Skip Navigation

Applicability of Healthcare Failure Mode and Effects Analysis to Healthcare Epidemiology: Evaluation of the Sterilization and Use of Surgical Instruments

  1. Robert A. Weinstein, Section Editor,
  2. Darren R. Linkin1,2,3,6,
  3. Caroline Sausman6,
  4. Lilly Santos6,
  5. Clarence Lyons6,
  6. Catherine Fox6,
  7. Linda Aumiller6,
  8. John Esterhai4,6,
  9. Beverly Pittman6, and
  10. Ebbing Lautenbach1,2,3,5
  1. 1Division of Infectious Diseases, Department of Medicine, Philadelphia, Pennsylvania
  2. 2Center for Clinical Epidemiology and Biostatistics, Philadelphia, Pennsylvania
  3. 3Center for Education and Research on Therapeutics, Philadelphia, Pennsylvania
  4. 4Department of Orthopedics, University of Pennsylvania, Philadelphia, Pennsylvania
  5. 5Department of Biostatistics and Epidemiology, University of Pennsylvania, Philadelphia, Pennsylvania
  6. 6Veterans Administration Medical Center, Philadelphia, Pennsylvania
  1. Reprints or correspondence: Dr. Darren R. Linkin, 114 Blockley Hall, 423 Guardian Dr., Philadelphia, PA 19104 (linkin{at}mail.med.upenn.edu).

  1. Presented in part: 15th annual meeting of the Society for Healthcare Epidemiology of America, Los Angeles, California (abstract 85).

Adverse events in complex systems, such as health care delivery, are typically the result of multiple inherent errors (latent errors) in the system that predispose individuals in the system to, in turn, commit errors (acute errors) leading to adverse events [1, 2]. For example, lack of readily available hand hygiene alcohol rub dispensers or hand washing sinks near patient rooms (a latent error) may lead to inadequate hand hygiene by hospital staff (acute errors). Healthcare Failure Mode and Effects Analysis (HFMEA) is a qualitative methodology for detecting and correcting such latent system errors in the health care setting before they lead to adverse events.

The HFMEA methodology is an adaptation of the Failure Mode and Effects Analysis (FMEA) process for the health care setting by the Veterans Administration National Center for Patient Safety [3]. The HFMEA materials are set in the medical context. For instance, the severity grades of adverse outcomes refer to injuries to patients, staff, and visitors and damage to the facility (e.g., “most severe” includes patient death or permanent loss of function). In contrast to HFMEA and FMEA, root cause analysis (RCA) or standard quantitative methods (e.g., case-control study) may be used to investigate adverse events that have already occurred, although the latter may be problematic if there are a limited number of outcome events.

HFMEA may be useful in prospectively evaluating the instrument sterilization process. Invasive procedures performed with insufficiently sterilized instruments have the potential to transmit infection with such pathogens as HIV and hepatitis B virus. The cleaning, sterilization, testing, and subsequent inspection and use of sterile surgical instruments comprise a complex process. Complete killing of spores in an enclosed tube—a “biological indicator”—is used to test the completeness of sterilization. However, it is not standard to quarantine nonimplantable surgical instruments until a final, negative biological indicator reading is obtained at 48 h after sterilization [4, 5]. It is thus possible for a reading to have a positive result after the associated surgical instruments are used. Other immediately available tests of sterilization (e.g., visual color-change indicators) are also used. Alternatively, the results of a reading of biological indicators may be falsely negative. These scenarios have the potential to lead to the transmission of infection or to cause psychological harm to patients who are recalled for the evaluation of such a potential transmission. In addition, the discovery of sterilization problems—especially as the time of surgery approaches—may lead to the delay of surgery as the questionable instruments are resterilized or replaced. This delay may cause the patient to experience adverse events if anesthesia is induced before the case is aborted or if the underlying illness progresses during the delay. Finally, the process of investigating a positive reading of biological indicators, including calling patients back for testing, requires significant expenditure of hospital staff time. Although there are other real-time means to double-check for sterilization adequacy (e.g., automated temperature, pressure, and time of sterilization monitoring by sterilizer machine and color change of paper indicators), biological monitoring is the accepted gold standard of sterilization completeness.

