OCD FY2006: FDA Goal 1 - Empowering Patients and Consumers and Enhancing Public Health through Better Information about Regulated Products
Through its Risk Communications Outreach Program, CDRH communicates risk/benefit information on medical devices and radiological products to Center stakeholders - consumers, healthcare professionals, and industry. During FY 2006, CDRH continued to relay information to stakeholders in a variety of ways.
Better information enables consumers to make smarter choices about the medical devices they rely upon daily. During FY 2006, CDRH staff responded to over 8,400 consumer inquiries concerning regulated products received via phone and fax, electronically, and through the mail.
CDRH Consumer Information on the Web
Important information about medical devices is available to the public via the CDRH home page on the FDA website. The page links users to news and events, health topics, device program areas, and consumer information. www.fda.gov/cdrh
- RightNow Inquiry Management System
To make outreach to consumers more efficient, CDRH launched the web-based RightNow inquiry management system. The system offers visitors a user-friendly way to find answers to frequently asked questions and the opportunity to submit new questions. Answers to questions posed online are integrated on the website. The link “Questions?” now appears in the CDRH banner at the top right of the Center’s home page; the link will eventually appear on every CDRH web page.
- Medical Device Recall Website
Medical devices that are defective and/or pose a risk to health are recalled to address the problem. CDRH alerts the public to recalled products via public health notices, press releases, and its recall website. In its recall website FDA posts consumer information about the most serious medical device recalls. These products are on the list because there is a reasonable chance that they could cause serious health problems or death. - http://www.fda.gov/MedicalDevices/Safety/RecallsCorrectionsRemovals/ListofRecalls/default.htm
- Contact Lenses Web Page
CDRH launched the contact lenses web page in May 2006. This device-specific page provides all current contact lens related information in one place. The page contains basic information about contact lenses including the different types, valid prescriptions, a link to approved contact lenses, risks, everyday eye care tips, and what to look out for when buying online - http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ HomeHealthandConsumer/ConsumerProducts/ContactLenses/default.htm
- Maturity Health Matters
CDRH published the inaugural issue of Maturity Health Matters. The aim of the online newsletter is to provide older adults and their caregivers with the latest information on medical products that help people live longer, more productive lives. The inaugural issue explored the link between diabetes and heart disease, highlighting the key role of medical devices in diabetes management. The newsletter will be published three times a year and feature information on FDA, regulated medical products, and health news.
- FDA & You
For the third year, CDRH published FDA & You, an informative e-newsletter for secondary school students, parents, and educators. Published three times during the school year, FDA & You keeps students informed of latest news on medical products. Educators can use supplementary lesson plans for news-related classroom activities. Soft Contact Lens: Risk of Serious Eye Infection is an example of a newsletter article posted online during the fiscal year.
- FDA Centennial at CDRH
To commemorate the 100th anniversary of FDA and the major milestones celebrated by CDRH in 2006, the Center launched the FDA Centennial at CDRH website. The site includes an overview of CDRH, a chronological recap of Center milestones, and insights on challenges faced by past and present Center leadership. In conjunction with the website, CDRH developed a Centennial brochure and a commemorative calendar.
Public health is improved when the clinical community is well-informed about the safe use of medical devices. During FY 2006, CDRH continued educational outreach to healthcare professionals in a variety of ways.
Epidemiology and Surveillance
CDRH staff were principal authors as well as editors of Epidemiology and Surveillance. The textbook describes how epidemiology and surveillance are conducted on marketed medical devices and why this is necessary in order to ensure that devices remain safe and effective during the course of their use. Because there are currently no published books, university courses, or professional societies that focus on the topic, Epidemiology and Surveillance will fill an important void in the American public’s knowledge of this subject.
Medical Device Safety
The Center’s resource for health care professionals is the Medical Device Safety page on the CDRH website. In FY 2006, staff consolidated and organized all medical device safety information (safety tips and articles, public health notifications, the adverse events database, etc.) and related links to appear on the page. To enhance effective distribution of safety information, CDRH updates the page regularly to feature high priority risk messages. http://www.fda.gov/MedicalDevices/Safety/default.htm
Safety Tips for Laboratorians
During the postmarket lifecycle of in vitro diagnostic devices (IVDs), CDRH collects information on a variety of experiences relating to the proper use of the devices. This experience-based information also includes precautions that laboratorians, prescribing physicians, or the lay user must exercise in order to perform tests and use results appropriately. To communicate this valuable postmarket experience, CDRH posts Safety Tips For Laboratorians on its website at http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/TipsandArticlesonDeviceSafety/ucm109356.htm. The short articles on conducting laboratory tests properly include guidance on test limitations and interfering factors that cause false or inaccurate test results.
