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U.S. Department of Health and Human Services

MedSun: Newsletter #23, April 2008

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Newsletter #23, April 2008

Articles

Epidural Conduction Device Fractures and Complications of Retained Fragments

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By Robert Fischer, RN, MSN

FDA Medical Device Safety Page (Article reprinted from American Association of Nurse Anesthetists Journal. February 2008. Vol. 76, No. 1, p. 37-40.)

Fracture and retention of anesthetic conduction device tips can cause serious injuries and other problems such as spinal stenosis, nerve root compression, and subcutaneous effusion. The article gives tips to nurse anesthetists on how to prevent potential problems through good practices and encourages the practice of recording catheter retention in medical records and informing patients of retained devices.

Additional Information:

Epidural Conduction Device Fractures and Complications of Retained Fragments
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/TipsandArticlesonDeviceSafety/ucm070030.htm

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FDA Requests Comments on Dissemination of Information on Unapproved Uses of Medical Products

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Agency accepting public comments for 60 days

FDA Press Release

The U.S. Food and Drug Administration (FDA) today issued draft guidance on "Good Reprint Practices" for industry use in the distribution of medical or scientific journal articles and reference publications that involve unapproved uses of FDA-approved drugs and medical devices.

"Articles that discuss unapproved uses of FDA-approved drugs and devices can contribute to the practice of medicine and may even constitute a medically recognized standard of care," said Randall Lutter, FDA deputy commissioner for policy. This guidance also safeguards against off-label promotion."

Previously, Section 401 of the Food and Drug Administration Modernization Act set out guidelines that allowed the dissemination of information on unapproved uses of FDA-approved products. As long as the guidelines were met by the manufacturers, the dissemination of such materials was not viewed by the FDA as evidence of an intent to promote the product for an "off-label" use. However, Section 401 expired on Sept. 30, 2006.

The FDA's "Good Reprint Practices" draft guidance recommends principles manufacturers should follow when they distribute scientific or medical journal reprints, articles, or reference publications.

Some of the principles include ensuring that the article or reference be published by an organization that has an editorial board. The organization also should fully disclose any conflicts of interest or biases for all authors, contributors or editors associated with the journal article. Articles should be peer-reviewed and published in accordance with specific procedures.

In addition, the draft guidance recommends against distribution of special supplements or publications that have been funded by one or more of the manufacturers of the product in the article, and articles that are not supported by credible medical evidence are considered false and misleading and should not be distributed.

The FDA retains legal authority to determine whether distribution of an article or publication constitutes promotion of an unapproved "new use," or whether such activities cause a product to be considered misbranded or adulterated under The Federal Food, Drug and Cosmetic Act.

The FDA welcomes public comments on the draft guidance. Typed comments should be submitted within 60 days of the Federal Register notice announcing the availability of the draft guidance.

Submit comments to:
Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852

To submit comments via the Internet, go to Docket Number FDA-2008-D-0053 on the Regulations.gov Web site.

All comments should be identified with the docket number, FDA-2008-D-0053. For single copies of the draft guidance, call 301-827-3360 or contact: Office of Policy, Food and Drug Administration, 5600 Fishers Lane, Room 14-101, HF-11, Rockville, MD 20857.

Additional Information:

FDA Requests Comments on Dissemination of Information on Unapproved Uses of Medical Products, (Agency accepting public comments for 60 days). FDA Press Release. February 15, 2008.
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2008/ucm116859.htm

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FDA Approves Drug-Eluting Stent for Clogged Heart Arteries

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FDA Press Release

The U.S. Food and Drug Administration today approved the Endeavor Zotarolimus-Eluting Coronary Stent for use in treating patients with narrowed coronary arteries, the blood vessels supplying the heart.

The Endeavor is the first drug-eluting stent approved since 2004 and the first since FDA convened its Circulatory System Devices Panel in 2006 to discuss evidence of the rare risk of blood clots occurring in patients who receive drug-eluting stents.

Manufactured by Medtronic, Inc., of Minneapolis, the device is a tiny metal mesh tube coated with a small amount of a new drug, zotarolimus, developed only for use on a stent. It is crimped around a balloon and delivered to the narrowed section of the coronary artery via a long thin catheter during a procedure known as an angioplasty. Once the stent is positioned, the balloon is inflated, expanding into the vessel wall where it will remain in place, acting as a mechanical scaffold to keep the artery open.

Slow release of zotarolimus over time prevents the artery from re-narrowing when new tissue begins to form. This process, known as restenosis, can eventually require a repeat angioplasty.

"The Endeavor drug-eluting stent provides cardiologists with another option for treating the one million patients who undergo an angioplasty procedure every year to open their clogged coronary arteries," said Daniel Schultz, M.D., director of the Center for Devices and Radiological Health. "This important approval is the result of a substantial amount of clinical evidence and a careful review by both FDA and its advisory committee."

