More from September 2014 - Vol. 33 No. 09
Stewart I. Adam, MD, resident, Yale-New Haven Hospital
Many physicians go into training and practice with the goal of helping patients and contributing meaningfully to society’s betterment. Perspective on the privileges and accompanying responsibilities of being a physician can sometimes be lost, especially during training, where a large body of specialty-based knowledge and surgical skills are developed in the midst of a busy clinical experience. My travel to Riobamba, Ecuador, November 8-16, 2013, helped reinvigorate a personal sense of humanitarianism as the driver of compassionate, artful care.
Our team consisted of 25 healthcare workers, including anesthesiologists, pediatricians, scrub techs, nurses, and two otolaryngologists. Howard Boey, MD, led the group for the ninth year and provided me great mentorship and training. We worked with the private charitable organization FIBUSPAM (http://www.clinicadulcerefugio.com), which was integral in providing a base in Riobamba, organizing patient recruitment, and facilitating the use of the Galapagos Military Hospital for cases requiring general anesthesia.
For a few team members, including myself, the mission was our first experience in Ecuador. Riobamba is a small Andes Mountain city in the Chimborazo Province, nestled between active volcanoes, about 125 miles south of Quito, the country’s capital city. The average household income is about $4 a day. Indigenous populations are prevalent and subsistence farming is the dominant economic activity. There is widespread poverty, unemployment, and hopelessness. Basic primary medical care is limited, and the more indigenous and impoverished people have virtually no access to surgical subspecialties such as ENT.
After taking a redeye flight to Quito and a five-hour drive through the Andes to Riobamba via military buses, we were greeted with a reception featuring indigenous music and dance at the FIBUSPAM clinic. Medical supplies were largely donated and consisted of surgical instruments/kits, medications, anesthesia equipment, microscope, NIMS machine (charitable donation from Medtronic, Inc.), food, etc. Each team member transported supplies in large hockey bags. The equipment required significant manpower in organizing, assembling, and deploying.
Our first workday was spent screening 200-plus patients at the military hospital site. Some patients traveled more than 10 hours from the Amazon basin region of Ecuador. A significant portion of patients had cleft lips, palates, and noses in various pathologies and stages of repair. Some were infants with primary lips, others returned to have their palates repaired following successful lip surgery from the previous mission. A few patients developed palate fistulas following repair, and some teenagers and young adults arrived for cleft nose surgery. Following patient screening, we planned the next four operative day schedules.
We completed 61 surgical procedures in four days. Cases included cleft lip repairs, cleft palate repairs, definitive open septo-rhinoplasty for cleft nose, thyroidectomies, tympanoplasties, a few adenotonsillectomies, and two congenital aural atresia repairs. The operative cases provided a great supplement to residency training and experience in managing cleft patients. The most meaningful part of the trip and surgical care was talking with the parents following the cases in our make-shift PACU and seeing the looks of joy, excitement, and hope on their faces.
The mission met its goals of creating accessible care to those most in need. A key factor to this successful trip was working through a well-established organization that coordinated appropriate patients for screening. The most disconcerting aspect of the care we provided is not being able to directly follow up with our patients. The FIBUSPAM clinic did arrange follow-up and we have been able to correspond with two local general surgeons and see patient photos. Working in Riobamba was enriching. I plan to participate in future medical mission trips and strongly encourage my peers to do the same. I am grateful to the AAO-HNS humanitarian grant for funding my trip. From the AAO-HNS Medical Devices and Drugs Committee
Committee Chair and Series Editor: Anand K. Devaiah, MD
Associate Professor, Departments of Otolaryngology, Neurological Surgery, and Ophthalmology
Boston University School of Medicine and Boston Medical Center
Anjum Khan, MD, MPH
Medical Officer, Division of Ophthalmic and Ear, Nose, and Throat Devices
Office of Device Evaluation, CDRH, FDA
Adjunct Clinical Associate Professor of Surgery, Uniformed Services University, Bethesda, MD
Marilyn Neder Flack, MA
Executive Director, Association for the Advancement of Medical Instrumentation (AAMI) Foundation at AAMI, Silver Spring, MD
Rahul Shah, MD, Associate Professor of Otolaryngology and Pediatrics, Children’s National Medical Center and George Washington University, Washington, DC
Member, ENT Device Advisory Panel, FDA
Introduction
As scientific and technological advances enhance the pace of medical device1 innovation, there is increasing reliance on medical devices for patient care. Otolaryngologists, who may work in settings such as outpatient, emergency, surgical, and/or nursing home care, use a wide variety of devices for diagnosis, mitigation, and treatment of medical conditions for their patients.
