Putting Patient Safety First: The Sterile Processing Department and Healthcare Technology Management

Abstract

Patient care equipment, used throughout healthcare facilities, is a category of essential medical devices. Examples of such equipment include infusion pumps for intravenous administration of medications, feeding pumps for delivery of nutrition, hypothermia and hyperthermia machines for cooling or warming of patients, patient-controlled analgesia (PCA) pumps for administration of pain medication, suction machines (continuous or intermittent), continuous passive motion (CPM) machines for movement of joints, and sequential compression devices (SCDs) for prevention of blood clot formation.The sterile processing department (SPD) is generally responsible for the cleaning, disinfection, reassembly, and/or sterilization of patient care equipment, and reusable surgical instruments/devices, and possibly their storage and distribution. In ambulatory care facilities, these duties may fall to the processing technician.This equipment can also be dedicated to a specific nursing unit, to be cleaned and disinfected within that unit. Equipment collection and distribution vary significantly between facilities. For example, used equipment can be collected by the sterile processing or nursing staff, delivered by nursing units to the SPD, and distributed by the SPD, a general dispatch department or materials management department.Regardless of which department is responsible for specific duties, good processing procedures (including inspection of defects) must be developed and adhered to, and there must also be collaboration with the healthcare technology management (HTM, also known as clinical engineering or biomedical) department.Incorrect cleaning, disinfection, testing, or storage of equipment can have dire consequences for patients. This article focuses on best practices for patient care equipment, and how to establish and maintain a collaborative relationship with the HTM to ensure patient safety.The HTM department is responsible for ensuring that patient care equipment is safe and in good working order. The department works closely with the SPD to ensure safe and timely management of the process. There are several opportunities for the SPD to refer patient care equipment to the HTM department:Recently, The Joint Commission recommended that all flexible and rigid endoscopes be under the purview of HTM departments.1 To effect this, it is essential that healthcare technology management and sterile processing departments work together to track and document all rigid scopes (e.g., laparoscopes and arthroscopes), and flexible endoscopes (such as colonoscopes and gastroscopes). The SPD may also assist HTM engineers with the identification of semirigid scopes, and possibly gastrointestinal endoscopes.All reusable patient care equipment must be properly cleaned and disinfected after its use, when it can become contaminated with body tissue. This can present a challenge to personnel managing this process, or designated staff in other areas when not enough equipment is available. Fleet size of equipment should be based on patient volume and the length of the process should never be shortened. Minimum turnaround time should be identified and communicated to user departments.If the equipment is to be returned to the SPD's decontamination area for processing, it should be contained, if possible, during transport (e.g., placed in a covered cart or enclosed in a plastic bag or covered tote bin). All used patient care equipment is considered contaminated and/or soiled, and should be clearly identified as contaminated, and separately staged (for example, with designated marked areas for pick up), to distinguish it from clean equipment. Personnel who collect or process such equipment should observe standard precautions and wear personal protective equipment (PPE) for protection against blood and body fluids.In 1972, Dr. Earle H. Spaulding developed a classification system for reprocessing contaminated medical devices that was later adopted by the Centers for Disease Control.2 The system classifies devices as critical, semicritical, or noncritical based on the risk to a patient of contamination from a device.Patient care equipment is considered noncritical according to the Spaulding classification, and cleaning followed by low-or intermediate-level disinfection is therefore recommended. According to the Centers for Disease Control (CDC) “intact skin acts as an effective barrier to most microorganisms; therefore, the sterility of items coming in contact with intact skin is ‘not critical.'” Virtually no risk has been documented for the transmission of infectious agents to patients through noncritical items “when they are used as noncritical items and do not contact nonintact skin and/or mucous membranes (CDC, 2008).”3The CDC also states that “noncritical environmental surfaces include bed rails, some food utensils, bedside tables, patient furniture, and floors. Noncritical environmental surfaces frequently touched by hand (such as bedside tables and bed rails) potentially could contribute to secondary transmission by contaminating hands of healthcare workers, or by contacting medical equipment that subsequently contacts patients.”3It is important to note that cleaned and processed equipment can be cross-contaminated.4 The CDC also notes that “reusable cleaning cloths are regularly used to achieve low-level disinfection on environmental surfaces. However, they often are not adequately cleaned and disinfected. Single-use disposable towels impregnated with a disinfectant also can be used for low-level disinfection when spot-cleaning of noncritical surfaces is needed.”3Policies and procedures for disassembly, cleaning, disinfection, and reassembly of medical instruments and devices should be based on the equipment manufacturer's written instructions. In-hospital services for all equipment procedures should be provided to SPD personnel, or those who are responsible, and personnel competency should be verified regularly.For effective disinfection, equipment should be cleaned before it is disinfected. Multipart equipment should be disassembled. During the disassembly and cleaning process, personnel should wear appropriate PPE. The equipment manufacturer might recommend special detergents or other chemical agents to ensure adequate cleaning, and to prevent damage that can occur if a cleaning agent is incompatible with the materials used to fabricate the equipment. The equipment manufacturer's processing instructions and the detergent manufacturer's instructions for concentration and other aspects of use should always be followed.Personnel responsible for cleaning and disinfection must follow all Environmental Protection Agency (EPA) label instructions for EPA-registered disinfectants, including use dilution, shelf life, storage, material compatibility, safe use, and disposal. Exposure/contact times for the disinfectant to remain wet on the surface