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2005 Advisories and Alerts

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FDA issues reminder on Dec. 31 medical telemetry deadline
On November 16, 2005, The Food and Drug Administration issued a public health notification to health care facilities, warning them that after Dec. 31, 2005, any wireless medical telemetry system operating in the 460-470 MHz frequency band is at increased risk for interference, which could compromise patient safety. On November 17, the American Hospital Association (AHA) and ASHE issued a joint regulatory advisory urging hospitals to assess their risks of interference to wireless medical telemetry systems operating in the 460-470 MHz band and to migrate out of the band by Dec. 31, 2005. This FDA notification reinforces previous advisories issued by AHA and ASHE on June 15, 2005 and July 23, 2004, updating members on the issue.


ASHRAE Proposed New Standard 170, Ventilation of Health Care Facilities – Comments due by November 7, 2005
This standard defines ventilation system requirements that provide environmental control for comfort, asepsis, and odor in health care facilities (including hospitals, nursing facilities, and outpatient facilities). The new standard addresses:

  • Systems and Equipment (including air handler design, outside air intakes and exhaust discharges, filtration, cooling coils, drain pans, and humidifiers)
  • Space Ventilation (including general requirements, AII & PE rooms, critical care units, wound units, operating rooms, invasive imaging rooms, morgue and autopsy rooms)
  • Planning, Construction, and System Startup (including planning for HVAC services in new and existing facilities, infection control during remodeling, and duct cleanliness)
  • Appendices on negative differential air pressure and air distribution, design and construction of drain pans, and Operations and Maintenance procedures.

It is critical that ASHE members review and provide comments to the ASHRAE before it is adopted as a new standard.


EPA Proposes Standards on New Generators
On July 11, 2005, the Environmental Protection Agency (EPA) published a proposed rule in the Federal Register that sets performance standards for stationary compression ignition internal combustion engines. Although this proposed rule affects many industries, it specifically affects healthcare providers with emergency generators, engine powered fire pumps, and generators used for peak shaving or load curtailment.


Meeting the Requirements of USP <797>: Understanding Pharmaceutical Clean Room Design
A key component of the USP <797> standard is the creation of environmental controls to reduce the potential for airborne contaminates at and around the work surfaces where compounding of sterile drug products is performed. A proper HVAC system is a critical part of the creation of this pharmaceutical clean room environment. ASHRAE has granted ASHE special permission allowing ASHE members to access the article Understanding Pharmaceutical Clean Room Design by John Zhang, P.E.

This article, originally published in the ASHRAE Journal – September 2004, describes the fundamental of clean room design, the sources of and controls for airborne particles, the air change rates to achieve ISO classifications of particulate matter in room air. This article provides a clear engineering approach to the design of clean rooms and provides invaluable insight into the complexities of meeting USP <797> clean room requirements.

To access this article go to www.ashe.org/ashe/codes/epa/ pdfs/JournalSept2004PharmacyDesign.pdf.


ASHE Proposes Amendment To NFPA 99 For Safe Usage Of Alcohol Based Surgical Prep Solutions, suggests hospitals cited by CMS consider requesting a waiver
ASHE has submitted a tentative interim amendment (TIA) request to the National Fire Protection Association (NFPA) for the Standard on Health Care Facilities (NFPA 99). This proposed TIA amends and expands language that currently does not permit the use of alcohol based surgical prep solutions in surgical cases where an ignition source (cautery, laser, etc.) may be used. The current code language dates back to the mid 1970's and has not kept up with current surgical practice. ASHE's TIA expands the current language and provides requirements for increased management of the solutions and practice to assure that the surgical site is dry before the ignition source is introduced to the surgical site therefore eliminate the potential for ignition of flammable vapors from the flammable liquid. More...


FDA Alert – Vail hospital bed systems
The Center for Devices and Radiological Health, Food and Drug Administration has posted on the FDA website an update to the Preliminary Public Health Notification, Vail Products Enclosed Bed Systems. The Notification is available at www.fda.gov/cdrh/safety/032505-vail.html. The Notification provides important updated safety information to prevent entrapment for users of Vail Products Enclosed Bed Systems.


JCAHO announces 2006 Patient Safety Goals
On June 1, 2005 the Joint Commission on Accreditation of Healthcare Organizations released six National Patient Safety Goals and associated requirements for accredited hospitals and critical access hospitals in 2006. Additions to the fourth annual JCAHO goals include a requirement under the goal to “improve the effectiveness of communication among caregivers” that hand-off of patients between caregivers be standardized, with particular attention to assuring the opportunity for asking and responding to questions. JCAHO removed a requirement under the same goal that hospitals identify three organization-specific “do not use” abbreviations, acronyms or symbols in addition to the list defined by JCAHO. A new requirement under the goal to “improve the safety of using medications” specifies that all medications, medication containers and other solutions used in perioperative settings are to be labeled. Overall, the 2006 goals have the same number of requirements as this year, JCAHO noted. Click here for the goals.