The inaugural article in this series for the Bulletin introduces the basic concepts of how the Food and Drug Administration (FDA) functions in regulating devices and drugs. Having a more in-depth understanding of the FDA, and how it works to ensure the safety and effectiveness of medical devices used by otolaryngologists in the above care settings is important. It enables otolaryngologists to know how they may play an active role in protecting the safety of their own patients, and in contributing to the nation’s public health related to medical devices. As discussed in this two-part article, one critical role otolaryngologists can play in assisting FDA in its mission to protect and promote the public health is that of an “active reporter”of problems they encounter with actual clinical use of medical devices.
The FDA’s Center for Devices and Radiological Health (CDRH) is responsible for reviewing pre-market applications for medical devices to ensure the devices meet the regulatory requirement of a reasonable assurance of safety and effectiveness. CDRH utilizes both pre-market programs to review device information prior to permitting manufacturers to legally market medical devices and post-market programs to perform surveillance of device performance once it is in widespread clinical use. It also has research, compliance, and educational components that round out the center’s efforts to protect and promote the public health with respect to medical devices. The focus of this article is on the pre-market and post-market work conducted by CDRH, and how otolaryngologists can contribute to ensuring and optimizing medical device safety for their patients.
CDRH Pre-market Activities
Medical devices vary greatly in the complexity of their technology. A device may be as simple as a tongue blade or as technologically complex and sophisticated as a fully implantable hearing aid or cochlear implant.
In 1976, the Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act acknowledged and accommodated for the differences in complexity and level of safety of the myriad medical devices by creating a three-tiered, risk-based classification. The level of regulatory oversight for each device type is based on the classification level (Class I, II, or III) into which it is assigned.
Class I devices pose a low-to-moderate risk for causing patient or user injury and have minimal potential for harm. Examples of otolaryngologic devices in this category include tuning forks, tongue blades, and most air-conduction hearing aids. Most of these items are, in fact, exempt from pre-market review by FDA. They are still required to comply with certain general regulatory controls such as good manufacturing practices, provisions regarding adulteration and misbranding, reporting of certain types of post-market problems, and others to provide reasonable assurance of the device’s safety and effectiveness. Safety and effectiveness of these devices are generally well understood and they constitute about 47 percent of all devices in the marketplace.2
Class II devices typically pose moderate to high risks for patient or user injury and are generally more complex than Class I devices. General controls alone are insufficient to provide a reasonable assurance of their safety and effectiveness. Most require thorough review of a Pre-Market Notification [also known as a “510(k)”] to demonstrate that the device is “substantially equivalent”to a legally marketed “predicate”device. Most 510(k) submissions do not require clinical data if bench/animal data are sufficient to show substantial equivalence (SE) to a predicate device(s). A device is substantially equivalent if, in comparison to a predicate it:
Has the same intended use as the predicate; and
Has the same technological characteristics as the predicate; or
Has the same intended use as the predicate; and
Has different technological characteristics and the information submitted to FDA in the 510(k):
Does not raise different questions of safety and effectiveness; and
Demonstrates that the device is at least as safe and effective as the legally marketed device.3
Thus, a new device may be different from its predicate in composition or technological characteristics and may still claim SE as long as: 1. the new device does not have a new intended use, 2. the new device raises no different questions of safety and effectiveness, and 3. adequate performance data are provided to support the safety and effectiveness of the changes compared to the predicate. For example, when a company marketing endoscopes (e.g., laparoscopes, laryngoscopes, and cystoscopes) makes changes to design or materials of the scopes, but the function and the indications for use of the scopes remain similar to a previous generation of the scopes, marketing clearance may be granted without the manufacturer submitting clinical data with the new device, although relevant preclinical bench performance testing would likely be required. Almost 43 percent of all medical devices currently in the marketplace are reviewed through the 510(k) pre-market notification (PMN) program.4
Otolaryngologic devices in this Class II category include endoscopes, PORPS/TORPS, tinnitus maskers, radiofrequency tonsillectomy devices, and tracheo-esophageal prostheses. As noted above, Class II devices, in additional to the general controls required for Class I devices, have additional data requirements. These typically include submission of a 510(k) and special controls (e.g., specified performance testing, clinical testing, specific information in physician and/or patient labeling) to ensure a reasonable assurance of safety and effectiveness. For example, performance testing for audiometers requires compliance with American National Standard Institute S3.6-1996, “Specification for Audiometers.”