Medtronic provided data from seven clinical trials in its marketing application. Studies showed that the Endeavor significantly reduced the number of major coronary events – heart attack, cardiac death and repeat procedures to re-open the artery – compared to a bare-metal stent (a stent without a drug coating). It also cut the restenosis rate by about half.

Imaging studies on a subset of patients indicated that the Endeavor’s restenosis rate was higher than what is seen in currently marketed drug-eluting stents. However, the Endeavor had a similar number of coronary events when compared to one of these stents.

The number of adverse events experienced by patients implanted with the Endeavor stent was similar to those that occurred in patients implanted with bare-metal stents and existing drug-eluting stents.

Based on recent concerns over the rare but serious side effect of blood clots or stent thrombosis, FDA asked Medtronic to combine data from all Endeavor trials to determine how often this happened at various points in time following stent implantation. The stent thrombosis rate was 0.4 percent at one year and 0.5 percent at two years, a rate similar to that for bare-metal stents. To reduce such clotting risk, patients receiving the Endeavor will need to take blood-thinning medication for at least six months after implantation and should consider continuing this regimen for 12 months if they are not at an increased risk for bleeding complications.

The safety and effectiveness of the Endeavor stent in smaller diameter arteries or for longer blockages requiring more than two stents has not been studied and there has been no evaluation of the stent’s safety and effectiveness in patients who are having an acute heart attack, patients who had previous intravascular radiation treatment, or patients who have their blockage in a bypass graft, in the left main coronary artery, or in more than one vessel.

Patients who are allergic to zotarolimus or to cobalt, nickel, chromium, or molybdenum should not receive an Endeavor stent. Caution is also recommended for people who have had recent cardiac surgery and for women who are nursing or who may be pregnant.

Medtronic will continue to follow patients enrolled in six of the Endeavor trials for five years. Additionally, the company will conduct a 2,000-patient U.S. post-approval study, which will be combined with 3,300 patients from a study conducted outside the United States, to assess the long-term safety and effectiveness of the Endeavor stent and to look for rare adverse events such as stent thrombosis. Medtronic will also collect clinical data to identify the optimal duration of blood-thinning medication.

Before drug-eluting stents were available, about 15 percent to 30 percent of patients experienced restenosis within a year, requiring a repeat angioplasty. This number has dropped to 10 percent of patients since drug-eluting stents entered the U.S. market in 2003.

Additional Information:

FDA Approves Drug-Eluting Stent for Clogged Heart Arteries. FDA Press Release. February 1, 2008.
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2008/ucm116848.htm

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Managing Medical Device Recalls

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By Alex Koustenis

ADVANCE for Nurses, March 2007
When healthcare professionals are informed of a medical device recall, there is often uncertainty about the appropriate action to take within their clinical settings.

This uncertainty can be exacerbated by confusion over the severity of the recall, whether the device needs to be removed from the healthcare facility, what to do about patients currently using the device and what corrective action the manufacturer is going to take.

A medical device recall is initiated when the device is in violation of Food and Drug Administration (FDA) law. This can include the following:

•The device is defective.
•The device poses a risk to patient health.
•The device is both defective and poses a risk to patient health.

For the most part, it is the manufacturer that voluntarily recalls the violative device. They also notify the FDA who oversees the manufacturer's actions to ensure they are adequate to protect the public health.

Keep in mind that the word recall does not necessarily mean that use of the device should be halted or returned. It can sometimes mean that the device requires a field correction on site, such as component replacement or software updates.

In some cases, temporary work arounds or short term instructions are provided for use until the long term fixes are put into place at each device location.

Even if a recalled medical device is an implant, it does not necessarily need to be removed.

Manufacturers often inform doctors of the device's potential to fail unexpectedly and the risks associated with these failures. They also provide monitoring instructions for their patients and allow the physicians to make the risk versus benefit decision on device removal.

FDA classifies a medical device recall into one of three categories; classification usually occurs after the company has issued its recall. These categories, relative degrees of risk, include the following:

Class I Recall

A situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences. The manufacturer uses a press statement and a recall letter to notify it's customers with information such as the name of the device being recalled, identifying lot or serial numbers, reason for recall and how to correct, avoid or minimize the problem.

Class II Recall

A situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. Customers are notified but generally there are no press releases issued.

Class III Recall

A situation in which use of or exposure to a violative product is not likely to cause adverse health consequence. Customers are notified but generally there are no press releases issued.

Classification

Classification serves several functions for FDA, industry, and public including:

•Provides the FDA's Health Hazard decision of the recall for the public and device consignees.
•Enables FDA to set uniform audit recall levels.
•Assists FDA with information to determine the need for Public Warnings.
•Provides guidance for future Industry/FDA recall actions.

