"My experience in talking to O.R. directors around the country suggests to me that the periOperative team (RN’s, surgical technologists) is trying very hard (because it’s these individuals that are getting stuck or cut), but the ‘pushback’ from surgeons is incredible," said Brian Mach, vice president, sales & marketing, Sandel Medical Industries LLC. "I’ve never seen ‘pushback’ from surgeons on any product like safety scalpels – and I’ve been in the operating room arena for over 20 years."

At the heart of the issue is a natural resistance on the part of the surgeons to change techniques that they’ve grown accustomed to.

"Anytime you talk about using a safety device for any procedure – if you’re used to using a conventional device it may require a change in technique to use. And people are resistant to change," said Gina Pugliese, R.N., MS, vice president, Premier Safety Institute. "When you’ve perfected a technique – whether it’s a technique for inserting IV lines, making surgical incisions, or suturing – all of the features and performance characteristics of a safety device come into play… its weight, its length, its balance (where it’s weighted in the front and the back), the size, the sharpness, how complicated it is, how reliable the safety mechanism is, and whether the safety mechanism can be activated and un-activated."

Adding to the issue of physician preference in sharps safety is OSHA’s lack of authority over surgeons. "Getting surgeons to comply with the use of safety devices in the operating room is something that is always a challenge. Because the surgeons are not employees of the hospital, technically they’re not under OSHA," explained Pugliese. Employers can mandate their employees to use safety devices. But the caveat for hospitals is that, "technically, according to OSHA, if something in the environment of the worker puts them at risk, you’re responsible as an employer." And surgeons who don’t use the appropriate safety devices or who don’t practice safe sharps handling protocol are putting members of their surgical team at a risk, she added.

So how do you get surgeons to comply? "If you really want surgeons to accept and adopt safer products, you have to make them products that they want to use," said Steve Blinn, executive vice president, sales and marketing, SuturTek Incorporated.

"You want your surgeons to want to use the devices, and to accomplish that you will have to find devices that they like to use, and feel comfortable using," agreed Pugliese.

Manufacturers are answering the call for sharps safety devices that are similar to the devices that surgeons are used to using in hopes that more will adopt the technology.

"There have been recent advances in technology so that hospitals now have options for sharps safety products that have a similar ‘feel’ to the surgeon and this has prompted the O.R. to make a serious effort in evaluating these new technologies," said Craig Fernandes, marketing director, DeRoyal Products.

DeRoyal’s Reusable Metal CANICA safety Scalpel Handle was designed to help address the issue of physician preference in safety devices. According to the company, it is the only reusable metal safety handle that takes standard scalpel blades that are already in use at the hospitals and allows for them to be safely retracted into the handle for passing and then removed in a touchless fashion when changing blades, said Fernandes.

"DeRoyal has developed the CANICA Safety Handle to match the weight and feel of a standard scalpel, while allowing for similar performance because it takes the same standard blades that the O.R. currently stocks," said Fernandes.

"The key is to provide a product that the surgeons will use during the procedure – which means that it must be intuitive to activate the safety feature. If the safety feature is not activated then the device really does not add any real value," he added.

Sandel Medical offers a disposable safety scalpel with an OSHA-compliant protective safety shield that is weighted for the "feel" that surgeon’s demand. The safety shield locking and unlocking mechanism can be activated with the right or left hand. For an added safety bonus, the Sandel safety scalpel has a "Time Out" removable sleeve on every scalpel as a reminder to comply with JCAHO’s universal protocol.

"Time Out became a JCAHO requirement for every procedure on July 1, 2004, and I’ve heard that no more than 50% of the 27,000,000 procedures annually take a Time Out," said Mach.

Sandel promotes the scalpel in conjunction with its Z-Tray and Z-Instrument Drape for safe passing and placement of sharps during procedures. Noted Mach, "Sandel’s sharps handling safety products are orange in color. We are promoting ‘If it’s orange, it’s Sharp’. In other words, the facility can place all their sharps in our Orange passing tray, or Orange Instrument drape."

In addition to scalpels, suture needles are also a cause for concern, as they make up a good portion of needlestick injuries that occur in the O.R. According to the American College of Surgeons (ACS), the most common cause of suture needlestick injury is fascia closure, which accounts for 59 percent of all reported sharps injuries in the O.R.

Pugliese cites a study published in 1997 from the Centers for Disease Control and Prevention in which the use of blunt-tip suture needles was associated with a significant reduction in percutaneous injury rates, minimally clinically apparent adverse effects and general acceptance by surgeons in the three hospitals studied.2

Another advancement over the sharp suture needle, SuturTek Incorporated recently introduced its SuturTek 360º Fascia Closure Device at the American College of Surgeons Annual Congress last October. It uses a standard sharp fascia closure needle that is pre-loaded and contained within a sterile, disposable suture cartridge at all times, so that the sharp point is never exposed – from loading, to passing, to disposal.

"We’re not asking surgeons to change their surgical technique. They don’t have to change how they suture, the type of suture needle they use or the suture material that they use," said Blinn.

In addition to improved safety, the SuturTek fascia closure device is also faster and easier than hand suturing, plus it eliminates the risk of puncturing the patient’s viscera, Blinn contends.

"What we’ve done is automated suturing. Even if there wasn’t a safety issue as far as the dangers of being stuck with a suture needle, this is an excellent device for improving suturing," said Blinn. "We have a whole family of safe suturing products in development that are going to be introduced during the next few years."

