About FDA
FY 2005 OCER Annual Report - Communication
World Wide Web
CDRH Web Sites
OCER manages a large portion of CDRH’s outreach efforts through the World Wide Web. This tool allows prompt dissemination of information to our wide array of customers. We maintain the multitude of CDRH Web sites and a few of our new Web sites are mentioned below.
- Recently Approved Devices Web site
As part of our effort to inform the public about new device technology, CDRH posts short news items when devices with significant new advances are approved or cleared. Located on the Web page titled “Recently Approved Devices,” these short summaries or “one-pagers” are plainly written and intended primarily for consumers. Each product listing contains information about medical uses for the approved device, when it can be used, and when it should not be used.
In FY 2005, OCER reviewed 39 one-page summaries. OCER provides the plain language review of these “one-pagers” and identifies links to other related sources of unbiased, well-researched consumer information.
- Medical Device Recall Web site
OCER redesigned the CDRH Medical Device Recall Website to provide a user-friendly, plain language overview of medical device recalls. This website now explains the various classes of medical device recalls and the procedures that FDA and companies follow during a recall. In addition, it describes each Class I recall in a plain language format and provides access to the CDRH recall database.
- FDA & You
FDA & You, an educational newsletter for secondary school students and health educators, was published for the second year. This publication is a collaborative effort between CBER, CDER, CDRH, CFSAN, and CVM and is edited and coordinated by OCER.
Issued on the Web three times a year, FDA & YOU addresses teen health and safety topics and features articles on health and science. Past issues have featured articles about decorative contact lenses, breast implants, ephedra, tanning safety, and healthy eating. Through our FDA & YOU feedback system, we receive consumer inquiries and comments. Inquires include requests for educational materials, information, speakers, and scientific and health questions that are answered by the appropriate Center representative.
Disease Specific Web Sites
OCER continues to improve the availability of consumer information for diabetes and cardiovascular disease by maintaining Web sites to provide timely and detailed information about both.
- Diabetes
The FDA’s Diabetes Web site provides detailed consumer information about the products we regulate to diagnose and treat diabetes, with links to additional diabetes information. In addition, through partnerships with the diagnostics industry, health professionals, and individuals with diabetes, we assure that safe and effective diagnostics are available that are more accurate, less invasive and easier for patients to use.
- Cardiovascular Disease
The FDA’s Heart Health Online Web site provides consumer information about the products FDA uses to diagnose, prevent, and treat cardiovascular disease, with links to additional cardiovascular information. This site was selected as one of the Biomaterials Network top five Internet sites, based on general quality, scientific value, and suitability to Internet browsing.
Device Specific Web Sites
OCER leads CDRH’s effort in creating websites for new and emerging technologies as they come to market. OCER develops these websites to keep the public informed about new technologies and their impact for consumers. We also list on these websites how these products may be able to benefit the customers.
- Cochlear Implants
On October 15, 2004, OCER launched a new Web site on cochlear implants. The site contains the history of cochlear implants, how cochlear implants work, advice for patients and parents, a description of implant surgery, and advice for educators and health professionals about the risks and benefits of cochlear implants. In addition, it provides links to approved devices and a link to recent recall information. The site includes impressive flash presentations showing the operation of normal ears, ears with hearing loss, and those with implants.
- Phakic Intraocular Lenses
On April 21 , 2005 , OCER launched the Phakic Intraocular Lenses Web site. This site contains basic information about this newly approved first-of-a-kind device. It provides an explanation of phakic lenses, the risks, a description of the surgery, and questions to discuss with the doctor. Like the cochlear implant website, this website includes a link to approved devices and flash illustrations showing how phakic lenses are implanted and how they work.
Contacts Listing
The Contacts Listing database collects the names of individuals interested in helping CDRH examine issues, develop policy, and inform people with specific interests. The Contacts Listing expands on the idea of a listserv by gathering information about a participant that enables CDRH to target its shareholders more accurately. In FY 2005, the total membership of the list approached 2000 subscribers with diverse interests in healthcare.
Breast Implants
OCER has two representatives on CDRH's Breast Implant Committee. The Committee meets monthly to review and discuss PMA submissions, premarket and postmarket compliance issues, interactions with the plastic and aesthetic surgery organizations, new articles in the scientific and medical journals, and problems reported by consumers and their advocacy groups. The Committee has also established a Web site and updated a handbook entitled "Breast Implants: An Information Update" and "Breast Implants - Potential Local Complications and Reoperations."
