Revatio® (Generic Name: sildenafil citrate)

Revatio (re-vah-tee-o) is a fairly new drug on the market used to treat pulmonary hypertension.  Pulmonary hypertension causes increased blood pressure in the blood vessels of the lungs.  Because of this, patients are not able to tolerate physical activity and exercise as they used to.  You may find patients with COPD that also have pulmonary hypertension.  It is very important for all EMS providers to be aware of Revatio because it is made of the same drug as Viagra.  The generic name for Viagra and Revatio is sildenafil (sill-dena-fill).  Patients on Revatio are contraindicated from receiving Nitroglycerin the same as those on Viagra, Levitra or Cialis.  Administration of nitroglycerin to a patient on Revatio could cause a sudden and severe drop in blood pressure.  This is an important thing to remember because oftentimes the patient is on a generic form of a drug rather than the brand name.  Look for patients with a history of chronic breathing problems—especially when brought on by exertion, to be on Revatio.  If you encounter a patient taking Revatio that has indications for nitroglycerin (chest pain), document that the patient is on Revatio and therefore, is unable to receive nitroglycerin.  As a reminder, the State and Regional protocol for withholding nitroglycerin has been increased to 72 hours in the presence of Viagra, Levitra, and Cialis (erectile dysfunction drugs).  You can find additional information at: http://www.drugs.com/pro/revatio.html

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Problem

An ECRI investigation of a fire that occurred between an oxygen regulator and an E-cylinder valve revealed that the fire resulted from the use of two washers between the regulator body and the E-cylinder yoke. In this incident, a specific model oxygen regulator, which had a durable washer, had been placed on a new E-cylinder without first removing the cylinder’s disposable washer. The use of two washers allowed an oxygen leak on the high-pressure side of the regulator, which, in the presence of minor hydrocarbon contamination, resulted in a flash fire between the regulator and the cylinder valve.

Discussion

Most new oxygen regulators are supplied with a plastic or nylon yoke washer that may develop leaks with repeated use. Hospitals tend to remove these washers and use the disposable yoke washer that is commonly supplied with a new oxygen cylinder. However, this model regulator is supplied with a replaceable, durable, partially metallic yoke washer that is less susceptible to developing leaks. Users familiar with nylon washers may not be aware that this regulator has a more durable washer, especially since this regulator is most commonly used in the prehospital environment. In addition, the manufacturer’s operating instructions and labeling do not inform users of the washer’s new design and use in its regulator. At least one other regulator manufacturer, of those known to ECRI, also markets regulators with durable yoke washers.

Action

With the new design, it is essential that any washer present on an oxygen cylinder yoke be removed before installing the oxygen regulator. Only one washer of any type should be used at any time. We encourage all manufacturers of oxygen cylinder regulators equipped with durable yoke washers to label their regulators with instructions to remove the yoke washer on the cylinder before installing the regulator. In the interim, we urge users to follow the recommendations below.

Recommendations

1. Determine whether your oxygen regulators are equipped with a durable yoke washer. If so, affix a label or tag stating: This regulator is equipped with a durable yoke washer. Remove any washers from the oxygen tank cylinder before installing the regulator.
2. Ensure that all respiratory therapy, nursing (including nurses aides), emergency medicine, and anesthesia personnel are made aware of this report.
3. If you are uncertain whether your oxygen regulators are equipped with a durable washer, contact the regulator supplier.

See full article at http://www.mdsr.ecri.org/summary/detail.aspx?doc_id=8245

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Defibtech LLC, DBP-2800 Battery Pack for ReviveR AED™ and Lifeline AED® Semi-automatic External Defibrillators

Recall Class: Class I

Date Recall Initiated: May 21, 2010

Product(s): DBP-2800 Battery Pack for the Defibtech ReviveR AED™ and Lifeline AED® semi-automatic external defibrillators

Affects only DBP-2800 battery packs distributed prior to June 4, 2007 and used with the ReviveR AED™ and Lifeline AED® devices.

Affected battery pack serial numbers range:

• Between 202001005 and 202005916, or,
• Between 206001001 and 206009871

In a letter to customers dated May 20, 2010, Defibtech states that the company is mailing to all affected customers a battery pack update data card that will allow customers to update device software to correct the problem while allowing the devices to remain in their locations.

Defibtech notification and instructions on determining whether a battery pack is affected.

Reason for Recall: If the AED is used with an affected battery pack, the AED may falsely detect an error condition, cancel charge and not provide therapy.

