FDA Releases Guidance, GE Receives Regulatory Approval for Instrumentarium, ECRI Evaluates Sharps Disposal Containers

FDA Releases Guidance
On August 19th, the US Food and Drug Administration issued a guidance for industry and FDA staff titled “The Mammography Quality Standards Act Final Regulations Modifications and Additions to Policy Guidance Help System #6.” The document deals with testing of a mammography unit’s automatic exposure control (AEC) component and is intended to provide guidance to mammography facilities and their personnel.

In February the FDA released “The Mammography Quality Standards Act Final Regulations Modifications and Additions to Policy Guidance Help System #6 Draft Guidance” for public comment; 14 comments were submitted. In addition, the National Mammography Quality Assurance Advisory Committee reviewed the draft guidance and provided additional comments. In response to these comments, the FDA has modified this guidance by 1) further clarifying the term “equipment configuration,” 2) adding different image receptor sizes as separate equipment configurations, 3) not recommending that target-filter combinations be tested separately, and 4) emphasizing the need to minimize non-AEC component variability when conducting the AEC performance test.

The FDA guidance documents do not establish legally enforceable responsibilities. Instead, they represent the agency’s current thinking on a topic. They should be viewed as recommendations unless specific regulatory or statutory requirements are cited. The guidances are based on a review of relevant scientific and legal requirements and reflect what the FDA believes is the least burdensome way to be compliant with the requirements.

The final version of the guidance can be viewed at www.fda.gov/cdrh/mammography/pubs/1435.pdf   Comments and suggestions regarding the guidance may be submitted electronically to www.fda.gov/dockets/ecomments  Refer to Docket No 03D-0025.

ECRI Evaluates Sharps Disposal Containers
Sharps disposal containers help protect health care workers, patients, and visitors to health care facilities from accidental needle sticks and other sharp-object injuries. In the United States, the use of sharps containers was mandated with the introduction of the US Occupational Safety and Health Administration’s 1992 blood-borne pathogens standard. The standard was revised in January 2001 with a further requirement that facilities involve employees in the selection of sharps containers.

Even sharps containers designed for the same applications can look and operate differently, and they provide effective protection only if they are well designed and properly managed. Containers that are poorly designed or improperly placed—or allowed to become overfilled—can increase the risk of injury. For example, the size and width of sharps container inlets vary for different models. If a large device, such as a 20 mL or 30 mL syringe, is used in an area where a 5-quart container is installed, a health care worker may attempt to force the device into the container, resulting in possible needle stick. Other design characteristics, such as overfill protection, cabinets, and handles, also affect the safety and utility of sharps containers.

In July 2003, ECRI published the results of a survey of eight sharps containers, all single-use containers designed for patient rooms or patient treatment areas. Models from BD, Bemis, Kendall, and Medical Action were evaluated. The models were typically mounted on a wall near the location where needles or other sharps would be used. The sharps containers were evaluated under their usual conditions of use and all rated containers were of 5-quart size. Ten characteristics were rated:

  • Inlet and closure characteristics
  • Ease of disposing of the various-sized devices
  • Freestanding capability
  • Overfill warning
  • Impact resistance
  • Puncture resistance
  • Handles
  • Labeling
  • Cabinets
  • Quality of construction, assembly, and instructions

ECRI is an independent nonprofit international health services research agency and a Collaborating Center of the World Health Organization.

For information on obtaining copies of the survey results, visit the ECRI Web site at www.ecri.org.

AAMI Presents 2-Hour Online Seminar
In July 2003, a new and final version of the quality system standard ANSI/AAMI/ISO 13485:2003 was completed by the international medical device community and is now available to medical device manufacturers. The updated version of 13485 is a stand-alone standard intended for the medical device industry. The requirements complement those of the US Food and Drug Administration Quality System Regulation and do not directly reference ISO 9001 as did the previous version. This means that medical device manufacturers should not need to establish two different quality systems. It is imperative that medical device companies understand the differences between the 13485:2003 standard and the QSR to demonstrate that their quality management systems and products consistently meet customer and FDA regulatory requirements.

On Dec 17, AAMI will conduct a 2-hour online seminar during which presenters will walk attendees through a clause-by-clause comparison of the new standard and the QSR, and explain what medical device manufacturers need to know about complying with both and dealing with the key differences.

The program will also provide a brief discussion of the general quality management system principles and the process approach upon which the standard is based, the status of transition guidances and options, the status of international adoption of 13485:2003, and key differences between ISO 9001:2000 and 13485:2003.

To register online, go to www.krm.com/regonline/amivcregs.nsf/ami8052,   or print out the registration form and mail or fax it to:

KRM Information Services Inc
PO Box 1187
Eau Claire, Wis 54702-1187
Fax: (800) 676-0734

You can also call KRM’s customer service line at (800) 775-7654, or link to the registration form through AAMI’s Web site.

Note: The standard is not included in the seminar fee but is available in print or PDF format to AAMI members for $50 and to nonmembers for $95.

d02b.jpg (13137 bytes)Assessment of Patient’s Peripheral Circulation Made More Accurate
Instrumentarium’s Datex-Ohmeda Division is enhancing its portable handheld oximeter, TuffSat,® with PIr® perfusion index clinical tool. The proprietary technology, already a feature in the company’s stand-alone oximeter product line, is a clinical tool for assessing perfusion or blood flow at the sensor site.

