Author: David Jagrosse CRCST CHL
- Understand the importance of proper inspection, cleaning and maintenance of insulated instruments
- Review the new AAMI guidelines: Amendments A1:2020, A2:2020, A3:2020, A4:2020
- Learn how to implement a robust inspection program to include using insulation testers and an instrument tracking software at your facility
The inspection of insulated instruments is one of the most crucial yet sadly often overlooked processes within the sterile processing department. I have witnessed noncompliance of inspection during my career in SPD both within the hospital and also recently as a fulltime SPD consultant performing assessments throughout the country.
Many times, it is due to a simple lack of awareness of how dangerous these medical devices can be when they are damaged. Other times there are robust policies in place, and it is overlooked or forgotten for a myriad of reasons. This is unacceptable, as we are all on the front line for patient safety. It is of critical importance that these devices are inspected every time they are processed. Until recently, there has been a lack of guidance within current standards and the manufacturers’ instructions for use on these devices indicating they should be inspected every time they are processed. This has changed since AORN and AAMI have updated the standards to reflect that these devices should be inspected before each use.
What can go wrong? There can be serious patient safety implications if this task is not performed. Here are some statistics:
According to business wire “nearly 15 million laparoscopic procedures are performed every year, globally and the U.S. alone contributes to 32% of the number, i.e. around 4,800,000 procedures. Since the advent of laparoscopy in the 1990s, the technique has been used to perform 1.2 million cholecystectomies.”
There is also some limited data on deaths and injuries. For example:
“In a 2014 review of the FDA’s manufacturer and user facility device experience (MAUDE) database, reported surgical Energy base device injuries index were reviewed from January 1994 to December 2013.” (Overbey et al 2015) Among these reports, 178 deaths and 3553 injuries were attributed to electrosurgical complications. Of these 324 injuries in 14 patient deaths were attributed to installation failure.
From a technical standpoint “what goes wrong” is that the high energy that is used in these laparoscopic devices is targeted to be used at the distal end where the doctor is working and can actually see it.
In operations these electrosurgical devices are used for:
- Ablating (removal)
- Modifying a target tissue to be treated
High energy in the form of electricity at the frequency ranges can cause:
60Hz Cardiac Arrest
100,000Hz No longer stimulates the muscles
3,300,000Hz RF range (used in ESU); Can cut and coagulate tissue/skin
Clearly, we would not want this energy directed to an area of the patient’s body where it is not intended. The following picture shows a simplified illustration of the surgeon’s field of view while using a typical insulated instrument. If there is a defect anywhere on the instrument the patient can be harmed by worse the surgeon will not even know about it if it occurs in the “yellow” area illustrated in the image below. This is why many of these injuries and deaths are often under reported or misdiagnosed until it is too late.
About 95% of the active electrode is outside of the surgeon’s visibility as shown on this laparoscopic instrument.
Yellow is OUTSIDE the surgeon’s field of view. Green is IN the surgeon’s field of view.
AAMI Standards update late 2020:
Recently AAMI (Association for the Advancement of Medical Instrumentation) published updated to the ANSI/AAMI ST79 comprehensive guide to steam sterilization and sterility assurance in health care facilities. These were released as Amendments A1:2020, A2:2020, A3:2020, A4:2020.
We will specifically look at A.2: Amendment for Inspection of Insulated Instruments.
This new amendment adds two new subsections, 8.2 and 8.2.1. For a quick overview, it now includes more definitive recommendations for the inspection of insulated instruments during processing. This includes assessing the cleanliness and integrity of the device using enhanced inspection tools, such as lighted magnification and borescopes. Electrosurgical devices needing additional testing are identified as well as appropriate inspections steps, including testing for electrical integrity, insulation integrity, and other physical damage. It is important to note that cords should be included when inspecting a device that includes one.
Section 8.2 Inspection of Instruments.
This section speaks about inspecting medical devices for cleanliness and integrity every time one is processed. This is a key statement because it identifies that even if a device is not used during a procedure, the simple act of reprocessing can cause damage. Therefore, devices must be checked each time they are processed regardless of if they were used in a procedure. The standard outlines that enhanced inspection with magnification, borescopes, or other inspection methods may be used to verify cleanliness and integrity.
Borescopes are devices that allow technicians to be on the same par of magnification as the doctor in the operating room. They are very slender and can fit down narrow channels. In the standard, it mentions using borescopes or other methods to check the internal channels of instrumentation for cleanliness and integrity unless otherwise recommended in the instrument’s written IFU. If enhanced visualization is recommended in the instruments IFU, the IFU for both the instrument and for the enhanced visualization tool should be followed.
The standard also states that “Health care facilities should have a method of ensuring the cleanliness and integrity of every instrument and medical device used in every procedure. Upon inspection, medical devices with retained soil or residue should be subjected to repeated cleaning and decontamination processes until the device is completely clean. Damaged instructions should be removed from service; damage is addressed according to organizational policy and procedure (e.g., evaluation, repair).”
Another point to consider is how and who is responsible for repairing instruments that fail the inspection. Each facility should determine if they are going to use the original equipment manufacturer (OEM) for repair or a third party. Consideration should be given as to what quality repair a third party can perform. Do they use the same insulation materials, and does it meet the same specifications? Is it warrantied?
