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U.S. Department of Health and Human Services

MedSun: Newsletter #3, April 2006

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Newsletter #3, April 2006

Articles

Light Can Wreak Havoc on CVCs

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By Roberta Sullivan, RN, BSN, MPH

A Central Venous Catheter (CVC) was successfully placed in an infant through the femoral vein. Less than 24 hours later, the catheter had broken, and a portion of it remained inside the infant’s vascular system. After it was removed, a second CVC was inserted. Within minutes, it also broke for no apparent reason. The patient required additional intervention to retrieve the second catheter segment, which was also hard and brittle.

What went wrong?
The hospital stored these products, which come in transparent wrap, in a carousel inventory control system with a clear front panel, which exposed them to ultraviolet (UV) light. The catheters were made of polyethylene, which is susceptible to degradation by UV light over time. Both catheters were close to their labels’ expiration dates but weren’t yet outdated.

What precautions can you take? Use these guidelines to store and use medical devices safely:

•Follow labeling recommendations that specify cool, dark, and dry places for storage.
•Consider using opaque double wrapping to protect products from light exposure.
•Routinely check expiration dates before using any medical device.
•Closely examine all devices before use; if any fail your inspection, notify your facility’s biomedical services or engineering department.
•Return devices involved in adverse events or malfunctions to your facility’s biomedical services or engineering department, which will check them before returning them to the manufacturer. These steps can help to determine what went wrong and prevent future problems.
•Follow your facility’s policies and procedures for reporting incidents.

Roberta Sullivan is on the Social and Scientific Systems, Inc. staff.

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FDA Proposes Regulations for Preventing Deaths and Injuries From Medical Gas Mix-Ups and Contamination

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The Food and Drug Administration (FDA) is issuing a proposed rule designed to make the contents of medical gas containers more readily identifiable, in order to prevent deaths and injuries from inadvertent use of incorrect medical gas or from use of contaminated medical gas.

Medical gases such as oxygen, nitrous oxide, and nitrogen, are administered to patients in healthcare facilities and the home, for a variety of purposes. For example, oxygen is often administered to patients suffering from various respiratory conditions, such as emphysema.

In some cases, injury or death has resulted from a medical gas mix-up caused by one of several factors, including mistaken administration of industrial gas to patients, improper connection of industrial gases to medical oxygen supply systems, and contamination of medical gas cylinders with residues of industrial cleaning solvents. Between 1996 and 2006, the agency received reports of medical gas mix-ups that resulted in at least 8 deaths and 18 serious injuries.

“By issuing this proposal, FDA is heightening consumer and industry awareness about this specialty area of regulated products. Greater understanding of the possible problems associated with the use of medical gases and the steps we can take to eliminate them will only lead to safer use of these products," said Steven Galson, MD, Director, Center for Drug Evaluation and Research.

This regulation would apply to medical gas manufacturers and distributors and will require that certain portable medical gas containers comply with the following requirements:

•have gas use outlet connections (used to connect these containers to gas supply systems) that cannot be readily removed;
•be identified by labels that wrap all the way around the tops of these containers;
•have high-pressure medical gas cylinders painted according to a standard color-coding system that corresponds to the gases stored in them; and
•be dedicated to medical use and not converted from industrial use.

FDA has undertaken a careful evaluation of the operations and processes required to produce suitable medical gases. Since 2000, the agency has conducted several public meetings to elicit comments from the medical gas industry as well as patients, professional associations, and manufacturers.

In addition to agency efforts, the medical gas industry and other bodies, including the Joint Commission on Accreditation of Healthcare Organizations and the National Fire Protection Association have taken steps to help prevent medical gas mix-ups and ensure the safe use of medical gases.

The proposed rule is intended to supplement existing FDA regulations and guidance regarding the safe use of medical gases by adding requirements—based largely on current, recommended, industry practice—to minimize the incidence of medical gas mix-ups and contamination. It is intended to ensure that health care facilities and patients receive only appropriate, safe, effective, and high-quality medical gases.

There is a 90-day public comment period on the proposed regulation before FDA develops the final rule.

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Bausch & Lomb Recalls Soft Contact Lens Solution

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The Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) have alerted health care professionals and their patients who wear soft contact lenses to the recent increase in reports of a rare but serious fungal infection of the eye that can cause vision loss requiring corneal transplant. FDA, CDC, and State and local public health authorities are continuing to investigate reports of Fusarium keratitis in at least 17 different States. Early results from these studies indicate widespread use of a Bausch & Lomb ReNu brand contact lens solution among patients reporting infections. Now Bausch & Lomb has announced that it is withdrawing all ReNu with MoistureLoc products and is recommending that consumers stop using ReNu with MoistureLoc immediately.

Consumers are also advised to practice good basic hygiene, to follow manufacturers’ instructions for proper use, cleaning, and storage of their lenses, and to report any signs of infection to their doctors.

Additional Information:

FDA Advice for Patients
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PublicHealthNotifications/ucm062098.htm

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FDA Highlights Agency Accomplishments in 2005

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On the eve of its 100th anniversary, the Food and Drug Administration (FDA) is assessing its past year as one of considerable accomplishment. Performance of all of the agency’s core functions was strengthened: ensuring the safety and effectiveness of drugs, biologics, and medical products; protecting the safety and security of 80 percent of the food supply; making certain that cosmetics and equipment that emits radiation do no harm; and ensuring the safety of animal drugs and feed. FDA took major steps in implementing its strategic plan and advancing its long-term strategic objectives, specifically in the areas of innovative technology, patient and consumer protection, bioterrorism, better manufacturing practices for pharmaceuticals, and modernizing its infrastructure and regulatory operations.

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Joint Commission International Center for Patient Safety Launches New Resource

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The Joint Commission International Center for Patient Safety has announced the launch of a new database, accessible through the Center’s Web site, that will allow health care professionals as well as patients and their families to access information about safety issues in health care settings. Patient Safety Practices: An Online Resource for Improving Patient Safety features more than 500 links to a wide variety of respected domestic and international patient safety Web sites. The easy-to-use database is being introduced as a work in progress to encourage users to submit additional safe practices that can be shared and to suggest ways in which the database can become even more helpful.

Additional Information:

Patient Safety Practices: An Online Resource for Improving Patient Safety
http://www.jointcommissioninternational.org/Quality-and-Safety-Risk-Areas/Patient-Safety/

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DS-X Device Safety Exchange, a MedSun Program

DS-X Lessons Learned

Question of the Month with Comment

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Question:
We are going to be implanting, for the first time, a pressure monitoring device during an endovascular repair of an abdominal aortic aneurysm. The device is implanted between the stent and the wall of the aneurysm to monitor the pressure in the aneurysm sac post stent implantation. This device is new to the market. Is this considered a “trackable” device?

Answer:
From FDA: FDA has not required this device to be tracked. FDA requires certain (relatively few) devices, such as automatic implantable cardioverter/defibrillators, to be tracked from their manufacture through the distribution chain. The purpose of device tracking is to ensure that manufacturers will be able to promptly locate the devices in commercial distribution. Tracking information is typically used to facilitate notifications and recalls ordered by FDA when the devices present serious risks to public health.

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Updated April 1, 2006

Return to MedSun: Medical Product Safety Network

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