Medical device stakeholders give House feedback on 4 separate bills

A variety of stakeholders in the medical device industry testified before the House Energy and Commerce Committee with respect to a number of bills related to devices, including the Over-the-Counter Hearing Aid Act (H.R.1652), the Medical Device Servicing Safety and Accountability Act (H.R. 2118), the Fostering Innovation in Medical Imaging Act of 2017 (H.R. 2009), and a bill to amend the Federal Food, Drug, and Cosmetic Act to improve the process for inspections of device establishments and for granting export certifications (H.R. 1736), which would enhance the authorization Medical Device User Fee Amendments (MDUFA IV). While stakeholders took opposing viewpoints with respect to some bills, those that spoke to MDUFA IV, including Director of the FDA’s Center for Devices and Radiological Health Jeffrey Shuren, all expressed their support.

Over-the-Counter Hearing Aid Act

The Over-the-Counter (OTC) Hearing Aid Act would permit the sale of OTC hearing aids for use in adults with mild to moderate hearing impairments. Speaking on behalf of the Hearing Industries Association (HIA), Dr. Thomas Powers of Powers Consulting, LLC supported the sales of OTC hearing aids for mild hearing impairments, but opposed the provision of such hearing aids for moderate use. Hearing impairment, particularly moderate and severe impairments, are complex and, in Powers’ opinion require consultation and fitting with hearing health professionals; in addition, he cited to a study indicating that hearing impaired individuals were more likely to be satisfied and wear hearing aids fitted by a professional.

Frank R. Lin, M.D., Ph.D., Associate Professor in the Departments of Otolaryngology-Head & Neck Surgery and Geriatric Medicine at the John Hopkins School of Medicine and in the Departments of Epidemiology and Mental Health at the Johns Hopkins Bloomberg School of Public Health, on the other hand, opined that OTC sales would make hearing aids more accessible and affordable to the hearing-impaired population; currently, less than 28 percent of the nearly 38 million Americans with significant hearing loss have access to the devices. He argued that alleged safety concerns about the sale of OTC hearing aids to individuals with moderate hearing loss were raised by parties looking to preserve the status quo, which offers little incentive for innovation of new market entry, with, “98 percent of the world’s hearing aid marketplace being controlled by six companies.” He likened the risks of OTC hearing aids to the risk of OTC reading glasses or aspirin.

Medical Device Servicing Safety and Accountability Act

H.R. 2118 would require establishments that service medical devices to register with the FDA, establish a complaint-handling system, and report adverse events to the agency. Joe Robinson, Senior Vice President of Health Systems Solutions for Philips North America, offered his support of the bill on behalf of the Medical Imaging & Technology Alliance (MITA). He noted that improper servicing of medical devices by non-manufacturer entities can injure patients via direct or indirect bodily harm, and can also cause problems for manufacturers down the road. For example, the manufacturer may not be aware of adverse events or may not be familiar with the chain of events that ultimately led to an adverse event, may experience difficulty upgrading parts that have been altered by a third party, or may have its device certification voided. MITA believes that registration and complaint handling is an important first step to improve service and safety.

Robert J. Kerwin, General Counsel for the International Association of Medical Equipment Remarketers and Services, Inc. (IAMERS), adamantly opposed the bill. He argued that the legislation provided a solution for a problem that does not exist, noting that, of the 177 public comments submitted to the FDA in response to its request for comments, including comments on service regulation, nearly none of them made negative comments about third-party device services, and that The Joint Commission, in its comment, stated that it “has no knowledge of any statistically significant level of safety problems resulting from the activities of any kind of maintenance/service provider.” Kerwin contrasted MITA’s opinion that increased regulation is necessary to prevent improper servicing with its members’ decisions to subcontract with IAMERS members to perform repair work. He further emphasized that the language of the bill would classify any type of repair work performed as a complaint, increasing the burden on third-party services, and hurt rural and regional hospitals that rely heavily on third-party servicers.

Fostering Innovation in Medical Imaging Act 

H.R. 2009 would “provide clarity with respect to the regulation of diagnostic imaging devices intended for use with contrast agents.” Currently, the FDA will not approve imaging devices or enhancements for use with approved contrast agents, if the agents are not specifically labeled for that use. MITA approved of the bill’s provision of “a clear regulatory pathway” to promote innovation.

H.R. 1736

Patricia Shrader, Vice President for Global Regulatory Affairs at Medtronic, Inc., spoke on behalf of AdvaMed, the Advanced Medical Technology Association, to offer its support of the bill, which would establish a risk-based inspection schedule based on a medical device facility’s risk profile. Shrader opined that this would allow the FDA to consider a facility’s compliance history and other related factors in scheduling inspections, as opposed to aligning the frequency of inspections with the classification of the devices a facility manufactures. She applauded the bill’s plan to improve FDA and facility communications prior to, during, and after inspections, noting that facilities would no longer need to wonder from day-to-day, during the course of an ongoing inspection, whether an inspector would be able to travel to the facility. The bill would also require the FDA to provide non-binding feedback on proposed remediation plans, so that facilities are not left wondering what changes they should make. Finally, the bill would require the FDA to implement a process to address refused international device certifications—certificates to foreign governments (CFGs)—when those refusals result from lack of FDA confirmation, rather than issues with the devices.

Leapfrog names the ABCs of hospital-acquired conditions

Since the 2012 establishment of the Leapfrog Group’s Hospital Safety Grade health care rating system, patient safety has improved across the country, including a 21 percent reduction in hospital-acquired conditions (HACs). However, significant patient safety problems persist. For example, over 1000 people are estimated to die each day from preventable errors—the third leading cause of death in the country.