Class III devices pose the highest risk for patients or users and include devices that support or sustain human life, are of substantial importance in preventing impairment of human health, or present a potential unreasonable risk of illness or injury. The safety and effectiveness profiles of these types of devices are typically not well understood, such that special controls cannot be established to provide a reasonable assurance of safety and effectiveness (as for Class II devices). In this case, the safety and effectiveness of the device is evaluated through review of a Premarket Approval (PMA) application. The manufacturer must receive FDA approval of its PMA application prior to marketing the device. Approval of the application is based on a determination by FDA that the PMA contains sufficient information, which usually includes data from a well-designed clinical trial, to provide a reasonable assurance of safety and effectiveness of the device for its intended use(s). Examples of devices in this classification include implantable vagus nerve stimulators, cochlear implants, and auditory brain stem implants. Only about 10 percent of all devices in the marketplace have required review under this program.5
Sources
1. Medical Device Definition as defined in section 201(h) of the Food, Drug, and Cosmetic Act: A medical device diagnoses, cures, mitigates, treats, or prevents a disease /condition or affects the function or structure of the body and does not achieve Intended Use through chemical action and is not metabolized (Source: http://www.gpo.gov/fdsys/pkg/USCODE-2010-title21/pdf/USCODE-2010-title21-chap9-subchapII-sec321.pdf see page 5) (Last accessed on 11-26-13).
2. Classification of Devices http://www.fda.gov/MedicalDevices/ResourcesforYou/Consumers/ucm142523.htm (Last accessed on 11-25-13).
3. Premarket Notification (510k)> How to Find a Predicate Device www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/default.htm (Last accessed on 11-25-13)
4., 5. http://www.fda.gov/MedicalDevices/ResourcesforYou/Consumers/ucm142523.htm (Last accessed on 11-25-13) Liana Puscas, MD
Chair, AAO-HNS Delegation to the AMA House of Delegates
The American Medical Association (AMA) conducted its annual House of Delegates (HOD) meeting in Chicago, Illinois, from June 7-11, 2014. At the meeting, the AAO-HNS was represented by Liana Puscas, MD, MHS, delegation chair; Delegates Michael Goldrich, MD, and Shannon Pryor, MD; and Alternate Delegates Robert Puchalski, MD, and Academy EVP/CEO David R. Nielsen, MD. Joy Trimmer, JD, senior director of Government Affairs, and Danielle Jarchow, JD, health policy analyst provided staff support for the Delegation and OTO Section Council.
Among the many items of business on the agenda affecting the general House of Medicine, the following issues are highlighted due to their potential influence on members of our Academy.
Guidelines for Medical Healthcare Teams. The AMA’s Council on Medical Service presented its report regarding model healthcare teams and clearly delineated physician leadership of healthcare teams.
Grace Periods under the ACA. Under the Affordable Care Act, patients enrolled in federal plans have a 90-day grace period for paying their premiums. During this time, care provided by a physician would not be covered if the patient does not pay the premiums that are in arrears. The AMA passed policy favoring advocacy in support of insurance company notifications of a patient’s grace period status upon eligibility verification by the physician.
Health Insurance Formulary Transparency. The AMA supports legislation or regulation that ensures private health insurance carriers declare their formularies by October 1 of the preceding year. This would include information regarding generic versus trade formulations, copay responsibilities, and the inability to change a medication to a higher tier within the policy term.
FDA Regulation of All Nicotine Products. The AMA passed resolutions opposing any FDA rule that exempts any nicotine-containing products, including e-cigarettes and cigars, from FDA regulation.
Super Magnetic Toys. The AMA passed a resolution asking for a ban of neodymium magnetics whose magnetic strength index is greater than a certain threshold due to gastrointestinal and choking hazards produced by such toys.
Restrictive Covenants. The AMA adopted a report opining that competition among physicians is ethically justifiable when based on factors such as quality of services, skill, experience, and conveniences offered to patients. Covenants aimed to reduce competition can disrupt continuity of care and limit access to care.
Hospital Policies on Interactions with Industry. The HOD adopted a report by the Board of Trustees that encourages hospitals to craft policies concerning the relationships and interactions between hospital personnel and industry representatives within the hospital setting.
Place of Service Code for Observation Services. In alignment with the Academy, the AMA continues to support advocacy with CMS to modify the rules that govern observation versus inpatient status. Many patients admitted for observation require the same level of care as those who are formally classified as inpatients, especially when that length of stay extends beyond a 24-hour period. Patients are often liable for services provided as part of observation care, and reimbursement is lower for observation status patients than inpatient status patients, even if the services provided by the physician are identical.
Sunshine Act. The AMA website is prominently featuring information and guidelines for physicians during the tiered implementation of this Act.
The next meeting of the AMA HOD is scheduled for November 8-11 in Dallas, Texas. As a reminder, since AMA delegations are in proportion to an organization’s number of AMA members, it is imperative that we continue to grow our AMA membership to maintain otolaryngology’s representation in the HOD.
