Evaluations & Guidance - Alerts

Electrical Safety in Healthcare: Collected Resources

Published 12/24/2014

EXECUTIVE SUMMARY
Find answers to many common electrical safety questions, plus practical advice on a variety of topics, including:
Sorting through the confusing array of standards governing the electrical safety of devices used in the hospital, including which edition of the standards you should use,
important changes in the latest editions, and an explanation of patient care vicinity and other potentially confusing location and equipment classifications
How limits for leakage current are established and how the limits should be applied in special cases such as permanently wired equipment, equipment in labs, and devices
with redundant grounding (This includes what standards now refer to as "touch current"leakage current from the equipment case or enclosure.)
How double-insulated devices should be handled
How the various types of electrical isolation principles used in hospitals differ
What ground-fault circuit interrupters (GFCIs) are, how they work, and the potential danger associated with their use
What electrical safety concerns affect home care devices
What precautions are necessary to ensure the safety of off-the-shelf computer equipment used in hospitals
Why we think relocatable power tapspower stripscan be safely used to power medical devices in patient care areas, including the patient care vicinity, as long as
appropriate measures are applied

Ensuring the electrical safety of devices used in the healthcare environment, while not the labor-intensive undertaking it was decades ago, is still a fundamental responsibility of
biomedical engineers and other healthcare technology management personnel.
ECRI Institute regularly receives electrical safety questions from its member hospitals. We've developed a series of articles to help explain this complex and sometimes confounding
topic. You'll find practical guidance and recommendations on key issues, as well as explanation of the concepts and rationales behind electrical safety requirements. Experienced
personnel can use this guide as a handy reference, while those new to the field will find it to be a helpful educational resource. It consists of the following:
Electrical Safety in Healthcare Facilities: Practical Applications
Fundamental principles and practical guidance related to issues such as applying leakage current limits in special cases, dealing with double-insulated devices, and
understanding electrical isolation principles.
Electrical Safety in Healthcare Facilities: Clarifying the Standards
Clarification of common areas of confusion surrounding the key standards governing the electrical safety of devices used in the hospital.
Using Off-the-Shelf Computer Equipment: It's Safewith the Right Precautions
Why we think the use of off-the-shelf equipment near the patient does not, if a few key safety measures are taken, create concerns about touch (leakage) current or other
safety issues that should prohibit its use.
Electrical Safety Q & A
Our insights and advice on some commonand not-so-commonquestions we've come across through the years.
Position Statement: Relocatable Power Taps Can Be Used If CMS Categorical Waiver Requirements Are Met
We believe that relocatable power tapspower stripscan be safely used to power medical devices in patient care areas, including the patient care vicinity, as long as
appropriate measures are applied.

How Electrical Safety Requirements Have Evolved

Medical devices are safer than ever, at least when it comes to electrical hazards. Today's devices are designed, manufactured, and tested to rigorous standards that adequately
ensure their electrical safety throughout their lifetime, as long as they are otherwise in good physical and working order.
But it wasn't always like that.
More than four decades ago, widespread concerns and fearswhich later turned out to be largely unfoundedcirculated regarding the possibility of patients and staff receiving
electrical shocks from medical devices. Although the "electrical safety scare" of the late 1960s and early 1970s involved more fiction than fact, it did prompt some positive changes:
Device manufacturers were compelled to design safer products, and hospitals were prompted to implement safety-focused equipment management programs. This issue also helped
hospitals understand the broader need for engineering support of patient care, including judicious selection, purchase, inspection, and preventive maintenance of medical equipment.
(In fact, electrical safety played a larger role in advancing the field of clinical engineering than perhaps any other technical issue.)
Thanks in part to these changes, revised electrical safety codes and standards have been issued over the past 20 years that, unlike the earlier generation of standards, do not
require undue expenditures of time and money. And today, it is widely recognized that while continued vigilance is required, the frequent, burdensome routine electrical safety testing
of medical devices that had been common practice in hospitals is, for the most part, no longer necessary.

Our advice: Address electrical safety as needed, but keep it in perspective. Spending too much time on it can divert resources from more critical
safety initiatives.

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Currently, medical device electrical safety in the healthcare facility environment is based primarily on the following:[1]
The National Fire Protection Association's NFPA 99, which is used by hospitals in the United States as well as by hospitals in other countries that follow U.S. standards.
The International Electrotechnical Commission's IEC 60601-1 and related standards, which have been adopted in many countries.
The release of the 2012 and 2015 editions of NFPA 99 continued the trend toward less strict standards, with significantly relaxed requirements for routine electrical safety testing of
medical devices. This reflects the very low risk of medical-device-related electrical safety incidents in hospitals today.
In ECRI Institute's experience, most healthcare facilities already have adequate procedures in place for addressing electrical safety issues. In fact, some facilities may find that they
can further reduce their efforts without adversely affecting patient or staff safety, thereby freeing up resources for more critical safety initiatives, including, for example, addressing
the many high-risk healthcare IT and cybersecurity issues.
Still, it is necessary for health technology personnel to maintain familiarity with electrical safety requirements, and ECRI Institute continues to receive questions from hospitals looking
for guidance on electrical safety topics.
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[1] In the United States, the requirements of accreditation agencies (including the U.S. Centers for Medicare & Medicaid Services) will often need to be taken into account as well.
These requirements may deviate from current, commonly accepted practices and are covered in Electrical Safety in Healthcare Facilities: Clarifying the Standards.

TOPICS AND METADATA

Topics
Biomedical Engineering
;

Laws, Regulations, Standards

;

Service and Maintenance

;

Technology Selection

Caresetting
Ambulatory Care Center
;

Ambulatory Surgery Center

;

Assisted-living Facility
;

Behavioral Health Facility

;

Dialysis Facility
;

Emergency Department
;

Endoscopy Facility
;

Home Care
;

Hospice
;

Hospital Inpatient
;

Hospital Outpatient
;

Imaging Center
;

Independent Living Facility

;

Physician Practice
;

Rehabilitation Facility
;

Short-stay Facility
;

Skilled-nursing Facility
;

Substance Abuse Treatment Facility

;

Trauma Center

Roles
Biomedical/Clinical Engineer
;

Regulator/Policy Maker
;

Risk Manager

Information Type
Alerts

2016ECRIInstitute