“Our accomplishments are what you don’t see”

Safety and Accountability. Medical errors may account for between 44,000 and 98,000 deaths per year in the U.S.. How do equipment failures contribute to this statistic? Safety and Accountability: who knows what?
Copyright, June, 2003.

Our Accomplishments
In Clinical Engineering, the over-riding issues in selling a system approach to problem analysis is–how one establishes the value in prevention. After all, almost everyone today, wants to know what their money is going to. But how does one demonstrate–a missed treatment prevented (and the resulting discomfort to a patient plus the increase in length of stay), an injury avoided, or a savings in legal defense cost–when there is no evidence? How can one present the work one does when a part of that work is to find way to make it unnecessary to begin with?

“Dammed if you do, and damned if you don’t.”

Cited Quotes


“As many as 44,000 to 98,000 people die in hospitals each year as the result of medical errors (Institute of Medicine. To Err is Human: Building a Safer Health System. Washington, DC: National Academy Press, 1999).”

The subject of medical errors is large and complex–far outdistancing the scope of these pages. Stated here are some comments that relate to the technology side of this issue.

“A sentinel event is an unexpected occurrence involving death or serious physical or psychological injury, or the risk thereof. Serious injury specifically includes loss of limb or function. The phrase, “or the risk thereof” includes any process variation for which a recurrence would carry a significant chance of a serious adverse outcome. Such events are called “sentinel” because they signal the need for immediate investigation and response.”

There have been a total 2,034 Sentinel Events reviewed by the Joint Commission (JCAHO) between May 7, 2003 and January, 1995.

On the face of it, the number 2,034 seems small when you consider that JCAHO accredits more than 17,000 healthcare organizations. Underreporting of
Sentinel Events is a recognized problem, as is standardizing and collecting data in one place.

In 12/16/2002, the president of JCAHO, Dennis S. O’Leary, M.D., called attention to underreporting in a “Dear Colleague Letter.”

Key agencies and organizations addressing the issue of patient safety:

Health And Human Services

FDA (U. S. Food and Drug Administration)
Agency for Healthcare Research and Quality (AHRQ)  
Government agencies with general oversight for health and safety in the U.S..

AMA (American Medical Association)
National Patient Safety Foundation (NPSF)
Private non-governmental, nonprofit organizations with the same goals as the oversight Federal agencies.
National Academy of SciencesInstitute of Medicine (IOM) Private non-governmental, nonprofit organizations usually working with government agencies addressing specific issues.
Joint Commission on Accreditation of Healthcare Organizations (JCAHO) Private non-governmental, nonprofit organization–industry self regulation.

ECRI, (Emergency Care Research Institute)
Private non-governmental, nonprofit organization–the “Consumer Reports” of the medical industry.

Types of Errors

“The IOM (Institute of Medicine) defines medical error as “the failure to complete a planned action as intended or the use of a wrong plan to achieve an aim.” An adverse event is defined as “an injury caused by medical management rather than by the underlying disease or condition of the patient.”

“Most people believe that medical errors usually involve drugs, such as a patient getting the wrong prescription or dosage, or mishandled surgeries, such as amputation of the wrong limb. However, there are many other types of medical errors, including:

Diagnostic error, such as misdiagnosis leading to an incorrect choice of therapy, failure to use an indicated diagnostic test, misinterpretation of test results, and failure to act on abnormal results.

Equipment failure, such as defibrillators with dead batteries or intravenous pumps whose valves are easily dislodged or bumped, causing increased doses of medication over too short a period.

Infections, such as nosocomial and post-surgical wound infections.

Blood transfusion-related injuries, such as giving a patient the blood of the
incorrect type.

Misinterpretation of other medical orders, such as failing to give a patient a salt-free meal, as ordered by a physician.”

Publication No. AHRQ 00-PO37, current as of February 2000


“It has been generally perceived that with numerous sources of patient data it is possible to easily fathom the cause of a medical error. This does not hold related to medical device-related medical errors…With the universe of medical devices comprised of some 5,000 different device types, research into “medical error and medical devices” it is simply too general an approach.”

“Equipment failure can trigger an accident or it may complicate the recognition and treatment of other problems. The equipment failure itself may occur due to a variety of causes, such as equipment defect, improper set-up or maintenance, or environmental factors and, as noted above, that failure is rarely the sole cause of the adverse device event. Other factors combine with equipment failures to result in the accident…Needed is a system for collection of accurate information so that an effective initial analysis can be performed, hopefully leading to early resolution, or lead to undertaking of an effective investigation.

Such research could be conducted using a large-scale healthcare accident databases that could facilitate the study of risk factors associated with medical technology and could help identify opportunities for accident prevention.”


Currently, as of 2003, there is no universally recognized database responsible for collecting data on healthcare mishaps that identifies the roll technology plays.
FDA database, MAUDE. “Data represents reports of adverse events involving medical devices. The data consists of all voluntary reports since June, 1993, user facility reports since 1991, distributor reports since 1993, and manufacturer reports since August, 1996.

An on-line search is available which allows you to search the CDRH’s database information on medical devices which may have malfunctioned or caused a death or serious injury.”


Searchable databases.

Medical devices are cataloged by the FDA. Device and adverse events information is available in searchable, if non-user friendly, database on the Web.

FDA Failure Report

Totals of “adverse events involving medical devices” recorded in 2002:

Total, over 65,000. Of these, 1,260 were reported as involved in some way with the death of a patient.

FDA database, MedWatch.

“A & A Medical/Rocket USA/Lifequest Ob/Gyn and Surgical Products (Posted 3/19/2002)

Bone Cement in Vertebroplasty and Kyphoplasty Procedures (Posted 10/31/2002)

Cochlear Implants (Posted 7/29/2002; UPDATED 8/15/2002)

Diathermy Interactions with Implanted Electrical Leads (Posted 12/20/2002)

Human Tissue Processed by Cryolife, Inc. (Posted 8/22/2002)

Olympus America Video Bronchoscopes Recall (Posted 3/20/2002)

PVC Devices Containing the Plasticizer DEHP (Posted 7/15/2002)”

MedWatch recorded a total of 7 “medical product safety alerts, Class I recalls, market withdrawals, or public health advisories,” for 2002.

“Like other components of FDA, the Center for Devices and Radiological Health has established advisory committees to provide independent, professional expertise and technical assistance on the development, safety and effectiveness, and regulation of medical devices and electronic products that produce radiation. Each committee consists of experts with recognized expertise and judgment in a specific field. Members have the training and experience necessary to evaluate information objectively and to interpret its significance. These persons are not regular employees of FDA, but are paid as “special government employees” for the days they participate as members of a panel. This is time they take from their daily occupations to provide their professional skills to FDA. The committees are advisory — they provide their expertise and recommendations — but final decisions are made by FDA.


Notice the lengthy description of what amounts to a “consultant.”

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