OCD FY2005: Improving Communication of Medical Technology Information
In FY 2005 CDRH continued to improve communication by providing increased access to information on regulated products and health issues on its FDA web sites, in newsletters, through increased outreach efforts, and through internal operational initiatives. CDRH’s web sites offer new and in-depth information on how to get healthy and stay healthy. They also offer information on current CDRH activities to ensure that medical devices and radiation-emitting products are fit to use.
Medical Device Recall Web Site
In FY 05 CDRH redesigned the Medical Device Recall web site to provide a web-friendly, plain language overview of medical device recalls. The web site now explains the various classes of medical device recalls and the procedures that FDA and companies follow during a recall. The web site continues to describe each Class I recall in a plain language format and provides access to the new recall database.
Public Health Notifications
Notices, available on the Public Health Notification web site , are issued to mitigate risk from medical device problems. FY 2005 notifications covered issues such as:
- Ralstonia bacteria contamination of a humidifier used in neonates
- Recommendations for clinicians concerning the recalled Enterex implantable device for Gastroesophageal Reflux Disease (GERD)
- Information about failures with the Guidant Implantable Cardioverter Defibrillator
- Recommendations to avoid entrapment of vulnerable patients in the Vail bed.
FDA Patient Safety News (FDA PSN)
CDRH coordinated the agency production of FDA Patient Safety News, an award-winning monthly television news show and web site distributed to health care practitioners across the nation. FDA PSN covers a wide range of stories on medical errors, patient safety, recalls and alerts, and newly approved drugs, devices and biological products. The news show is a major agency vehicle for communicating FDA safety messages on medical products to physicians, nurses and pharmacists. The video feature of the program often improves the understanding of safety issues, particularly in circumstances such as identifying counterfeit drugs, demonstrating how medical errors occur, and depicting recalled products. Because of this, the video program is often used by risk managers and educators to train health care staff on the safe use of drugs, devices, and biologics. In FY 2005 the FDA PSN web site received about 8,500 “hits” per month, an increase of about 40 percent over the previous year.
CDRH developed and updated various topic-specific web pages, including those for breast implants and cochlear implants. These sites provide information about high interest topics, including newly approved and first-of-a-kind device technologies. Information in the sites includes questions to discuss with the doctor. Currently, there are eight sites, including a newly launched Phakic Intraocular Lenses web site (http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ ImplantsandProsthetics/PhakicIntraocularLenses/default.htm).
FDA & YOU
Now in its second year of online publication, the FDA & You newsletter targets secondary school students and health educators. FDA & You provides information on FDA topics of interest to teenagers.
Small Manufacturers, International and Consumer Assistance
CDRH’s Division of Small Manufacturers, International and Consumer Assistance (DSMICA) was mandated by the 1976 medical device legislation to provide technical and regulatory assistance to small manufacturers and help them comply with Food and Drug Administration (FDA) requirements for medical devices.
Through DSMICA and its Device Advice Website (http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/default.htm), CDRH provides regulatory assistance to medical device manufacturers, consumers and foreign governments. CDRH provides manufacturers assistance with:
- product classification
- premarket and postmarket requirements
- manufacturing requirements (quality system)
- import/export issues for medical devices
- reporting requirements for electronic products.
Consumers can obtain information on medical devices and radiation-emitting products that help them enhance their ability to avoid risk, achieve maximum benefit, and make informed decisions about the use of medical devices and radiation-emitting products.
CDRH also identifies and supports international and global harmonization activities, including educating foreign governments on the medical device regulatory process, and directing U.S. firms to sources of information on foreign requirements for medical devices.
In FY 2005 CDRH continued providing assistance and outreach to help small manufacturers and international producers comply with FDA requirements for medical devices. CDRH answered 44,000 requests for information, 7,000 responses involving international activities, and distributed 82,000 guidance documents on inspection and enforcement procedures, product development, and regulatory submissions. CDRH’s outreach efforts took the Center to 47 domestic and international manufacturers’ meetings, conferences, and workshops.
