About FDA

FY 2000 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. As consumers, patients and device-users, we 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, provide extensive information on our website, and collaborate extensively with other CDRH Offices and outside groups to prepare information on important medical device and healthcare issues.

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 Webpage

Our "Consumer Page" on the CDRH website is one of our most important tools for communicating with consumers and patients. It was created in June 1999 to complement the FDA Consumer Page (http://www.fda.gov/ForConsumers/default.htm). By visiting the CDRH consumer page, you will find:

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 FY2000, our consumer specialists responded to approximately:

4,500 telephone inquiries;
2,000 e-mails;
700 letters and faxes; and
2,700 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.

TMJ Implants

We prepared a webpage to provide consumers with the latest information on approved TMJ implants and those under review. This information is important to patients suffering extreme TMJ symptoms and to their healthcare providers. By visiting the webpage, you will be able to download a copy of the consumer handbook entitled "A Consumer Information Update – November 1999."

Internet Sales

A growing number of medical devices are available for sale on the Internet. We prepared two articles that will provide consumers with information about the benefits and risks they face when purchasing medical devices online. These articles will be available on FDA’s webpage "Buying Medicines and Medical Products Online."

New Device Approvals

In October of 2000, we collaborated with other CDRH Offices to launch a webpage for New Device Approvals. This page includes brief, plain language information on the most recently approved medical devices. Primarily intended for consumers, the page links to other sources of consumer information, Premarket Approval (PMA) databases, and the labeling for these devices.

Reuse

Insufficient data exist regarding the safety of reprocessing single-use devices (SUDs). Therefore, on August 14, 2000, FDA announced that it will regulate hospitals and third parties engaged in reprocessing SUDS in the same way that the agency regulates device manufacturers. This policy impacts hospitals, healthcare professionals, and the public. OHIP is working closely with the CDRH Reuse Steering Committee to provide up-to-date information reuse to our stakeholders. Our accomplishments included:

Working with the CDRH’s Office of Systems and Management, we created a Reuse Homepage. It includes CDRH documents on reuse, a listing of standards relevant to reprocessing, frequently asked questions, a calendar of upcoming meetings at which FDA will speak on reuse, copies of previous presentations, and e-mail capability to ask questions or to register to receive updates on reuse. This webpage received more than 50,000 hits in August of 2000, making it the most popular site in FDA.
A CDRH interactive satellite teleconference entitled, "Proposed FDA Strategy for Reuse of Single-Use Medical Devices" was broadcast on November 10, 1999. Industry experts, healthcare professionals, and consumers joined in the interactive discussion on CDRH’s proposed strategy on SUDs. The teleconference, produced in our studio, provided a forum for stakeholders and other interested parties to comment and offer alternative approaches to the proposed regulatory strategy. A second teleconference was held December 13, 2000.
We provided videotaping, artwork, registration, and administrative support for an open public meeting on reuse held on December 14, 1999.
Working with other CDRH staff, a one-day workshop on the reuse of SUDs was developed and presented at the annual meeting of the Association for the Advancement of Medical Instrumentation in June 2000.
A reuse packet was mailed to over 6,100 hospitals to inform them about their new responsibilities if they reprocess SUDs. The packet included a cover letter from the Center Director and a copy of the August 14, 2000 guidance document, "Guidance for Industry and for FDA Staff: Enforcement Priorities for Single-Use Devices Reprocessed by Third Parties and Hospitals."

A trifold reuse brochure was prepared in a Question and Answer format. The Joint Commission on Accreditation of Healthcare Organizations (JCAHO) is distributing the brochure. It will also be used at FDA exhibits nationally and will be mailed out in answer to requests for information about the reuse of SUDs. Copies of the brochure are also available on the Reuse Homepage.

To inform consumers about the new CDRH policy on reuse of SUDs, we developed an informational letter that was sent to 35 consumer organizations. They, in turn, were asked to inform their membership about the new policy. We also worked with the FDA Consumer magazine in publishing "Reusing Medical Devices: Ensuring Safety the Second Time Around" (September/October 2000).

