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MCN Healthcare: StayAlert! - Immediate Regulatory Updates Icon

StayAlert! Headlines

Feb 23 2015
Class I Recall of Certain GE MR Systems with Superconducting Magnets

The U.S. Food and Drug Administration (FDA) has issued a Class I Device Recall for certain GE Healthcare MRI systems with superconducting magnets.  According to the FDA's recall notice and the GE Healthcare press release, all GE MR Systems with superconducting magnets that were manufactured from 1985 through today are included in the recall.

GE Healthcare determined that some MR Systems in India have been modified by service personnel or by equipment users to disable the Magnet Rundown Unit. The Magnet Rundown Unit is one of the methods that may be used to shut off the magnetic field of the MR system in response to an emergency situation in or around the MR system. In emergency situations, a disconnected Magnet Rundown Unit could delay removal of a ferrous object from the magnet, potentially resulting in life threatening injuries. The Magnet Rundown Unit must be connected to the magnet at all times.

GE Healthcare has been notifying customers with superconducting magnets through an Urgent Medical Device Correction letter which:

  • Alerts users of the possible concern.
  • Advises users that the red Rundown button should be pressed only in an emergency situation.
  • Instructs the users to perform a short test that confirms if the Magnet Rundown Unit is functioning properly and has not been disabled. This test is an action that operator manuals currently advise users to do on a regular basis.
  • Informs the users that a GE Healthcare service representative will be visiting their site to inspect the Magnet Rundown Unit and make any corrections if needed.

GE Healthcare is following up with all customers and will correct affected systems at no cost to customers. For additional information regarding this field action, please contact GE Healthcare's Customer Service line (24 hours a day, 7 days a week) at 800-437-1171.

In an update GE Healthcare has also clarified the following:

  • The recall is not related to any manufacturing defect or product-related error. It was a case of human error on site, and is in response to a single safety incident in India. GE Healthcare wanted to ensure this human error was not occurring at other sites globally.
  • The action instructs MRI customers to perform a five minute check to ensure no one on site post-installation has disconnected the magnetic rundown unit (MRU), which is effectively an "emergency off switch" for the magnet. It is a common industry practice to have an "emergency off switch" for the magnet, which should be checked regularly. GE Healthcare already recommends that this check be done weekly.
  • Once the five minute check is confirmed, MRI operations can continue as normal.

Follow the links below for additional information.

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Feb 20 2015
CMS Issues Q&A Document on EMTALA and Ebola

The U.S. Centers for Medicare and Medicaid Services (CMS) is augmenting the guidance they issued in November 2014, regarding EMTALA requirements in the case of individuals potentially exposed to Ebola, with a new question and answer document.  Key points from the Q&A document include:

  • EMTALA applies to all individuals who come to the dedicated emergency department (ED) of a Medicare-participating hospital, regardless of type or presence of insurance coverage or ability to pay. Further, Medicare-participating hospitals with specialized capabilities are required within the limits of their capability and capacity to accept appropriate transfers of individuals protected under EMTALA from other hospitals, without regard to insurance or ability to pay.
  • The EMTALA requirements for hospitals are the same for individuals with possible Ebola Virus Disease (EVD) symptoms as all other possible emergency medical conditions (EMCs):
    • Provide an appropriate Medical Screening Exam (MSE) to every individual who comes to the Emergency Department (ED) for examination or treatment of a medical condition, to determine if they have an emergency medical condition (EMC)
    • Provide necessary stabilizing treatment for individuals with an EMC within the hospital's capability and capacity; and
    • Provide for appropriate transfers of individuals with EMCs if the hospital lacks the capability to stabilize them. Specific to EVD, hospitals are encouraged to follow the CDC guidance for appropriate isolation procedures to minimize the risk of cross-contamination to other patients, visitors, and healthcare workers. For example, the CDC publishes and updates accepted national standards of infection control practice for EVD. Hospitals should consult the latest CDC guidance and coordinate with State/local public health authorities for guidance related to ongoing care and treatment of patients with EVD.
  • All hospitals are expected, at a minimum to screen, isolate, and begin stabilizing treatment, as appropriate, for any individual with possible EVD symptoms. Hospitals should coordinate with their State/local public health authorities regarding ongoing care and treatment, including when it is appropriate to transfer individuals to hospitals with specialized capabilities and capacity to provide further assessment and/or stabilizing treatment for suspected or confirmed EVD.
  • In the event of an EMTALA complaint related to an inappropriate transfer and/or a refusal of a recipient hospital to accept an appropriate transfer, CMS will determine, with a case-specific review to determine whether the hospitals in question had the capability and capacity to provide the treatment necessary to stabilize an individual with EVD.
  • The CDC released interim guidance recommendations on December 2, 2014 suggesting three categories of designation of hospitals with respect to EVD: Frontline Healthcare Facilities; Ebola Assessment Hospitals; Ebola Treatment Hospitals. According to CMS, the CDC guidance is consistent with the EMTALA requirements for screening, stabilization and appropriate transfers because it presumes that hospitals at any of these levels would be expected to screen, isolate and begin stabilizing treatment, as necessary, of any individual who presents to the ED with possible EVD symptoms. The guidance also calls for hospitals to immediately contact their State and local health departments to coordinate ongoing care of individuals suspected to have EVD, including when transfers to higher levels of care are appropriate. This guidance is consistent with the EMTALA requirements for screening, stabilization and appropriate transfers.