New Web Features
In FY 2005 several new features were added to the CDRH web site to offer users options regarding how they receive information about medical devices and radiation-emitting products information. New tools included:
- Email subscription management system
- Real Simple Syndication (RSS) feeds
The email subscription service alerts customers when information of interest to them has been added or updated on the web sites. It allows users of the CDRH web site to create profiles of interest by subject area. RSS feeds deliver news directly to a user’s desktop. RSS is an XML-based format for sharing and distributing CDRH Web content, including new device approvals, recalls, and other news items.
CDRH uses multiple tools to ensure efficient outreach efforts. In FY 2005 these tools included:
- satisfaction surveys
- program evaluations
- web usability testing
- unsolicited feedback (i.e., letters and phone calls)
- conference participation
- paper media (e.g., newsletters and brochures).
In FY 2005, CDRH conducted an online survey of 1,006 CDRH web site users. CDRH asked user what they needed from its web sites and their satisfaction with the information available. This information will help CDRH improve the services it provides to the public. CDRH also participated in six professional and health educator conferences. At the conferences Center staff provided patient safety information and promoted CDRH communication programs.
CDRH promoted the use of risk communication methodologies throughout the Center raising awareness about the importance of effective communication with internal and external groups. This was accomplished by providing training conducted by expert Risk Communicators and Center Staff.
Various easy-to-read health brochures are available to the public through CDRH. This year the CDRH updated its Human Factors, Breast Implant, and Office of In Vitro Diagnostics (OIVD) brochures. These brochures are disseminated through various mechanisms including web, conferences, and professional and industry meetings.
Uniting Pre and Postmarket: CDRH Defibrillator Working Group
Established in FY 2005 the CDRH Defibrillator Working Group unites both premarket and postmarket working groups with the goal of disseminating relevant information regarding device approvals, adverse events, recalls and other pertinent issues. This working group is an example of the Center’s Total Product Life Cycle (TPLC) approach in that the information learned from the postmarket arena can then be used to support premarket reviews.
Information Technology (IT) Solutions
CDRH’s Information Management Steering Committee (IMSC), whose members are CDRH senior management, began working in FY 2005 towards ensuring that IT projects are consistent with Center strategic goals and priorities, and toward developing a meaningful CDRH IT Strategic Plan. In addition, CDRH began using project management plans, a performance measurement tool, to implement and monitor the progress of major IT projects.
IT systems allow for better monitoring and tracking of premarket submissions and for improved communication and coordination among review teams. CDRH continued using the Center-level premarket tracking system to help monitor and manage CDRH workload to ensure that appropriate scientific expertise is used to review each document. In FY 05 the Center began piloting the use of eRoom, a web-based collaboration tool, in support of Premarket Approval Application reviews. The software allows for real-time information sharing and communication among review team members and provides a central location for document storage and retrieval. Additional FY 2005 projects included:
- tracking system for Conditions of Approval postmarket studies (COATS)
- electronic consultations tracking (eConsult)
- device nomenclature management system (DNMS)
- enhancements to the system for the generation and electronic submittal of in vitro diagnostics (IVD) applications (Turbo510k)
- program for accepting electronic premarket submissions (eCopy)
- program for accepting and processing electronic adverse event reports (eMDR).
The Center’s top priority is to increase its ability to obtain critical information about medical device failures and to communicate this information clearly and rapidly to physicians and the public so they can use it to make sound, informed medical decisions.
CDRH maintains cooperative relationships with professional societies and trade organizations to promote effective public health communication. These organizations include the American College of Cardiology; American Dental and American Diabetes Associations; American Association of Pediatrics; American College of Radiology; Conference of Radiation Control Program Directors; AdvaMed; Food and Drug Law Institute, and Medical Device Manufacturers Association.
Policy Conference on Implantable Cardioverter Defibrillators (ICDs) and Pacemakers
The September 2005 Heart Rhythm Society (HRS) policy conference on implantable cardioverter defibrillators and pacemakers was a good step toward improving communications with clinicians, patients, industry representatives, and regulators. The purpose of the conference was to review the current process for recalls and to discuss the important elements of risk communication that can help guide physicians in treating patients with recalled defective devices.
