Defective equipment and worker safety

I received a letter today from Janssen pharmaceuticals regarding problems that have been identified with the syringes used with risperdal consta.  The problem is that the needles can detach during use.   I was pleased to be notified of the problem, and naturally thought the rest of the letter would identify how they had re-engineered the syringe to eradicate the problem. 

I was initially pleased that the company had even gone so far as to be transparent in informing healthcare professionals about the problem.  The problems include:

• the needle could fall off before, during, or after administration, 
• the needle may remain in the arm after withdrawal of the syringe. 
• detachment resulted in several workers being stuck with a contaminated syringe.  

Luckily none of these needle stick injuries have resulted in transmission of HIV or hepatitis... At least not yet.

Imagine my dismay when I read the rest of the letter, which explained the procedure to follow to avoid or reduce the chance of needle disengagement during preparation or administration of the injection! 

There is something wrong with this picture!

Why not package the shot with a safer more reliable syringe-needle attachment?!  The best way to deal with an occupational safety problem is to universally protect workers... in this case by re-engineering of the needle-syringe (remember that hierarchy of controls?).  

I am deeply disturbed that hundreds or maybe thousands of nurses everyday place themselves at risk of a needle stick injury while doing their job.  Isn't there something wrong with this? I think these types of syringes are used in many settings.  What are they thinking?  (by the way - I recognize that it may not be Janssen that manufactures the syringe/needle used -but they are requiring us to use the system to be able to reconstitute and prepare the injection)

I have actually read and re-read their directions several times in the past.  I have always been left to wonder whether this new safety covered needle is really worth the effort?  If you look at the drug information leaflet (http://www.janssencns.com/shared/pi/risperdal/risperdalconsta.pdf) you can see the 'simple' 17 steps involved in preparing the injection!!!  

Doesn't the addition of this new risk move the equation to the side of not worth the effort? 

Am I alone in thinking this was a misguided attempt to use the current technology despite evidence of a problem?  Is the device really that much better than others available?

Am I supposed to inform my patient that there is a risk of the needle remaining in his arm after I withdraw the syringe? This is a risk of the procedure, should it be part of consenting?  Unfortunately that may not happen often given that the reason we use injectable depot antipsychotics is to improve adherence in that group of patients who are not as interested in staying on the medication or don't actually want to take it every day.

Again, what are they thinking?  Can anyone provide a reality check for me on this subject?

If HIV had been transmitted would that change things and promote the withdrawal of a poorly designed and manufactured syringe-needle product? 

Could they perhaps try a little harder to fix the needle disengagement issue?

Actually, I remember using similar needles in the past, with detailed directions on how to 'correctly use' the  syringe.  I think I recall a flu shot clinic many years ago as well as other pre-filled type syringes where this can happen.

I have had the experience of the needle remaining behind in the patients arm... Not a very happy moment in my practice experience. I am pretty sure that was the last flu shot that person ever came in for.  Luckily I did not get stuck while removing the needle from the patient's arm - and miraculously the patient allowed us to perform the procedure again (with a different syringe and needle). 

So if this is both a patient and worker safety problem, why isn't it being fixed?  I would think the risk of HIV or hepatitis transmission would be a great enough risk that someone would push for recall of the device?

I would love to hear what all of you think about this!