Corrective Actions

The types of corrective actions by the manufacturer are often based on the severity of the recall. FDA audits of the recalling firm's actions are also based on the classification of the recall.

Class I recalls are audited with FDA visits to a number of device locations, Class II with phone contacts and Class III by examination of the recalling firm's internal records of its own audit.

These audits are made to ensure the recalling firm has issued a recall notification, that the notification provides the end users with the proper information to initiate the recall at its’ site, understand the defect and risks, and to return, correct, and/or monitor patients with implanted devices as instructed by the recalling firm's notification.

Importantly, healthcare sites should maintain some internal records of each recall conducted at their site and its outcome to facilitate the FDA audit.

When healthcare professionals better understand the meaning of a medical device recall and FDA classifications it prevents confusion over what corrective action to take at each healthcare facility and also helps to ensure the safety of the public.

Alex Koustenis is a member of the Patient Safety Staff at FDA. Michael Verdi, Recall Coordinator for the FDA Center for Devices and Radiological Health, contributed to this report.

Additional Information:

Managing Medical Device Recalls. Koustenis, Alex. ADVANCE for Nurses. March 2007.
http://nursing.advanceweb.com/editorial/content/editorial.aspx?cc=108836

For more information on medical device recalls, visit:
http://www.fda.gov/cdrh/recalls/learn.html

To see FDA Recalls, Market Withdrawals and Safety Alerts, visit:
http://www.fda.gov/oc/po/firmrecalls/recall_defin.html

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Surveyed hospitals: Only 10-30 percent use successful CA-UTI prevention practices

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Safety Share Newsletter, Premier Inc.

A recent national survey of urinary tract prevention infection practices revealed that more than 50 percent of hospitals did not have a monitoring system for patients with indwelling catheters and greater than 70 percent did not monitor the duration the catheter was in place.

VA study

Ann Arbor VA researchers conducted a national survey in order to characterize the current practices in use in hospitals today to prevent hospital-associated UTIs. Results of the survey sent to infection control specialists in over 700 hospitals nationwide yielded a response rate of 72 percent. Hospitals included Veterans Affairs (VA) hospitals as well as non-federal hospitals.

Survey results

The survey indicated that monitoring practices across VA and non-VA hospitals were similar. Over 50 percent of hospitals did not have a monitoring system for patients with indwelling catheters, greater than 70 percent did not monitor the duration the catheter was in place, and almost 30 percent of reporting hospitals did not have any CA-UTI surveillance. Prevention practices included 30 percent of hospitals reporting the use of antimicrobial urinary catheters and portable bladder scanners, 14 percent reported using condom catheters in men, with only nine percent using catheter reminders and suprapubic catheters.

Important findings

The findings indicate that despite evidence that links indwelling catheters to UTIs, only a small minority of hospitals actually track their hospitalized patients with indwelling catheters and there are no common widely used strategies to prevent hospital acquired UTIs. The two most commonly reported prevention practices – use of antimicrobial catheters and bladder ultrasounds – were used in fewer than one-third of surveyed hospitals.
VA hospitals were more likely to use bladder scanners but less likely to use antimicrobial catheters. Another important finding: less than 10 percent of hospitals used urinary catheter reminders despite the evidence indicating the success of this practice. In an accompanying editorial, Lindsay Nicolle, MD, reinforces the idea that to optimize patient safety, monitoring the use of and duration of indwelling urinary catheters is necessary. "There seems no reasonable argument against expecting facilities to collect, distribute, and act on this information for indwelling urethral catheters," Dr. Nicolle stated.

UTI in post-op, older patients

In another recent study that monitored postoperative indwelling urinary catheters in older patients, researchers found those patients have poorer outcomes. The main purpose of this study was to characterize the relationship between the extended postoperative use of indwelling urinary catheters and outcomes for older patients who have undergone cardiac, vascular, gastrointestinal, or orthopedic surgery in skilled nursing facilities, and to describe patient and hospital characteristics associated with the extended use of indwelling urinary catheters. Twenty three percent of more than 170,000 Medicare patients over the age of 65 included in the study were discharged to a skilled nursing facility with and indwelling catheter in place. These patients were found to have a higher risk of re-hospitalization for UTIs and death within 30 days than those patients who did not have catheters. Patients from hospitals in the northeastern or southern regions of the United States had a lower likelihood of having an indwelling urinary catheter, compared with hospitalized in the western region. This disparity led researchers to conclude that there are geographic variations in practice that should be the focus of further study.

The use or non-use of preventive practices for hospital acquired UTIs may soon have major implications for all hospitals. The Centers for Medicare and Medicaid (CMS) has decided that for all discharges occurring on or after October 1, 2008, hospitals will not receive reimbursement for cases in which certain hospital acquired conditions (HAC) were not present on admission. This includes the additional costs associated with treating hospital acquired CA-UTIs.

Downloads and links [located online at Safety Share Newsletter, Premier Inc.]

