In hospitals, the mission of the central sterile services (CSSD) or sterile processing department (SPD) is to process instrumentation and equipment for patient care, so that it is ready and in perfect condition when needed by the caregiver. To be processed correctly, the instructions for use (IFU) for the device must be reviewed and followed closely. IFU are valuable resources. Medical device manufacturers, validation laboratories, and the U.S. Food and Drug Administration (FDA) all have different perspectives on IFU. This article focuses on how cleaning IFU affect an SPD. The intent is to make the other stakeholders aware of the diverse issues faced by sterile processing departments.
The processing of common medical devices such as the handheld instrumentation, patient care utensils, and rigid scopes is performed according to the device manufacturer's IFU, and recommended practices provided by Association for the Advancement of Medical Instrumentation (AAMI) and the Association of periOperative Registered Nurses (AORN).
For decades, these guidelines have been used in concert with central services technician training manuals, such as the ones published by the International Society of Healthcare Central Service Materiel Management (IAHC-SMM), to develop SPD departmental policies.
IFU are presented with new instruments when they are received in the SPD. Sterile processing staff maintain files of these IFU and refer to them in the daily processing of medical devices. During a SPD survey (which may be conducted by either the Joint Commission, or the Centers for Medicare & Medicaid), the surveyor may request to review the IFU for a medical device, and question staff to ensure that they are being followed.
IFU issues differ between general instrumentation (cleaned using a standard procedure) and complex instrumentation (more detailed cleaning IFU in addition to basic cleaning steps).
IFU issues differ between general instrumentation, cleaned using a standard procedure, and complex instrumentation, with more detailed cleaning IFU in addition to basic cleaning steps. Both of these types of instruments are discussed here.
Having clear and complete IFU for instrument sets and complex instrumentation—such as air-powered instruments, endoscopes, and instruments with lumens or channels, or instruments requiring extensive disassembly—is essential.
Cleaning errors often occur with complex instruments if the IFU are inadequate, confusing, or simply not available. If the necessary steps are not performed, debris can be left in the device, and/or the instrument may not perform according to its design capabilities.
Complex instrumentation can have numerous parts that require manipulation for cleaning, or requires disassembly—which can result in incorrect reassembly or even missing parts. Having detailed IFU, particularly including graphics describing the parts and steps to be taken, enables a sterile processing technician to properly process the device. Often, details are posted in the cleaning area of a sterile processing department for quick and easy reference. Information posted in a decontamination room should be laminated, to facilitate cleaning.
Comprehensive IFU for complex instrumentation include all information unique to the instrument, such as a brush size needed to clean a lumen, sequential order of disassembly and assembly, quality checks, special lubrication, water requirements, use-life, flushing, methods of drying, and any other special method necessary. While providing the necessary specific information is indispensable for complex instruments, too much specificity in conventional steps is arduous.
An example of unique essential information would be the size of brushes required to clean a lumened device. An IFU that merely states, “brush a lumen with an appropriate brush,” but does not provide specific brush size or type, leaves brush selection to chance. Should an incorrect brush be used, debris may remain in the lumen, or the lining of the lumen may be damaged.
Information on the disassembly and reassembly of instruments is also vital. Providing disassembly instructions makes it clear that the instrument can and should be disassembled for thorough cleaning. Some technicians will see debris in an instrument and then disassemble it without instructions, resulting in a broken instrument.
IFU on how to properly disassemble an instrument eliminate guesswork and reduce breakage. Reassembly instructions provide valuable information, such as how to include all necessary pieces, the correct assembly order, and quality checks to ensure the instrument will function as designed.
IFU on how to properly disassemble an instrument eliminate guesswork and reduce breakage.
Some IFU state a specific use-life for a device. While this may be helpful information for benchmarking, tracking the use-life of an instrument can sometimes be challenging for a sterile processing department, because of the volume of instrumentation processed, and the method of tracking. The design and material of some devices makes the identification difficult because they cannot be marked. Automated methods for tracking uses, for example, in DaVinci robotic arms, are more practical. IFU that include an inspection method to determine use-life may be more representative of real use, as some devices may falter before the stated use-life, while others may not have been used, but have gone through the cleaning process. Ideally, all pertinent information for a device to function as designed should be included in the IFU.
