Positive change in the Bloodstream infections and Cataract connectors: the first communication to the

Sent date: 11. August 2010

Public:Health professionals

Medical Specialty:Infection Control

A summary of the issue and scope:

A number of peer review, clinical trials, a report on the putting into service and use of positive displacement, as well as health-care establishments needleless connectors to the reduction of infection after changing to another type of bloodstream infections needleless connector.However, the amount of the bloodstream infection risk compared to other needleless devices, these connectors, or whether the risk of some or all of the information relating to the positive displacement is probably the connectors were incomplete. FDA is ordering product safety to better understand the use of bloodstream infections, the risk of positive displacement connectors needleless.

Device:

Positive displacement needleless connector is part of the system, with regard to the use of intravascular needleless. these devices can also be referred to as the "activated luer valves," "connectors," or "run" and may refer to the "positive pressure" or "positive displacement", their descriptions.

Healthcare Professionals recommendations:

In 2008, the two professional associations adopted guidelines for the small hospital acquired infections (http://www.journals.uchicago.edu/toc/iche/2008/29/s1). For the purpose of these guidelines, in so far as it is not, as a matter of routine, "do not use positive pressure connectors mechanical valves before needleless risks, benefits and proper management of a foods natural appetite suppressors
thorough assessment of the training."FDA's original assessment supports this recommendation.

Postmarket Surveillance Studies

FDA requires companies that produce positive displacement postmarket surveillance tests needleless connectors. studies clarify these devices in order to limit the risk of infection and the risks and benefits. manufacturers shall provide for the collection of information to patients who have received the patients who have received compared with other types of connectors needleless devices bloodstream infections: for more information, see the FDA Letter infection control professionals.

Reporting problems with FDA

Prompt notification of adverse events to help the FDA identify and better understand the risks associated with medical. If you suspect problems with the use of positive displacement needleless connectors, we recommend a voluntary report, FDA MedWatch safety information and events through the reporting program to a file. medical devices by the FDA for reporting in device action is subject to the staff in their facilities reporting procedures.

Health care providers are invited to inform the port facility also infected control staff, where they have doubts concerning the positive displacement connector into the bloodstream infection needleless.

Contact information:

If you have any questions about communication, contact small manufacturers Division, International and Consumer Assistance (DSMICA) dsmica@fda.hhs.gov or 800-638-2041.

For more information about:

This document reflects the FDA in accordance with the information available to the public are informed of the ongoing safety reviews of medical devices in order to reinforce our commitment to the nature of the current analysis., and this situation will not be liable for any public health effects are not yet clear.

    

Safety investigation of a suspected counterfeit Combat Application finally (C-A-T ®): the first communication to the

Sent date:9. August 2010

User group:

People who use eventually: Military buyer, military personnel, Emergency first responders (Fire Fighters, Police Officers, EMTs), individuals, who may find themselves in a situation where they need to stop serious bleeding: Hunter, for hikers, Rock ClimbersConsumers: Friends and Family, military personnel, Paintball players, war-Re-enactors

Medical Specialty:An error occurred while reading the Medicine, an error occurred while reading the responders trauma

Device:

Combat Application Tourniquet (C-A-T ®) consists of the belt, which is placed on the injured part (head), and then in the bond market tightened tension rod (windlass) with blood flow are protected in the same place Windlass. in such a way that the victim may be transported for the first aid post. Tourniquet to self-applied according to the victim, or it can be applied to any other person.

The other side of the tourniquet is, inter alia, of the Pink Car Mats other characters, C-A-T ® logo outline cat and national supply number NSN6515-01-521-7976. it is a compendium of resources which are manufactured and distributed the following distributors:

The rescue of North America, LLC-Greer, SCCardinal Health – Mcgaw Park, ILOwens and Minor-Mechanicsville, VAAmerican purchasing Services-Opa Locka, FLPhoenix Textile Corporation-O'Fallon, MO

A summary of the problem and scope:

THE FDA has become aware of a suspected counterfeit C-A-T ® finally finally. suspected counterfeit is subtle differences in the stitching thread ID, and printing of plastic parts molding. they are packaged and labelled other than an authorized distributor or distributors.

Preliminary testing has shown that in the case of a suspected counterfeit tourniquet does not perform the same as the Composite resources produced by the Windlass is lower in the case of the tourniquet. in the case of a suspected counterfeit products and breaks or bends, until the necessary force can be applied to put an end to the blood flow.Excessive blood loss is liable to endanger the victim's life and eventually lead to death.

Recommendations/functions:

Use only the C-A-T ® finally Composite resources produced by and one of those listed above, I would like to purchase from authorized distributors. others may be counterfeit, and may fail If use., you have the C-A-T ® Finally you suspect of being counterfeit, replace them as soon as possible to the actual devices in the event of possible counterfeits. If fails, it endangers the life of the patient. Notify THE FDA's Office of Criminal investigation (OCI), if you suspect that the tourniquet counterfeit, contact: Alex Alvarado, Special Agent FDA Office of Criminal investigation-(240) 276-9407.

FDA activities:

FDA and the Ministry of defence and the deposit facility will remain unchanged to examine this issue and determine the suspected counterfeit products we will update this communication sources. available for more information.

Reporting problems with FDA

Prompt notification of adverse events to help the FDA identify and better understand the risks associated with medical devices if you suspect problems. Finally, we recommend a voluntary report, FDA MedWatch safety information and events through the reporting program to a file. medical devices that FDA user personnel employed by the port facility reporting requirements shall be complied with in respect of their facilities reporting procedures.

You can help us to get as much information as possible relating to adverse events in the end, you may want to include the following information in the reports, if available:

The manufacturer's name (Brand name) NameDevice date device had ManufacturedDistributor's events NameDetails and medical or Surgical Interventions (if applicable)

Contact information:

If you have any questions about communication, contact small manufacturers Division, International and Consumer Assistance (DSMICA) at dsmica@fda.hhs.gov, 800-638-2041, or 301-796-7100.

This document reflects the FDA in accordance with the information available to the public are informed of the ongoing safety reviews of medical devices in order to reinforce our commitment to the nature of the current analysis., and this situation will not be liable for any public health effects are not yet clear.