See also Synthes, External Fixation Reprocessing Program, Corporate Market Material, Synthes USA (2004). See also, The Economic Impact of Reprocessing External Fixation Components, The Journal of Bone and Joint Surgery, Inc., Horwitz, Daniel S. MD, Schabel, Kathryn L.S. MD, Higgins, Thomas F. MD, Department of Orthopaedics, University of Utah, Salt Lake City (2007; 89: 2132-2136) (stating that “Stryker Orthopaedics applied for, and was granted, United States Food and Drug Administration (FDA) 510(k) approval of this recertification process…” and “We believe that we are the first to examine an FDA-approved program for recertification of external fixation components by the original manufacturer…”); See also, Millstone Medical Outsourcing Launches Customized After-Market Services To Optimize Deployed Inventory, Three of the Top Five Orthopaedic Manufacturers Already Save Millions Yearly (March 8, 2005).
[7] Testimony of the American Hospital Associationbefore the Health, Education, Labor and Pensions Committee of the United States Senate on Reuse of Medical Devices, (June 27, 2000).
[8] American Academy of Orthopedic Surgeons,Academy Statement on Reprocessed Single-Use Devices, (February 14, 2002).
[9] 2000 GAO Report, supra note 1.
[10] See, U.S. Food and Drug Administration, Center for Devices and Radiological Health, Establishment Registration & Device Listing database.
[11] http://www.fda.gov/regulatoryinformation/foi/electronicreadingroom/default.htm
[12] Testimony of Dr. Daniel Schultz, Director, CDRH, FDA, at 2 (September 26, 2006) [hereinafter, Schultz testimony].
[13] 2008 GAO Report, supra note 1, at 21-22 (emphasis added). The quote goes on to conclude, “That is, the available information regarding safety, while not providing a rigorous safety comparison between reprocessed SUDs and other devices, does not indicate that reprocessed SUDs currently in use pose an increased safety threat;” See also, U.S. Government Accountability Office, GAO-08-1091R, Health-Care-Associated Infections in Hospitals, at 6 (September 26, 2008) “none of the experts we interviewed cited the use of reprocessed single-use devices as a factor contributing to [hospital acquired infections] in hospitals”; See also, U.S. Government Account Office, GAO/HeHS-00-123, Single-Use Medical Devices: Little Available Evidence of Harm From Reuse, but Oversight Warranted, at 11 (June 2000) (“and studies have shown both that reprocessed procedures can be safely accomplished and that patient outcomes are not adversely affected by the use of SUDs”).
[14] Letter from the U.S. Food and Drug Administration to the Honorable Tom Davis and Henry Waxman, (January 23, 2006).
[15] Guidance for Industry and for FDA Staff, Enforcement Priorities for Single-Use Devices Reprocessed by Third Parties and Hospitals (14 August, 2000), at 1 [hereinafter “FDA Guidance of 2000”].
[16] 68 Fed. Reg. 23139 (30 April, 2003), citing 21 U.S.C. § 360(o) (emphasis added).; See also, CDRH, FDA, Validation Data Guidance, at 14-19.
[17] Letter from Tim Krock, Microvasive Endoscopy, September 23, 1999.
[18] AMDR, http://www.amdr.org/news/2012/08/reprocessing-industry-overwhelmingly-supported-by-u-s-news-world-report%E2%80%99s-2012-13-%E2%80%9Chonor-roll%E2%80%9D-hospitals/
[19] See e.g., Dr. Stephen Hammill, Director of Electrocardiography and Electrophysiology Laboratories at the Mayo Clinic (“For more than 20 years, the catheters used in electrophysiology procedures have been reprocessed at Mayo and have continued to function normally without any evidence of infection. Reprocessing the catheters has allowed us to use each catheter five or six times, greatly decreasing the cost of the procedures . . . Reprocessing of the catheters has proven to be a safe and effective technique and has allowed us to gain the most use from the catheters, making them as cost efficient as possible.”); Letter from Stephen C. Hammill, M.D., Professor of Medicine and Director of Electrocardiography and Electrophysiology Laboratories, Mayo Clinic, Rochester, Minnesota to Senator Paul Wellstone (June 23, 1999); See also, Testimony of Dr. John Clough, representing the American Hospital Association (AHA) before the Senate Committee on Health, Education, Labor and Pensions (June 27, 2000) (“[m]any medical products can be safely reused as evidenced through decades of hospital experience in reprocessing both reusable devices and those labeled ‘for single use.’ The AHA is unaware of any evidence to demonstrate a problem with reprocessing devices labeled ‘for single use.’”); Testimony of John Clough, M.D., Chair of Health Affairs, Cleveland Clinic Foundation, Cleveland, Ohio, on behalf of the American Hospital Association before the Senate Committee on Health, Education, Labor and Pensions 3-4 (June 27, 2000); see also Association for Professionals in Infection Control and Epidemiology (APIC), Reprocessing of Single Use Medical Devices, Position Statement (August 31, 2007); Association for Healthcare Resource and Materials Management, Position Statement;American College of Cardiology, Position Statement (2000; American Medical Association, Report 3 of the Council on Scientific Affairs; Reprocessing of Single Use Medical Devices (2000); Association of Peri-Operative Registered Nurses, Position Statement; Environmental Responsibility (March 2006);Hospitals for a Healthy Environment, Regulated Medical Waste; North American Society for Pacing and Electrophysiology (NASPE) (now Heart Rhythm), Letter to Senator Richard Durbin, (June 22, 1999); American Association of Orthopaedic Surgeons (AAOS), (August 30, 2001). For links to other statements of support, see AMDR’s Web site at www.amdr.org.
[20] http://www.amdr.org/legislationregulation/mdufma-mdufsa/
[21] 21 U.S.C. § 360c.
[22] Title III of MDUFMA amended the FDCA (Public Law 107-250). The law required FDA to identify “critical” and “semi-critical” 510(k)-exempt devices for which the exemptions should be terminated when the devices are reprocessed, “in order to provide a reasonable assurance of the safety and effectiveness of the devices” (21 U.S.C. § 360(o)). For devices that lost exemption from the premarket notification requirement, reprocessors had to submit a 510(k) within 15 months of FDA’s publication of a notice terminating the exemption, or the device in question could no longer be legally marketed. 21 U.S.C. § 360(o)(2)(B); see also 68 Fed. Reg. 38071 (26 June, 2003). [23] See Schultz Testimony, supra note 11 (“Congress mandated a number of new requirements for SUD reprocessors including, for certain SUDs, the pre-market submission of data to the agency that exceeded the requirements for the original manufacturers (OEMs)”) (emphasis added).
[24] 68 Fed. Reg. 23139 (30 April, 2003), citing 21 U.S.C. § 360(o) (emphasis added). For a full description of the validation data reprocessors must submit on a premarket basis, including more particular guidance on cleaning, functional testing, and sterilization data requirements, see CDRH, FDA, Validation Data Guidance, at 14-19.
[25] 21 U.S.C. § 360 and 21 C.F.R. Part 807, subpart B.
[26] 21 U.S.C. § 360i(a) and 21 C.F.R. Part 803.
[27] 21 U.S.C. § 360i(e) and 21 C.F.R. Part 821.
[28] 21 U.S.C. § 360i(f) and 21 C.F.R. Part 806.
[29] 21 U.S.C. § 360j(f) and 21 C.F.R. Part 820.
[30] 21 U.S.C. § 352 and 21 C.F.R. Part 801.
[31] FDA Guidance of 2000, supra note 2. FDA also has a Reprocessed Single-Use Device Timeline, outlining the regulatory requirements put in place since 2000.
The Business Case for Reprocessing