The ECRI Institute, an independent group that evaluates medical devices and procedures, has issued its latest list of the 10 most perilous technologies in healthcare health providers should keep an eye out for in 2011.
This year's list reflects the group's judgment based on:
- A review of recent recalls
- Analysis of information found in the literature and in the medical device problem reporting databases of ECRI Institute, and other organizations
- ECRI experience in investigating and consulting on device-related incidents
The goal "is to increase awareness of these hazards and to stimulate action within healthcare facilities to formulate programs" to minimize dangers, authors say.
1. Radiation Overdose and Other Dose Errors During Radiation Therapy.
This underreported problem makes the number one spot on the list for two reasons.
First, the consequences of a radiation overdose rarely manifest right away, "meaning that certain errors—such as those resulting from improper device setup or an inappropriate treatment plan—could lead to a patient being repeatedly exposed to an inappropriate dose before the error is noticed in clinical review. And by that time, the damage has already been done, and can't be undone."
And second, radiation treatment plans are more complex, "leaving very narrow margin for error," the report states.
Administering the wrong dose, or treating the wrong site or patient are all caused by human error, software problems, and provider or operator inexperience with the fast pace of technological change.
For example, the report says, in one year from July 2009 to July 2010, there have been over 40 reports of software errors, manufacturing-required software modifications or dose calculation errors for radiotherapy systems, linear accelerators and radiation treatment planning systems.
The report advises hospitals to make sure personnel have up-to-date and appropriate certifications and training and that staffing levels are adequate. Maintain systems to ensure that patient treatment procedures are documented and followed, with attention to providing oversight of incident reporting and safety alerts management.
2. Alarm Hazards
Alarm-related adverse events also ranked second on last year's list.
"Clinical alarm problems were once again in the news in 2010 when the Boston Globe reported the death of a patient whose treatment may have been delayed because of a critical physiologic monitoring alarm had been turned off," authors say.
Many such incidents can result from a phenomenon some call "alarm fatigue" when the number of alarms begins to overwhelm staff provoking them to modify alarm settings to reduce alarm overload.
In effect, that may result in the alarm being disabled.
3. Cross Contamination from Flexible Endoscopes.
This hazard, which results from improperly reprocessed flexible endoscopes, was ranked No. 1 in ECRI's 2010 list but remains a significant issue.
"At minimum, endoscope reprocessing problems, when discovered, can inconvenience patients and create anxiety; at worst, they can lead to life-threatening infections," report says.
For example, the U.S. Department of Veterans Affairs tested at least 10,000 patients after discovering that endoscopes and accessories weren't properly decontaminated at several medical centers. And in June, two hospitals reported contacting thousands of patients regarding potential exposure to infection.
With the scheduled removal of the Steris System 1 sterilizing units, hospitals will be purchasing new units, changing protocols, and maybe buying new endoscope models, the authors say. They advise providers to review protocols, staff training and maintenance schedules.
4. The High Radiation Dose of CT Scans.
With a 2009 study suggesting that 29,000 cases of cancer may have been caused by radiation doses administered during CT imaging scans in 2007 alone, the CT scan's use and perhaps overuse has come under the spotlight. "While the increased risk of cancer cannot be reliably quantified, it clearly is a risk that healthcare facilities must take steps to mitigate," the authors write, adding "there is no regulatory dose limit in diagnostic radiology."
"The crux of the problem is that a delicate balance must be achieved between keeping doses low and maintaining adequate image quality."
5. Data Loss, System Incompatibilities and Other Health IT Complications.
Medical technology and health information technology are on a converging path, the authors write. Now, technology will funnel data from medical devices, such as physiologic monitors and ventilators, and medication management systems into medical records. But convergence can also present risks if data is lost, overwritten, unsuccessfully transmitted, or associated with the wrong patient.
With HIT increasing dramatically, "it is vital that healthcare organizations take steps now to keep HIT problems from exploding at their facilities," the report said.
The issue has caught the attention of the U.S. Food and Drug Administration, which has gone on record with a warning. In the past two years there have been 260 HIT-related incident reports, with 44 injuries and six reported deaths. These included a confusing user interface that led to the "overwriting of one patient's data with another patient's study" and an improperly configured database that caused manually entered patient data to be overwritten during automatic updates."
6. Tubing Misconnections
Tubing and catheter misconnections can result in gases or liquids to be introduced into the wrong lines.
The ECRI researchers say that between January, 2008 and September 2009, 36 reports of tubing miscommunication were reported just in Pennsylvania, with incidents ranging from near misses to serious events. A New York Times report in August detailed a death of a patient when nutrients intended for the gastrointestinal tract went into a patient's vein instead.
7. Oversedation During Use of PCA Infusion Pumps.
A newcomer on the lineup of potentially hazardous technologies, the patient-controlled analgesic (PCA) infusion pump made this year's ECRI list "because of the particular dangers associated with delivering opioids" through this mechanism, usually used to deliver high-alert medications.
"The most significant danger when using PCA pumps is oversedation, which can lead to potentially life-threatening narcotic-induced respiratory depression," the authors write.
An August, 2007 study found that "when patients undergoing PCA therapy were monitored with continuous oximetry and capnography, respiratory depression was identified in 41% of the patients," far more than the 1% to 2% incidence previously reported.
8. Needlesticks and Other Sharps Injuries.
A long-standing healthcare-associated risk, ECRI researchers say the number of injuries "remains staggering, despite the implementation of safety devices and the emphasis on training over the past 15 to 20 years."
The report suggests that prevention programs in these settings may be outdated. "It is easy to become complacent after initial efforts succeed in reducing the frequency of injuries. However, continuing injuries are a signal that additional attention is needed."
The report advises healthcare facilities to routinely review and refine their sharps safety efforts, making sure that all personnel are trained and that there are enough personnel should be considered in high risk areas such as the operating room, emergency department, nuclear medicine, and home care staff.
9. Surgical Fires.
Another holdover from 2010 is the surgical fire, 600 of which are estimated to occur each year, about as common as wrong-site surgeries. ECRI last year developed clinical practice recommendations for delivering oxygen during surgery, in conjunction with the Anesthesia Patient Safety Foundation.
Staff should be made aware of fire hazards from oxidizers, ignition sources, and operating room fuels.
10. Defibrillator Failures in Emergency Resuscitation Attempts.
The ECRI researchers point to their own reporting system, as well as an FDA database to document "many reports of incidents in which defibrillators didn't discharge during resuscitation attempts for various preventable reasons, (such as depleted batteries)."
To guard against these mishaps, clinicians responsible for using defibrillators should perform recommended checks "at least daily" and that the unit is plugged in and batteries are charging.