Tuesday, November 12, 2013

Are "safety scalpels" safer than standard scalpels?

A Twitter follower wrote me this: "hospital making me use 'safety scalpel' w/retractable sheath. I've almost cut myself x 2. Do you know of any data about it?"

That got me interested because I like to question things. Was this going to be yet another rule without evidence?

I thought I would have to do an exhaustive search to see if anyone had ever studied the question of whether so-called 'safety scalpels' really are safer than standard scalpels.

I was pleasantly surprised to find a 2013 paper in the Canadian Journal of Surgery which reviewed the literature on the subject. The authors, from the University of British Columbia, found no studies that addressed harm reduction and the use of safety scalpels. A previous paper from Australia in 2009 also found no randomized trials of safety scalpel use.

In their discussion, the authors point out that the introduction of safety scalpels might have the opposite effect on safety due to factors such as personnel not being familiar with how they work and that safety scalpels have never been subjected to rigorous evaluation by failure mode and effects analysis. And they noted that injuries related to the use of safety scalpels have been reported.

Since there is no proof that safety scalpels are effective in reducing injuries, there seems to be no rationale for regulatory agencies or hospitals to mandate their use.

The paper noted that at least 24 different safety scalpels have been developed and approved for use in the United States. An Internet search confirmed that there are at least that many types of safety scalpels on the market.

I attempted to find a specific mandate about scalpels in the Needlestick Safety and Prevention Act of 2001 but was unable to do so. If the act says anything about scalpels, perhaps someone could let me know.

Among the issues with safety scalpels are that surgeons complain that they do not have the correct feel, quality or precision of standard scalpels.

The use of devices that allow for safer removal and replacement of scalpel blades may be a better alternative than using safety scalpels.

In 2011, the magazine Outpatient Surgery and the International Sharps Injury Prevention Society surveyed 186 operating room clinicians and found that 60% of respondents were not using safety scalpels at their hospitals. OSHA is not fining many institutions since 95% of those who answered said they had never been fined.

Meanwhile, safety scalpel use is far less than expected. The use of safety scalpels appears to have been based on an unwarranted assumption that safety scalpels are safer.

It is certainly possible that safety scalpels do reduce the incidence of injuries, but it is equally possible that the rate of injuries in the same or even worse with the use of safety scalpels.

As a byproduct of their investigation, the authors mention that the use of hands free passing techniques for sharps, double-gloving and avoidance of using hands as retractors have been shown to be effective in reducing sharps-related injuries.

But not safety scalpels. So why are they being used at all?


Korhomme said...

Interesting. For a very long time, we used the sharps in a kidney dish technique. Only once had a scalpel injury; but that was from a gynaecologist, so it doesn't count!

Anonymous said...

The "standard" scalpel suppliers don't have a Washington lobbyist. Take away a 30 cent tool and mandate use of a $2 one, yet another way to siphon "healthcare dollars" away from the actual delivery of healthcare.

pamchenko said...

at our hospital we still pass sharps in the kidney basin. on the floor/ER we use safety scalpels. I like the safety scalpels with the plastic top that can come off with a easy thumb motion. I've used the box cutter type safety scalpels and they were a little clumsier. The only time I had a scalpel injury was when I was in a rush as a resident doing a central line. This was frustrating because it was a medicine patient and my vascular attending volunteered the surgical resident (me). I was very busy and needed to get it done quickly because I had to rush to the operating room to help with an appendectomy. when I was cleaning up, I forgot about the scalpel and when I rolled up the wrapper/kit to dispose of, I put the non protected 11 blade into the palm of my hand. I saw the blood fill the inside of my glove. I started to cry because it was also my birthday. I'm of the male gender. My lesson? be more careful when rushing on your birthday.

Anonymous said...