A pre-publication paper by David N. Fisman M.D., MPH, Visiting Scholar Center for Health and Wellbeing, Woodrow Wilson School, Princeton University, shows a net cost-savings due to needlestick prevention associated with use of the SuturTek device.

Engaging physicians in the selection of sharps safety devices early on will be key to adoption. "You’re not going to get anybody to comply if they’re not involved in the process," said Pugliese. "You have to get the surgeon involved in the process of the selection." She recommends that hospitals "get a physician champion to assist, and try devices out. And also have enough different kinds of devices that they can choose from."

Fernandes agrees that providing surgeons with a variety of choices in safety devices will prove most successful. "Try all the devices in a particular category, regardless of the brand or size of the company that is producing them. Many times there is great technology in a little know brand that may be overlooked in favor of the larger, more well-known brands. Don’t make this mistake – try them all – and let the clinical evaluation and safety team be the litmus test on which ones are incorporated into practice."

Ultimately, surgeons can be persuaded to adopt new technology that provides greater benefits for both patients and staff.

"Surgeons don’t like to change, but they are willing to change for the right reasons," emphasized Blinn. HPN

References:

1. U.S. Department of Labor, Occupational Safety & Health Administration, Regulations (Standards - 29 CFR), Bloodborne pathogens. - 1910.1030. http://www.osha.gov/pls/
oshaweb/owadisp.show_document?p_table=STANDARDS&p_id=10051

For example, gastric bypass surgery performed with a surgical robot versus standard laparoscopy is more comfortable for the surgeon, helps to reduce hand tremor and fatigue, provides enhanced 3-D visualization, and allows for smaller incisions. For the patients, that means better results, less pain, and quicker recovery.

High-tech means
high-maintenance

While the benefits of robotic surgery are clear, maintaining the instruments requires high-tech thinking on the part of sterile processing professionals.

"We’re doing things through keyholes instead of making big incisions. So the instrumentation is now more complicated, and along with that, we really need a higher knowledge-base, if you will, for sterile processing," said Rose Seavey, R.N., MBA, CNOR, ACSP, director of the sterile processing department at The Children’s Hospital, Denver. She is also Immediate Past President, AORN of Denver, and Past President, ASHCSP, 2003.

According to Seavey, sterile processing professionals need to be trained ahead of time with specific cleaning, disinfecting, assembly and sterilization instructions, so that they are not surprised by any new instrument that presents for processing. In fact, she said, "SPD needs to be in the loop anytime that something new is ordered."

Education may begin with the manufacturer — and certainly most manufacturers will post cleaning and handling instructions on their web sites — but more formalized training should be used for ongoing education of new recruits and technology updates.

To help bridge the disconnect gap and improve communication regarding these expensive and delicate instruments, Seavey is an advocate for the "walk a mile in my shoes" theory.

"It would be helpful for the SPD workers to go up to the O.R. and see how the instruments are being used and actually witness procedures." At the same, O.R. workers should include a visit to the SPD in their orientation, so they can observe the processing of instruments, she said. Ultimately all will benefit with instruments that perform up to standard throughout their maximum life span.

Seavey and colleague Betsy Vane, Lieutenant Colonel, U.S. Army Nurse Corps., chief of perioperative nursing services at Landstuhl Regional Medical Center, Germany, discussed the processing challenges associated with robotic instruments during a presentation at the 2005 ASHCSP (American Society for Healthcare Central Service Professionals) conference. For some general guidelines for cleaning and sterilizing robotic instruments excerpted from the presentation see page 50.

Robotic Instruments – Processing Challenges for SPD
• Proper care and handling is essential for satisfactory performance
• Maintain best possible performance
• Challenges for SPD
› Instruments have limited uses.
• Communication must come from the O.R.
› Cleaning
› Sterilizing
› Case Scheduling

Cleaning Robotic Instruments
• Inspect before and after each use
› Broken, cracked, chipped or worn parts
• Cleaning starts immediately after each use (in the O.R.)
› Discard removable parts (single use blades, tips and hooks)
› Discard or tag end of use instruments
• Flush all ports with pressurized water
› While flushing, hold the tip down and move the wrist in full range of motion (x8)
› Continue until water is clear
› Repeat with enzymatic cleaning solution
• Immerse in enzymatic ultrasonic bath
› For at least 15 minutes
› Enzymatic solution <98F (37C)
• Manually scrub outside
› Soft nylon bristle brush
›While scrubbing, move the wrist in full range of motion (x8)
• Rinse
› All ports inside with pressurized water
› While flushing, hold the tip down and move the wrist in a full range of motion (x8)
› Rinse outside
• Lubricate with neutral pH
• Ensure instruments are dry before sterilization

Note: Do NOT "flash" sterilize any instrument or accessory!!!

Surgical Case Scheduling
• Back-to-back cases
› Turnover time – min 2.5 hrs. from time instruments reach SPD
• Labor intensive manual cleaning
• Min. 15 in ultrasonic
• No flashing
• Put in writing in "Case Scheduling" policy to minimize last minute concerns.

Editor’s Note: The opinions of this article do not reflect the opinion of the U.S. Army or the Department of Defense.

"Surgical Robotics: No longer science fiction", presented at the 2005 ASHCSP (American Society for Healthcare Central Service Professionals) Conference & Exhibition in Albuquerque, NM, Sept. 17-20, 2005, by Rose Seavey RN, MBA, CNOR, ACSP, Director - Sterile Processing Department, The Children’s Hospital, Denver, and Betsy Vane, LTC/AN, Chief, PONS, Landstuhl Regional Medical Center, Germany.