Rating

The Leapfrog Hospital Safety Grade is the only national health care rating focused on errors, accidents, and infections. The program has assigned letter grades—A, B, C, D, F—to general acute-care hospitals in the U.S. since 2012 based upon national performance measures from CMS, the Leapfrog Hospital Survey, the Agency for Healthcare Research and Quality (AHRQ), the Centers for Disease Control and Prevention (CDC), and the American Hospital Association’s Annual Survey and Health Information Technology Supplement.

Improvement

A significant area of improvement is the 21 percent reduction in HACs between 2010 and 2015. The positive stride is attributable, in part, to Patient Protection and Affordable Care Act (ACA) (P.L. 111-148) provisions designed to reduce HACs (see By any measure, national effort to increase health care safety succeeded, Health Law Daily, December 13, 2016). However, the HAC progress is not without its caveats. Estimates of hospital related patient harms put the number of hospital deaths related to preventable errors at over 400,000 per year.

The Leapfrog Group identified other areas of progress, regarding the reduction of medication errors through increased adoption and functionality of computerized physician order entry systems, as well the development of public and private partnerships to reduce HACs.

Grades 

Five years into the Leapfrog Hospital Safety Grade scoring, 63 out of over 2,600 hospitals have achieved an “A” in every national scoring update. In the most recent rating of 2,369 hospitals, 823 earned an “A,” 706 earned a “B,” 933 earned a “C,” 167 earned a “D” and 10 earned an “F”. The five states with the highest percentage of “A” hospitals were Maine, Hawaii, Oregon, Wisconsin and Idaho.

Too much ‘noise’ in system at root of device recall delays

Postmarket surveillance of medical devices, which includes device manufacturers’ investigations of complaints about their devices, are generally not logged in the FDA’s adverse event report system. In a study sponsored by the University of Minnesota and published in the journal Production and Operations Management, the researchers found that the more adverse event reports there are for a ­particular device, the more likely it was a company would have “under-reaction” bias in deciding whether a recall was appropriate.  In other words, device manufacturers, when presented with multiple adverse event reports for a specific device, actually took longer to react on the recall decision.

Each year, the FDA receives several hundred thousand medical device reports (MDRs) of suspected device-associated deaths, serious injuries, and malfunctions. The FDA uses MDRs to monitor device performance, detect potential device-related safety issues, and contribute to benefit-risk assessments of these products. A Manufacturer and User Facility Device Experience (MAUDE) database houses these MDRs submitted to the FDA by mandatory reporters (manufacturers, importers, and device user facilities) and voluntary reporters, such as health care professionals, patients and consumers.

Although MDRs are a valuable source of information, they provide only a passive surveillance system. Limitations include the potential submission of incomplete, inaccurate, untimely, unverified, or biased data. In addition, the incidence or prevalence of an event cannot be determined from this reporting system alone due to potential under-reporting of events and lack of information about frequency of device use. Because of this, MDRs comprise only one of the FDA’s several important postmarket surveillance data sources. As the researchers applied digital analytics to millions of medical device product reports and recall records for their study, they found a high “signal to noise” ratio correlated with the delays. Not only did these indicators create detection issues, older and widely used devices tended to have multiple adverse event reports in MAUDE, making safety-signal detection difficult.

In 2012, the FDA announced plans to develop a National Evaluation System for Health Technology (NEST) to generate better evidence for regulation and agency decisions throughout the lifespan of a device. Whether the system will provide a better way for both the agency and industry to monitor postmarket safety of medical devices is indeterminate, but the FDA is counting on the system providing more collaboration than the current one.

GNC agrees to reform and pays $2.25M over illegal supplements

GNC Holdings Inc. (GNC), the world’s largest dietary supplement retailer, agreed to pay $2.25 million under a non-prosecution agreement to resolves the retailer’s liability for selling dietary supplements produced by a firm under indictment. GNC also agreed to reform its practices related to potentially unlawful dietary ingredients and pledged to undertake voluntary initiatives designed to improve the quality and purity of dietary supplements.

Investigation

The FDA, the U.S. Attorney’s Office for the Northern District of Texas, and the Consumer Protection Branch of the Department of Justice’s (DOJ’s) Civil Division conducted an investigation which revealed the inadequacy of GNC’s practices regarding the legality of the products on its shelves. The investigation found, in 2013, GNC sold, nationwide, OxyElite Pro™ Advanced Formula, a product of Dallas-based USPlabs LLC (USP Labs). GNC sold the product based upon representations from USP Labs that the product and its ingredients complied with the law. However, GNC did not undertake additional testing or require additional certifications to confirm those representations.

USP Labs

In 2015, USP Labs was indicted and is currently awaiting trial. The indictment alleges that USP Labs conspired to import ingredients from China using false certificates of analysis and false labeling. USP Labs subsequently lied about the source and nature of those ingredients after it put them in its products. Additionally, the indictment alleges that USP Labs told retailers it used natural plant extracts in some of its products, when, in fact, it was using synthetic stimulants manufactured in a Chinese chemical factory.

Agreement

Under GNC’s non-prosecution agreement, the retailer has agreed to:

  • Immediately suspend the sale of a product upon learning that the FDA has issued a public written notice that a purported dietary supplement or an ingredient contained in a purported dietary supplement is not legal and/or not safe;
  • establish two lists—a “restricted list” containing ingredients that are not to be used in dietary supplements and a “positive list” containing ingredients that are approved for sale;
  • substantially revise its internal approach to dealing with the vendors whose products GNC sells, including requiring more explicit guarantees from its vendors that their products do not contain ingredients on the “restricted list”;
  • voluntarily work to develop an industry-wide quality seal program; and
  • update its adverse event reporting policy to ensure that its employees understand the proper procedures to employ if a customer complains of injuries associated with a dietary supplement bought at GNC.