With questions regarding this report and other AMA House of Delegates activities, please email govtaffairs@entnet.org. With the AAO-HNSF 2014 Annual Meeting & OTO EXPOSM only days away, now is the time to learn more about the legislative advocacy-related programming available at this year’s meeting. An exciting development for this year is the availability of a second Legislative Advocacy booth, which will provide attendees with greater access to information regarding the Academy’s legislative, political, and grassroots programs. Visit one (or both) of the booths to meet the Government Affairs team and learn more about our various programs. The booths will be easily accessible in the Orlando Convention Center on either the West Concourse Level 2 or outside Hall B.
Be sure to visit to:
Sign our petition to Congress on a key AAO-HNS legislative issue and receive updates on bills affecting your practice and your patients.
Join the ENT Advocacy Network to receive timely updates on political and legislative issues affecting the specialty and a free subscription to a biweekly e-Newsletter, The ENT Advocate.
Volunteer to be a “state tracker”for the specialty.
Learn how to get involved in the grassroots “I-GO”program.
Obtain information on becoming a 2014 ENT PAC Investor*.
See which training program is leading in the Resident and Fellow-in-Training Advocacy Involvement Campaign.
To recognize our 2014 Investors, the ENT PAC Board of Advisors and staff have also scheduled various events during the meeting. Please mark your calendars to join these events.
The annual ENT PAC Investors “thank-you”reception. This popular event is scheduled to take place from 7:00 to 8:30 pm Monday, September 22, at BB King’s Blues Club. U.S. AAO-HNS members who make donations to ENT PAC prior to, or during, the meeting are invited to the event.
A special “thank-you”luncheon for members of the ENT PAC Chairman’s Club ($1,000+ donors) and winners of the 2013 SRF Advocacy Involvement Campaign. The luncheon, hosted by the ENT PAC Board of Advisors, is a unique opportunity to learn about the Academy’s political strategy and decision-making process while also networking with fellow colleagues. The year’s luncheon will take place from 11:30 am to 1:00 pm on Monday, September 22.
For more information on any of the above-listed programs, email govtaffairs@entnet.org or visit www.entnet.org/advocacy. We look forward to seeing you in Orlando!
*Contributions to ENT PAC are not deductible as charitable contributions for federal income tax purposes. Contributions are voluntary, and all members of the American Academy of Otolaryngology-Head and Neck Surgery have the right to refuse to contribute without reprisal. Federal law prohibits ENT PAC from accepting contributions from foreign nationals. By law, if your contributions are made using a personal check or credit card, ENT PAC may use your contribution only to support candidates in federal elections. All corporate contributions to ENT PAC will be used for educational and administrative fees of ENT PAC, and other activities permissible under federal law. Federal law requires ENT PAC to use its best efforts to collect and report the name, mailing address, occupation, and the name of the employer of individuals whose contributions exceed $200 in a calendar year. From time to time, Education staff receives calls from members regarding aspects of the Foundation’s Education Program. With the launch of the new AcademyU®, www.entnet.org, and ENTConnect, member attention has provided fresh opportunity to address these concerns and questions.
Myth 1—CPD is the Same as CME
Continuing medical education (CME) is the component of continuing professional development (CPD) that offers education credit for physicians. CPD encompasses a larger view of professional development focused on addressing the education needs of all healthcare professionals. CPD goes beyond just providing credit and explores the critical education needs of all ENT professionals.
Myth 2—AAO-HNSF Oversees Maintenance of Certification (MOC)
The Academy is not in charge of MOC.
The American Board of Otolaryngology (ABO), as a part of the American Board of Medical Specialties, oversees the program. Information about MOC can be found on ABO’s website. However, the Foundation is continuously adding to its resources that aid in the MOC process. These include the AcademyQ™question app, live and recorded Clinical Fundamentals courses, and the updated “Otolaryngology Lifelong Learning Manual”out this fall.
Myth 3—AAO-HNSF Produces ENT e-Pimp
ENT e-Pimp is not a Foundation education product, but we do have a robust set of study questions in the AcademyQ™app. An additional 400 questions and a version of the app for Android users will be available this year.
Myth 4—With PMP Going Away, AAO-HNSF Will No Longer Have Case-based Education
While Patient Management Perspectives has been retired, it is the Foundation’s intention to offer a dynamic set of case-based courses available for multiple platforms that will meet the members’wishes for interactive and engaging learning.
Myth 5—The Foundation Provides Certificates for Its Education Activities
We do not provide certificates for individual activities. The only exception is the Annual Meeting & OTO EXPOSM. Instead, we provide everyone who has participated in a Foundation education activity an annual transcript listing activities and total credit awarded. In the future, transcripts will be replaced with 24/7 access to individual credit records through ENTConnect. It is important that every member has a profile in the member portal. 