Retrospective Review of Pacemakers and Implantable Cardioverter Defibrillators (ICDs)
As part of the agency’s ongoing commitment to improve the safety monitoring of ICDs and provide earlier notices to doctors and patients of potential problems, FDA announced its retrospective review (initiated in 2003) of ICD’s and pacemakers malfunctions. FDA’s findings were released at the September 16, 2005 Heart Rhythm Society (HRS) Policy Conference in Washington, DC.
Promoting the Safe Use of Infusion Pumps
The CDRH Home Health Care Committee is tasked with reviewing what the Center does to address problems when devices are used in the home and recommending further Center actions to assure that devices are being used safely and effectively in the home environment. In FY 05 CDRH continued its efforts to address the needs of the growing number of patients using clinical medical devices in this environment. The Center developed an outreach strategy to promote the safe use of infusion pumps. The Center asked manufacturers of infusion pumps to submit instructions for use and basic pump information for every pump marketed during or after 1984. With this information, the Center developed a prototype electronic repository of manufacturers’ infusion pump labels containing pump information and instructions for use. The repository is under review and CDRH continues to receive information from manufacturers. Once collected, the label information will become part of CDRH’s publicly accessible home health care device website. Label availability will increase the likelihood that patients, the families and health care providers will have continuous access to pump information and instructions, helping to ensure safe and effective home use.
Educating Health Professionals: Troponin
The laboratory safety tip was posted by the Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) on its web page. It is a follow-up to a signal identified from MDR reports and literature on falsely elevated results for Troponin, an indicator test for heart attack. CDRH worked with industry to address this educational need. AdvaMed, a trade association representing medical device manufacturers, drafted the tip in response to concerns about this issue expressed by FDA.
Building Quality Into Device Clinical Trials Workshop
In FY 2005, the CDRH Bioresearch Monitoring Group collaborated with the Food and Drug Law Institute (FDLI) to improve the quality of device clinical trials by using a “Best Practices” approach. CDRH developed and presented a workshop for the domestic and international industry entitled “Integrating Quality into Device Clinical Trials”. The telecast reached 115 US and international sites with approximately 1000 attendees.
510(k) Workshop for New Manufacturers
CDRH worked collaboratively with members of industry to host a workshop on 510(k) submissions at the annual meeting of the Association of Medical Device Manufacturers. The workshop helped companies new to the in vitro diagnostics industry learn how to develop and submit high quality 510(k) submissions. Both CDRH and industry believe that helping companies understand good trial design and how to develop submissions conforming to CDRH administrative and scientific requirements will produce more reliable and rapid reviews which will benefit device manufacturers and the public.
FDA Medical Device Workshop
In September 2005 CDRH and FDA Los Angeles District Office conducted a FDA medical device three workshops in Los Angeles, CA. The three-day event consisted of a one-day workshop each day. The three topics addressed were:
- Premarket Requirements
- Quality System Requirements
- CDRH’s Office of In Vitro Diagnostic Device (OIVD) Evaluation and Safety.
Over 4,000 FDA registered establishments in the Los Angeles district were invited to attend these workshops. Registration is limited to 200 attendees per workshop-day. There was no registration fee for attendees to these workshops.
Workshop on Drug-Diagnostics Translational Research
The new field of pharmacogenetic research will enable pharmaceutical companies to develop drug treatments that precisely target the needs of particular patient populations. By linking drug treatments to diagnostic tests that can accurately identify appropriate receptive patients, pharmaceutical companies aim to decrease drug adverse events, increase drug response rates, and ultimately save healthcare dollars. In April 2005 CDRH held the third in a series of national workshops on drug and diagnostic co-development. The workshop gave stakeholders a public venue for scientific suggestions and concerns about FDA regulatory practices in this important and growing new area. CDRH is using the proceedings of this conference to develop guidance to ensure that this research translates in a rapid and cost-effective manner to new joint products that can quickly enter the medical marketplace.