July 2006

Monthly Archive

Reprocessing of Single-Use Medical Devices Comes Under Fire

Posted by Jamie on 31 Jul 2006 | Tagged as: Budgets & Spending, EMS, Medicine

File this one under “you must be kidding me”:

For years services have re-used single use devices like cervical collars, head-immobilizers, and tourniquets in an effort to reduce waste keep costs down. The theory was, “a few squirts or disinfectant and they’re good as new.” Historically durable stainless steel surgical devices like forceps and spreaders have been steam autoclaved or otherwise sterilized before reuse. It is prohibitively expensive for facilities to just throw away durable equipment after a single use but they are designed to be used over and over unlike fragile tracheal and endotracheal tubes which are made of plastic or other soft materials.

This is the first that I have heard of sterilizing and reusing single-use invasive medical devices like endotracheal tubes.

Reprocessed devices are soaked in sterilizing solutions, disassembled, blasted clean with a fine powder, reassembled and inspected, then packaged, sterilized and resealed. On average, they’re reused three to six times.

Today, the AP reports on federal legislation that will address the increasing use of “reprocessed medical devices” and the medical and ethical complications that arise such as those suffered by Sean Van Duyn after an Orlando hospital placed a reprocessed single-use only tube in his tracheal stoma. There is also the issue of informed consent as Van Duyn’s parents, for example, were never told that the devices labelled “single use only” were in fact used on other patients, up to six other patients.

Federal regulators say reprocessing is safe, but original device manufacturers say they can’t guarantee recycled products will work correctly — and that they are wrongly blamed for malfunctions and patient harm caused by reprocessing.

A federal law taking effect Tuesday, requiring reprocessors to put their company name on recycled devices as well as the packaging, could help determine who’s at fault when problems occur. For devices too small to mark, detachable stickers could be transferred to the patient’s chart.

“That’s like a ‘Sue Me!’ sticker,” and may not be used much, said Josephine Torrente, a lawyer and biomedical engineer who consults for device manufacturers.

The practice, that reportedly saves hospitals 50% over purchasing new equipment, has become so prevalent that there is even a professiona organization that represents the reprocessing companies, the Association of Medical Device Reprocessors. Their position is that the, “products are totally safe because each item is inspected before being shipped.”
The argument has, however, extended past the bounds of ethical medical practice and solid patient advocacy and has become one of copyright.

Johnson & Johnson subsidiary Ethicon Endo-Surgery is suing the biggest reprocessor, Ascent Healthcare Solutions, for trademark infringement over reprocessing its single-use devices.

“It is impossible to reuse them,” said Robert O’Holla, J&J’s head of regulatory affairs for medical devices, because they are not designed to be taken apart for cleaning. Yet J&J gets complaints from customers about problems with devices showing excessive wear or bleach on them — signs of reprocessing.

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Doppler Vein Finder

Posted by Jamie on 31 Jul 2006 | Tagged as: EMS, Medicine, Research and Development

veinfinder.jpg

Researchers at the Georgia Institute of Technology’s GTRI have developed an ultrasonic device that promises to make difficult veinipunctures and other peocedures that require vascular access much easier. The unit, designed specifically for use by paramedics and EMTs in the field uses the Doppler Effect to assist in determinig the key location, depth, and angles required to access hard to find veins in patients with severe bruising, burns, or a history of vein-destroying diabetes.

“Although the use of Doppler technology isn’t new, the novel aspect of our vein finder is the system’s design, which makes it both portable and economical,” says Peter Rogers, a professor in Georgia Tech’s School of Mechanical Engineering.

The patent-pending vein finder is composed of two parts: A reusable unit houses the electronics and signal processing components, while a disposable coupler box holds a reflector and needle guide. The needle guide is positioned parallel to the sound beam being transmitted by a transducer in the device’s reusable section.