•Saint S. et al, CID, January 2008 Survey abstract.
•Nicolle, CID, Editorial January 2008
•ICHE, Wald, ICHE Post op study January 2008
•Hospital-acquired conditions (HAC) information available; Premier Safety Institute’s CMS standards, HAC

Additional Information:

Surveyed hospitals: Only 10-30 percent use successful CA-UTI prevention practices. Safety Share Newsletter, Premier Inc.
http://www.premierinc.com/quality-safety/tools-services/safety/safety-share/02-08-full-txt.jsp#story-06

Hospital-acquired conditions (HAC) information available; Premier Safety Institute’s CMS standards, HAC
http://www.premierinc.com/quality-safety/tools-services/safety/topics/guidelines/cms-guidelines-4-infection.jsp#HAC

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Testing the technology acceptance model for evaluating healthcare professionals intention to use an adverse event reporting system

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Wu JH, Shen WS, Lin LM Greenes RA, Bates DW
Oxford Journals

Abstract:

Background. Many healthcare organizations have implemented adverse event reporting systems in the hope of learning from experience to prevent adverse events and medical errors. However, a number of these applications have failed or not been implemented as predicted.

Objective. This study presents an extended technology acceptance model that integrates variables connoting trust and management support into the model to investigate what determines acceptance of adverse event reporting systems by healthcare professionals.

Method. The proposed model was empirically tested using data collected from a survey in the hospital environment. A confirmatory factor analysis was performed to examine the reliability and validity of the measurement model, and a structural equation modeling technique was used to evaluate the causal model.

Results. The results indicated that perceived usefulness, perceived ease of use, subjective norm, and trust had a significant effect on a professional's intention to use an adverse event reporting system. Among them, subjective norm had the most contribution (total effect). Perceived ease of use and subjective norm also had a direct effect on perceived usefulness and trust, respectively. Management support had a direct effect on perceived usefulness, perceived ease of use, and subjective norm.

Conclusion. The proposed model provides a means to understand what factors determine the behavioral intention of healthcare professionals to use an adverse event reporting system and how this may affect future use. In addition, understanding the factors contributing to behavioral intent may potentially be used in advance of system development to predict reporting systems acceptance.

Keywords: technology acceptance model, trust, patient safety, reporting systems

Additional Information:

Testing the technology acceptance model for evaluating healthcare professionals intention to use an adverse event reporting system. Wu JH, Shen WS, Lin LM Greenes RA, Bates DW. Oxford Journals.
http://intqhc.oxfordjournals.org/cgi/content/abstract/mzm074v1

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HeartNet

Of Special Interest to Electrophysiology and Cath Lab Staff/HeartNet

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Prevent life-threatening communication breakdowns

By Roberta Sullivan, RN, BSN, MPH and Ann Ferriter, BS

FDA Medical Device Safety Page (Article reprinted from February Nursing2008, Volume 38, Issue 2.)

A patient died after uneventful elective surgery because his implantable cardioverter defibrillator (ICD) was not turned back on after the procedure. The ICD had been inactivated because exposure during surgery to any electromagnetic interference (EMI), and particularly to electrocautery devices, can cause ICD malfunction. The article gives tips on communication strategies and utilization of the facility’s patient-safety systems to prevent these types of adverse events.

Additional Information:

Prevent life-threatening communication breakdowns. Sullivan, Roberta; Ferriter, Ann. FDA Medical Device Safety. February 7, 2008.
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/TipsandArticlesonDeviceSafety/ucm070060.htm

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LabNet

Of Special Interest to Laboratorians/LabNet

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FDA Reminds Healthcare Professionals About Falsely Elevated Glucose Levels

FDA is reminding healthcare professionals of the potential for life-threatening falsely elevated glucose readings in patients who have received parenteral products containing maltose or galactose, or oral xylose and are subsequently tested using glucose dehydrogenase pyrroloquinolinequinone (GDH-PQQ) based glucose monitoring systems. In patients undergoing peritoneal dialysis with drugs such as Extraneal (Icodextrin) falsely elevated glucose levels have been observed and acted upon with blood glucose monitoring devices and test strips that use GDH-PQQ based methods. Subsequent to several documented deaths and injuries requiring intervention that occurred previous to 2005 and 2006, label warnings were added to the drug(s) and to the meters.

This remains an ongoing interest to the FDA, as they have recently received a medical device report where a hospital patient, administered with Extraneal and tested using a GDH-PQQ based meter and test strip, was treated for a falsely elevated hyperglycemia and died of hypoglycemia.

For additional information:

FDA Office of In Vitro Diagnostics News Archive. FDA Reminds Healthcare Professionals About Falsely Elevated Glucose Levels.


FDA Center for Biologics Evaluation and Research. Important Safety Information on Interference With Blood Glucose Measurement Following Use of Parenteral Maltose/Parenteral Galactose/Oral Xylose-Containing Products.

