Emerald Coast Surgical Team Puts Anzen Safety Scalpel To The Test

March 5, 2019

The Needlestick Safety and Prevention Act of 2001 mandated employers to “identify, evaluate and implement” safer medical devices, including those used during surgery. Despite the legislation, operating rooms across the country did not widely convert to the use of safety scalpels as a solution.

To learn why, MediPurpose conducted nationwide surveys that studied sharps safety awareness of surgeons and surgical technologists. The surveys took place at surgical conferences and expos across the country from 2015-2017. The purpose was to learn about the industry’s knowledge on safety scalpels and gain insights into what surgeons require in a safety scalpel.

Building on this consumer insight, Medipurpose continued to test and improve the Anzen Safety Scalpel. The study at Emerald Coast Surgery Center, FL is one example.

Emerald Coast Surgery Center Simulated Use Study of the Anzen Safety Scalpel

In July 2016, MediPurpose conducted a series of simulated use studies at Emerald Coast Surgery Center to validate the Anzen Safety Scalpel design. Surgical technologists and surgeons completed simulated use evaluations of the Anzen Safety Scalpel so they could complete a survey and report their experiences.

The response was mixed – while the surgical technologists found the scalpel safe and easy to use, the trial revealed surgeons felt the Anzen blades were not sharp enough. Some surgeons were also not happy with the weight of the handle. MediPurpose then re-engineered the device, incorporating their feedback into the new design.

Emerald Coast Surgery Center Blind Blade Study of the Anzen Safety Scalpel

To address the surgeons’ feedback on the blade sharpness, MediPurpose asked them to evaluate blades from 3 different suppliers. MediPurpose selected the sharpest blade based on the evaluation results and incorporated it into the improved version of the Anzen Safety Scalpel.

Emerald Coast Surgery Center Actual Use Study of the Anzen Safety Scalpel

Between June and September 2018, Emerald Coast Surgery Center participated in a second trial of the  improved Anzen Safety Scalpel. Seven surgeons and four surgical technologists performed an evaluation in an actual use setting. The research indicated that the new version achieved what end-users wanted: a safety scalpel device with sharper blades that retained most of the original features – especially the weight and balance of the blade handle.

Interview With Susan Hislop, OR Manager at Emerald Coast Surgery Center

In a follow-up interview, Susan Hislop, the Operating Room Manager who coordinated the testing at Emerald Coast, shared the team’s experience with the Anzen Safety Scalpel:

MediPurpose: Are you familiar with the Needlestick Safety Act, OSHA and sharps safety in general?

Susan Hislop: Yes

MediPurpose: How did you come to know about the Needlestick Safety Act and sharps safety? Does your facility have training courses regarding these topics? If so, what kind?

Susan Hislop: Our Stericycle rep has mentioned that we are to evaluate a sharp safety device annually.  We also worked for SCA in the past and they made sure this requirement was addressed. FSASCA conventions also mention the Safety Act. AAAHC also checks for Sharps Injury Log and verifies the compliance with Safety Act.

MediPurpose: Have you witnessed or personally experienced a sharps safety injury occurring in the OR? More specifically, what about a scalpel related injury?

Susan Hislop: Yes I have.

MediPurpose: Can you say more about what happened?

Susan Hislop: Orthopedic Surgeon was accidentally cut with scalpel during a case. Room was low lighting which was felt to have contributed to the incident.

MediPurpose: What kind of device was it?

Susan Hislop: Scalpel

MediPurpose: Was the device being used a sharps safety engineered device?

Susan Hislop: No

MediPurpose: Do you think that if a sharps safety device was used instead, it could have prevented the injury?

Susan Hislop: Yes, when used properly.

MediPurpose: What is the process at your facility when a sharps injury has occurred?

Susan Hislop: Wash the injury with soap and water. Workman’s comp forms for employees. Blood draws on patient and affected team member, follow up with Urgent Care, Risk Manager.

MediPurpose: Did experiencing the sharps injury affect the ability to work?

Susan Hislop: The surgeon was able to finish the day.

MediPurpose: What was the emotional/mental effect?

Susan Hislop: The surgeon did not display more than normal concern. Was not overly worried about the patient having communicable disease.

MediPurpose: Can you say more about what happened that led to this injury occurring?

Susan Hislop: Normally (this is a generalization) it is some variation of handoff of sharp instrument or lack of intention when passing instruments, accidentally poking when recapping needles. We now have hands free recapping needles and the pads.