Hospital epidemiologists are familiar with the use of quantitative investigative techniques (i.e., using surveillance with benchmarking, then investigating with retrospective cohort or case-control studies). However, qualitative techniques, such as FMEA, are also useful and may be complementary [6]. Infection control is increasingly recognized as a critical component of patient safety [7, 8]. However, there are no healthcare epidemiology FMEAs in the medical literature to demonstrate the utility of this technique and to provide further guidance for its use in this field. With use of the HFMEA methodology, we undertook an investigation of the system of surgical instrument sterilization and use at our institution, primarily in response to the occurrence of positive biological indicators.

 
Next Section

Methods

The standard HFMEA methodology from the Veterans Association National Center for Patient Safety was used and is briefly summarized here [3, 9]. Of note, the spreadsheets, scoring instructions, and algorithms used in our HFMEA are all publicly available on the internet [3]. First, the topic and processes to be examined were defined. A multidisciplinary team that included methodological advisors was then assembled. Next, the process of surgical instrument sterilization was described in a flow diagram. The diagram included the process of sterilization as well as the testing and inspection of the sterilization process and instruments. A hazard analysis then iterated potential “failure modes” (i.e., ways that a process step can fail) for each step in the flow diagram, iterated causes for each failure mode that met preset criteria for the probability of the failure mode occurring and the severity of its consequences for patients, and similarly scored the failure mode causes. Finally, for each failure mode cause meeting preset criteria (defined in the referenced HFMEA instructions [3]), we determined actions to be taken to eliminate or control the failure mode cause, outcome measures to evaluate the actions, and the responsible person(s) for each action and outcome measure. Information gathering from other sources—interviews with subject matter experts and reviews of source documents or literature—were performed as needed. The results of the HFMEA analysis were then presented to the executive administrative group of our hospital (Veterans Administration Medical Center, Philadelphia, PA).

We calculated the number of person-hours spent on the HFMEA by multiplying the total number of hours the team met by the number of team members and then adding a conservative estimate of the unscheduled time spent outside of meetings. The institutional review board of the Veterans Administration Medical Center approved the study.

Previous SectionNext Section

Results

The specific topic of the HFMEA was determined through conversations between the Department of Infection Control, the Department of Surgery, and our hospital's Quality Management group. The executive hospital administrative group then formally commissioned the HFMEA to be performed. The hospital epidemiologist directed the HFMEA team. The team was also composed of 2 methodological experts from the Quality Management group; 2 infection-control practitioners; the chief of the Supply, Processing, and Distribution Division (SPD), which is the area where instrument sterilization is performed; a surgeon; and the operating room nursing supervisor.

During the course of the HFMEA, the team gathered information from interviews, meetings, and published materials. The HFMEA director conducted interviews with technical experts from the manufacturer of the biological indicators and the associated incubators (by telephone), the relevant national administrative leaders within the Veterans Health Administration (by telephone; to clarify areas of uncertainty in interpreting the Veterens Health Administration sterilization guidelines), and the surgery leadership at our institution (in person). A member of the surgery leadership also attended a meeting for further discussions with the HFMEA team. Reviewed materials included the manufacturer package insert for the biological monitors, the Centers for Disease Control and Prevention dental infection control recommendations (which address the monitoring of instrument sterilization) [5], the Veterans Health Administration guideline addressing instrument sterilization procedures [4], a healthcare epidemiology textbook [10], and other guidelines [11–13]. Information gathering occurred throughout the study period as areas of uncertainty arose.

The HFMEA director created a preliminary flow diagram after initial discussions by the HFMEA team. The team then expanded and edited the diagram into its final form using their knowledge of the various facets of the process. Given its complexity and length, the original flow diagram was divided into 5 foci. To limit the HFMEA to a more manageable scope, the team chose 3 of the 5 foci for the current investigation that, a priori, were thought to have the system errors most in need of correction. The current HFMEA addressed the following 3 foci: “Sterilization Process,” which included the logging of instruments (i.e., recording on a form what instruments were put into each tray) through the actual sterilization run; “Reading of Biologicals,” which included the procedure for performing both device-assisted and visual interpretations of the biological indicators; and “Use of Equipment,” which included tracking the surgical instruments to the operating room area and through their use with patients and return for reprocessing (figures 1 and 2). The 2 foci (of the original 5 foci) that were deferred involved, first, the delivery of instruments to SPD for cleaning and, second, the initial cleaning and sorting of instruments before sterilization.

