New JCAHO Standards, FCC Lifts Freeze, ACCE and ECRI Collaborate

New JCAHO Standards, FCC Lifts Freeze, ACCE and ECRI Collaborate

d02a.JPG (9752 bytes)New JCAHO Standards Now Online
On June 16, the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) announced the release of revised accreditation standards. The standards are effective January 1, 2004, and will impact hospitals, home care organizations, ambulatory care clinics, behavioral health care organization, laboratories, and long-term care organizations.

There are substantial changes, all with the goal of reducing the paperwork and documentation burden of the accreditation process. The total number of standards in the hospital accreditation program has gone from 550 to 260, and Environment of Care (EC) standards have been reduced from 40 to 24. Standards EC 6.10 and 6.20 have to do with the management of medical equipment risks and the maintenance, testing, and inspection of such equipment. The previous planning and implementation standards have been merged into one revised standard, and the EC education and staff knowledge requirements have been moved to the human resources chapter. Requirements addressing reporting, monitoring, and annual evaluation have also been moved.

The 2004 standards revision is an element of JCAHO’s “Shared Visions—New Pathways” initiative, an overview of which was presented on July 14 at the 2003 American Society for Healthcare Engineering Annual Convention in San Antonio.

The standards can be accessed prior to publication of the official accreditation manual on the JCAHO Web site: A crosswalk, which compares the old standard with the new, is also available on the site. The direct link to the hospital standards page, which includes the EC standards and crosswalk of EC standards, is at:

FCC Lifts Freeze
d02a.JPG (9752 bytes)Beginning October 16, 2003, the Federal Communications Commission will lift its freeze on the licensing of high-power mobile radio transmitters that operate in the same frequency range as many medical telemetry monitoring systems. This is likely to result in an increase in the number of licenses granted for new portable radio equipment, which may, in turn, cause random interference with medical telemetry monitoring systems.

Both the American Hospital Association and the American Society for Healthcare Engineering (ASHE) have been concerned with the problem of interference for the past several years. Until recently, interference from digital TV stations has been the focus of attention by hospitals. With the lifting of the freeze, any devices operating within 460 to 470 MHz will cause greater potential for random interference.

The American Society for Healthcare Engineering warns that interference can cause lapses in patient monitoring, missed alarms, unanticipated patient outcomes, and potentially, missed life-threatening events. The society recommends that an assessment be conducted to determine whether a facility’s telemetry equipment is at risk of interference before the freeze is lifted. It further recommends that safety and bioengineering personnel evaluate alternatives to equipment that might be at risk, make sure procedures for equipment inspection and maintenance are in place, ensure that contracts with service vendors protect the organization from any risk associated with interference, educate staff about risks associated with interference and the signs that warn of potential interference, and encourage reporting of events associated with interference.

Nellcor and ARCF Donate Pulse Oximetry Technology
On July 28, Nellcor (Pleasanton, Calif), a supplier of pulse oximetry and airway management products, announced that it has partnered with the nonprofit American Respiratory Care Foundation (ARCF) to donate Nellcor pulse oximeters and educational resources to 75 accredited respiratory therapy programs.

The ARCF selected recipients of the donated oximeters during the American Association for Respiratory Care Summer Forum, which was held in Lake Buena Vista, Fla, in July.

ACCE and ECRI Collaborate on HIPAA Special Report
The Health Insurance Portability and Accountability Act of 1996 (HIPAA) Security Rule has been finalized. Recognizing that this new federal regulation will have a major impact on biomedical technology programs, the American College of Clinical Engineers (ACCE) and ECRI, a nonprofit health services research agency, plan to enter into a cooperative agreement whereby the organizations will coproduce a special report on the HIPAA Security Rule as it relates to the field of health care technology. The document will contain an overview of the HIPAA Security Rule and will review compliance measures that must be taken related to medical technology and provide recommendations for implementing the rules, with specific medical technology-related examples. Both ACCE and ECRI expect this to be an important tool for all health care facilities’ HIPAA compliance programs.

The special report will be written primarily by ACCE, and ECRI will provide technical review and will be responsible for editing, production, printing, and distributes the report. ECRI will also be responsible for the development, design, and printing of promotional materials, with input from ACCE’s HIPAA task force. Both organizations will market the document on their respective Web sites and distribute the marketing materials to their members. ECRI will be responsible for processing all sales. Revenues will be shared equally between the two organizations.

Update of FDA Software Validation Guidance
Copies of the new US Food and Drug Administration regulatory guidance manual are now available from Biomedical Market Newsletter Inc. The manual, Medical Software Validation Guidance Manual, Vol 3 – 2002™, is a collection of nine FDA regulatory guidance documents, articles, and resources. The documents are intended for medical equipment, instrument, and device manufacturers that must validate the software that operates their products or is used during the manufacturing process.

ACCE Announces Clinical Engineering Certification Program
In response to the suspension of the Association for the Advancement of Medical Imaging (AAMI)–affiliated certification program for clinical engineers, the American College of Clinical Engineering (ACCE), under the auspices of the Healthcare Technology Certification Commission (HTCC) of the ACCE Healthcare Technology Foundation, announces a new certification program.

There are two ways for individuals to become certified in clinical engineering under this program:

1) HTCC certification via recognition of prior certification: Clinical engineers who have been certified by the International Certification Commission (affiliated with AAMI) may apply to have that certification recognized by the HTCC. The deadline to apply for recognition of prior certification is October 31, 2003.

2) HTCC certification via examination: Examination for HTCC certification in clinical engineering will be held periodically. The first examination will be held on November 22, 2003, in several cities throughout the United States. The deadline to apply for this examination is September 3, 2003.

Application forms are available at:

Questions may be directed to: