By Kelly M. Pyrek
To help address the tough questions related to its inquiry into third-party servicing and refurbishment of medical devices, the Food and Drug Administration (FDA) scheduled a two-day public workshop for late October. Stakeholders are many and quite diverse, ranging from clinicians, patient safety managers and HTM professionals, to original equipment manufacturers (OEMs) and those aforementioned third-party firms; all of whom will be providing their perspectives on how to ensure patient safety while controlling costs in an environment where organizations vary in how they repair and generally maintain devices.
The workshop, titled “Refurbishing, Reconditioning, Rebuilding, Remarketing, Remanufacturing, and Servicing of Medical Devices Performed by Third-Party Entities and Original Equipment Manufacturers," follows the FDA’s announcement in March that it was soliciting comments from all interested parties on this issue because of safety concerns, particularly as it relates to the use of third-party entities. The announcement in the Federal Register triggered a significant number of public comments which will be used to help inform a set of working questions "designed to promote an understanding of challenges and best practices to mitigate risks associated with these activities,” the FDA said. The goals of the workshop include establishing working definitions for third-party and OEM activities; discussing benefits, challenges and risks for stakeholders; identifying best practices when it comes to third-party activities; and determining whether “specific procedures are necessary for each activity as it relates to third-party services performed.”
At issue is the level of regulatory action -- if any -- that the FDA will take.
A panel session held during the Association for the Advancement of Medical Instrumentation (AAMI)'s annual conference earlier this year assembled Mary Logan, outgoing AAMI president and CEO; Dave Francoeur, senior director of program development and support at Sodexo; Dale Munson, manager of service and biomedical training at Medtronic; Gabe Viscomi, vice president of service at Block Imaging; and Binseng Wang, vice president of quality and regulatory compliance at Greenwood Marketing LLC. Viscomi speculated that the FDA will choose a select few comments that involve some level of evidence and scrutinize them further. He also said that “the cost for FDA to implement some type of licensing would be immense, and I don’t see that happening.” He added, “From the imaging perspective, my greatest fear is that FDA implements labeling regulations. It would be discouraging if the few bad players end up causing the vast majority, who handle repairs responsibly, to face unnecessary labeling requirements."
According to the FDA’s original comments in the Federal Register, "Stakeholders have expressed concerns that some third-party entities ... may use unqualified personnel to perform service, maintenance, refurbishment, and device alterations on their equipment and that the work performed may not be adequately documented. Possible public health issues arising from these activities include ineffective recalls, disabled device safety features, and improper or unexpected device operation.”
OEMs have stated they are worried about the quality of repairs made in the field, as the OEMs are the ones regulated and held liable by the FDA for any post-market issues that may occur with their devices, not third-party repair firms.
There is some precedent that can be studied, according to Wang, who pointed to the late 1990s when reprocessors of single-use devices (SUDs) were subject to additional regulations. According to AAMI, since 2000, the FDA has considered reprocessors of SUDs to be manufacturers, and therefore they are subject to the full range of requirements that apply to OEMs, as well as additional requirements that apply only to reprocessors. Wang called for “meaningful rules,” adding that a “shotgun approach would kill good birds as well as bad birds in the process.” Ultimately, he foresees “segments of devices coming under greater scrutiny and being controlled more rigorously this time,” similar to what occurred for reprocessors of SUDs.
While noting that the FDA’s call for information suggests that the agency does not have a predetermined path, Logan said that she was “neither optimistic nor pessimistic.” “Do I think they are going to do nothing? No. But I think it’s so complex that it’s going to take them a long time to figure out what they are going to do,” Logan added.
In a statement earlier this year, Logan observed, “This is a very important conversation that the FDA is starting, and we applaud the agency’s interest. There are many opinions about service and repair, and what we hope the conversation will bring out is data that will support a strong analysis of the issues."
The FDA has drafted a list of questions to which it is seeking answers:
- Who are the different stakeholders involved with the medical device activities listed previously?
- What are their respective roles?
- What evidence exists regarding actual problems with the safety and/or performance of devices that result from these activities?
- What are the potential risks to patients or users and the failure modes introduced as a result of performing the previously defined activities?
- Are the risks different depending on who performs them?
- Are these activities more difficult or riskier to perform on certain devices than others?
- What information do third-party entities need in order to perform these activities in a way that results in the safe and effective operation of the medical device?
- What additional challenges do stakeholders encounter with devices that result from these activities?
In addition, the FDA would like input and suggestions for the definitions of terms included in this rule: recondition, service, repair, refurbish, remanufacture, and remarket. Of note, the agency said that this proposal would not deal with the reprocessing of medical devices. However, reprocessing of medical devices -- and highly publicized outbreaks -- have colored this dialogue. According to AAMI, "The recent and highly visible problems with endoscopes complicate general perceptions about the quality of service of medical devices. Scopes are complex and difficult to clean and repair, and it is very difficult to ascertain whether there are microscopic cracks or other problems with these unique devices. There are many individuals from the service business generally who believe, without really knowing for sure, that the issues associated with endoscopes taint what would otherwise be an overall positive view about all service."
The FDA solicited comments from the general public, and at the closure of this public comment period, more than 200 remarks had been submitted. Public comments also tended to be persuasive and fervent. AAMI was among the stakeholders submitting comments to the FDA; the organization offered an overview of the service industry and declared its general preference for “standards over regulation” in tackling problems related to healthcare technology. In these comments, AAMI did not take a stance on who should repair or service equipment, neither did the association answer the FDA’s more detailed questions about service. Instead, AAMI noted the different perspectives and players, acknowledged the various concerns, underscored the value of consensus-based standards in any solution, and encouraged the FDA to take a comprehensive and long-term view in deciding what to do.
“As is often the case with complex issues that involve multiple disciplines, multiple service models, lack of standardization, paucity of reliable data about the industry, uneven lobbying capabilities across the sector, strong opinions, and stories galore, there is a huge risk of unintended consequences from a regulatory answer,” AAMI noted in its comments. “AAMI applauds the FDA for taking a conservative approach of requesting information to help it assess the questions it asked.” The association added, “AAMI in general prefers standards over regulation and believes that consensus-based standards … can solve most technology-oriented problems. Decisions made by the FDA, working alone, tend to have unintended consequences. Likewise, decisions made by industry or healthcare delivery organizations while working alone in their own silos tend to have unintended consequences. Standards that are developed through an open consensus-based approach—with all stakeholder perspectives represented in the process—tend to solve problems without creating new ones and also tend to build the strongest buy-in from all stakeholders because they contributed to the solution rather than being told what they must do.”
While there have been a few highly visible incidents in recent years, AAMI says that research conducted by the ECRI Institute and a separate analysis published in AAMI's peer-reviewed journal BI&T show that the number of technology-related adverse incidents caused by poor maintenance or repairs is very low, even when operating under “worst-case” assumptions. “Many in the industry assume that this is a slippery slope toward regulation,” AAMI reported, referring to the FDA’s call for comments. However, as a standards development organization and a “neutral organization that highly values its neutrality,” AAMI highlighted the value of a consensus-based approach to the issue. “AAMI in general prefers standards over regulation and believes that consensus-based standards … can solve most technology-oriented problems,” AAMI wrote.
The association added, "Decisions made by the FDA, working alone, tend to have unintended consequences. Likewise, decisions made by industry or healthcare delivery organizations while working alone in their own silos tend to have unintended consequences. Standards that are developed through an open consensus-based approach—with all stakeholder perspectives represented in the process—tend to solve problems without creating new ones and also tend to build the strongest buy-in from all stakeholders because they contributed to the solution rather than being told what they must do.”
AAMI has developed a New Work Item Proposal to create a consensus-based standard on the terminology used in the FDA docket and throughout the service industry. It also offered ideas for other possible standards that could be helpful in this space, such as equipment acquisition considerations, processes and policies; core competencies for technicians; core elements of verification, validation, calibration and testing of devices that are repaired or refurbished; service documentation; inventory management; quality assurance for component parts; and quality assurance for refurbished equipment."
Logan encouraged all stakeholders to view the FDA’s call for comments in a positive light. “No matter which direction this FDA initiative ends up going, the entire industry will be better informed because of the diversity of perspectives the FDA has gathered during this process,” she said.
Despite some differences of opinion, AAMI points out that stakeholders across the entire service industry share some common goals, including ensuring patient safety through proper service and repair; clearly defining responsibilities between OEMs and HTM professionals; verifying the competencies that are necessary to support medical equipment; and coming to agreement on the types of OEM resources and documentation that should be available to end-users.
Coming from a third-party perspective, David Anbari of Mobile Instrument Repair, Inc. says Mobile agrees with the FDA's desire to gain a better understanding of refurbishment practices, especially since current adverse-event data is being debated. "We support the FDA’s inquiry as it will show there is no evidence of a problem with medical device servicing," Anbari says. "There is ample data regarding adverse events and nothing suggests that there would be fewer events if the FDA were to become involved. ECRI’s research of more than a decade of data did not find any evidence of a systemic problem with service activities by manufacturers or others. There is a perceived risk that seems to be driven more by manufacturers’ desire to control the market than any real evidence of a problem."
Anbari does give pause to the FDA's attempt to regulate. "Without evidence that FDA regulation would improve safety, there is no basis for the FDA to step in," he says. "FDA would have to invest in people and resources to support a new oversight regime which costs real dollars and focus. At the same time, competition for services would be reduced resulting in a climate where manufacturers can charge end users even higher prices to acquire and maintain devices. With no gain in safety and higher costs, there is no case for regulation."
Anbari says he believes that potential FDA regulation or other restrictions on service would increase the cost of healthcare in general as well as increase the cost of refurbished equipment or third-party repairs specifically. "Regulation will increase the cost of healthcare and at the same time reduce completion for services. It is well proven that lack of a competitive marketplace for any product or service will increase costs and medical devices are not immune. Manufacturers can force premature upgrades of functional devices by discontinuing support. Service monopolies will allow manufacturers to charge much more for repairs. Preventive maintenance will decline as end users fear high maintenance costs resulting in unexpected device failures and premature replacement." He continues, "The addition of regulatory requirements will inevitably reduce the number of alternative service providers and result in higher prices and service monopolies for devices with less widespread distribution. For many devices, there is already a monopoly for parts as manufacturers refuse to sell them to service providers or end users. Without a viable alternative, manufacturers charge excessive prices and in some cases force costly upgrades prematurely by discontinuing service for a device. If there are additional regulatory requirements, we must ensure that the market is fair and open by requiring manufacturers to engage with service providers."
As we have seen, the FDA may define service terminology, and Anbari says that "A common terminology will help ensure consistent treatment of market participants. We think the FDA has proposed too many roles in its comment document. The proposed activity definitions can be simplified by focusing on the actual actions performed on devices instead of the business purpose for which the activity was performed. For example, recondition” and 'refurbish' and 'remanufacture' refer to varied degrees of repair for different business purposes. And there is no mention of maintenance in the definitions proposed. This overlooked function is vital to avoid repairs and premature replacement." He adds, "After enduring decades of listening to manufacturers say, “If we don’t repair your device, it is not safe,” end users need to know the facts. There is no evidence that regulation will improve safety and it is inevitable that costs will go up with regulation. End users to speak their minds now. Our fear is that end users will not speak up until the FDA makes a decision to regulate and then it will be too late for their voice to be heard."
The bottom line in this discussion is risk management. As AAMI notes in its comments to the FDA, "An essential element of all medical device service, whether it is routine preventive maintenance, repair, or refurbishment, is managing risk. The service industry culture, training and expertise has, at its very core, the management of risk, including risk to patients, risk to staff, and risk to institutions."