Roche Diagnostics Safety Alert. ACCU-CHEK Blood Glucose Monitoring Systems – Reminder of Potential for Falsely Elevated Blood Glucose Readings Due to Drug Interferences.

______________________________________________

Reminder: Users of Blood Glucose Meters Must Use Only the Test Strip Recommended For Use With Their Meter

Background:

The US Food and Drug Administration, Abbott Diabetes Care, and LifeScan are aware of instances where incorrect results were obtained using LifeScan OneTouch® Ultra® test strips with Abbott Precision Xtra® meters. OneTouch® Ultra® test strips are not intended for use with Precision Xtra® meters, and doing so may lead to lower than expected blood glucose results. Similar problems can also occur if other brands and models of meters and strips are not used in proper combination.

It is important for users to understand that if they use a test strip that is not recommended for their meter, the device may fail to give results or may generate inaccurate results.

Recommendations:
Users of blood glucose meters should carefully read the Owner’s Manual and only use the test strips that are specified for that meter. As an additional check, the test strip inserts identify the blood glucose meters with which they should be used.

Healthcare providers and pharmacists should advise their patients to use only test strips that are compatible with their meter.


_____________________________________________

FDA's Office of In Vitro Diagnostics has cleared the following devices for marketing:

Here you can see new In Vitro Diagnostic Devices recently approved for marketing:

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

Click under the left hand column "Quick Links" on the link "New OIVD products (since 2/21/2008)"
______________________________________________

Additional Information:

Fatal Iatrogenic Hypoglycemia: Falsely Elevated Blood Glucose Readings with a Point-of-Care Meter Due to a Maltose-Containing Intravenous Immune Globulin Product
http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/ucm155099.htm

FDA Center for Biologics Evaluation and Research. Important Safety Information on Interference With Blood Glucose Measurement Following Use of Parenteral Maltose/Parenteral Galactose/Oral Xylose-Containing Products.
http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/ucm154213.htm

Users of Blood Glucose Meters Must Use Only the Test Strip Recommended For Use With Their Meter
http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/InVitroDiagnostics/GlucoseTestingDevices/ucm162016.htm

Here you can see new In Vitro Diagnostic Devices recently approved for marketing
http://www.fda.gov/cdrh/oivd/

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Highlighted MedSun Reports

Highlighted Reports

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This section contains a sample of reports from all the MedSun reports received during a particular period. The reports were submitted by MedSun Representatives. In some instances the reports have been summarized and/or edited for clarity. The entries that follow represent a cross section of device-related events submitted by MedSun reporters during the period January 1 through January 31. All other reports can be searched under the ‘MedSun reports’ menu pane. Note: the two month delay is due to quality control and follow-up.

ANESTHESIOLOGY

Device: Blade, Laryngoscope; FiberOptic Light Blade; GreenLine
Manufacturer: Sun Med Healthcare
Problem: The fiber-optic laryngoscopes blades are labeled with small identification markers that look like plastic green dots, and are approximately 1/4 inch in diameter. The green dots, which are located at the back side above the interface with the handle, come loose after sterilization. The loose dots present a patient safety hazard of being swallowed, or otherwise being absorbed into bodily cavities. The hospital received about 100 new fiber-optic laryngoscope blades, and after the first sterilization cycle, it was noticed that loose green dots were present within the sterilization packages. The inventory was removed from service, and the vendor was contacted to immediately replace the defective inventory. Unless users are trained to examine each product for a loose or missing dot defect, it is difficult to detect this problem.

Device: Anesthesia Machine; S/5 Anesthesia Delivery Unit (ADU); Compact Block P/N 8503666
Manufacturer: GE Medical Systems, LLC
Problem: Obese male patient in OR for explorative laparotomy for incarcerated hernia. Rapid Sequence Induction with cricoid pressure planned for patient's morbid obesity and unsure NPO status. Difficulties occurred with laryngoscope, necessitating mask ventilation. Oxygen saturation fell to 88%. Unable to fill bag on machine. Patient was hand bagged and then intubated. Check of machine showed broken connection at seat of CO2 absorber. Machine replaced in room and patient suffered no further problems. Biomed checked out equipment after the event. Problem initially could not be duplicated, but on closer inspection one of 4 plastic latching pins had broken off even though testing did not replicate previous problems.
======================
Manufacturer response for Anesthesia Machine, GE Datex Ohmeda
======================
The GE Datex Ohmeda representative stated that the compact block style we use is obsolete and no longer in production. He also stated that this type of breakage (one plastic pin was broken although problem could not be duplicated) has been noted by other users who autoclave their blocks. Our concern is that there may be other users of this type of compact block that could be at risk. As of the date of this report, current production style compact blocks that use metal pins have been delivered and will be put into service as soon as possible.