There are over twenty questions and answers in the new Q&A document - covering topics including patient insurance / payor status, specialized capabilities, Screening Examinations and Stabilizing Treatment Requirements, patient rights and enforcement.  Follow the link below to access the full CMS EMTALA and Ebola Q & A document.

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Feb 19 2015
FDA Issues Drug Safety Communication Advising that Design of Endoscopic Retrograde Cholangiopancreatography (ERCP) Duodenoscopes May Impede Effective Cleaning

The U.S. Food and Drug Administration (FDA) has issued a drug safety communication to raise awareness among health care professionals, including those working in reprocessing units in health care facilities, that the complex design of ERCP endoscopes (also called duodenoscopes) may impede effective reprocessing.

Recent medical publications and adverse event reports associate multidrug-resistant bacterial infections in patients who have undergone endoscopic retrograde cholangiopancreatography (ERCP) with reprocessed duodenoscopes, even when manufacturer reprocessing instructions are followed correctly. Meticulously cleaning duodenoscopes prior to high-level disinfection should reduce the risk of transmitting infection, but may not entirely eliminate it.  Unlike most other endoscopes, duodenoscopes also have a movable "elevator" mechanism at the tip. The elevator mechanism changes the angle of the accessory exiting the accessory channel, which allows the instrument to access the ducts to treat problems with fluid drainage.

Although the complex design of duodenoscopes improves the efficiency and effectiveness of ERCP, it causes challenges for cleaning and high-level disinfection. Some parts of the scopes may be extremely difficult to access and effective cleaning of all areas of the duodenoscope may not be possible. In addition, a recent FDA engineering assessment and a growing body of literature have identified design issues in duodenoscopes that complicate reprocessing of these devices.

The FDA is closely monitoring the association between reprocessed duodenoscopes and the transmission of infectious agents, including multidrug-resistant bacterial infections caused by Carbapenem-Resistant Enterobacteriaceae (CRE) such as Klebsiella species and Escherichia coli. In the meantime the FDA recommends the following:

For Facilities and Staff that Reprocess ERCP Duodenoscopes:

  • Closely follow all manufacturer instructions for cleaning and processing.
  • The FDA recommends adherence to general endoscope reprocessing guidelines and practices established by the infection control community and endoscopy professionals, as described in the Additional Resources section, below. In addition, it is important to follow specific reprocessing instructions in the manufacturer's labeling for each device.
  • Even though duodenoscopes are inherently difficult to reprocess, strict adherence to the manufacturer's reprocessing instructions will minimize the risk of infection. Deviations from the manufacturer's instructions for reprocessing may contribute to contamination. The benefit of using cleaning accessories not specified in the manufacturer's instructions, such as channel flushing aids, brushes, and cleaning agents, is not known.
  • Follow these additional general best practices:
    • Meticulously clean the elevator mechanism and the recesses surrounding the elevator mechanism by hand, even when using an automated endoscope reprocessor (AER). Raise and lower the elevator throughout the manual cleaning process to allow brushing of both sides.
    • Implement a comprehensive quality control program for reprocessing duodenoscopes. Your reprocessing program should include written procedures for monitoring training and adherence to the program, and documentation of equipment tests, processes, and quality monitors used during the reprocessing procedure.
    • Refer to the Multisociety Guidelines on Reprocessing Flexible Gastrointestinal Endoscopes: 2011, link provided below.

Recommendations for Health Care Providers:

  • Inform patients of the benefits and risks associated with ERCP procedures.
  • Discuss with your patients what they should expect following the ERCP procedure and what symptoms (such as fever or chills, chest pain, severe abdominal pain, trouble swallowing or breathing, nausea and vomiting, or black or tarry stools) should prompt additional follow-up.
  • Consider taking a duodenoscope out of service until it has been verified to be free of pathogens if a patient develops an infection with a multidrug-resistant organism following ERCP, and you suspect that there may be a link between the duodenoscope and the infection.
  • Submit a report to the manufacturer and to the FDA, via MedWatch, if you suspect that problems with reprocessing a duodenoscope have led to patient infections.

Recommendations for Patients:

  • Discuss the benefits and risks of procedures using duodenoscopes with your physician. For most patients, the benefits of ERCP outweigh the risks of infection. ERCP often treats life-threatening conditions that can lead to serious health consequences if not addressed.
  • Ask your doctor what to expect following the procedure and when to seek medical attention. Following ERCP, many patients may experience mild symptoms such as a sore throat or mild abdominal discomfort. Call your doctor if, following your procedure, you have a fever or chills, or other symptoms that may be a sign of a more serious problem (such as chest pain, severe abdominal pain, trouble swallowing or breathing, nausea and vomiting, or black or tarry stools).

 

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