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A quarterly
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In This Issue: |
A patient with myocardial infarction and bifascicular block was admitted to the ICU. A physician inserted a temporary invasive cardiac pacing catheter. However, because the catheter pin design was incompatible with the pacer adapter, the staff members could not connect it to the pulse generator. Instead, they connected the patient to a transcutaneous pacemaker. The patient was transferred to another facility and died shortly after arrival.
What went wrong?
A temporary invasive cardiac pacing system produces an electrical pulse to stimulate the heart. Because pacing systems and pacing catheters vary, assembled temporary systems may contain equipment from one or more manufacturers. The U.S. market currently offers two different types of cardiac pacing connectors. Without the proper connection to the pulse generator, the device will not pace properly. In the above case, the incompatible equipment used to assemble the system created a faulty connection.
What precautions can you take?
To prevent delays in pacing therapy, careful planning and selection of compatible connectors is needed.
If a death, serious injury or device malfunction occurs, notify the person in your facility responsible for reporting adverse events to the either the manufacturer or the Food and Drug Administration or both. You may voluntarily report a medical device problem:
Diane Dwyer is a nurse-consultant in the Center's Office of Surveillance and
Biometrics.
*Adapted from an article by the author in Nursing 2002: 32(9), 76.
When selecting a third-party reprocessor of single-use devices (SUDs), FDA suggests you talk with other hospitals to determine their experiences with third-party reprocessors and arrange to visit the reprocessor's facilities. In addition, you might consider asking a potential reprocessor the following questions:
To obtain the 483 inspection report from a reprocessor's most recent FDA inspection,
contact FDA's Freedom of Information Staff by fax at 301-443-1719 or 301-443-1726.
Also, you can obtain information about a reprocessor's inspection history at
http://www.fda.gov/cdrh/foicdrh.html.
The Center for Devices and Radiological Health developed a CD ROM entitled: "An Overview of the Regulatory Requirements for Reprocessing of Single-Use Devices by Hospitals." While supplies last, a free copy of the CD-ROM is available by request at http://www.fda.gov/cdrh/Reuse/reuse-messages.html.
The two-disc set covers the regulatory requirements that a hospital must meet if it reprocesses single-use devices (SUDs). Topics include:
To see the PowerPoint presentations from the CD ROM, visit the Reuse Events
Page at http://www.fda.gov/cdrh/reuse/reuse-documents.html#10.
| Editor's note: The following excerpt is from the August 2002 broadcast of FDA Patient Safety News. For additional information about the televised series and to read scripts from previous broadcasts, visit http://www.fda.gov/cdrh/psn/. |
This time we want to talk about three recent articles by the Institute of Safe Medication Practices (SMP), warning of the potential danger of misusing patient- controlled analgesia, or PCA.
The articles point out that when the patient is truly controlling the administration of the analgesic drug, there's a built-in safeguard, because when the drug dose exceeds the amount needed for analgesia, the patient becomes sedated, and then he or she can no longer push the button to administer more of the drug.
The problem occurs when other people push the button, bypassing this built-in safeguard. That can happen when well-meaning family members push the button, and sometimes even when staff members do so. As the ISMP puts it, "PCA means patient controlled analgesia. It does not mean family-controlled, visitor-controlled or clinician-controlled."
One of the articles cites the case of a 72-year old women who received morphine through PCA after Surgery, and who died of an overdose. Despite the patient's inability to verbalize pain, and the fact that she remained obtunded after surgery, nurses pushed the PCA button and delivered frequent doses of morphine for 48 hours. The patient suffered a cardiorespiratory arrest and seizure, and died several months later without having regained consciousness.
ISMP points out that in this case, nurses did not recognize the signs of morphine toxicity, and they continued to administer the drug despite serious hypotension and very shallow respiration.
The ISMP articles don't say that nurses should never push the patient's PCA button. They say that nurse-controlled analgesia may be appropriate in critical care settings, but only with guidelines for selecting patients, along with tools to assess the level of pain and sedation.
Here are the ISMP recommendations:
Additional Information: ISMP Medication Safety Alert - More on avoiding opiate
toxicity with PCA by proxy: http://www.ismp.org/MSAarticles/PCA.htm.
If you would like to be notified electronically (via e-mail) when a new issue of the User Facility Reporting Bulletin is released, you can sign-up for our List Service at:
http://www.fda.gov/cdrh/subscribe.html
FDA Patient Safety News is a televised series for health care personnel, carried on satellite broadcast networks aimed at hospitals and other medical facilities across the country. Each edition features information on new medical devices, on FDA safety notifications and product recalls, and on ways to protect patients when using medical devices.
This site (http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTopic/psn/index.cfm) contains the text for each broadcast, plus links for more information on each story. You can also search the Patient Safety News Headlines. It also has instructions for purchasing videotapes of previous broadcasts and sending comments to FDA about the broadcast.
Topics from September 2002 Broadcast...
Updated October 7, 2002
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