March is Workplace Eye Wellness Month and there’s no better time than now for a little review and fast facts.

Thousands of eye injuries occur in the workplace every year. However, did you know that 90% of all workplace eye injuries can be avoided by using proper safety eyewear?

According to OSHA’s eye and face protection standard (1910.133) this is what should be enforced on the job front, “the employer shall ensure that each affected employee uses appropriate eye or face protection when exposed to eye or face hazards from flying particles, molten metal, liquid chemicals, acids or caustic liquids, chemical gases or vapors, or potentially injurious light radiation.”

Of course the workplace is only a portion of our lives and accidents at home can just as easily happen. In fact, four out of ten accidents that cause blindness happen at home. So, what is it exactly that we’re doing at home that is so dangerous? We’re cleaning, cooking, taking care of the yard, fixing the car, playing sports…you know, living. Don’t discount school and the youngsters either. Think about the playground, gym class, science class/labs, sports, the list goes on.

The moral of the story is you need to protect your eyes by properly wearing safety glasses, goggles, face shields, etc. when appropriate. Make sure your protective eyewear is not too tight or too loose. Wash it regularly with mild soap and water, or eyeglass cleaner, and polish with a soft cloth or tissue. Avoid damage to lenses by storing your protective eyewear carefully.

You’ve only got one set of eyes. Don’t lose them because the ones in the back of your head don’t count.

Sources: NSC.org, SeeClearly.com

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Are you ready to share your opinion? Of course you are! Josh King, Director and Paramedic with Richland County Ambulance Service in Sidney, Montana, is asking for your input about your time with Emergency Medical Services.

Take a moment of your time to fill out this quick survey in a national effort to identify where individual care providers feel EMS is, and which areas of EMS can be improved.

Check out Josh’s personal letter to you:

Dear Emergency Care Provider or Emergency Response Personnel:

My name is Josh King; I am Director and Paramedic with Richland County Ambulance Service in Sidney, Montana. I’m writing today to ask for your input about your time with Emergency Medical Services.

The field of volunteer Emergency Medical Services is at a critical point in its history – many volunteer services are finding it increasingly difficult to recruit new and retain their existing volunteers.  Within the past five years, many rural volunteer services have been forced to close their doors, forcing neighboring community’s agencies to provide care to a larger area, and thus stretching their own resources.  As state and federal levels of government develop revisions in policy to reverse this trend, it is up to these volunteer services themselves to ensure their communities’ available care at all times.  

As part of this process, this ambulance service has begun collecting data from emergency response personnel nationwide to help identify tactics every individual volunteer EMS or emergency response service can employ to maximize its volunteer base and availability. Clicking this link will direct you to a quick online questionnaire – I invite you to please fill it out with the most appropriate answers to you as an individual.  

This project is the second stage of a national effort to identify where individual care providers feel EMS is, and which areas of EMS can be improved.  We have seen exciting results from the first stage of this project, and through your help and input we plan to share what we’ve learned and raise the bar for emergency services and professionals nationwide.

We would like to hear from as many ambulance attendants as possible throughout the United States.  I encourage you to pass this link onto your coworkers, neighboring crews, or anyone else you may know in the field.  The questionnaire link will be open until April 2nd 2010.  
           
This questionnaire is compiled from common issues reported by Emergency Medical Technicians throughout the United States and will help to identify demographic information as well as key problem areas in the EMS field.  We project to complete analysis of the collected data in March 2011, and the results will be made available through Richland County Ambulance Service’s website, or will be sent to your email address if you like.
           
Whether paid, volunteer, or somewhere in between it is each of our responsibilities to ensure that our communities are safe and remain covered by our services.  We at Richland County Ambulance Service thank you for your time and dedication to the EMS field and likewise, to the wellbeing of others.

Sincerely,
                         
Josh King, EMT-P
Richland County Ambulance Service Director                                  

Hearshell VanLuven, EMT-B
Richland County EMT                      

216 14th Ave SW • Sidney, Montana 59270 • Phone: (406) 488-2180 • www.sidneyhealth.org

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Media Inquiries: Karen Riley, Karen.Riley@fda.hhs.gov, 301-796-4674

FDA Committed to Addressing Growing National Overdose Problem

The U.S. Food and Drug Administration (FDA) recognizes the five-fold increase in unintentional drug overdose deaths noted by the Centers for Disease
Control and Prevention between 1990 and 2006 as a serious public health concern. Much of this increase follows from increases in the deaths from the use of opioid drugs, which in 2006 accounted for more overdose deaths than heroin and cocaine combined. The agency is also concerned about misuse of benzodiazepines (e.g., Valium and Xanax), which accounted for 272,000 emergency department visits in 2008 (compared to 306,000 for opioids).