DHS issues Bulletin on False Hospital Inspections
On Monday April 25, the American Hospital Association (AHA) released a Disaster Readiness Advisory to members disseminating information contained in an information bulletin from the Department of Homeland Security (DHS) titled: False Hospital Inspections. The AHA advisory is intended to raise awareness of individuals, alleging to represent JCAHO or other organizations, seeking to gain access to hospitals or information on hospital operations. The advisory provides contact information for reporting suspicious behavior to the FBI or Homeland Security. The DHS bulletin details three incidents of individuals posing as JCAHO surveyors to obtain entry into hospitals in Los Angeles, Boston, and Detroit. In this bulletin, DHS provides multiple recommendations to hospitals and specifically identifies locking restricted areas (including HVAC and utility equipment areas) and increased surveillance by security forces.


Revised JCAHO Standard Focuses on the Statement of Conditions LSC Assessment
Effective July 1, 2005, the Joint Commission (JCAHO) will survey for an additional Element of Performance (EP) focusing on the assignment of the person(s) who complete the organization’s Statement of Conditions (SOC). Although the EP is new, the expectations that it establishes are not new and should not present an additional compliance issue for most organizations. Because this new EP highlights a current expectation, organizations should be prepared to discuss their process and compliance strategy. ASHE's Regulatory Advisory describes the new element of performance and offers clarification and guidance on compliance.


FDA issues safety alert on Vail hospital bed systems
In a response to ongoing concerns about quality and labeling, the U.S. Food and Drug Administration and the Department of Justice yesterday seized three models of “enclosed bed systems” from Vail Products Inc. in Toledo, OH. The FDA said the Vail 500, 1000, and 2000 models pose a public health risk if used, because patients can become entrapped and suffocate, resulting in severe neurological damage or death. The agency is aware of roughly 30 entrapments resulting from use of the bed systems, at least seven of which resulted in death. In addition to the bed systems seized from the manufacturer, about 1,000 of the Vail 2000 bed systems and 400 of the Vail 500 bed systems have been distributed to health care facilities, while about 3,600 of the Vail 1000 model have been distributed to consumers, a FDA spokesperson said. She said those health care providers and consumers should immediately stop using the beds, and can call (800) 638-2041 for more information.


NFPA proposal for annual testing of fire and smoke dampers is defeated - ASHE member’s grass roots advocacy is credited for the reversal
The NFPA 90A committee proposal to increase testing of dampers from every four years to annual testing was defeated in the January 2005 vote of the technical committee. This stunning reversal (the proposal had originally been accepted by a vote of 20-2) was a direct result of the comments submitted by 753 ASHE members. In rendering this decision the committee stated: “The committee appreciates the damper reliability data gathered by the healthcare industry during the comment period” and “Data provided by the health care industry indicated the reliability of dampers when properly installed”.

NFPA identified four reasons for rejecting the proposal (these reasons were consistently identified in the comments):

  • No data was provided by the submitter of the proposal substantiating the need for increased frequency of testing
  • Low failure rate of dampers during testing, particularly during subsequent testing cycles. Most hospitals reported a 2-3% failure rate on the second or third cycle (often improper installation was identified a the reason for failure during initial testing)
  • The testing process raises dust and may cause increased risk of infection to susceptible patients.
  • The increased cost (4X) is prohibitive given the small failure rate.

Doug Erickson and Dale Woodin represented ASHE members at technical committee meeting (December 8-11, 2004) to encourage the committee’s review of the data and discussion that led to the rejection of the proposal. The ASHE member data substantiated the argument that, when dampers are installed properly, and not damaged during maintenance or renovation work, they are not typically prone to failure. In recognition of this finding, the committee developed new code language allowing routine damper testing in healthcare organizations to be extended to every six years provided that acceptance testing is performed on all newly installed or repaired dampers or where work on the duct system is performed within 6 ft of a damper.

The value of the industry-supplied data in improving this testing standard cannot be overstated. There is a direct cause and effect relationship between the data supplied in ASHE member comments and the recognition that routine testing frequency can be reduced without reducing patient safety or device performance. The success of this process opens the door for further opportunities to evaluate routine testing requirements of other fire safety devices and systems up against their actual performance. Please take a moment to review the list of 753 ASHE members who took the time and effort to supply comments - and then recognize their grass roots contribution next time you see them at your chapter meeting or at the ASHE Annual Conference. Because of their work, the technical committee had the right information to make the right decision.

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