Figure 1
View larger version:
Figure 1

Summary flowchart of subprocesses involved in the sterilization and use of surgical instruments

Figure 2
View larger version:
Figure 2

Detailed flowchart of subprocesses involved in the sterilization and use of surgical instruments.

The hazard analysis was then performed (figure 3). Although the overall process is the same, the precise algorithm used for scoring and determining what score necessitates action may differ among FMEA methodologies. Thirty-one failure modes were iterated during the hazard analysis for the 17 subprocesses listed in figure 1. Seventeen of these failure modes met criteria to continue with the hazard analysis, which led to the iteration of 39 potential causes of the failure modes. Twenty-eight of the potential causes met criteria for action to be taken. The following are selected, abridged examples from the hazard analysis.

Figure 3
View larger version:
Figure 3

The Healthcare Failure Mode and Effects Analysis (HFMEA) hazard analysis of the sterilization and use of surgical instruments. The first panel of the HFMEA hazard analysis is shown in the print edition.

False-negative visual biological indicator readings (failure mode) as a result of incorrect reading (cause) can be prevented by a double-check of final readings by supervisor (action).

False-positive rapid (florescence) biological indicator reading (failure mode) as a result of contamination via handling (cause) can be prevented by conversion to a newer incubator that automates early readings and decreases the need for handling of biological indicators (action).

The surgical instrument tray not passing inspection by the operating room circulator, leading to delay in surgery and/or potential abortion of operation after the induction of anesthesia (failure mode), as a result of an alternative tray not being immediately available (cause) can be prevented by increasing surgical equipment available on-site and evaluating the possibility of a protocol for starting induction of anesthesia after initial inspection of surgical equipment.

The 8 HFMEA team members met for a total of 26.5 h in 19 meetings during February–August of 2004 (for a total of 212 person-hours). We estimate that the HFMEA director and other selected team members spent >40 h between meetings and after the final meeting editing materials generated by the team (i.e., the flow chart and hazard analysis). In addition, all team members worked outside of meetings reviewing supporting documents and critically reviewing drafts of the flow diagram and hazard analysis. The final draft of the HFMEA was submitted to the hospital administration in January of 2005. The Quality Management group at our facility maintains a list of proposed actions for all HFMEAs (and RCAs); they will provide follow-up with the person responsible for each action to ensure completion. We estimate that >250 person-hours were spent on the HFMEA.

Previous SectionNext Section

Discussion

We used the HFMEA methodology to address an issue not amenable to quantitative techniques: the evaluation of system errors in the process of instrument sterilization and use. We found the methods from the Veterans Health Administration National Center for Patient Safety to be applicable to our issue. Our investigation uncovered multiple causes of the potential ways in which the system could fail (failure modes), as well as determining actions to correct these latent system errors. However, our investigation required a large amount of personnel resources.

Transmission of infection through inadequately sterilized surgical instruments has not been described in the modern sterilization era. However, after multiple positive biological indicators, there was sufficient interest in verifying the reliability of our system to warrant an investigation. There were no patients with documented transmission of infection, few instances of positive biological indicators, and many of the system errors that we found were not known before the study. Therefore, it was not possible to conduct a quantitative study (e.g., a case-control study evaluating risk factors for either transmission of infection or positive biological indicators). However, qualitative methods, such as FMEA and RCA (if there are any adverse events), are appropriate tools for this setting [6].

Qualitative investigations are required by the Joint Commission on Accreditation of Healthcare Organizations for health care—associated infection sentinel events [14, 15] and are complementary to quantitative methods for addressing healthcare epidemiology problems [6]. However, there are few publications providing guidance for performing qualitative investigations in the medical setting [3, 9, 16], particularly for healthcare epidemiology [6, 8].