For further info-  http://www.fda.gov/MedicalDevices/Safety/RecallsCorrectionsRemovals/ListofRecalls/ucm215407.htm

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Physio-Control Inc., LIFEPAK 15 Monitor/Defibrillator

Recall Class: Class I

Date Recall Initiated: March 4, 2010

Product(s): LIFEPAK 15 Monitor/Defibrillator

See under Useful Links to search for affected devices by serial number.
The serial number is located on the underside of the device.

These devices were manufactured between March 26, 2009 and December 15, 2009 and distributed between March 27, 2009 and December 15, 2009.

Use: The LIFEPAK 15 monitor/defibrillator is designed for use by trained medical personnel in out-of-doors and indoor emergency care settings to monitor patient heart rhythms and to treat patients experiencing cardiac arrest.

Recalling Firm:
Physio-Control, Inc.
11811 Willows Road NE
Redmond, Washington 98052-2003

Reason for Recall: There is a potential for the device to unexpectedly:

• Power Off then On by itself.
• Power Off then NOT turn On.
• Power Off by itself requiring the operator to turn it back On.
• Stay powered On and not allow itself to be turned Off.

Public Contact: Physio-Control Technical Support at

via List of Medical Device Recalls Physio-Control Inc., LIFEPAK 15 Monitor/Defibrillator.

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Airgas South, Inc., a distributor of industrial, medical, and specialty gases, today announced an expanded voluntary recall of medical gas products filled at its Chattanooga, Tennessee facility. The recall is being initiated as a precautionary measure because these products may have been manufactured under conditions that did not sufficiently comply with current Good Manufacturing Practices (cGMPs).  See more at the link below.

http://www.fda.gov/Safety/Recalls/ucm220227.htm

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4 plus years ago a 49 year old man lost his life while blowing the snow off his sidewalk. A Paramedic (the patients son) witnessed the arrest and started CPR (and I am sure this would be the most wholehearted effort at CPR that he could do). In spite of his best efforts his father died, possibly due to the fact that the debibrillator that arrived with the first responding fire engine had a dead battery. To make matters worse the second battery was dead as well. Shortly thereafter this 49 year old gentleman was also pronounced dead.

An investigation has shown that these batteries were more than 2 years past the manufacturers suggested replacement date. There also seems to have been a failure to identify the dead batteries due to a regular checkout of the defibrillator. There has been a settlement of 3.2 Million dollars in this case (which would have more than paid for those batteries).

Beyond the dollars involved we must remember what got most of us (from the field provider to the administrator)  into this business – the desire to help someone.

Lets keep our eye on the ball and ensure we do everything possible to provide that high level of care we all talk about.

By the way, we may save our self a load of money on the side!

Read the rest of this entry »

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The CDC has posted a good podcast on how to don an N-95 Mask (excerpt below).

N95 respirators are designed to protect you from breathing in very small particles that may contain viruses. These types of respirators fit tightly to the face so that air is inhaled through the filter material. N95 respirators should be worn only once and then thrown away in the trash.

Manufacturers supply important instructions with respirators on how they are to be put on and checked to make sure they’re properly positioned. Always follow the manufacturer’s instructions, specific to the product you’re using.

Check out the podcast here.

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Spina Bifida (a developmental defect of the spine) is a factor related to a high incidence of latex allergies (especially in children and infants).

Before treating a child, try to elicit a history from the parent or caretaker paying special attention to any reference that is made to spinal deformities.  If in doubt, use only latex-free equipment and supplies.

For additional information you can go to the website of the Spina Bifida Association.

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Things that keep us safe are always worth reviewing.

Misuse of tank-to-regulator washers accounted for a number of incidents where leaking oxygen caused fire or explosions.

In a nutshell – NIOSH (National Institute for Occupational Safety & Health) states: Do not reuse the “crush” washers that usually come free with each refilled O2 tank. Whenever possible, use the “metal-bound” sealing washers that come with new regulators and are designed for re-use. If the original washer is lost or damaged, you should replace it with an equivalent washer.

See the original FDA and NIOSH Public Health Notification for further clarification.

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Agencies should consider the storage temperature requirements of common medications (as stated by the manufacturers).

Albuterol Sulfate, for example, should be stored between 36 and 77 degrees Farenheit. Epi-Pens are even more restrictive; the manufacturer requires storage at 77 degrees with temporary variances from 59-86 degrees allowable.

While some agencies probably cannot guarantee these temperatures exactly, they should ensure that the drugs they store in ambulances and first response vehicles are kept within these ranges. Other meds have similar requirements and should be reviewed as needed.

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