Follow-up reveals that the compact block is a part of the anesthesia machine to which the CO2 absorber cannister is attached, and held in place by the latching pins described in the report (One of which broke). In the newer production style compact blocks, the plastic pins opposite the locking / releasing latch have been replaced by a metal pin that extends from one side, through the block to the other side. GE Datex Ohmeda was unable to differentiate the production styles based on the part number alone. Only the metal pin style is available at this time. The company's tech support department was unable to define the changeover more precisely than around November of 2003. The compact blocks are date coded in the format YYYY-WW. The blocks we have with all-plastic tabs are date coded from 1999 and 2002.

Device: Valve, Tracheostomy, Speaking; Shiley Phonate Speaking Valve; catalog #SSVO
Manufacturer: Nellcor
Problem: Pt. had a speaking trach valve in place. Anesthesiologist inflated cuff, therefore, pt. could not exhale (acts as a 1-way valve for speaking when cuff deflated). The device was not labeled as such and physician unfamiliar with valve. Able to get air in lungs, but not exhale. Pt. suffered a cardiac/respiratory arrest and died.

Device: Ventilator; model #840
Manufacturer: Puritan Bennett Corporation
Problem: Pt on ventilator was having difficulty breathing. When Resp therapist attempted to adjust vent parameters, screen went black and high-pitched tone emitted from machine. Pt removed from vent and bagged w/ 100% oxygen. After shutting off vent, restarted with same black screen present. Vent removed and sent to Biomed. Pt placed on new vent. Biomed report: Vendor service requested. Vendor tech reported GUI CPU failure; warranty replacement of GUI keyboard necessary.

Device: Monitor, Module, Anesthesia; S/5, M-PRETN; model #M-PRETN
Manufacturer: GE Medical Systems Information Technologies
Problem: Prior to a surgical procedure and during a patient intubation, the anesthesia machine monitor exhibited a non-invasive blood pressure failure giving a "NIBP Occlusion Fail" error message. Even after replacing (removing and reinserting) the module the error message would not clear unless the monitor power was recycled. Biomedical has sent modules back for repair with this problem only to be returned back to us un-repaired due to "no problem found". Later the same module would fail once again. We have returned up to 6 modules for this exact failure to the manufacturer (MFR). They come back with could not duplicate any of the failures. The modules returned to us with replaced boards would become operational once again. Biomedical has determined that there is an intermittent problem with these modules that can fail at any time and the problem lies in the NBP interface PCB. Biomedical was able to recreate the failure. During calibration of the NIBP module failure mode, biomedical note that transducer B2 would gave a zero reading during a pressure increase on the test bulb. Transducer B1 would track the increase in pressure. Another module would be placed on the same anesthesia machine and a calibration check would show that the good module would have both transducers B1 & B2 track the pressure increase correctly. A similar failure was confirmed by the manufacturer (MFR). The Field Service Report (FSR) and module were sent back for analysis. The MFR could not duplicate the problem on a returned module tested by the Field Service Engineer (FSE), but they still replaced the NIBP interface PCB as a precaution.

Device: Adapter, Hose, Respiratory; catalog #1422; Other device #15 mm I.D./ 22mm O.D.
Manufacturer: Hudson Respiratory Care, Inc.
Device: Nebulizer; Micro Mist; catalog #1883
Manufacturer: Hudson Respiratory CAre, Inc.
Problem: The patient was admitted to the PACU with anesthesia at the bedside. On admission the patient was non-responsive with an oral airway and endotracheal tube (ETT) intact. Breath sounds clear bilaterally. The patient was connected to a monitor with oxygen saturations 88-89 increasing to 92%, respirations deep at 16, EKG with a sinus rhythm , heart rate at 105, BP 107/62. Anesthesia requested breathing treatment. An order was placed and Respiratory Therapist responded within minutes. Oxygen saturation remained at 88-92% with an intermittent waveform. The RT was going to get a ventilator, but stayed by the bedside and the assistant placed the nebulizer for the breathing treatment over the patient's ETT. The patient began coughing and RT stated the patient needed to be placed on a ventilator and went to get it. Within seconds, the patient's cheeks ballooned out and face became cyanotic. The apparatus was removed from the ETT with a "whooshing" sound when disconnected from the ETT. Immediately began bagging the patient with edema increasing in the face, eyes, neck and upper torso. Breath sounds were absent on the right. The EKG was sinus brady with a rate in the 50's. Code Blue called and CPR initiated. Physician at bedside punctured left chest with audible sound of air escaping. Patient transported to OR and expired a couple of days later. Additional device identifiers are not available. The issue is the inner diameter of the adapter allowed it to be attached directly to the end of the ET tube. We have now switched to a larger diameter adapter.