We found the Veterans Health Administration National Center for Patient Safety HFMEA methodology [3] to be applicable to our healthcare epidemiology investigation. The HFMEA investigation found multiple system errors that had not been previously considered and acted upon. These errors have the potential to cause patients to experience adverse events. By taking action to correct these causes of failure modes, we may avert future adverse events. Our flow diagram and hazard analysis will also provide a blueprint for solving future problems at our institution, as well as assist other institutions in improving their system for sterilizing and using surgical instruments.

The HFMEA required 7 months of scheduled meetings in addition to substantial time commitments between and after the meetings to summarize and review the team's findings. In part, this is because of the scope of our investigation. We could have chosen any 1 of our 3 foci for the entire HFMEA. Even with only 3 foci, our HFMEA was one of the largest ever performed at our facility. We agree with other authors that the hazard analysis is tedious (albeit useful) and that, given the significant human resources needed to complete them, these investigations should be reserved for the most clinically significant problems [17]. Conversely, positive biological indicators, one of our outcomes of interest, necessitate a time-consuming investigation and raise the possibility of significant physical and psychological harm to patients. We believed that our investigation was worth the effort because of the multiple, correctable system errors that were discovered in this critical process and the creation of a valuable blueprint (i.e., the flow diagram) to use when addressing future surgical instrument issues. We also believe that subjecting the system to a rigorous investigation by the involved parties was educational for the HFMEA team members and will enhance communication and cooperation among the different hospital areas.

Our case may be an example of when the HFMEA methodology is useful: when there is concern or evidence that either system errors are present and there have been or there is the potential for serious adverse events. We believed that our case was too multifocal for a single RCA. We were concerned with positive biological indicators, but we didn't want to limit the investigation to that single end point. Likewise, a case-control study would have been limited as a result of too few (or no) adverse events, multiple potential outcomes of interest (e.g., positive biological indicators and transmission of disease), and the suspicion that many potential risk factors were not known before the study was completed.

Our study has several limitations. As in other qualitative investigations, it is difficult to demonstrate a statistically or clinically significant decrease in rare events (e.g., a decrease in the occurrence of positive biological indicators), and it is impossible to demonstrate a decrease in events that have not occurred (e.g., transmission of infection). Thus, we cannot prove that the HFMEA will increase the safety of patients at our institution nor can we perform a cost-benefit analysis. The lack of quantitative outcome data may increase the difficulty of obtaining administrative support for interventions, particularly if monetary investment is involved. However, our study uncovered previously unacknowledged system errors that potentially may have led to adverse events for patients. The face validity of such findings may be helpful in gaining administrative support for proposed changes.

We are reporting the use of the HFMEA methodology to address system errors in the sterilization and use of surgical instruments. This is, to the best of our knowledge, the first published use of HFMEA in the healthcare epidemiology literature. Our study provides an example of the use of the HFMEA methodology in healthcare epidemiology. The flow diagram and hazard analysis of an instrument sterilization and use system is also presented for others to use. Although it is difficult to verify the utility of these resource-intensive qualitative investigations, the HFMEA methodology is complementary to quantitative investigations and useful in identifying latent errors in complex medical systems.

Previous SectionNext Section

Acknowledgments

We thank Edmund Weisberg for his editorial assistance in preparing the manuscript.

Financial support. Ruth L. Kirschstein National Research Service Award (F32-HS-023982) from the Agency for Healthcare Research and Quality of the National Institutes of Health (NIH) and the Mentored Patient Oriented Research Career Development Award (K23) from the National Institute of Allergy and Infectious Diseases of the NIH (to D.R.L.); and the Public Health Service grant DK-02987-01 of the NIH (to E.L.).

Potential conflicts of interest. All authors: no conflicts.