The OCER representatives established a Listserv dedicated to consumers. By subscribing, consumers receive periodic electronic information on breast implants such as new articles in the literature, public meetings, recalls, safety alerts, citizen petitions, and adverse events. For the latest information on breast implants, subscribe to the breast implants list. OCER also has designated a staff member to answer consumer inquiries on breast implants. This enhances the quality and consistency of our responses and the information we provide.
Managing the Web (Internet and Intranet)
Standard Operating Procedure (SOP) for posting new material
In an effort to improve coordination among various Web outreach efforts, OCER developed a SOP for posting new material to the CDRH Web site. This has proved to be very beneficial in tracking changes and updates to the Web site and maintaining consistency when dealing with our customers.
Improving the Web (Right Now & GovDocs)
OCER purchased two new systems that provide accurate and timely information about medical devices and related topics to our customers. The RightNow inquiry management system provides a user-friendly mechanism for visitors to the CDRH Web site to find answers to frequently asked questions. Visitors to the site can scroll through a list of commonly asked questions, search the list by specific topics or keywords, or submit new questions online.
In the spring of 2005, OCER began researching the use of the GovDelivery ®system to send out emails related to information posted on our Web site.
GovDocs/GovDelivery ® is a Web-based email subscription management system through which users of the CDRH Web site may subscribe to news and information that is most important to them directly from the Web site. GovDelivery ® allows users of the Web site to create profiles of interest by subject area through subscription points adjacent to the specific information they seek. When information is updated, subscribers receive automatic email alerts on their self-selected topic areas, with click-through links back to the CDRH Web site. GovDelivery ® handles bounce back and undeliverable emails automatically, freeing up employee resources. GovDelivery ® will most likely replace the major functions of Contacts Listing in 2006.
In early 2005, OCER conducted an online survey of 1,006 current CDRH Web site users on what they seek from our Web site and their satisfaction with the information currently available on the site. The survey results indicated the areas of information most users were looking for, how easy or difficult it was to find that information, and key areas for improvements to the site.
Patient & Consumer Safety
Hospital Bed Safety
CDRH continued to lead the multidisciplinary group known as the Hospital Bed Safety Workgroup (HBSW). The workgroup’s goal is to reduce the number of patient deaths and injuries from hospital bed entrapments in all care settings, including hospitals, nursing homes, and private homes.
On August 30, 2004, OCER published the draft guidance entitled Hospital Bed System Dimensional Guidance to Reduce Entrapment. The guidance provides dimensional limits on the gaps around a bed’s mattress and/or rails to prevent entrapment in newly manufactured hospital beds. Health care facilities are also encouraged to use this guidance to determine whether existing beds pose a risk for entrapment. Since its publication, we have reviewed over 100 public comments on the guidance document.
Members of the HBSW completed validation testing of measurement procedures and finalized work on a test tool simulating the head and neck – two body parts typically at risk for entrapment. The tool would be used with the test procedures to assess the bed for entrapment hazards. As a result of these new components, FDA expanded its guidance and is revising it for publication. We have planned an outreach effort to raise awareness about entrapment hazards and to help facilities understand and prevent entrapment.
Reducing Use Error
FDA recognizes that most use errors with medical devices are not “inevitable human error.” Rather, they are largely influenced by medical device design and labeling. OCER seeks to promote the safe and effective use of medical devices through our Human Factors program, labeling efforts, and research activities.
Hazards associated with device use are a common and serious problem. Errors made while using these devices can lead to hazards, which can affect patients, family members, and healthcare providers. Evidence from researchers suggests that the frequency and consequence of hazards resulting from medical device use error far exceed those arising from device failures.
Patient Labeling
OCER reviews patient labeling for all new Premarket Approval (PMA), 510(k), and Humanitarian Device Exemptions (HDE) submissions when CDRH’s Office of Device Evaluation (ODE) determines patient labeling is necessary. If patient labeling is not submitted as part of a PMA submission, OCER reviews the submission to decide if labeling would contribute to reducing use error or allow the patient to make a more informed choice concerning their healthcare. This was the ninth year that OCER has worked with ODE to perform these reviews. During FY 2005, OCER conducted:
- 67 Original PMA reviews;
- 3 Expedited Original PMA reviews;
- 9 PMA Supplement reviews;
- 14 510(k) reviews; and
- 4 HDE reviews.
Human Factors
Human Factors (HF) is a science devoted to the interaction of people and equipment. ‘Human Factors,” “human engineering,” “usability engineering,” and “ergonomics” are often used interchangeably. In the field of medicine, the objective of Human Factors is to improve human performance and reduce the likelihood of use error and patient injury.
