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A quarterly bulletin to assist hospitals, nursing homes, and other device user facilities Issue No. 39  Summer 2002

In This Issue: August 14: Important Enforcement Date for Reprocessing of Single-Use Devices Cell Phones in Healthcare Facilities: Use With Caution Reuse CD ROM Available Latex Allergy: Recent Developments in Glove Use and Safety Public Health Notification: PVC Devices Containing the Plasticizer DEHP FDA Public Health Web Notification: Cochlear Implants Recipients May Be at Greater Risk for Meningitis

AUGUST 14: IMPORTANT ENFORCEMENT DATE
FOR REPROCESSING OF SINGLE-USE DEVICES

On August 14, 2002, hospitals that reprocess single-use devices (SUDs) must meet all of the regulatory requirements of a device manufacturer under the Federal Food, Drug, and Cosmetic Act as amended. These requirements include:

• Establishment registration and device listing
• Premarket clearance or approval
• Labeling
• Corrections and removals
• Medical device tracking
• Medical device reporting (MDR)
• Quality system regulation (QS).

For additional information about SUDs reprocessing, visit the Reuse Website at: http://www.fda.gov/cdrh/reuse/index.shtml. The following tables summarize the regulatory requirements that hospital reprocessors of SUDs must meet.

DATES FOR MEETING PREMARKET SUBMISSION REQUIREMENTS

*Provided that the reprocessor

(1) submitted a premarket notification by August 14, 2001;
(2) has not received a "not substantially equivalent" determination; and
(3) provides timely responses to the Food and Drug Administration’s requests for additional information.

DATES FOR MEETING NON-PREMARKET REQUIREMENTS

CELL PHONES IN HEALTHCARE FACILITIES:
USE WITH CAUTION*

A patient in the intensive care unit was receiving epinephrine by an infusion pump when a visitor received a cell phone call. When the phone was answered, the infusion pump increased the rate of the drip. The patient received an unintended bolus of medication and subsequently developed epinephrine toxicity.

What went wrong?

Under certain conditions, cell phone radio transmissions can cause electromagnetic interference (EMI) and disrupt the functioning of electrically powered medical devices as in this case with an infusion pump. EMI related patient injuries are relatively rare, but sources of electromagnetic energy such as radio signals, AC power line disruptions, and electrostatic discharge can disrupt medical device performance. Most medical devices are tested for EMI and meet applicable performance standards, but in certain situations medical devices may be susceptible to potentially serious problems.

What precautions can you take?

• Educate yourself and your colleagues about the potential for EMI with medical devices and learn how to recognize and report problems.
• Develop and follow policies and procedures to ensure electromagnetic compatibility, especially in areas where critical-care devices are used. For more information, refer to the Food and Drug Administration's Web site at http://www.fda.gov/cdrh/emc/index.html.
• Manage the use of radio transmitters near electrically powered medical devices. Post signs prohibiting cell phone use where necessary. Make sure all patients, visitors, and staff members understand and adhere to these policies.
• If a death, serious injury, or device malfunction occurs because of actual or suspected EMI, notify the person in your facility responsible for reporting adverse events to the manufacturer and/or the Food and Drug Administration. You may voluntarily report a medical device problem by calling FDA's MedWatch reporting system at 1-800-FDA-1088; by fax: 1-800-FDA-0178); or on-line at http://www.fda.gov/medwatch.

Julia Marders is a nurse-consultant in the Center's Office of Surveillance and Biometrics, and Donald Witters is a biomedical engineer in the Office of Science and Technology and Chairman of the Electromagnetic Compatibility Group in the Center.

*Based on the authors' article "Don't Answer That Cell Phone" that was published in the June issue of Nursing 2002.

REUSE CD ROM AVAILABLE

The Center for Devices and Radiological Health developed a CD ROM entitled: "An Overview of the Regulatory Requirements for Reprocessing of Single-Use Devices by Hospitals." While supplies last, a free copy of the CD-ROM is available by request at http://www.fda.gov/cdrh/reuse/reuse-important.shtml.

The two-disc set covers the regulatory requirements that a hospital must meet if it reprocesses single-use devices (SUDs). Topics include:

• Introduction about reprocessing SUDs
• Registration and Listing
• Premarket Review
• Labeling
• Corrections and Removals
• Medical Device Tracking
• Problems with Reprocessing
• Medical Device Reporting
• Quality System Regulation
• Useful Information

To see the PowerPoint presentations from the CD ROM, visit the Reuse Events Page at http://www.fda.gov/cdrh/reuse/reuse-events.shtml.

LATEX ALLERGY:
RECENT DEVELOPMENTS IN GLOVE USE AND SAFETY

In the 10 years since allergy to natural rubber latex (NRL) was identified as a serious concern for frequent users of medical gloves, researchers have worked to minimize or prevent allergic reactions and future sensitization.

The use of medical gloves has continued to increase (at an annual rate of 2.6 percent) because of the need for reliable protection from blood-borne pathogens. This trend will probably continue at a similar pace. However, the recent threat of possible bioterrorism acts will probably increase the use of protective gloves.

The notable progress in managing latex allergy was achieved by: (1) reducing the potential of NRL gloves to cause allergic reactions and (2) developing better diagnostic tests to evaluate product allergenicity.

Today's gloves have less potential for sensitization than gloves of a decade ago. As a result of intensive research, increased regulatory controls, and educational activities, manufacturers have improved their products. The table below shows a general trend in glove use and a rough estimate of protein and powder level changes between 1990 and 2002. In parallel to the advances in technology of glove production, there has been significant progress in the diagnostic methodology and assays for evaluation of product allergenicity. The American Society of Testing and Materials (ASTM) developed new standard methods for antigenic proteins (D6499) and glove powder measurement (D6124). The ASTM also determined standard maximum limits for protein and powder levels that are included in pre-existing glove standards D3577 and D3578.

With the widespread usage of natural latex gloves, the problem f allergy to NRL proteins is still an important issue. Better choices of less allergenic gloves and implementation of other preventive measures should reduce the extent and the intensity of the problem. Recent epidemiological studies indicate that the average prevalence of sensitivity in occupationally latex-exposed individuals is lower than reported several years ago. Similarly, the incidence of adverse reactions decreased as sensitized individuals are better informed and have better products. The progress is encouraging, but efforts must continue until the problem of latex allergy is resolved. The Food and Drug Administration is presently preparing a new regulation that would further improve the safety of NRL gloves.

Dr. Vesna J. Tomazic-Jezic is a research biologist in the Center's Office of Science and Technology.

ELECTRONIC NOTIFICATION FOR THE USER FACILITY REPORTING BULLETIN IS NOW AVAILABLE

If you would like to be notified electronically (via e-mail) when a new issue of the User Facility Reporting Bulletin is released, you can sign-up for our List Service at:

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCDRHNew/listman.cfm

Public Health Notification:
PVC Devices Containing the Plasticizer DEHP

The text of the Public Health Notification on PVC Devices Containing the Plasticizer DEHP is available by visiting this page.

FDA Public Health Web Notification: Cochlear Implant Recipients may be at
Greater Risk for Meningitis

The text of the Public Health Web Notification: Cochlear Implant Recipients may be at Greater Risk for Meningitis is available by visiting this page.

Updated August 21, 2002

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