Dehydration and cardiac arrest also present challenges which are compounded by the need for immediate vascular access with large-bore catheters. The time saved by using the acoustic vein finder could save numerous lives (and Quality Improvement statistics). Researchers promise that it will be small and inexpensive:

Once the system is successfully adapted for humans, data processing and electronics will be miniaturized in a prototype for field-testing. The researchers envision the final product will be about the size of a fat fountain pen.

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Prehospital Ultrasound for Evaluation of Abdominal Injuries

Posted by Jamie on 30 Jul 2006 | Tagged as: EMS, Medicine, Research and Development

portableultrasound.jpgWe often refer to the abdomen as “the big gray box” in the prehospital setting because, before the advent of portable ultrasound units like those by SonoSite that are sturdy and inexpensive enough for prehospital use, the only way to differentiate between a “surgical abdomen” that required immediate intervention by a trauma surgeon and an uninjured one were vague diagnostic signs and symptoms like “tender” and “rigid.” The value of early bedside ultrasound exams such as FAST (focused abdominal sonography for trauma) have been proven time and again in emergency departments but until the last few years the value of training EMTs and paramedics to perform the exams in the field was questionable.

There are a few interesting and very promising studies from Europe that deal the with feasability and diagnostic value of out-of-hospital ultrasonography for the evaluation of traumatic and atraumatic abdominal injuries. The initial results make a rather striking case for expanding research if not implementation of a FAST exam (or similar) protocol for use in ambulance and air-medical operations.

Pre-hospital ultrasound when applied by an proficient examiner using a goal-directed, time sensitive protocol is feasible, does not delay patient management and provides diagnostic and therapeutic benefit. Further studies are warranted to identify the exact indications and role of pre-hospital sonography.

More after the jump. Continue Reading »

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Ooops

Posted by Jamie on 30 Jul 2006 | Tagged as: Meta

Sorry it looks like I didn’t post yesterday but I did. I swear. I just accidentally posted it as a “private post.”

Whoops.

-ed.

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72 mpg VW Diesel Hatchback - Flycar?

Posted by Jamie on 28 Jul 2006 | Tagged as: Apparatus, Budgets & Spending, EMS

VW PoloI’ve been a big proponent of doing what they did in the UK a long time ago - getting away from the top-heavy, maintenance intensive 4 wheel drive gasoline flycar and moving to more durable diesel sedans that get excellent fuel mileage and are (and here’s the part that gets me heat every time) safer and just as useful.

I think the difficulty in convincing people that this is the right way to go is in overcoming the testosterone-factor that comes with the big 4WD sport utility vehicles that are commonly used for flycars in the states. There, I’ve said it and I mean it. Sure, the SUV has its place in climates where 4 wheel drive is useful (although my AWD sedan does just fine, as would an AWD vehicle - more on this weak justification after the jump) like in the montains and the snow-belt. Moving to something like this little diesel number from Volkswagen called the Polo has numerous advantages:

  • Fuel efficiency - let me see you squeeze 72 mpg out of a Chevy Tahoe or Suburban. Not only reducing cost, the increased mpg means fewer out of service trips to the pump and a higher unit hour utilization.
  • Maintainance - it’s a diesel, need I say more?
  • Size - if well layed out this vehicle can carry just as much useful gear as is needed in your average advanced life support flycar or supervisor vehicle. Also, its smaller size makes it able to fit in congested urban areas and busy-hospital parking spots that a Hemi-Durango couldn’t dream of.
  • Safety - its diminutive size may curb the agressive driving that causes quite a few accidents. Operators may be more conscious of their driving if they’re not in some lumbering beast.
  • Cost - The VW Polo retails for $19,990. Even using the State Bid process that beats the pants off of most SUV’s.

Sure, the Polo’s not the fastest thing on the road topping out at a blistering 62 mph; however, before I hear it — everyone go get their agency’s driving policy and show me that it’s okay to go faster than 62 in an urban setting where most posted speed limits are in the 25-35 mph range. Everyone got it? Okay.

More after the jump. Continue Reading »

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