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U.S. Department of Health and Human Services

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OCD FY2003: Access to Information

CDRH Website

CDRH’s website (http://www.fda.gov/MedicalDevices/default.htm) provides information on topics important to consumers, health care professionals and the industry. For example:

CDRH also maintains dedicated websites on key public health issues (“Hot Topics”). Examples include:

Patient Safety News (PSN)

FDA Patient Safety News is a monthly video news show for health care personnel, carried on satellite broadcast networks aimed at hospitals and other medical facilities across the country. It features information on new drugs, biologics and medical devices, on FDA safety notifications and product recalls, and on ways to protect patients when using medical products. The show is distributed to 4 health TV networks – with a combined reach of nearly 4,500 hospitals. More importantly, the program has a website – http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/index.cfm - where viewers can view either the entire show or just a select story, find more information on each story, search for previous stories, e-mail stories to colleagues, report adverse events (through a link to MedWatch) and sign-up for the PSN listserve. They also can e-mail a story to a colleague. The PSN website is currently receiving over 4,000 “hits” each month. The webcast center, where viewers can watch the whole show or just a select story, currently receives over 2,500 requests per month.

FDA Patient Safety News has made significant progress in the past year. Starting with the November 2002 show (#10), PSN realized its goal of incorporating all medical product centers into the program. CBER and CDER have been active partners and have made significant contributions to the program. PSN also has been able to occasionally include stories from other FDA centers. For example, it recently completed a story from CFSAN on the new trans-fatty acid labeling. In December PSN will reach the two year mark with episode # 24.

Starting with the November show, viewers will be able to download a video story to their own computer, network, or even a DVD – for viewing then or at a later time. PSN has received numerous requests for video copies of stories for use during staff meetings and in-services. This capability will allow users to download high-resolution mpeg files that can be played back either on a computer or TV.

Laboratory Safety Tips

The Laboratory Safety Tips webpage maintained by the Office of In Vitro Diagnostic Device Evaluation and Safety (http://www.fda.gov/MedicalDevices/Safety/ AlertsandNotices/TipsandArticlesonDeviceSafety/ucm109356.htm), gives information about maintaining a safe clinical laboratory environment, including laboratory safety tips, a discussion of quality control and quality assurance, details about reporting IVD problems, and resources for additional information. Examples of safety tips published this year include:

  • Follow good laboratory practices with waived laboratory tests
  • Performance and cautions in using rapid influenza virus diagnostic tests
  • Built in controls for single use disposable tests
  • Common problems with the use of glucose meters
  • Make sure glucose meters used in testing neonates are FDA-cleared for testing in neonates
  • Useful tips to increase accuracy and reduce errors in test results from glucose meters

Notifications

Notifications, in the form of Safety Alerts, Public Health Advisories and Public Health Notifications, are the primary means for CDRH to communicate to medical device users important information regarding postmarket safety issues. Web Notifications are updated as additional information becomes available so the public is encouraged to check back at this site. Alerts can be found at http://www.fda.gov/MedicalDevices/Safety/ AlertsandNotices/PublicHealthNotifications/default.htm.

Web Notifications

  • 10/31/2002 and Updated 4/1/2003 Complications Related to the Use of Bone Cement in Treating Compression Fractures of the Spine
  • 10/23/2002 Non-Corrective Decorative Contact Lenses Dispensed Without a Prescription
  • 7/24/2002and Updated: 9/25/2003 Risk of Bacterial Meningitis in Children with Cochlear Implants


Public Health Notifications

  • 12/19/2002 Diathermy Interactions with Implanted Leads and Implanted Systems with Leads

Targeted Outreach Efforts

In FY 03 CDRH placed six articles in periodicals, one North American Precis Syndicate (NAPS) article on consumer websites and posted a contacts listing database (http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/contacts/Index.cfm) in 188 newspapers, reaching 7.4 million potential readers.

  • Tampons and Toxic Shock Syndrome (TSS) - The new recommendations on tampons and TSS were disseminated though outreach efforts using women’s magazines and through the FDA & YOU newsletter available at http://www.fda.gov/ForConsumers/default.htm.
  • Hospital Bed Safety - Patient/Clinical video aimed to inform the public on how to prevent hospital bedrail entrapments by the elderly, frail, and long-term care patients was developed and distributed. The video entitled, “Do No Harm” was produced by American Association of Retired People (AARP). This 22 minute video for caregivers and health care facilities provides real-life situations on the use of bed rails in both acute and long-term care environments and offers insights by patients and their families, nurses and other caregivers.
  • Secondary School Project - The objective of this project is to effectively deliver device messages to secondary school students. During FY 03 CDRH talked with 50 secondary school experts to determine the best mechanism to use in reaching this audience and obtained contact points in 96% of states. CDRH developed a Web-based newsletter FDA & YOU, http://www.fda.gov/ForConsumers/default.htm. A packet containing a letter from CDRH officials, a one-time printed version of FDA & YOU and the Contacts Listing brochure was sent to 16,038 Health Educators, 19 FDA Public Affairs Liaisons (PALS) and 43 Public Affairs Specialists (PASers).
  • FDA & YOU is an educational newsletter intended for use by health educators, secondary school students and their parents. FDA & YOU is a cooperative effort, combining the skills and support of FDA’s five centers and was initiated to inform and encourage health educators and students to learn about the latest FDA medical product and health news. To coincide with the typical school year FDA & YOU is published three times per year, in the fall, winter and spring. The newsletter is now available online at: http://www.fda.gov/ForConsumers/default.htm.

The FDA Industry Website

At the end of FY 02, FDA (http://www.fda.gov) launched a new portal page -http://www.fda.gov/ForIndustry/default.htm - to make it easier for FDA-regulated companies to find information they need to comply with regulations. Featured links on the page include:

  • Guidance documents
  • Inspection references
  • Information on imports
  • Warning letters and other FDA enforcement activities

The portal also provides easy access to regulatory information from FDA’s centers. CRDH is a regular contributor to this website. Companies can use the portal to contact FDA with questions, submit comments online about proposed FDA regulations, or sign up to attend meetings for which registration is required.

Additional Consumer Information Resources

The Division of Small Manufacturers, International and Consumer Assistance (DSMICA) also provides information to consumers regarding medical devices and radiation-emitting products to enhance users ability to avoid risk, achieve maximum benefit, and make informed decisions about the use of such products.

Website: http://www.fda.gov/MedicalDevices/ResourcesforYou/Consumers/default.htm
E-Mail: dsmica@cdrh.fda.gov
Phone: Toll Free 1-888-463-6332 or 301-827-3990 directly between the hours of 8:00 a.m. – 4:30 p.m. EST
Fax: 301-443-9535