General Medical Devices And Instrumentation
Having a standardized process reduces errors, processing time, and expense, which is why manufacturers use standard processes in their operations. Healthcare sterile processing departments use standardized processes starting with the design of their facility, and implement policies and procedures based on “best practices,” in compliance with guidelines in ANSI/AAMI ST79, which applies to medical devices processed by a SPD.
A standardized process reduces errors, processing time, and expense.
While complex medical devices require additional instructions, basic processing protocol is still applied. Consensus documents based on science, expert opinion, and user input, such as ST79, provide guidance to healthcare personnel who process reusable instrumentation on how to set up a SPD and develop medical device processing procedures. These practices are also discussed in AAMI TIR12:2010, intended to assist medical device manufacturers in the design, testing, and labeling of devices manufactured for reuse and reprocessing in healthcare facilities.
The flow chart in Figure 1 shows a basic high level process flow of an SPD cleaning process, starting with the receipt of a case cart in the decontamination room. As can be seen, numerous steps are performed when processing instrumentation. A case cart may contain utensils, all types of instrumentation, power equipment, scopes, loaner sets, or any other type of medical devices that are used in the operating room.
IFU in Conflict with Recommended Practices
Often the IFU provided for devices conflict with recommended practices. As each manufacturer individually submits their device for clearance by the FDA with an IFU specific to their instrument, and as there is no industry consensus or FDA guidance for standardized cleaning instructions, the outcome is a wide variety of IFU for similar instruments.
For the instrument set in Figure 2, for example, several different processing recommendations—wash temperature, wash time, wash, sonic, rinse temperature, rinse time, lubrication, and washer-disinfector—are made in IFU from different manufacturers. Three processes are omitted from some of the IFU. For example, three do not include use of washer-disinfector, four do not include use of sonic cleaning, and seven do not include use of lubricant.
From the perspective of sterile processing personnel, standardized processes entail processing a set such as the one in Figure 2 all together—for minimal loss of instrumentation, increased productivity, and a decrease in turn-around time. In this scenario, disassembling an instrument set to follow each manufacturer's IFU is impractical and not cost-effective.
Table 1 shows a survey of 22 instrument manufacturers' cleaning instructions found in their IFU. The criteria for the sampling population were that the instrumentation had to be handheld, non-lumened, stainless steel, and that the manufacturer had wide range of instrumentation. The IFU were reviewed to determine how closely they matched ST79's basic instrument processing recommended practices.
Basic instrument processing includes the use of washer-disinfectors, sonic cleaners and instrument lubrication, which have been proven to be an effective means of cleaning medical instrumentation. These processes are critical to ensure the devices are thoroughly cleaned, safe to handle, and operational.
A major issue to be addressed when providing a range over specific values is that the FDA will require device manufactures to test the worst case value, and these are not likely to be the same for each device. In the case of soaking, for example, the worst case would be an instrument that has the greatest amount of soil, dried and denatured to the greatest degree, in the most extreme water temperature, and soaked for the shortest period of time.
Some IFU specify the precise water temperature and/or soak time, and may require specific cleaning chemistry. IFU for the same type of instrument can all differ in this area, and some have specific cleaning parameters which can be a practical challenge in an SPD that processes thousands of instruments daily.
For an SPD to follow such IFU exactly as written could take anywhere from one to 60 minutes for an instrument or set (including time to soak, flush, sonic, rinse, lubricate, and dry), placing constraints on personnel time, space, turn-around time and equipment.
There are many basic patterns of instruments that can come from numerous manufacturers, and specific recommendations differ between manufacturers. This means that sterile processing staff may need to process several similar devices in one instrument set using different times, temperatures and/or cleaning chemistries for each device according to specific IFU. Processing the instruments separately could result in dysfunctional work flow and even instrument loss.
One solution may be that cleaning solution dilution and temperature parameters be dictated by the detergent manufacturer, rather than the medical device manufacturer. When an instrument IFU specifies water temperature, it may be in direct conflict with the detergent manufacturer. It is also very difficult to maintain a specific water temperature during the entire cleaning and soaking process, and a temperature range may be more practical.
Manual soak and cleaning time is based on the debris on the instrument, instead of a specified wash or soak time. If the instrument has a lot of dried debris on it, it will take longer to process then an instrument that was not exposed to debris. The aim is to clean until there is no visible debris.