Device: Ventilator; Avea
Manufacturer: Viasys Healthcare Medsystems
Problem: While operating ventilator on batteries, ventilator would go into low battery alarm after very short periods of time despite battery indicators showing fully charged batteries. There were a couple of instances where ventilator failed to switch from external to internal batteries despite indications of fully charged batteries. In all cases, ventilation function stopped and ventilator went into alarm.


GASTROENTEROLOGY/UROLOGY

Device: Kit, Extracorporeal Photopheresis; lot # V744; catalog # XT125
Manufacturer: Therakos, Inc. (A Johnson and Johnson Company)
Problem: At start of Extracorporeal Photopheresis procedure treatment noted leakage in kit at site of inlet tubing connection to centrifuge bowl (connections had appeared secure). Breach of sterility & potential for air being pulled into kit. Contacted Therakos & aborted treatment. Approximately 30 ml blood loss in kit. Patient did not contact nonsterile blood or fluids as none was returned to patient from this kit. Assessed patient & labs & vital signs. Reprimed new kit - no leakage or loose connections noted. Continued with Extracorporeal Photopheresis procedure without problems; patient tolerating well. Returned 3" piece of tubing at leakage site to Therakos after cleaning with bleach solution 1:10. Notified MD.


GENERAL HOSPITAL

Device: Drug transfer device; PhaSeal
Manufacturer: Carmel Pharma Inc
Problem: Upon removing chemo from bag the spike had broken off and taxol spilled into bag and on the portable table. Appropriate spill protocol. New chemo ordered from pharmacy. Pt received treatment with minimal delay.
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Manufacturer response for Drug transfer device, PhaSeal
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Problem: The spike of the above adapters may fracture when used with a certain combination of drugs and intravenous bags. The manufacturer issued a Technical Bulletin letter. The firm has updated its training procedures for the above product, as well as the product's instructions for use. Health Canada has designated this action Type II Recall. Action Needed: Verify that you have received the Technical Bulletin letter from Carmel Pharma. Identify any affected product in your inventory. Refer to the manufacturer’s letter and updated instructions for use when using the above adapters. For further information, contact Carmel Pharma by telephone.

Device: Traction Assist System; Hill-Rom VersaCare Patient Helper Adapter; catalog #
00-0965-000-00
Manufacturer: Zimmer , Inc.
Problem: Hospital purchased Hill-Rom Versa Care beds for use on a newly opening Trauma Specialty Care Unit. We had a need for traction patient assist brackets for the new beds. (Hill-Rom publishes a document of traction accessories available from other vendors for the Versa Care bed on their website @ hill-rom.com ) We purchased the Zimmer Patient Helper bracket/bar assembly only to find out once they were installed on the beds that there is an inherent safety problem with the bracket set up. This helper bar slides into a tube attached to the head of the bed and is secured by a hand knob at an adjustment clamp, allowing you to vary the height of the bar assembly above the patient. If you attempt to adjust the bar by loosening the hand clamp, and you are not holding onto the bar, it will slam down towards the patient's head. There is a potential for serious injury. The other problem identified; as the bar slams down, the metal on the bar gets shaved, to a point of having very sharp burrs left on the bar. Those burrs could cause cuts to caregiver’s hands or anyone who tries to get the bar off the bed.
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Manufacturer response for Traction Patient Assist Bar, Hill-Rom VersaCare Patient Helper Adapter
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Initially they indicated there was no type of safety lock or stop available and that when we adjusted the bar we had to hold on to it. Today we had a rep from Zimmer come in to see our concern first hand, we gave him a little demo of the slamming down of the bar on an empty bed, and showed him the shaved metal burrs on the bar afterwards.

Device: tubing, IV, Burette Set; Horizon; various lot #’s; model #375150
Manufacturer: B. Braun Medical, Inc.
Problem: Our facility has recently switched to B Braun's Horizon Pump Burette Set (Buretrol Set). It was noticed on our units that there is a "disc" in this device that is supposed to float on top of the medication and as the medication is delivered to the patient, it floats down and upon completion of delivery closes off the drip. Unfortunately this "disc" was floating down prematurely and closing off medication being delivered before completion. In contacting the company, they advised our staff to "turn the buretrol over if the chip floats to the bottom." Our staff members are not comfortable doing this and are afraid it could lead to safety issues. They feel this suggested fix is a nuisance and may actually cause errors with late infusions if the RN has to repeatedly go in to ensure device is infusing properly. We had previously used a set without a "disc" and will hopefully be switching to B Braun's device which is essentially the same as this minus the "disc." The device packaging of the product with the disc does indicate "re-floating of the disc" and advises how to do so.

Device: bed, hospital; 3002 Secure II
Manufacturer: Stryker Medical
Problem: There has been a chronic problem with bed brakes not working after two to three months. The facility has had numerous discussions with the manufacturer to resolve the problem. Manufacturer has developed several repair kits which have not resolved the problem. Current kit reduces the brakes ability to prevent caster swiveling.

