"Dammed if you do, and damned if you don't."

"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)."

"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 January, 1995 and May 7, 2003.

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

http://www.ahcpr.gov

"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."

http://www.ecri.org

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."
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/search.cfm
 

"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)"

"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.
http://www.fda.gov/cdrh/