MediPurpose: Before testing our Anzen Safety Scalpel, were you aware of the existence of safety scalpels?

Susan Hislop: Yes

MediPurpose: Can you tell us a bit more about the different kinds of safety scalpels you were aware of besides Anzen? What was your overall impression of these scalpels? What were the problems you had with these safety scalpels?

Susan Hislop: Previously evaluated Safety Scalpels were completely disposable – handle and  blade. Typically surgeons were not happy with the feel of the handles, complained about the blade sharpness.  I don’t feel they were serious about accepting the fact that this is needed. I think as time goes on, they will realize the importance of finding and helping engineer an acceptable product.

MediPurpose: What are the “best practices” that your facility uses in the OR to minimize sharps injuries? E.g. use of safety engineered devices, passing zone, etc.  

Susan Hislop: Safe Zone announced in Time Out, Safety Needles, Viscot Soffzone Syringe Tray for recapping needles.

MediPurpose: What has your facility done when it comes to evaluating safety scalpels?  

Susan Hislop: This trial with Anzen.

MediPurpose: How did you come to know of our Anzen Safety Scalpel?

Susan Hislop: ASCA Conference

MediPurpose: What was your process for evaluating our Anzen Safety Scalpel?

Susan Hislop: Staff encouraged surgeons to trial the blade. It was a 3-part process. First we did a simulated use study where surgeons and surgical techs familiarized themselves with the product using a simulated skin product to cut on. We also did a blind blade study where surgeons tried out blades from different suppliers and ranked them according to how sharp each blade was.  Once the company reviewed the results, we were given the winners to trial on actual patients

MediPurpose: Who were involved in evaluating the Anzen Safety Scalpel?

Susan Hislop: OR Staff and surgeons willing to test the product.

MediPurpose: What were the results from the first evaluation of our Anzen Safety Scalpel?

Susan Hislop: In July 2016, 5 surgical technologists completed simulated use evaluations of the Anzen Safety Scalpel. The feedback from the surgical technologists was favorable – they found it easy to use and safe. However, there were comments from the surgeons that tried the product that the blades were not sharp enough.

MediPurpose: What prompted you to give Anzen a second chance?

Susan Hislop: MediPurpose approached Emerald Coast again once there were sharper blades available and Emerald Coast was keen to try them again.

MediPurpose: What were the results from the second evaluation of our Anzen Safety Scalpel (with sharper blades)?

Susan Hislop: Between June – September 2018, 7 surgeons and 4 surgical technologists performed the second evaluation of the Anzen Safety Scalpel in an actual use setting.

All surgeons agreed that the Anzen Safety was easy to extend and retract without looking at the blade (score of 4.9 out of 5, where 5 is strongly agree, 1 is strongly disagree), and that the weight and balance of the Anzen Safety Scalpel was comparable to a traditional scalpel (score of 4.5 out of 5). Also, all surgeons strongly agreed that “the Blade remained firmly locked in the open (exposed) position when performing an incision.” (score of 5.0 out of 5)

In addition, the surgeons believed that the blade sharpness of the new blade was acceptable (score of 5 out of 5) and they would use the device in their facility (score of 4.6 out of 5).

All surgical technologists agreed that the Anzen Safety Scalpel Cartridge was easy to attach and detach from the handle (score of 4.8 out of 5) and that it was safer to pass the surgeons the Anzen Safety Scalpel with the blade retracted (score of 4.3 out of 5).

All the surgical technologists also stated that they would use the Anzen Safety Scalpel in their facility (score of 4.8 out of 5).

MediPurpose: What is your overall impression of our improved Anzen Safety Scalpel with sharper blades?

Susan Hislop: Positive feedback from staff and surgeons. Overall, I would say that if required to use a safety scalpel, they would be ok with this product.

MediPurpose: What do you think are the most important factors to get a facility to convert to safety scalpels?

Susan Hislop: Feel of the blade handle as far as weight and balance.

MediPurpose: What recommendations do you have for other facilities in evaluating safety scalpels?

Susan Hislop: Encourage participation with younger surgeons and educate the surgeons about the need to convert to some type of safety scalpel in the near future. It will likely be mandatory at some point.

The trial testing at Emerald Coast is a prime example of the MediPurpose commitment to improving sharps safety in operating rooms across the country. It’s through these critical insights, that MediPurpose continues to improve the engineering of the Anzen Safety Scalpel, giving it the highest standards for protection, while meeting the needs and expectations of surgeons.