Device: Bed, Patient, Alarm; VersiCare Bed with Prime Air Mattress; model #455
Manufacturer: Hill-Rom Company, Inc.
Problem: The bed scale and bed alarm are coordinated. Staff unfamiliar with how the bed operates, inadvertently "zero" the bed by randomly pushing buttons. When this happens the bed alarm cannot be reactivated until the patient is removed from the bed and the scale is again "zeroed" out. Therefore, those patients’ at risk for falling out of bed do not have the bed alarm protection.

Device: Drape, Slush; lot #0907003; catalog #ORS-320
Manufacturer: OR Solutions, Inc.
Problem: The OR staff were setting up for a CABG. The scrub technician reported that she had a puddle on the floor before she pulled the tables up to the operative field. She questioned the circulator, and both thought that some saline may have been accidentally poured on the floor when the slush machine was initially loaded for the case. However, during the surgery, the scrub technician reported needing more saline to make slush. Otherwise, the surgery itself was uneventful. At the end of the case, as staff were taking the equipment down, staff noted that there was a hole in the drape that lined the slush machine and that saline was standing in the machine. Upon closer examination, there was an area around the disk in the drape that was steadily leaking. Per staff, no instruments are placed in the slush machine. Staff state that it is not possible that an OR instrument or another piece of equipment could have caused or contributed to the hole. No patient or staff were harmed in this event. The rep was notified of the event and has already picked up the device. Staff suspect that the hole was present prior to opening the drape. In reviewing the event, staff are confident that the saline they saw on the floor was a result of the leaking drape and not a spill.
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Manufacturer response for Sterile Slush drape, (brand not provided)
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The rep was contacted on the day of the event, and came to the hospital to pick up the device.


GENERAL SURGERY

Device: Table, Orthopedic; Pro FX; model # 6850
Manufacturer: Orthopedic Systems, Inc.
Problem: A technician described the problem with our Orthopedics Systems, Inc. (OSI) model ProFX, orthopedic table. The malfunction is an intermittent failure whereby the table will fail to go up or down (change elevation). In order to change the elevation of the table, all 4 brakes must be on. When the brakes are on the brake light indicator should be "on." The problem is that the indicator light is showing the opposite of what is true. In other words, when the brakes are on the indicator light is "off" and when the brakes are off the indicator light is "on." Thus the user, thinking the brakes are properly engaged because the indicator light is "on," is unable to change the elevation of the table as expected. To resolve this problem and change the elevation of the table, the user must either press the override button or perform the additional steps of locking and unlocking the table brakes to get the electronics in sync with the foot brakes. The table will then go up or down properly. This failure is believed to be a result of the electronic safety update performed late last year. There may be a new upgrade available to resolve this newest safety operation issue. This orthopedic table is only 10 months old. Another model, Allegro may also be prone to this failure.


LABORATORY

Device: Monitor, PT/INR; INRatio PT Monitoring System
Manufacturer: HemoSense, Inc.
Problem: The patient has a history of post-op DVT and pulmonary emboli diagnosed five weeks ago after ventral hernia repair. He was treated with IV unfractionated Heparin and Coumadin at that time. He was eventually stabilized on oral Coumadin and was discharged home with instructions to continue with Coumadin 5mg po every night, and to have daily PT/INR levels called to the physician. A day prior to the event, the PT/INR level was obtained per fingerstick, and the level was 1.6. The physician was contacted and he increased the Coumadin dosage to 15mg. The patient had been participating in physical therapy at home. The next day, the patient was noted to have left back pain, and shoulder discomfort along with generalized weakness. He suffered a syncopal episode and was transported to the hospital. His lab results included a hemoglobin (9.1) and hematocrit (27.1). The platelets were 199,000 and the INR was 10.5. The patient was admitted to the ICU and given Vitamin K. There were two separate HemoSense machines that could have been used and both are sequestered and will be analyzed.


NEUROLOGY

Device: Monitor, EEG; model# nEEG
Manufacturer: Nicolet Biomedical
Problem: The NicoletOne nEEG amplifier has an event button for the nurses or family to press when the patient is seizing. Activation of the event button will mark the patient’s record and activate a relay. The relay is used to call the nurse for help by activating the nurse call system. The marking of the record works fine with every button press. The nurse call activation will not work if the button is pressed more than once in a two second period. The button can be repeatedly pressed for long periods of time without triggering a call to the nurse. If the button is pressed just once it works fine. There is a two second delay from when the button is pressed to when the nurse call is activated by the Nicolet relay. This delay may cause the user to press the button again because it appears as though it didn’t work the first time.
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Manufacturer response for Long-term EEG monitor, Nicolet Biomedical
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They have reproduced the problem. They may try to resolve through changes in the software programming.

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Updated April 1, 2008

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