FDA Patient Safety News
CDRH leads the Agency production of FDA Patient Safety News (FDA PSN), an award winning televised series carried on satellite broadcast networks aimed at hospitals and other medical facilities across the country. Now in its fifth year of production, FDA PSN is a major Agency vehicle for communicating FDA safety messages on drugs, medical devices, and biologics to physicians, nurses, pharmacists, risk managers, and educators across the nation. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/index.cfm
Public Health Notifications
CDRH communicates critical health information the health care community through public health notifications. The notifications alert consumers and healthcare providers to actual or potential risks associated with use of a medical device and provide recommendations to avoid or reduce risks. In addition to being posted on the CDRH website, public health notifications are disseminated through MedWatch (the FDA safety information and adverse event reporting program), professional associations, two listservs, and press releases. CDRH encourages readers to subscribe to email updates to receive email announcements when a new or revised notification is issued. - http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PublicHealthNotifications/default.htm
Outreach to educate industry stakeholders is a Center priority. During FY 2006, CDRH staff responded to over 63,000 industry requests concerning regulated products received via phone and fax, electronically, and through the mail; collaborated with trade organizations to co-sponsor educational activities on a range of topics; and solicited industry expertise concerning new initiatives. Center outreach to industry is international; during FY 2006, staff met with 22 foreign officials representing 5 foreign governments to improve the safety of medical devices around the world. Below are some examples of CDRH outreach to industry during FY 2006.
Frequently Asked Questions for Manufacturers of Electronic Products that Emit Radiation
CDRH launched the Frequently Asked Questions for Manufacturers of Electronic Products that Emit Radiation web page in July 2006. The web page provides basic explanations to common questions related to manufacturer reporting and recordkeeping responsibilities, report acknowledgement letters and accession numbers, product certification to performance standards, and importation of electronic products. http://www.fda.gov/Radiation-EmittingProducts/ElectronicProductRadiationControlProgram/GettingaProducttoMarket/default.htm
Unique Device Identifiers
FDA published a notice requesting comments to help the Center understand how the use of unique device identifiers (UDI) similar to identifiers mandated for drugs might enhance patient safety. CDRH subsequently held a public meeting which focused on factors influencing the development of a UDI system (e.g., costs, benefits, design and implementation challenges, data repository, automatic identification technologies). The Center is currently analyzing the comments to determine FDA’s role and approach to a UDI system.
- PMA and 510(k) Device Submission Workshops
In March 2006, several CDRH staff members participated in the annual PMA and 510(k) Device Submission Workshops sponsored by the Advanced Medical Technology Association (Advamed) Medical Technology Learning Institute (MTLI). The objective of these annual workshops is to educate regulatory professionals on how to prepare a successful PMA or 510(k) application, and how to comply with FDA regulatory requirements. During the workshops, CDRH staff also share practical review experience with the participants.
- IVD Roundtable 510(k) Workshop
In April 2006, CDRH and the Association of Medical Diagnostics Manufacturers (AMDM) co-sponsored the In Vitro Diagnostic Devices (IVD) Roundtable 510(k) Workshop. The objective of the workshop was to foster communication among the professional, manufacturing, and regulatory communities. During the interactive workshop, participants had the opportunity to learn from CDRH experts who review 510(k) submissions. Experienced industry regulatory affairs personnel also provided guidance and helpful tips on 510(k) submissions.
- PMA and 501(k) Web Casts
In May 2006, CDRH regulatory experts were invited to participate in the Regulatory Association Professional Society (RAPS) web cast. The objective of this web cast was to educate the regulated industry on the fundamentals of 510(k) and PMA applications. CDRH staff also discussed tips on how to prepare for an FDA panel meeting. The training was broadcast over the Internet and attended by many regulatory professionals throughout the world.
- Medical Design and Manufacturing (MD&M) East 2006 Conference
In June 2006, CDRH staff participated in the annual MD&M East 2006 Conference. CDRH staff hosted a booth at the conference and sponsored a one-day seminar dealing with pre- and postmarket activities. The MD&M East 2006 Conference attracted more than 25,000 design engineers, production managers, quality control specialists, manufacturing executives, and other product development professionals from across the industrial landscape.
- Good Manufacturing Practices/Quality System Requirements and Industry Practices
This Association for the Advancement of Medical Instrumentation (AAMI)course offered in September 2006 was co-presented by CDRH and industry instructors to educate members of regulated industry on the fundamentals of the Quality System Regulation. CDRH staff presented multiple training modules and provided guidance on FDA expectations related to implementing medical device Current Good Manufacturing Practice Requirements/Quality System Regulation.
- Risk Communication on Medical Devices: Sharing Perspectives
In September 2006, FDA and the Advanced Medical Technology Association (AdvaMed) presented a workshop entitled Risk Communication on Medical Devices: Sharing Perspectives. Senior FDA and industry representatives explained to participants how the government and the medical device industry communicate expected and unexpected risks to practitioners, patients, and the public. Attendees also learned from physicians, risk managers, and the media how this information is received and transmitted to hospital staff, patients, and the public.
- Connecting the Dots on FDA's Postmarket Safety Activities
This was the first in a series of planned public workshops on postmarket safety of medical devices. The goal of the workshops, held in collaboration with the Advanced Medical Technology Association (AdvaMed) Medical Technology Learning Institute (MTLI), is to improve regulatory processes and oversight of marketed medical devices by gaining a better mutual understanding of current barriers to postmarket device monitoring and follow-up. Workshop topics included FDA analysis of postmarket trends; industry's perspective on postmarket issues and regulations; new perspectives on product recalls, removals, and corrections; future trends in postmarket regulation; and industry/FDA collaboration.