FDA is pursuing a variety of programs and initiatives in an effort to strike the right balance between ensuring patients access to important pain medications and mitigating the risks. These efforts include:

· The Safe Use Initiative: The mission of the Safe Use Initiative is to create and facilitate public and private collaborations within the healthcare community. Its goal is to reduce preventable harm by identifying specific, preventable medication risks and developing, implementing and evaluating cross-sector interventions with partners who are committed to safe medication use (see http://www.fda.gov/Drugs/DrugSafety/ucm187806.htm). Collaborations of this kind are essential for drugs like opioids, given the diverse factors that influence their use (e.g., legal, social, medical) and the many stakeholders working to assure they are used safely and effectively.

· Risk Evaluation and Mitigation Strategies (REMS) for Opioid Drugs: In 2007, Congress provided FDA with the authority to require REMS if that was necessary to ensure that the benefits of a drug outweigh its risks. These can include, for example, requirements for prescriber, pharmacist, and patient education about the risks and appropriate use of a drug, or other tools to better manage a drug’s risks On February 6, 2009, FDA sent letters to manufacturers of certain opioid drug products, indicating that these drugs will be required to have a REMS. The affected opioid drugs include long-acting and extended-release brand name and generic products that contain the active ingredients fentanyl, hydromorphone, methadone, morphine, oxycodone, and oxymorphone (see http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm163647.htm). FDA held a series of public stakeholder meetings in 2009 and opened a docket to receive public comments. FDA continues to accept public comments on the Agency’s approach to opioid REMS and plans to hold a public advisory committee meeting in the summer of 2010 to discuss proposals for this important safety program.

· Efforts on Acetaminophen: Every year in the United States, about 30,000 people are hospitalized with overdoses associated with acetaminophen – approximately half of which are unintentional. In June 2009, FDA convened an advisory committee meeting to provide expert input on options to reduce harm while maintaining access to this effective medication for pain. Potential strategies are currently under review.

· Strategies for the safe disposal of drugs: Certain medicines may be especially harmful and, in some cases, fatal in a single dose if they are accidentally taken. For this reason, FDA lists 26 drugs, including a number of potent opioids, that have special disposal directions indicating they should be flushed down the sink or toilet after the medicine is no longer needed. If disposed of down the sink or toilet, they cannot be accidently used by children, pets, or anybody else (Learn More: Disposal by Flushing of Certain Unused Medicines: What You Should Know).

· Evaluating the abuse potential of drugs: FDA has entered into a research collaboration with the National Institute on Drug Abuse (NIDA) to assess particular drugs for their abuse potential. The results of this research are provided to the Drug Enforcement Administration (DEA).

· Supporting efforts to identify safer pain medications. Janet Woodcock, MD, Director of the Center for Drug Evaluation and Research recently reviewed this area in the New England Journal of Medicine. See http://content.nejm.org/cgi/content/full/361/22/2105.
Through these efforts and others, FDA will join with sister agencies, medical professionals, health care institutions, patient organizations and others to reduce the number of overdose deaths.

For more information from the Centers for Disease Control and Prevention: http://www.cdc.gov/Features/PoisonPrevention/

Presidential Proclamation — National Poison Prevention Week: http://www.whitehouse.gov/the-press-office/presidential-proclamation-national-poison-prevention-week

Source: fda.gov

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FOR IMMEDIATE RELEASE - March 12, 2010 - Limerick, PA - Teleflex Incorporated provided an update today on the previously announced Arrow International, Inc. voluntary recall of ALL lots of its Arrow custom intravenous administration products (IV tubing sets and accessories) and certain Arrow arterial embolectomy catheters distributed prior to February 19, 2010.

Testing revealed pin holes in some of the pouches in which the products are packaged, and it has been determined that product sterility cannot be guaranteed. If product sterility has been compromised, there is a potential for infection, which could lead to serious injury or death. Arrow International has notified the United States Food and Drug Administration (FDA) and other health authorities of this recall.

Consumers who have:

· any Arrow product with a part number beginning with W followed by five numeric digits (e.g., W12345);
· any Arrow product with a part number beginning with MPI followed by five numeric digits (e.g., MPI-12345) which is an IV tubing set or tubing set accessory;
· either of the following two part numbers IV-850001-AAMC and IV-85020-UW;

should STOP using and return the items to Arrow International. Customers can find the entire affected product list at www.teleflexmedical.com.

The affected product was distributed globally to healthcare institutions and distributors.

No injuries have been reported to date however significant under-reporting of adverse events may have occurred.