Hospital Bed Rails

FDA issued a Safety Alert entitled "Entrapment Hazard with Hospital Bed Side Rails" in 1995. Since then, FDA has continued to receive reports of deaths and injuries caused by patient entrapment between the rails of the bed and in the gap between the mattress and side rails. To address this complex problem, we worked with CDRH’s Office of Surveillance and Biometrics to create a forum for the exchange of information related to patient entrapment associated with hospital beds. The result was the formation of the Hospital Bed Safety Workgroup. The Workgroup includes representatives from the medical bed industry, national healthcare organizations, patient advocacy groups and other federal agencies. As the issues unfolded, possible labeling and compliance issues were identified, so CDRH’s Office of Device Evaluation, Office of Compliance, and Office of Science and Technology have participated as well.

During FY2000, the Workgroup collaboratively developed a brochure entitled, "A Guide to Bed Safety." The brochure discusses bed rail patient safety, considers some of the potential benefits and risks of using hospital bed rails, and gives suggestions on how to meet patients’ needs without the use of bed rails. The Workgroup is widely distributing the brochure in hardcopy as well as through the member’s websites.

The Workgroup is concurrently addressing several issues related to the entrapment problem and its members are committed to finding a long-term solution. In FY2000, the Workgroup began several projects, including:

development of a clinical guidance describing how clinicians should approach the use of bed rails;

review of entrapment zones in and around the bed and development of recommended design limits for the size of gaps;
development of an assessment tool to determine a bed’s compliance with the new recommendations;
development of a decision tree to help in determining whether to keep or replace older beds that do not meet the recommendations; and
widespread distribution of information on preventing entrapment through publication in national journals and presentations at major medical meetings.

Contacts Database

In FY2000, we began testing a "Contacts Database" to support CDRH’s outreach programs. The database will be a tool to identify contact information for consumers, health professionals, industry and others interested in medical device issues. The data will be searchable by area of interest and/or affiliation and will provide us with a rapid means of sending information to interested organizations and individuals. When the database is completed, members of the public will be able to use their Web browsers to self register and indicate or change the types of CDRH information they would like to receive.

User Facility Reporting Bulletin

In the fall of 2000, we prepared the 32nd 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.

Year 2000 and FDA

The Year 2000 (Y2K) computer "bug" had the potential to affect many of the products that FDA regulates. OHIP served on a CDRH-wide coordinating group responsible for all Y2K issues; played a major role in outreach to health professional organizations, healthcare facilities, consumers, and manufacturers; participated in the staffing the CDRH Y2K Emergency Operations Team that was on duty during the rollover into the new year; and worked with other CDRH Offices to assure that our "internal" computer systems and databases were Y2K compliant. Our accomplishments included:

A Public Health Notification letter was developed and sent to the Administrators, Risk Managers, and Biomedical/Clinical Engineers of 67,000 hospitals and healthcare facilities in the U.S. This was followed up with another letter in November 1999 to further encourage facilities to complete their contingency and remediation planning to avoid serious adverse events.
Information on all CDRH Y2K activities was compiled into a single, comprehensive package. These packages were used in discussions and planning with other government and Congressional staff. Copies were distributed to FDA’s nationwide Public Affairs Specialists. Also, distribution was leveraged by working with medical professional organizations for further publication in their journals and newsletters, notices on their webpages, copies to regional, state and local chapters, etc.
We provided the majority of FDA speakers and coordinated speaker requests for a series of HCFA-sponsored outreach meetings entitled, "Transition 2000-Y2K Readiness Strategies for Medicare and Medicaid Providers." The meetings informed healthcare providers about the Y2K issue and methods to prepare for it. Each session featured one speaker from FDA, from a device manufacturer, and from a healthcare facility.
Through extensive planning, evaluation and documentation, we assured that the database system (MPRIS) for the mammography quality assurance program was Y2K ready.