Section 8.2 goes on to say
“Altering instruments from their original state can cause fractures or surface damage and can affect the device’s ability to perform as intended. When an instrument is purchased, all inspection equipment should be present and available prior to first use of equipment.”
For each standard there are rationales that explain the why behind the recommendation. The rationale typically provides a deeper explanation as to what the purpose of the guidance is.
“Rationale. Proper inspection prevents instruments with bioburden, foreign material, or damage from going unnoticed and being distributed. Inadequately cleaned instruments can interfere with the sterilization process. Damaged instruments or incomplete instrument sets/trays may cause a delay or cancellation of a surgical procedure and/or increase risk of patient harm related to instrument malfunction.”
The next section of the amendment 8.2.1 Inspection of Instruments Intended to be Used with Electric Current states:
“Damage to insulated instruments including cords can occur during normal use, processing, contact with sharp instruments, and high voltage. Instruments should be organized and protected from damage. Repeated use/processing of these instruments and cords can cause damage to the insulation.”
This speaks to how trays are organized but it’s not just for sterilization. Consideration has to be given for what happens during transport and processing. This is where damage can occur also.
Steps are given and should be adopted into our processes.
“The following steps should be taken:
a) Instrumentation intended for use with electric current should be tested for integrity each time it is processed in accordance with the instrument manufacturer’s written IFUs for inspection. NOTE; Any damage to the coating can compromise the safety of the device.
b) Unless otherwise directed, the insulation should first be inspected using lighted magnification.
c) Insulation material should be free of defects as defined by the manufacturer’s written IFU.
d) Insulation testing should be performed following instrument manufacturers’ instructions for use. Testing devices should be used following the testing device manufacturer’s IFU.
e) The insulation should be checked at appropriate inspection points for the instrument.
f) Cables/cords are also a source of concern and need to be inspected and checked for integrity and continuity. When indicated, testing devices should be used following testing device manufacturer’s IFU.
g) When damage is noted, the device should be removed from service following facility policy and procedure.”
These are very specific and clear steps and as always with anything we do the manufacturers IFU should be reviewed and incorporated into your policy/procedure.
An important part of the amendment is that it shows typical examples of damage that occurs and should be detected when inspection occurs. It speaks to having documented education and training and competencies in this area which is crucial. It also identifies insulation testers that can be used, stating:
“Insulation testing methods vary with insulation tester type. Each insulation tested may be supplied with a variety of accessories to test specific instrumentation and cables/cords based on their design and may require additional training and in-services. Refer to the instrument and insulation tester manufacturers’ written IFUs for their recommended procedures. Tabletop and handheld are available. Each is designed to detect small current leaks that can place the patient at risk for significant harm. Any time instrument insulation does not pass inspection, the device should be removed from service; damage should be addressed according to organizational policy and procedure (e.g., evaluation, repair, replacement). If any of these conditions occur, it shows that the instrument has been compromised and should be taken out of service.”
It is really important to understand the why behind best practice.
“Rationale: Insulated electrical current instruments are susceptible to physical and mechanical damage and degradation related to repeat use. Defects in insulation are not always visually detectable; some are only detectable through use of insulation and continuity testing devices. The use of malfunctioning insulated instrumentation places the patient at risk for significant harm (burns) from electrical current escape. Electrical current escape can go undetected during the surgical procedure if they occur outside the view of the surgical team, which is often the case. Smaller defects are particularly problematic because they can concentrate the escaped energy and cause more serious tissue injury.”
Let’s close with discussing implementing a robust inspection program to include using insulation testers. Make sure insulation testers are UL listed and safe. If they are portable that’s even better as they can be “passed” around table to table. I have noticed in my experiences when there is an “inspection table” or area set up that the technician has to walk over to perform the tasks there is a less likely chance of it occurring. Have them on workstations ready to go and charged. If the unit has a battery check with the manufacturer as to what happens when the batter is at or near the end of its charge. Will it still detect damage and beep?
Setting Up the Process and Start Date:
Once documented education and training is complete and the testers are in place you should choose your start date wisely. If using an electronic tracking system, it is a good idea to identify for technicians the instruments that need to be tested. Depending on the software, an assembly instruction can be added to the container or the actual instrument. Adding an instruction to the actual instrument such as “this instrument requires insulation testing” is best, because it identifies the instrument leaving no doubt. The technician acknowledges the alert during the assembly process providing documentation and accountability.
Block Times on the Schedule:
If your block schedule days for lap/gyn are Mondays that’s probably not a great day to start. It is quite possible that when you first start testing your insulated instruments, many may fail. You need to be prepared for this and have back up instruments available and your repair vendor mobilized. Meet with your vendors and find out how long a repair will take and what instruments you should have on hand. You do not want to start this important patient safety procedure and end up with incomplete sets which can cause delays and other issues. It is also a good idea to test all your back up instruments and peel pouched instruments first. The peel pouched instruments can then be part of your back up strategy as you start testing the sets. If your tracking software permits, marking your laparoscopic instrument allows for tracking each patient use, each test, and its repair history.
Be prepared and plan. We owe it to our patients, to ourselves and our families. When this is implemented properly and in place you can rest assured that you have done your part to keep our patients safe.