Arrow International initiated this field corrective action in February 2010 and included notification to customers by letter. Customers were directed to immediately quarantine affected product and call the Arrow Custom IV Tubing hotline at 866-396-2111 to arrange for product return.

Customers with questions can contact the Arrow IV Tubing customer service hotline at 866-396-2111 between the hours of 8am and 8pm, ET, Monday through Friday.

Arrow International, Inc. is committed to providing high quality, safe and effective products. Any adverse events experienced with the use of this product, and/or quality problems can also be reported to the FDA’s MedWatch Adverse Event Reporting program by telephone at 1-800-FDA-1088 or online by visiting the FDA website at http://www.fda.gov/Safety/MedWatch/ default and following the instructions for submitting the appropriate forms electronically or by mail.

Neither the estimated costs nor the impact of this recall are expected to be material to Teleflex’s 2010 financial results. The voluntary recall and estimated costs were previously reported in the company’s Form 10-K filed February 25, 2010.

About Teleflex
Arrow International is a subsidiary of Teleflex Incorporated, a diversified global company with a significant presence in medical technology and niche businesses serving aerospace and commercial markets. Teleflex Medical, the company’s largest business segment, designs, manufactures and distributes medical devices for critical care and surgical applications serving customers in more than 140 countries. The company is focused on medical device technology that enables healthcare providers to improve outcomes, reduce infections and improve patient and provider safety. Additional information about Teleflex Incorporated can be obtained from the company’s website at www.teleflex.com.

Source: fda.gov

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LifeScan, Inc. is conducting a voluntary recall in the United States of eight lots of OneTouch® SureStep® Test Strips, used by people with diabetes to measure their blood glucose levels at home. The test strips are being recalled because they may provide falsely low glucose results when the glucose level is higher than 400 mg/dL.

The eight lots of consumer OneTouch SureStep Test Strips being recalled are:

Lot #’s are located on the outer carton and test strip vial.

Patients with test strips from the recalled lots are asked to call LifeScan at 800 574-6139 between 5:00 am and 7:00 pm Pacific Time, seven days a week or visit www.SureStep.com to request replacement product. Replacement product will be shipped immediately and provided free of charge.

While waiting for replacement product to arrive, it is important that patients with recalled test strips continue to test their blood glucose. Patients with access to a meter that does not use OneTouch SureStep Test Strips should use this other meter to test their blood glucose until replacement product from LifeScan arrives. If an alternate meter is not available, patients may continue to test using the recalled OneTouch SureStep Test Strips. However, if patients obtain results above 400 mg/dL, they should contact their healthcare professional for further instructions because their glucose may be significantly higher.

LifeScan estimates approximately fourteen thousand packages (50- and 100-count) of consumer OneTouch SureStep Test Strips were distributed nationwide between August 1, 2009 and January 28, 2010.

No injuries associated with these recalled test strips have been reported. However, if patients use the falsely low test results to determine their insulin dose, they may give themselves too little insulin, which could result in poor blood glucose control. Patients with high blood glucose may or may not have certain symptoms including increased thirst, frequent urination, headaches, difficulty with concentration, blurred vision and fatigue (weak, tired feeling). High blood glucose must be recognized and treated promptly to avoid serious complications, such as coma and death.

Hospitals, clinics and other multi-patient facilities using SureStep®Pro®, SureStep®Flexx® or OneTouch® SureStep® Hospital Systems have also been notified of this issue. All three of these systems use SureStep®Pro® Test Strips which also may provide inaccurately low test results when the blood glucose reading is greater than 400 mg/dL. LifeScan has advised these facilities of the appropriate actions to take in order to continue to use these SureStepPro Test Strips. However, healthcare facilities with access to alternative means of testing should consider temporarily discontinuing their use of their SureStep Systems until replacement test strips are available.

This field action is limited to eight lots of OneTouch SureStep Test Strips sold for consumer use in the U.S., and select SureStepPro Test Strips used in healthcare facilities. Similar recall actions are being taken in other countries where the affected product was distributed.

In 2006 LifeScan stopped selling OneTouch SureStep Meters in the U.S. but continued to provide test strips. Today, OneTouch SureStep Meter users represent a very small portion of LifeScan’s total customer base. The vast majority of LifeScan’s customers now use OneTouch® Ultra® Brand Meters, which use an entirely different technology.

LifeScan, Inc. is a leading maker of blood glucose monitoring systems for people with diabetes. For information about diabetes care and LifeScan products and services, visit www.OneTouchDiabetes.com.

CONTACT: David Detmers, LifeScan, Inc., +1-408-942-5955

Source: fda.gov

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