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CIS Lesson Plans provide members with ongoing education in the complex and ever-changing area of surgical instrument care and handling. These lessons are designed for CIS technicians, but can be of value to any CRCST technician who works with surgical instrumentation.

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Each lesson plan graded online with a passing score of 70% or higher is worth two points (contact hour). You can use these points toward either your re-certification of CRCST (12 points) or CIS (6 points).

Mailed submissions to IAHCSMM will not be graded and will not be granted a point value (paper/pencil grading of the CIS Lesson Plans is not available through IAHCSMM or Purdue University; IAHCSMM accepts only online subscriptions of the CIS Lesson Plans)

Lesson Plan CIS 227
Surgical Instrument Maintenance Services
[Reprinted from Communiqué: September/October 2011]

Central Sterile Supply Department (CSSD) personnel must effectively maintain highvalue instruments to ensure they are safe to use in Operating Room suites. Modern instruments are increasingly complex, and this underscores the need for CSSD managers to understand the technical requirements of the instruments and equipment being purchased, and for their employees to evaluate instrumentation for possible damage and repair tagging. Doing so is critical to consistently attaining patient safety standards, infection control requirements, and optimal use of expensive instrumentation.

Instrument Maintenance Services

All CSSDs require some form of surgical instrument maintenance capability. The department’s processing volume, complexity of surgical procedures performed, and type of surgical scheduling system used (example: block scheduling on alternate days or everyday services) are critical factors in determining basic requirements.

Three instrument maintenance options may be considered: a within-facility program, a mobile repair and sharpening service, or a hybrid option which combines one of the former with individual service contracts for specific instrumentation. Note: Many expensive instruments, such as high definition cameras used in advanced minimally invasive surgery and power drills and shaver systems, must normally be serviced by the manufacturer. Use of any other service may void warranties and may preclude any future service on the instrument by the manufacturer. This is a special concern if your facility routinely upgrades instrumentation and depends on high trade-in values to reduce costs. Many manufacturers also do not sell parts to third parties, so outside repairs may be performed with second-hand parts or inferior quality substitutes. This is especially true for power, endoscopic and camera systems.

The department’s size, facility’s surgical mission, and the amount of instrument inventory impact the ability to cost-justify an in-house repair and sharpening capability. A hospital specializing in orthopedic, spine and total joint surgery is an example of a facility that would likely benefit from an in-house system such as repairs and sharpening at any time, and a reduced need to maintain costly extra instrumentation. It is not uncommon for a new or recently sharpened instrument to be severely damaged after the first use. The ability to provide immediate repair/service enhances the efficiency and patient safety goals that are a part of the CSSD’s service.

Three major factors should be considered in the decision to develop an in-house program: equipment costs including space with engineering and environmental requirements, the salary of a certified instrument technician to perform the repairs, and purchasing the inventory of parts needed for common repairs.

The average purchase cost of equipment for initial start-up may be between $25,000 – $30,000, plus related costs required to meet safety and environmental standards. Salary and benefits for a repair technician certified by a reputable instrument company may total between $80,000 – $120,000. The cost for parts and supplies may be the most expensive part of supporting an in-house repair and maintenance service, and depends on the complexity of the services performed. Medical grade parts are extremely expensive, and it is important that low-quality substitutes are not used.

While these costs are significant, planners must compare them to the costs for alternative services and recognize that inhouse repairs can be made more quickly. Also, in-house services may include container and case cart repair. A mobile repair service is the best option for many CSSDs because it is the most affordable, can be tailored to a specific facility’s needs, and can handle most basic repairs. The challenge: critical instrumentation can be damaged at anytime and long waits for repairs may not be an option, especially for specialty instruments.

The use of a hybrid option with either an in-house or a mobile repair service coupled with individual service contracts for necessary instrument vendors is almost standard in today’s high technology environment. Contracts and Statements of Work Since legal contracts are binding in public and private hospitals, they must be reviewed by the legal department and then be submitted through the contract office. The Contracting Officer represents the facility as its signee, and the CSSD manager should never sign a contract.

A Statement of Work (SOW) is an essential part of a service contract. It defines the work to be done by the vendor, and it explains expected outcomes. The purchaser must specify all qualifications needed for the service and state that the services provided must conform to applicable federal, state and local standards.

The SOW is the “who, what, when, how and where” of the service contract. All qualifications, certifications, ongoing training, bonding, and insurance requirements must be identified, as should the purchaser’s obligations that will allow the vendor to fulfill the contract. For example, there may be contractual requirements for the facility to provide power and water supply, and docking space at designated times if a mobile instrument repair service is used.

The purchaser must also provide a detailed list of items to be repaired. Any additional services, such as cart maintenance and periodic staff inservices on instrument care and handling, should also be included before the contract is signed because it may not be possible to add to the scope of work without contract modification.

Selecting an Instrument Sharpening/ Repair Service

When selecting a service company, ensure that the instrument technician has documented work experience, training by the instrument manufacturers and instrument vendors, required certifications for specific instruments, and safety records to conform to the services required.

Many CSSDs are computerized, and an eligible vendor should be familiar with your system and be able to track sharpening needs and maintenance requirements. Some systems enable the vendor to determine the sets to be serviced before arriving at the facility, and a CSS technician can pull the requested sets before the vendor arrives.

