By Arif Subhan, MS, CCE, FACCE
Patient safety is one of the topics in the certification in clinical engineering (CCE) examination under the area of “Risk Management/Safety.” This section of the exam makes up about 10% of the CCE examination questions. (The details about the content and areas of the CCE examination are provided in the Candidate Handbook, available at the Healthcare Technology Foundation website at www.thehtf.org.)
Clinical engineers have a significant and unique role to play in efforts to improve patient safety. The literature indicates that clinical engineering professionals have been involved with patient safety issues for a long time, including dealing with matters such as electrical safety, the requirements of isolated power, anaesthesia mishaps, radio frequency interference with medical telemetry, and medical device incident investigation.1
“Safety and effectiveness have long been watchwords for clinical engineers. Medical devices should do what the health care practitioner wants them to do (effectiveness) and not do what the practitioner does not want them to do (safety). These are the two sides of the coin of clinical engineering.”2
The American College of Clinical Engineering (ACCE) defines a clinical engineer as “a professional who supports and advances patient care by applying engineering and managerial skills to healthcare technology.”3 Clinical engineering professionals are essential members of the root-cause analysis (RCA) team and the patient safety committee. They apply their knowledge of engineering, sciences, and systems thinking to evaluate the processes involved and help determine the system (root) causes of medical device failures.4
National Patient Safety Goals
The National Patient Safety Goals (NPSGs) program was established by The Joint Commission in 2002. The first set of NPSGs became effective January 1, 2003. Their purpose was to help accredited organizations address specific areas of concern in regard to patient safety.
NPSGs are developed by a panel of widely recognized patient safety experts. This panel is referred to as the Patient Safety Advisory Group. This advisory group comprises nurses, physicians, pharmacists, risk managers, clinical engineers, and other professionals who have hands-on experience in addressing patient safety issues in different health care settings.
The advisory group works with Joint Commission staff to determine emerging patient safety issues. It recommends to The Joint Commission ways to address the safety issues through a variety of approaches, including NPSGs, Sentinel Event Alerts, standards, and survey processes. The Joint Commission determines if a particular NPSG is relevant to a specific accreditation program (eg, hospital, ambulatory health care, home care).5
The 2014 NPSGs are grouped into the following seven areas6:
1) Identify patients correctly
2) Improve staff communication
3) Use medicines safely
4) Use alarms safely
5) Prevent infection
6) Identify patient safety risks
7) Prevent mistakes in surgery
NPSG on Clinical Alarm Safety
In 2013, The Joint Commission introduced a new NPSG intended to improve the management of clinical alarm systems and reduce related risks to patient safety.
This new NPSG will be implemented in two phases. The first phase begins in 2014, when hospitals will be required to establish alarm safety as a priority for the hospital. The hospitals will be required to identify the most essential alarms to manage based on their own internal circumstances. The second phase begins in 2016, when hospitals will be expected to develop and implement specific components of policies and procedures, and to educate staff in the hospital about alarm management.5
As stated in the rationale for this goal, the purpose of the clinical alarm systems is to alert caregivers of possible patient problems. If the alarms are not properly managed, they can compromise patient safety. Alarm management is a complex problem. For example, individual alarm signals may be difficult to detect. Also, many patient care areas have a substantial number of alarm signals, and the resulting sound and displayed information tends to numb the clinical staff. This can cause the staff to miss or ignore alarm signals, or even disable them. Some of the other problems associated with effective clinical alarm system management include:
- Large number of medical devices with alarms,
- The default settings on medical devices that are not at an actionable level, and
- The alarm limits that are too narrow.
These issues differ significantly among hospitals and even within different units in the same hospital. There is a general agreement among healthcare personnel that this is an important safety issue. There are no universal solutions. It is important for each hospital to understand its own situation and to develop a methodical, coordinated approach to clinical alarm system management.
Although standardization contributes to safe alarm system management, it is understood that solutions may have to be customized for specific clinical units, groups of patients, or individual patients. This NPSG focuses on managing clinical alarm systems that have the most direct relationship to patients. Safety and clinical engineering professionals can play a key role in effective management of the NPSG.6
Additional information on alarm safety is available on the AAMI and ECRI Institute websites.7,8 The ECRI Institute has identified alarm hazards as one of the top 10 technology hazards for 2014. 24×7
1) Clinical engineering professionals have been involved with patient safety issues since:
a) The National Patient Safety Goals were established
b) The establishment of the American College of Clinical Engineering
c) January 1, 2003
d) The clinical engineering profession started
2) The National Patient Safety Goals program was established by The Joint Commission in:
3) The Patient Safety Advisory Group that develops the National Patient Safety Goals comprises which of the following?
c) Clinical engineers
d) All of the above
4) The new National Patient Safety Goal on alarm safety will be implemented in two phases, with the first phase beginning in _______ and the second phase beginning in _______.
a) 2014, 2016
b) 2014, 2015
c) 2014, 2017
d) 2015, 2016
5) Clinical engineering professionals can play a key role in implementing the new National Patient Safety Goal by which of the following practices?
a) Identify patients correctly
b) Improve staff communication
c) Use medicines safely
d) Use alarms safely
6) Which of the following organizations has identified alarm hazards as one of the top 10 technology hazards?
a) ECRI Institute
d) The Joint Commission
See answers below.
1. Enhancing Patient Safety—The Role of Clinical Engineering, a white paper prepared by the American College of Clinical Engineering, 2001. Available at: http://www.accenet.org/downloads/accepatientsafetywhitepaper.pdf Accessed December 7, 2013.
2. Baretich MF. Chapter on Hospital Safety Programs in Clinical Engineering Handbook by Dyro JF. (2004).
3. American College of Clinical Engineering (ACCE), clinical engineer (defined) http://www.accenet.org/default.asp?page=about§ion=definition
4. Biomedical Engineers: Teaming up for Patient Safety. September/October 2010. Available at: http://www.patientsafety.va.gov/TIPS/Docs/TIPS_SeptOct10.pdf Accessed December 7, 2013.
5. Facts about the National Patient Safety Goals, http://www.jointcommission.org/assets/1/18/Facts_about_National_Patient_Safety_Goals.pdf Accessed December 7, 2013.
6. 2014 Hospital National Patient Safety Goals http://www.jointcommission.org/assets/1/6/2014_HAP_NPSG_E.pdf Accessed December 8, 2013.
7. AAMI Clinical Alarms Available at: http://www.aami.org/htsi/alarms/ Accessed December 15, 2013.
8. ECRI Institute, Alarm Safety Resource Site Available at: https://www.ecri.org/Forms/Pages/Alarm_Safety_Resource.aspx Accessed December 15, 2013.
9. ECRI Institute, 2014 Top 10 Health Technology Hazards. Available at: https://www.ecri.org/2014hazards Accessed December 15, 2013.
Answers: 1—D, 2—A, 3—D, 4—A, 5—D, 6—A
Arif Subhan, MS, CCE, FACCE, is the chief biomedical engineer at VA Greater Los Angeles Healthcare System and a member of 24×7’s editorial advisory board. The suggestions and views expressed in this article are of the author. They do not represent the views of the Department of Veterans Affairs. For more information, contact [email protected]