Let's take a look at the public comments submitted to the FDA from several organizations:
Association for Professionals in Infection Control and Epidemiology (APIC)
Regarding proposed definitions of third-party and OEM activities, APIC says it agrees with the definitions proposed by the FDA, and adds, "We also suggest adding the term 'reprocess,' which generally refers to all operations performed (e.g., to cleaning, disinfecting, sterilizing and validation) to render a used reusable or single-use device patient-ready or to allow an unused product that has been opened to be made patient ready. APIC recommends that this term be defined as, 'the treatment of medical devices or equipment using validated technology and/or methods described by the original equipment manufacturer (OEM) in order to make them safe for reuse.'"
In terms of what evidence exists regarding actual problems with the safety and/or performance of devices that result from these activities, APIC points to the redesign of the endoscopic retrograde cholangiopancreatography (ERCP) duodenoscopes which affected the ability of end users to effectively clean the scopes, resulting in outbreaks at several institutions.
APIC also addressed the potential risks (patients/users) and failure modes (devices) introduced as a result of performing refurbishment activities on medical devices and noted, "Failures involving reprocessing, reconditioning, or remanufacturing reusable patient care devices can result in catastrophic patient outcomes. Recent infections involving Carbapenem-resistant Enterobacteriaceae (CRE) transmitted by Olympus TJF-180V (ERCP) duodenoscopes highlight this. Changes made by the OEM to the scope resulted in hard to reach crevices that increased difficulty in cleaning. The reprocessing of reusable patient care devices is a complex process with many steps. This is especially true in the case of duodenoscopes and endoscopic ultrasound scopes, which are highly complicated devices that are exceedingly difficult to clean effectively. In a prospective multisite study it was noted that all steps in manual high level disinfection are completed only 1.4 percent of the time. The same study reflected that all steps in high level disinfection with an automated endoscope reprocessor (AER) are completed only 75.4 percent of the time. For these reasons, accepting a manufacturer’s high-level disinfection process that assumes 100 percent compliance with the process does not re-flect the reality in the field, and an assumption that it will be followed puts patients at risk."
APIC added, "Key to risk mitigation is education of the individuals performing the tasks. They must have a clear understanding of the importance to detail in following the OEM guidance and raising concerns if they encounter difficulty complying with that guidance. Risk mitigation needs to occur with whoever is performing these activities, but a vulnerability for third-party entities is that to perform activities outside the OEMs guidelines may in some unpredictable manner alter the intended use and performance."
Association of periOperative Registered Nurses (AORN)
In its comments to the FDA, AORN observed, "The risks of performing refurbishing, reconditioning, rebuilding, remarketing, remanufacturing, and servicing of medical devices vary by the type of device, service being performed, the degree of modification to the original device design, and the qualifications of the service provider. The evidence-based AORN Guideline for Cleaning and Care of Surgical Instruments and the Guide-line for Processing Flexible Endoscopes recommend that qualified individuals should perform the preventative maintenance of flexible endoscopes, instruments, and cleaning equipment. Preventative maintenance requires special skills and knowledge that includes systemic inspection, testing, measurement, adjustment, detection, parts replacement, and correction of device or equipment malfunction either before it occurs or before it develops into major failure. Having qualified personnel perform preventative maintenance increases the probability that repair and service will be performed correctly."
AORN added further, "AORN recommends that instruments and equipment should be maintained and serviced in accordance with the de-vice manufacturer’s written instructions for use (IFU). Preventive maintenance requirements or recommendations are what the device manufacturer has determined as necessary to keep instruments and equipment in optimal working order. Providing instructions and equipment in optimal working order is critical to patient safety. Third-party preventative maintenance programs, when administered in accordance with the de-vice manufacturer’s written IFU by qualified service contractors, are safe and cost-effective mechanisms to maintain the quality and performance of medical devices. Requirements mandating exclusive original equipment manufacturers (OEMs) to service devices would be overly burdensome and costly to health care organizations, which could have significant consequences that interfere with the delivery of patient care."