of the device should never differ from the time recommended on the disinfectant label, or the facility will have to assume liability for any injuries resulting from failure to use the chemical in accordance with the label instructions. The facility can also face enforcement action under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).In addition to the disinfectant manufacturer's instructions for the correct dilution, contact time, and contact temperature, the manufacturer's instructions for the recommended quality of water to be used for dilution (if dilution is required) must be followed, as water purity is an important factor.All instructions should be read carefully. For example, how long does the disinfectant have to remain wet on the equipment for disinfection to be achieved? Before disinfection, is it necessary to rinse off the detergent used for cleaning? Will the detergent affect the disinfection process?It is important to understand that simply “wiping off” equipment might not be sufficient to render it safe for the next use. Reading labels cannot be stressed enough. The manufacturers of most disinfectant wipes on the market recommend pre-cleaning the device before using the wipes.In addition, not all disinfectants can be used on all materials, so it is important to follow the equipment manufacturer's instructions for disinfection. It should never be assumed that a disinfectant used for other purposes in SPD, or on a nursing unit can be used to disinfect patient care equipment. Some disinfectants can damage the materials in the equipment.It is important to check the date of the equipment's last preventive maintenance or incoming equipment inspection (depending on category and risk class) on the medical equipment tag or label. If the equipment is due or overdue for its manufacturer's recommended preventive maintenance inspection, it must be sent to the HTM department. Such inspections help promote safe and reliable operation of the medical equipment. Equipment critical to patient care (defined as critical if its failure may harm the patient, user or visitor) should be inspected on a continual basis to ensure optimal and safe operation.If left unchecked such equipment could be a patient safety concern. Defects or malfunctions must be reported to a supervisor and/or the HTM department, and the equipment taken out of service until it is repaired. After cleaning and disinfection according to written procedures, such equipment should be referred to the HTM department for repair. Equipment should never be sent to there unless it has been cleaned and disinfected first.The FDA's 1996 Medical Device Reporting (MDR) regulation5 requires healthcare facilities to report device-related patient deaths to the FDA and the manufacturer, and serious device-related injuries to the manufacturer. There should be a written procedure on handling patient care equipment involved in a patient incident that addresses special handling required for the equipment, the reporting chain, and the necessary documentation. However, facilities should have a Safe Medical Device Act Committee (SMDA) institutional policy.The purpose and function of the committee and policy is to manage the process, which includes reporting to the FDA and the Medical Product Safety Network (MEDSUN) on all events involving patient care devices, equipment hazards, and so on. A 1999 Institute of Medicine (IOM) report on patient safety6 indicates that reporting only serious injury and death is insufficient in such cases, because it is reactive, and the harm has already occurred. If there is a process in place to identify and report close calls, the facility may minimize harm by having risk-mitigating strategies in place, such as reporting and tracking technology-related issues, and having an SMDA committee for an ongoing review of complaints.There should be a process in place to ensure the quality of patient care equipment processing by initial audit and ongoing monitoring. For safe and effective patient care, the correct functioning of all equipment owned, leased, or rented by the facility should be ensured. This can be achieved by instituting routine inspection policy and procedure.All equipment critical to patient care should be included in a preventive maintenance program, carried out by qualified personnel, in accordance with the manufacturer's recommendations, risk levels, and past documented experience with the equipment. Preventive maintenance records should be retained by the SPD, the HTM department or repair service, according to the facility's medical equipment management plan. The quality and safety of patient care are directly linked to the availability of patient care equipment.All patient care equipment should be properly stored, available, and distributed in a timely manner in order to meet patients' needs. Procedures should be in place to ensure that an adequate supply of equipment is available at all times, and backup mechanisms (such as rental procedures) should be in place to meet unanticipated demand. During periods of high use, frequent collection of used equipment might be necessary. Equipment should also be organized in such a way as to facilitate accurate selection, careful handling, and timely availability. Recalled equipment should be removed from service immediately.After patient care equipment has been cleaned and disinfected, it should be identified in some manner, to allow personnel to verify that it has been processed. Methods of identification include placement in a clear plastic bag (an ideal method because the bag protects the equipment from dust and soil) and/or equipment tags stating that the equipment has been cleaned and disinfected. SPD policy on patient care equipment should specify which method is to be used, and nursing personnel should be advised of that method.A catalog of all patient care equipment should be available in all departments. At least one copy of the user manual for each type should be available in the SPD for reference. Ideally, equipment control mechanisms should be established to identify each piece of equipment. The following information can be included:Each use of the equipment should be documented, including information on patient, department, date dispensed, and date returned. In addition, all maintenance and repairs of patient care equipment should be documented and records maintained on file. To ensure equipment use is correctly billed, the facility's patient charge procedures should be followed. In the event of an equipment safety problem, the facility's procedure for reporting medical device problems should be followed.7Patient care equipment is an essential part of patient treatment, and SPD personnel play an important role in the processing and availability of such equipment. Adherence to good equipment processing policies and procedures—as well as the equipment manufacturer's instructions—and collaboration with the HTM department, will all help ensure safe and effective patient care.