How flexible is the vendor in meeting the department’s needs? Does the vendor have the ability to vary scheduled days of service, or is he or she tied to a schedule that does not permit variance? If the latter, the vendor may be over-committed and not always be available to meet the facility’s needs. Does the vendor have agreements with major instrument companies to purchase parts and the ability to send out critical instrumentation when services are either not within the scope of work or require more expertise? Having agreements pre-established with the original manufacturers and included in the statement of work enhances customer service and quickens instrument repair times.

Regardless of the repair service method used, the contract must include a thorough statement of work. If the mobile service option is chosen, it should clearly outline the services to be performed on- and off-site, and what must be sent out to other vendors or manufacturers for repair. The vendor should be able to provide this information after assessing the facility’s instrument and equipment lists.

What type of warranty is provided for services rendered? Does the vendor carry insurance for the instrumentation to be repaired? Does the mobile van pass vehicle and safety codes for your state? Note: Any vehicle weighing over 10,000 pounds is subject to Department of Transportation (DOT) regulations. What types of equipment and/or chemicals are present in the van? If any chemicals are present, are they being transported according to the DOT regulations? Are chemical spill plans prepared? Is there a potential for exposure of the facility’s staff to such a spill?

The more thorough the statement of work, the fewer CSSD and vendor misunderstandings will be encountered.

Include Basic Services in SOWs

Instrument sharpening is one of the most critical services needed by CSSDs. A dull or over-sharpened instrument becomes a weapon, not a surgical instrument. The instrument technician must be able to sharpen instruments correctly and also recognize when one is no longer safe to use. A system to tag nonrepairable items and remove them from service pending replacement is vital.

Requirements for other basic instrument repairs should be included, such as checking instruments’ alignment and box hinges, demagnetization, staining or rusting (which may indicate a facility water quality problem), and replacement of tungsten inserts on needle holders.

Laparascopic instrument repair and insulation testing is a basic service. Although laparascopic instruments should be tested after each use by CSSD personnel, they should additionally be tested and examined under magnification during routine maintenance by the service technician as a quality assurance validation.

The service technician should be able to make a repair based on the type of surgical grade steel. The American Society for Testing and Materials International’s Standard Specification for Wrought Stainless Steels for Surgical Instruments provides the following types of steel that are of acceptable quality for surgical instrumentation: Austenitic, Martensitic, Precipitation hardening, and Ferritic stainless steels.1

Maintaining high quality surgical instrumentation is an expensive capital investment requiring the performance of routine, life-extending maintenance. In addition, the CIS technician should be able to recognize and notify CSSD staff about instruments constructed of low-grade steel. These may have slipped into surgical sets from floor or clinical sets which are typically singleuse or low grade instruments.

Maintenance and repair of surgical case carts may be included in SOWs if the Bio-Med department does not service them. Case carts cost approximately $1000 and, if they are nonfunctional due to lack of maintenance and minor repairs, this is inefficient and frustrating to the end users, especially if carts are in short supply.

Hard-to-turn cart wheels represent a serious threat to safety in the OR suite, especially if a cart inadvertently compromises the sterile field due to awkward movements that jar the surgical back table. Castor wheels come in different grades, and the less expensive ones require more maintenance as they degrade over time when processed through a cartwasher. Cart doors may become unhinged, and spot welding is needed to keep the cart in service.

The SOW can include basics such as quarterly lubrication of wheel castors and replacement of damaged castors. This will maximize equipment life and provide a safer work environment when there are space constraints in the OR suite. When developing the SOW check with the Bio-med department to determine if services such as repair of case carts and lubrication of wheel castors can be done in-house.

Instrument container repairs should be included in a contract. A dented pan, damaged gasket or filter retainer compromises the sterility maintenance function and potentially allows contamination of the surgery performed. A vendor capable of performing these basic, onthe- spot repairs provides a valuable service to improve patient safety and convenience for the facility.

Color-coding or etching for specialty instruments (more applicable to CSSDs without instrument tracking systems) may be included in the SOWs.

Quality Assurance (QA)/Process Improvement activities can also be included in the contract. For example, because sterilized sets must be opened for servicing, this is a prime time to assess the accuracy of count sheets, the proper placement of items (such as heavy sets on the bottom), the use of tip protectors, and other QA concerns. Also, basic sterility and residual tests can be done with products that are currently on the market.

The technician’s expertise and experience can also be utilized for staff development inservices on the care and handling of surgical instrumentation

Conclusion

The high cost of surgical instrumentation, coupled with the need to provide surgeons with properly maintained and sharpened instruments, is critical to providing safe and effective CSSD services to users and, ultimately, the patients. Assessing a facility’s needs for required maintenance and repair services depends on many factors, including processing volume, the need for immediate repair/sharpening, surgical scheduling and costs. Understanding requirements and basic contracting principles enables CSSD personnel to make sound business decisions that will impact the provision of consistent and quality services.

References

1. American Society for Testing. Standard Specification for Wrought Iron Stainless Steels for Surgical Instruments. Designation: F899-09. February, 2009.

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