According to a company announcement, PIr enables clinicians to rapidly locate the sensor site with the strongest pulse signal by comparing the perfusion index at different sites on a patient. By locating the strongest pulse signal, clinicians can increase the validity of SpO2 and pulse rate data. They can also use this numeric, quantifiable value to document and trend peripheral circulation, confirm optimal sensor application, and assess collateral flow pre- and postarterial catheterization. PIr has been compared with laser flow Doppler, pulse volume recorder, and finger volume plethysmography.

Datex-Ohmeda has also enhanced the TuffSat with new white, pink, and blue color options for clinicians who want to keep track of their own TuffSat or distinguish between shifts or departments.

 GE Receives European Regulatory Approval for Instrumentarium
General Electric Company, through its GE Medical Systems division, has announced that the European Commission has approved GE’s acquisition of Instrumentarium for $2.3 billion. Instrumentarium is a medical technology company headquartered in Helsinki, Finland, and the parent company of Datex-Ohmeda, a supplier of anesthesia and critical care systems, equipment, and services.

GE originally tendered the offer for Instrumentarium in December 2002, and the companies entered into a definitive combination agreement that GE would acquire Instrumentarium.

The acquisition comes after months of negotiation in response to concerns—particularly the market impact the new company would have on breast screening equipment, mobile C-arms, and anesthesia monitors—by the European Commission, the regulatory arm of the European Union. To meet these concerns, GE has agreed to divest Instrumentarium’s Spacelabs business and grant the future owner of Spacelabs the authority to distribute and market certain Instrumentarium anesthesia machines nonexclusively and Cardiocap/5 gas monitor exclusively in the European Economic Area, along with a nonexclusive global gas module supply agreement.

GE is confident that shareholders will benefit from the transaction.

The transaction must still win approval from the US Department of Justice, which is evaluating possible antitrust implications.

AFSMI Appoints New Director of Marketing
The Association for Services Management International (AFSMI) announced that it has appointed James Gaidry as director of marketing. Gaidry’s primary responsibilities will include public relations and communications activities as well as developing and implementing marketing programs for conferences, workshops, seminars, membership programs, and sales promotion.

Gaidry has been a sales and marketing professional for more than 20 years, most recently serving as vice president of sales and marketing for Syntec Corporation. His career has included developing and implementing successful programs at Texas Instruments, Racal-Datacom, Memotec Communications, Genicom’s Enterprising Service solutions company, and Dell Computer.

“[His] ability to communicate with high-level executives in Fortune 100 companies and his depth of knowledge in services business development make a powerful combination,” says John Stonewalled, CEO of AFSMI. Gaidry holds BSEE and MBA/Marketing degrees from the University of Texas.

 Fluke and Korr Form New Partnership
Eric Perron, president of Fluke Biomedical Corp, has announced that Fluke has signed an agreement with Korr Medical Technologies Inc, whereby Fluke will acquire exclusive rights to the technology, manufacturing, and distribution of Korr’s gas flow analysis products for ventilator testing. Perron says they are pleased to have reached the agreement, adding, “VT Plus has been our top-selling analyzer since its release in 2000. With its new full RT-200 emulation and high-frequency oscillatory ventilation testing capabilities, we expect even broader acceptance among hospital biomedical departments, independent service organizations, medical device manufacturers, and the military.”

The cover photo for September’s cover story, “Wireless Technology in Health Care” was by Tom Strickland.

New Imaging Technology at Texas A&M
Engineers at Texas A&M’s department of biomedical engineering have developed a new, noninvasive technology called laser-induced photo-acoustic tomography (PAT) that will allow scientists to look at the brain in action.

Lihong Wang, professor of biomedical engineering and electrical engineering and director of the optical imaging laboratory in the biomedical engineering department, says that PAT combines optical waves and ultrasonic waves to create clearer images. The two kinds of energy that Wang and his team combined synergistically work together to allow for the highest contrast and best resolution when imaging the brain.

Wang explains that current brain-imaging methods such as functional magnetic resource imaging and x-ray computed tomography have their limitations. “X-ray CT provides only structural information and doesn’t show functional contrast,” Texas A&M Engineering News quotes Wang. “MRI does show functional and structural information, but it requires strong superconducting magnets, which are very expensive and can interfere with other nearby instruments.”

The new technology has been used only on rats thus far, and Wang says that two issues, the thickness of the human skull and the size of the human brain, must be addressed. Both factors can interfere with the waves PAT uses. Wang and his colleagues have received a 5-year grant from the National Institutes of Health to improve their technology.

 Columbus Hospital Receives JCAHO Gold Seal of Approval
Columbus Hospital, Newark, NJ, has achieved the Gold Seal of Approval for health care quality from the Joint Commission on Accreditation of Healthcare Organizations. Following a recent, extensive 3-day review, the hospital received full standards compliance with an overall score of 96, with no recommendations for improvement.

Tom Woodard, Columbus’s communications director, says that although the hospital is given 45 days to prepare for the review, Columbus strives to maintain compliance at all times.

Columbus Hospital opened in 1934 and today is a 210-bed, full-service acute care facility located in the North Ward section of Newark. The hospital offers a wide range of medical services, including outpatient diagnostics, preadmission testing, obstetrics care, pediatrics and children’s care, and orthopedics. The hospital is also the home to the Newark Eye and Ear Infirmary and the Children’s Eye Care Center of New Jersey.

Columbus was the recipient of the Press Ganey Compass Award for outstanding performance improvement in patient satisfaction. Press Ganey Associates is a satisfaction measurement and improvement firm serving 30% of all hospitals and 40% of hospitals of more than 100 beds. They supplied the surveys to Columbus, which then sent them to discharged patients for completion.