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MCN Healthcare: StayAlert! - Immediate Regulatory Updates Icon

StayAlert! Headlines

Sep 30 2014
CMS – Categorical Waiver for Power Strips Use in Patient Care Areas

CMS published a Memorandum on September 26, 2014 addressing a categorical waiver for power strips use in patient care areas.

CMS has determined that the 2000 edition of the National Fire Protection Association (NFPA) 101® Life Safety Code (LSC) contains provisions on the use of power strips in health care facilities that may result in unreasonable hardship for providers or suppliers. Further, an adequate alternative level of protection may be achieved by compliance with the 2012 edition of the LSC, which has extended allowances on the use of power strips in patient care areas.

CMS is permitting a categorical waiver to allow for the use of power strips in existing and new health care facility patient care areas, if the provider/supplier is in compliance with all applicable 2012 LSC power strip requirements and with all other 2000 LSC electrical system and equipment provisions and only if the waiver does not adversely affect the health and safety of patients.

Resident rooms in long-term care or other residential care facilities that do not use line-operated electrical appliances for diagnostic, therapeutic, or monitoring purposes are not subject to the more restrictive NFPA 99 requirements regarding the use of power strips in patient care areas/rooms. Resident rooms using line-operated patient care-related electrical equipment in the patient care vicinity must comply with the NFPA 99 power strip requirement and may elect to utilize this categorical waiver.

Individual waiver applications are not required.   Providers and suppliers are expected to have written documentation that they have elected to use the waiver.  A provider or supplier must notify the LSC survey team at the entrance conference that it has elected to use the waiver permitted under this guidance and that it meets the applicable waiver requirements. The survey team will review the information and confirm the facility meets the conditions for the waiver.

Requirements:

  • Patient bed locations in new health care facilities, or in existing facilities that undergo renovation or a change in occupancy, shall be provided with the minimum number of receptacles as required by section 6.3.2.2.6.2.
  • Power strips may be used in a patient care vicinity to power rack-, table-, pedestal-, or cart mounted patient care-related electrical equipment assemblies, provided ALL of the following conditions are met, as required by section 10.2.3.6:
    • The receptacles are permanently attached to the equipment assembly
    • The sum of the ampacity of all appliances connected to the receptacles shall not exceed 75 percent of the ampacity of the flexible cord supplying the receptacles
    • The ampacity of the flexible cord is suitable in accordance with the current edition of NFPA 70, National Electric Code
    • The electrical and mechanical integrity of the assembly is regularly verified and documented through an ongoing maintenance program
    • Means are employed to ensure that additional devices or nonmedical equipment cannot be connected to the multiple outlet extension cord after leakage currents have been verified as safe
  • Power strips may not be used in a patient care vicinity to power non-patient care-related electrical equipment (i.e., personal electronics).
  • Power strips may be used outside of the patient care vicinity for both patient care-related electrical equipment and non-patient-care-related electrical equipment.
  • Power strips providing power to rack-, table-, pedestal-, or cart-mounted patient care-related electrical equipment assemblies are not required to be an integral component of manufacturer tested equipment. Power strips may be permanently attached to mounted equipment assemblies by personnel who are qualified to ensure compliance with section 10.2.3.6.
  • Resident rooms in long-term care or other residential care facilities that do not use line operated patient-care-related electrical equipment are not subject to the more restrictive NFPA 99 requirements regarding the use of power strips in patient care areas/rooms
  • Resident rooms using line-operated patient-care-related electrical equipment in the patient care vicinity must comply with the NFPA 99 power strip requirement and may elect to utilize this categorical waiver.
  • If power strips are used in any manner, precautions as required by the LSC and reference documents are required, including but not limited to: installing internal ground fault and over-current protection devices; preventing cords from becoming tripping hazards; connecting devices so that tension is not transmitted to joints or terminals; no "daisy chaining" power strips; using power strips that are adequate for the number and types of devices, and no overloading power strips with high load devices. In addition, the use of ground fault circuit interruption (GFCIs) may be required in locations near water sources to prevent electrocution
  • Power strips providing power to patient care-related electrical equipment must be Special purpose Relocatable Power Taps (SPRPT) listed as UL 1363A or UL 60601-1
  • Power strips providing power to non- patient-care-related electrical equipment must be Relocatable Power Taps (RPT) listed as UL 1363.

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Sep 29 2014
Acute Neurologic Illness with Focal Limb Weakness of Unknown Etiology in Children

The Centers for Disease Control and Prevention (CDC) is working closely with the Colorado Department of Public Health and Environment (CDPHE) and Children's Hospital Colorado to investigate a cluster of nine pediatric patients hospitalized with acute neurologic illness of undetermined etiology. The illness is characterized by focal limb weakness and abnormalities of the spinal cord gray matter on MRI. These illnesses have occurred since August 1, 2014 coincident with an increase of respiratory illnesses among children in Colorado.

The purpose of this HAN Advisory is to provide awareness of this neurologic syndrome under investigation with the aim of determining if children with similar clinical and radiographic findings are being cared for in other geographic areas. Guidance about reporting cases to state and local health departments and CDC is provided.

The United States is currently experiencing a nationwide outbreak of EV-D68 associated with severe respiratory disease. The possible linkage of this cluster of neurologic disease to this large EV-D68 outbreak is part of the current investigation. CDC is seeking information about other similar neurologic illnesses in all states, especially cases clustered in time and place. CDC has particular interest in characterizing the epidemiology and etiology of such cases.

Recommendations:

  • Patients who meet the following case definition should be reported to state and local health departments:
    • Patients 21 years of age and younger with:
      • Acute onset of focal limb weakness occurring on or after August 1, 2014 AND
      • An MRI showing a spinal cord lesion largely restricted to gray matter
  • State and local health departments should report patients meeting the case definition to CDC using a brief patient summary form (www.cdc.gov/non-polio-enterovirus/investigation/). State health departments should send completed summary forms to CDC by email at limbweakness@cdc.gov.
  • Providers treating patients meeting the above case definition should consult with their local and state health department for laboratory testing of stool, respiratory, and cerebrospinal fluid specimens for enteroviruses, West Nile virus, and other known infectious etiologies.
  • Health departments may contact CDC for further laboratory and epidemiologic support by phone through the CDC Emergency Operations Center (770-488-7100), or by email at limbweakness@cdc.gov. Confirmation of the presence of EV-D68 currently requires typing by molecular sequencing.

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Sep 27 2014
FDA Issues Drug Safety Communication for Xolair (omalizumab)

A U.S. Food and Drug Administration (FDA) review of safety studies suggests a slightly increased risk of problems involving the heart and blood vessels supplying the brain among patients being treated with the asthma drug Xolair (omalizumab) than in those who were not treated with Xolair. As a result, FDA has added information about these potential risks to the drug label.

The review found no difference in the rates of cancer between those patients being treated with Xolair and those who were not being treated with Xolair. However, due to limitations in the 5-year study, FDA cannot rule out a potential risk of cancer with Xolair, so this information was added to the Warnings and Precautions section of the drug label.

Xolair is an injectable medicine for patients 12 years of age and older with moderate to severe persistent allergic asthma whose asthma symptoms are not controlled by asthma medicines called inhaled corticosteroids.

Patients taking Xolair should continue to take the medication as prescribed and discuss any questions or concerns with their health care professionals.

Read the MedWatch Safety Alert, including links to the Drug Safety Communication at the link below.

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