IFU that specify specific detergents can also be problematic. Numerous cleaning chemistries alter a standardized process, and can be affected by factors such as water quality and equipment. The SPD will need to select cleaning chemistries based on these factors, and may also lack storage facilities to store all types of cleaning chemistries that may be specified on IFU.
In addition, most healthcare organizations belong to buying groups or are under contracts requiring their SPD to purchase a certain type of detergent. The detergent specified on the IFU may not be on the contract.
Last but not least, instrument IFU that specify automatic wash cycles may also pose challenges to processing staff. There are several different types of automatic washers used in SPDs that come with preset instrument cleaning cycles.
While cycles can be added to most washers, automatic washer manufacturers engineer and test their washers to thoroughly clean instruments using preset cycles. In some cases using a specific cleaning chemistry is recommended by the washer manufacturer.
Washer-Disinfectors provide mechanical cleaning and thermal disinfection. Mechanical cleaning removes soil and microorganisms. The benefits of a mechanical washer are that the process is standardized, provides a thorough cleaning, and provides employee safety (no need for manual cleaning).
While cycle parameters vary between washer-disinfector manufacturers, they all generate clean, safe-to-handle devices, and labor time is greatly reduced. After cleaning, devices are thermally disinfected, preferably before handling, as they are usually then handled without gloves.
Ultrasonic cleaners are used to remove soil from joints, crevices, lumens, and other areas that are difficult to clean by other methods. Soil can become lodged inside of box locks, jaw tips, serrations, and screw areas. This equipment is critical to processing complex instrumentation where soil is difficult to remove with brushes and cleaning cloths.
Mechanical cleaners are of such high importance to the provision of clean instrumentation that it is essential that they undergo quality testing upon installation, preferably daily during routine use, and after major repairs, as stated in ANSI/AAMI ST79.
Lubrication helps maintain the integrity of surgical instruments and keeps them in good working order. Lubrication also prolongs instrument life and the action of the stainless steel scissors, prevents abrasion on blades moving against each other, and increases cutting action. Water-soluble instrument lubricants are specifically designed for compatibility with sterilization.
Having standardized IFU will alleviate the problem of multiple IFU for the same instrument pattern. Other problems with current IFU are that they may be incomplete, inadequate, or confusing. They may also be inconsistent with respect to recommendations on a specific water temperature, cleaning agent, soak time, or automated washer cycle.
In an effort to resolve these issues, AAMI is putting together a new technical information report (TIR) under working group AAMI ST/WG 12, to help standardize IFU for basic instrumentation, following recommendations from IAHCSMM textbooks, AORN, the Association for Professionals in Infection Control (APIC), AAMI, device manufacturers, independent consultants, and the FDA.
Standardized information will enable manufacturers to have their instruments validated to the same conditions as used in a SPD.
As most devices processed in a sterile processing department are basic hinged and nonhinged flat stainless steel instruments, this work group will first attempt to develop a document that standardizes IFU for these simple devices before moving on to complex instruments. In addition, recommending ranges for clean and safe instrumentation, rather than specific numbers may allow for more flexibility in reprocessing.
Having this type of standardized information will enable manufacturers to have their instruments validated to the same conditions as used in a SPD. As the instrument goes through the validation process, the processing parameters will already be set, and testing can be performed within recommended ranges.
Once the validation studies demonstrate cleanability within these ranges, the device can be submitted to the FDA for clearance. Manufacturers will know what is expected as the instrument goes through the FDA clearance process, thus speeding up the process and reducing cost. Once cleared for marketing, the standardized IFU can be used.
Standardization is clearly advantageous, but is a somewhat elusive goal. Until new documents are developed in the area of cleaning processes to ensure that medical devices perform according to design standards, SPD personnel will have to continue to manage multiple IFU and develop their own standardized procedures.
In addition, the SPD perspective is not the only one to consider. Other stakeholders such as the FDA, medical device manufacturers, and testing labs have their own points of view on IFU. In 2011, the FDA and AAMI hosted a summit that brought together all of the stakeholders in an effort to resolve reprocessing issues.
IFU are clearly a vital part of the cleaning process in a healthcare SPD, providing critical information required to process medical devices for safe and effective patient care use, a goal we all share.
About the Author
Susan Klacik is the central sterile services manager at St. Elizabeth Health Center in Youngstown, OH. E-mail: firstname.lastname@example.org