About FDA

FY 2001 OHIP Annual Report - User Education

CDRH regulates medical devices and radiation-emitting electronic products that touch upon every phase of our lives. Medical devices are an integral part of our healthcare system. Radiation-emitting electronic products include cell phones, microwave ovens, television sets, video display terminals and many other products that are routinely encountered in every day life.

The users of medical devices and radiation-emitting electronic products include patients and consumers, as well as caregivers and healthcare professionals. These users all need accurate and up-to-date information. Providing this information is an important part of CDRH’s public health mission. Within CDRH, OHIP plays a key role in user education. We respond to inquiries from individual consumers and patients, and work together with other CDRH Offices and outside groups to provide information on important medical device and healthcare issues. We accomplish this through a wide variety of outreach methods including the internet, public meetings, and print media.

Goals

To prepare and disseminate accurate information for consumers, patients and others who use medical devices and radiation-emitting electronic products.
To respond to consumer and patient inquiries and concerns in a timely and caring manner.

Consumer Assistance

OHIP is responsible for providing consumers with information needed to make informed decisions on the use of medical devices and radiation-emitting electronic products. We accomplish this by answering consumer inquiries and by developing information that addresses specific, high interest issues. For example, in FY 2001 OHIP represented CDRH at a Regional Risk Management Pilot Workshop on "Safe Medical Treatments-Everyone Has a Role." This workshop was held in conjunction with FDA’s New Jersey District and the Center for Drug Evaluation and Research (CDER). It provided a forum for consumers to discuss involvement in their own medical care.

Consumer Webpage

Our "Consumer Page" on the CDRH website is one of our most important tools for communicating with consumers and providing consumer-related information.

The CDRH consumer page includes the following:

information on the products that CDRH regulates;
explanation of the process for obtaining FDA clearance to market a medical device;
information on newly approved medical devices;
other consumer literature as well as links to other health related government websites; and
an easy way to automatically e-mail your questions to OHIP.

Consumer Inquiries

During FY2001, our consumer specialists responded to approximately:

3,600 telephone inquiries;
3,000 e-mails;
500 letters and faxes; and
4,180 requests for information packages on various medical device issues.

Breast Implant Information

We collaborated with other CDRH Offices in preparing and distributing a brochure entitled, "Breast Implant Risks - November 2000." The brochure alerts the prospective breast implant recipient of the known consequences of breast implant surgery. It describes fifteen known consequences and presents pictures of three frequent adverse outcomes. Both the brochure on risks as well as the FDA handbook entitled, "Breast Implants - An Information Update 2000" can be downloaded from the consumer page on the CDRH website.

Internet Sales

A growing number of medical devices are available for sale on the Internet. This year, we posted three articles about the sale of medical devices on the FDA webpage, "Buying Medicines and Medical Products Online." These articles include a general article providing advice for buying medical devices on-line and an article devoted to the on-line sale of in-vitro diagnostic products. The third article is a Question & Answer piece about buying contact lenses on the Internet, by phone or by mail. The article stresses the importance of having a current, correct prescription and receiving regular check-ups.

New Device Approvals

During FY 2001, we collaborated with other CDRH Offices to maintain a webpage for New Device Approvals. This page includes brief, plain language information on the most recently approved medical devices. OHIP provided plain language review of 55 one-page summaries for this webpage, which is primarily intended for consumers. The page links to other sources of consumer information, the Premarket Approval (PMA) database, and the patient labeling for these devices.

Medical Device Recall Webpage

OHIP and the Office of Compliance prepared a consumer-friendly version of medical device recalls for the CDRH website. This page provides brief information about CDRH recalls and includes Class I medical device recalls (those with the highest level of risk) and some Class II and III recalls with general public interest. At present, the page contains products recalled during calendar year 2001. As CDRH classifies new recalls, OHIP will post them to this webpage for public access.