Human Factors has been used extensively by the military, the transportation industry and in some consumer areas. It is now being applied to address use error problems in medicine. We believe Human Factors analysis and testing should be applied throughout the entire life cycle of a medical device. Our Human Factors efforts affect the Center’s premarket, postmarket, and field-inspection regulatory missions. In support of this effort, OCER conducted 10 Human Factors reviews in FY 2005.
Consumer Inquiries
Another way OCER promotes patient and consumer safety is through our outreach programs. In FY 2005, OCER received and responded to:
- 7,393 consumer inquiries, which includes telephone, letters/faxes, and email;
- 43,589 requests for information which includes telephone, letters/faxes, and email; and
- 6,858 requests for information regarding international activities, which includes telephone, letters/faxes, and email
Risk Communication
Course Development
OCER staff promotes communication methodologies throughout CDRH to raise awareness of the importance of effective communication with internal and external groups. One of the many ways this is accomplished is by providing training conducted by expert Risk Communicators and Center Staff. In addition, OCER’s Staff College is in the process of developing a risk communication course that will be offered on a regular basis.
Recalls
A recall is an action taken to address a problem with a device that violates FDA law. Medical Device Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health. OCER staff review Medical Device Recall notices for effective risk communication messages. In FY 2005, we reviewed 24 medical device recalls.
Guidance and Regulations
Good Guidance Practices (GGP)
Good Guidance Practices (GGPs) are FDA’s policies and procedures for developing and issuing guidance documents. The GGP policy standardizes the development process for guidance documents, provides opportunities for public comment, and clarifies the use of guidance documents. Each FDA Center is responsible for implementing its own GGPs. OCER leads implementation, administration, and monitoring of GGPs within CDRH.
Guidance Documents
Guidance documents are FDA’s interpretation of a policy on a regulatory issue. Guidance documents are routinely prepared for FDA staff, applicants, sponsors, and/or the public that relate to:
- the processing, content, and evaluation of regulatory submissions;
- the design, production, manufacturing, and testing of medical devices; and
- the inspection and enforcement procedures associated with those devices.
In FY 2005, OCER published 47 notices of availability for guidance documents, c leared 34 final guidance documents, and 4 draft guidance documents for comment purposes only.
Regulations
Regulations have the force and effect of law when FDA uses them within its authority and according to appropriate procedures. FDA publishes regulations to provide an avenue for constructive notice of the contents of the provisions. Like laws, regulations have the same binding legal effect and usually state general rules, rather than specifics. OCER is home to staff that develop and review regulations for CDRH. During FY 2005, OCER p ublished 16 final rules.
Citizens’ Petitions
In general, a Citizen’s Petition is any petition submitted by a person (including a person who is not a citizen of the United States). In FY 2005, we coordinated and drafted nine responses to Citizens’ Petitions.
Emergency Preparedness
Emergency Response
OCER plays an integral role in disseminating CDRH emergency information. In response to Hurricane Katrina, we posted documents for healthcare workers and consumers on reopening dialysis clinics and disposal of contaminated devices. We also posted information on how to dispose of medical devices that had been exposed to improper storage conditions such as heat, humidity, or lack of refrigeration. In preparation for a potential influenza outbreak, we posted a document containing frequently asked questions and answers about using personal protective equipment during influenza outbreaks.
Emergency and Disaster Operations Procedures are reviewed and updated yearly to reflect nuances to improve process and to keep personnel changes up-to-date. The Emergency Response Coordinating Workgroup (ERCW), the core component of personnel involved in emergency preparedness, meets every two months, or more frequently as needed, to keep emergency process and team personnel issues current. After Action Reviews (AARs) are conducted immediately following scheduled exercises and recommendations are followed up before the next scheduled ERCW meeting.
Continuity of Operations Plan (COOP)
CDRH's four individual COOP Plans are reviewed on a yearly basis and updated with changes or additions to the process or personnel as necessary to keep them current. Communication exercises, including testing of accessibility to pertinent databases, telephones, satellite telephones, etc. are conducted quarterly. COOP relocation exercises which include training of COOP coordinators, their alternates, and members of the COOP Emergency Response Group (CERG), are conducted four times per year. AARs are conducted no later than five days following a COOP exercise and recommendations are followed up on and completed prior to the next scheduled COOP exercise. During FY 2005, COOP exercises were held on November 4, 2004, and January 11, April 21, and August 24, 2005.
Public Meetings/Presentations/Exhibits
Each year, OCER participates in educational conferences and meetings to provide information to our stakeholders about the programs and services we provide. This year, OCER provided patient safety information and promoted CDRH communication programs by participating in six professional/health education conferences.