  • Received April 29, 2005.
  • Accepted June 6, 2005.
Previous Section
 

References

  1. ↵
    1. Reason J
    . Human error: models and management. Brit Med J 2000;320:768-70.
    FREE Full Text
  2. ↵
    1. Kohn LT,
    2. Corrigan JM,
    3. Donaldson MS
    . To err is human: building a safer health system. Washington, D.C.: Committee on Quality Health Care in America, Institute of Medicine; 1999.
  3. ↵
    Healthcare failure mode and effect analysis course materials (HFMEA). Veterans Health Administration National Center for Patient Safety. 2005. Available at: http://www.patientsafety.gov/HFMEA.html. Accessed 18 August 2005.
  4. ↵
    VA handbook 7176: supply, processing, and distribution (SPD) operational requirements. Washington, D.C.: Department of Veterans Affairs; 2002.
  5. ↵
    1. Kohn WG,
    2. Collins AS,
    3. Cleveland JL,
    4. Harte JA,
    5. Eklund KJ,
    6. Malvitz DM
    . Guidelines for infection control in dental health-care settings—2003. MMWR Recomm Rep 2003;52:1-61.
    Medline
  6. ↵
    1. Linkin DR,
    2. Lautenbach E
    . Agency for Healthcare Research & Quality. 2004. "Sandals in the OR". AHRQ WebM&M [series online]. Available at: http://www.webmm.ahrq.gov/case.aspx?.caseID=47. Accessed 18 August 2005.
  7. ↵
    1. Gerberding JL
    . Hospital-onset infections: a patient safety issue. Ann Intern Med 2002;137:665-70.
    Abstract/FREE Full Text
  8. ↵
    1. Lautenbach E,
    2. Woeltje K
    1. Linkin DR,
    2. Brennan PJ
    . Practical handbook for healthcare epidemiologists. In: Lautenbach E, Woeltje K, editors. Infection control and patient safety. 2nd ed. Thorofare, NJ: SLACK; 2004.
  9. ↵
    1. DeRosier J,
    2. Stalhandske E,
    3. Bagian JP,
    4. Nudell T
    . Using health care failure mode and effect analysis: the VA National Center for Patient Safety's prospective risk analysis system. Jt Comm J Qual Improv 2002;28:248-67. 209.
    Medline
  10. ↵
    1. Herwalt LA,
    2. Decker MD
    1. Rutala WA
    . Disinfection and sterilization of patient care items. In: Herwalt LA, Decker MD, editors. Practical handbook for healthcare epidemiologists. 1st ed. Thorofare, NJ: SLACK; 1998.
  11. ↵
    Recommended practices for sterilization in perioperative practice settings: standards, recommended practices, and guidelines. Denver, CO: Association of Operating Room Nurses; 2002. p. 333-42.
  12. (ST46). Association for the Advancement of Medical Instrumentation standards and recommended practices. Vol. 1.1. Sterilization part 1: sterlization in health care facilities. 4th ed. Arlington, VA: Association for the Advancement of Medical Instrumentation; 2003. Steam sterilization and sterility assurance in health care facilities; p. 13-77.
  13. ↵
    (ST41). Association for the Advancement of Medical Instrumentation standards and recommended practices. Vol. 1.1. Sterilization part 1: sterlization in health care facilities. 3rd ed. Arlington, VA: Association for the Advancement of Medical Instrumentation; 2003. Ethylene oxide sterilization in health care facilities: safety and effectiveness; p. 295-404.
  14. ↵
    Joint Commission on Accreditation of Healthcare Organizations. 2005. Hospitals' national patient safety goals Vol. 2003. Available at: http://www.jcaho.org/accredited+organizations/patient+safety/05+npsg/05_npsg_hap.htm. Accessed 18 August 2005.
  15. ↵
    Sentinel event policy and procedures. Joint Commission on Accreditation of Healthcare Organizations. 2002. Available at: http://www.jcaho.org/accredited+organizations/sentinel+event/se_pp.htm#6. Accessed 18 August 2005.
  16. ↵
    1. Spath PL
    . Using failure mode and effects analysis to improve patient safety. Aorn J 2003;78:16-37. quiz 41-4.
    CrossRefMedline
  17. ↵
    1. Burgmeier J
    . Failure mode and effect analysis: an application in reducing risk in blood transfusion. Jt Comm J Qual Improv 2002;28:331-9.
    Medline
| Table of Contents

This Article

  1. Clin Infect Dis. (2005) 41 (7): 1014-1019. doi: 10.1086/433190
  1. ExtractFree
  2. » Full Text (HTML)Free
  3. Full Text (PDF)Free

Classifications

Share

  1. Email this article

Navigate This Article

Current Issue

  1. March 1, 2012 54 (5)
  1. Clinical Infectious Diseases
  1. Alert me to new issues

Most