Whole-Body Computed Tomography (CT) Screening Webpage

OHIP led a CDRH working group in developing a webpage on whole-body CT scanning. Some medical imaging facilities are promoting this new use of CT. It is marketed to healthy individuals who have no symptoms or suspicion of disease as a preventive or proactive health-care measure. However, the effectiveness of whole-body CT screening has not been demonstrated scientifically. This webpage is intended to provide information regarding the appropriateness of whole-body CT screening to individuals considering such a procedure. Geared toward consumers and health professionals, it includes:

information on the use of whole-body CT screening;

explanation of what CT is and how it works;

information on radiation risk;

brief description on radiation quantities used to indicate patient dose;

brief explanation on the regulatory status of CT; and

extensive resource list and links to other CT related sites.

Reuse

The reprocessing of single-use devices (SUDs) by hospitals and third parties continues to be an important public health issue. During FY2001, CDRH conducted an extensive outreach program to educate hospital SUD reprocessors about their regulatory responsibilities. The outreach program included:

a brochure summarizing FDA’s regulatory requirements – the brochure was sent to 6,000 hospitals in the U.S.;

a consumer article released through the North American Precis Syndicate, Inc. (NAPS) to over 10,000 newspapers;

four guidance documents (premarket clearance, labeling, medical device reporting, and frequently-asked-questions) to further clarify the regulatory requirements;

featured articles in the User Facility Reporting Bulletin and FDA Consumer Magazine; one entire issue of the Bulletin was devoted exclusively to SUDs reuse;

an extensive reuse website that includes the many important polices, letters, and documents about SUDs reuse;

a list-serve subscription to alert readers about important issues and policies;

a reuse speaker's kit distributed to all FDA Field Personnel/Public Affairs Specialists to use as a tool in their educational efforts with hospitals; and

two medical Device Reuse Workshops – Orlando, FL on May 10-11 and Phoenix, AZ on May 30-31.

Diabetes Webpage

In August 2001, OHIP began leading an agency-wide effort to develop a web page on diabetes. This project supports the HHS effort to address racial and ethnic disparities in health care, as diabetes disproportionately affects many minority populations. The Diabetes Webpage is the Center's first disease-specific webpage. The page is expected to bring together information about all FDA regulated medical products used in the diagnosis and treatment of diabetes. The goal of the webpage is to provide the unique information the Agency has about the many FDA regulated products used by patients with diabetes and their caregivers. We hope the outcome will be healthier lives for the rapidly growing number of Americans that are diagnosed with diabetes. We collaborated with FDA’s Office of Women’s Health and the American Diabetes Association. Links to other government and non-profit organizations will be included to augment FDA's information. The page will be a working document and we will continue to add information targeted to populations which are disproportionately affected by diabetes.

Hospital Bed Safety

OHIP led a multidisciplinary group to address the safety issues of hospital beds and patients vulnerable to entrapment. The group included representatives from the US and Canadian governments, national health care organizations, manufacturers of hospital beds, patient advocate groups and medical researchers. This group is working to reduce the number of patient deaths and injuries from hospital bed entrapments in all care settings, including hospitals, nursing homes, and private homes. The CDRH-led Hospital Bed Safety Workgroup developed hospital bed guidance that defines the recommended limits for gaps or openings in hospital bed rails. The guidance also provides procedures for clinicians to assess whether a bed meets the recommended limits. In addition, the workgroup has developed an assessment tool for facilities to determine if an opening falls outside the recommended limits. Other projects nearly completed include a Correction Action Guide to assist facilities in modifying the beds determined to be at risk for entrapment, and Clinical Recommendations for caregivers to use when assessing their patients’ need and use of bed rails. As a result of these efforts, CDRH developed a website to report the work of the Hospital Bed Safety Workgroup, increase awareness of the entrapment issue and educate the public on the problems related to this issue.

User Facility Reporting Bulletin

In the winter of 2001, we prepared the 37^th issue of the User Facility Reporting Bulletin. First issued in 1992, the Bulletin is published quarterly. The Bulletin provides user facilities with:

important information on preventing adverse events with medical devices;
directions for reporting adverse events to the FDA; and
feedback on reported problems.

When first published, the Bulletin had a printed circulation of over 75,000. In order to make more efficient use of resources and technology, the Bulletin is now available solely on our website.