The key to actual sharps safety is in the design on the device. It must be capable of being really used by the real people that it in the real environment of use, and then achieving the desired goal of reducing sharps injuries. This requires ease of use and intuitiveness without adding any new hazards arising directly from trying to operate the sharps feature. It must also be compatible with the original function of the device, i.e. not interfere with the primary purpose. In this regard there is a world of difference between a safety device that could theoretically provide some safety and the ability to actually do so. Note here that the devices currently marketed have been "cleared" by the FDA, not "approved". Clearance requires a much lower standard of proof of safety and efficacy.

The same issues arise with needle "safety" devices. Some provide safety and others do not (and some are worse) as demonstrated by the ongoing rate of needlesticks.

Skeptical Scalpel said...
This comment has been removed by the author.
Skeptical Scalpel said...

Kor, Yes, they can't be trusted with sharp instruments.

First Anon, good point. They are more expensive.

Pam, I was stabbed by a resident once. He swears it was an accident. A safety scalpel wouldn't have helped because it was in the field. I reached for a clamp and he moved the knife into my path. I had a longitudinal tendon injury that sidelined me for 3 weeks.

Second Anon, I agree that cleared by the FDA means nothing. I found that many of the safety scalpels do not have the same "feel" as a regular scalpel, which is what the authors of the paper I mentioned in the post found too.

Clark Venable said...

Because it allows an administrator to claim they did something about sharps injuries in the OR.

Skeptical Scalpel said...

Clark, good comment. They can say they made a system change.

artiger said...

I don't have too much of a problem with today's safety scalpels, although I do find them slightly cumbersome. After a while, it's no big deal.

I first became acquainted with the hands free passing technique (aka, using a pan or basin) in 1991, on my 3rd year rotation on ortho, of all places (I was assigned to the reconstruction team, if I recall correctly). Back then, when I was only slightly dumber and more ignorant than I am now, I thought it was a pretty ingenuous idea. Who says orthopods aren't good for something?

These days, I ask that the scrub just put the scalpel down on the field, even with the safety, and let me pick it up. When I'm done with it, I just set it back down to let the scrub pick it back up.

Anonymous said...

During my general surgery internship year, I introduced a 11 blade "safety" blade right into my index finger as I was doing dialysis catheter. Your point about variance is correct - many of them have different safety mechanisms.

Anonymous said...

THis gynecologist enjoys your blog and is certain that you and Kor are just joking :)

Skeptical Scalpel said...

First Anon, thanks for the comment. Sorry that you suffered an injury from a "safety scalpel." But that is my point (no pun intended).

Second Anon, of course, just kidding. I used to wear Kevlar gloves whenever I scrubbed with a gynecologist. :-)

Anonymous said...

I really disagree with the statement that safety scalpels are not required by OSHA, actually you said the Needlestick Safety and Prevention Act of 2001. OSHA expects safety scalpels to be used in conjunction with work practice controls, as long as patient safety is not compromised. See standard interpretations:
• 12/22/2005 - Use of passing trays and single-handed scalpel blade remover in a surgical setting
• 09/01/2004 - Limiting factors for implementing the use of engineering controls, i.e., safety scalpels, under the Bloodborne Pathogens standard.
• 06/03/2005 - Definition of contaminated sharps; engineering controls and good work practice controls must be implemented; ECP must be reviewed annually.

Skeptical Scalpel said...

Anon, I appreciate your clarification of the OSHA standards. I was unable to find any of those references on its website.

A single handed scalpel blade remover is not the same as a safety scalpel though. It's a device that removes blades from standard (non-safety) scalpels.

The 09/01/2004 reference--does it say safety scalpels MUST be used.

And the 6/30/2005 one--does it specifically mandate safety scalpel use? And what is "ECP"?

I would like to see links to those items you listed, please.

Anonymous said...

So scrub nurses don't slap the scalpel into the surgeon's hand? Has Hollywood gotten it wrong for all of these years? I am shocked, shocked!

Skeptical Scalpel said...

There was a time when nurses slapped the instruments into surgeons' hands. It always worked better with clamps or scissors than with scalpels.

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