Devices & Technology

New Developments in Medical Device Safety


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By Suzi Birz, principal, HiQ Analytics, LLC, contributor

Nov. 20, 2009 - Nurses work with medical devices in many patient care activities, and the input from practicing nurses has helped improve the packaging and safety of these products.

This growing market--estimated close to $90 billion in the United States alone--continues to expand and change, based on continual feedback from health care workers, patients and legislators.

Here is some recent medical device news worth noting:

AORN Survey Reflects Packaging Priorities

A recent survey by the Association of periOperative Registered Nurses (AORN), reported at the HealthPack 2009 conference, addressed medical package design issues such as ease of opening, labeling, sustainability and sealing.

According to discussion panelists, speed of opening the package was ranked as the most important feature for nurses, followed by producing the least amount of packaging waste, offering the smallest possible package, and dealing with consistent packaging sizes from device manufacturers.

The survey also found that labeling-related issues remained a critical concern for nurses. Respondents voiced frustrations in finding and being able to read use-before dates, instructional details, and color-coding, which can vary from one manufacturer or product to the next. Nurses may be trained not to recognize colors to avoid potential problems. Sterilization indicator tags or labels were also challenging for nurses to locate on the pack.

IOM to Study Premarket Notification Exceptions

The Food and Drug Administration (FDA) is responsible for protecting the public health by assuring the safety, efficacy and security of medical devices, based on a well-defined process. Recent reports, however, have questioned whether the process allows too many products to incorrectly bypass the detailed review process using an exception, known as a 510(k) process, which applies to devices that are not substantially different from a device already being marketed.

The FDA recently announced that it has commissioned the Institute of Medicine (IOM) to study this premarket notification program. While the IOM study is underway, the FDA's Center for Devices and Radiological Health will convene its own internal working group to evaluate and improve the consistency of FDA decision making in the 510(k) process.

"The 510(k) process has become so popular with manufacturers who wish to avoid the more onerous and lengthy PMA [premarket approval] procedure that over 75 percent of medical devices are approved through this process," stated Sharona Hoffman, co-director of the Law-Medicine Center and professor of law, Case Western Reserve University School of Law, Cleveland, Ohio.

New Portal Links Device Standards from Four Organizations

The FDA Recognized Consensus Standards database helps people determine what standards apply to a device. Standards related to medical devices are created by several national and international standards organizations.

Recognizing the complexity of standards that apply to medical devices and the imperative that decisions be made quickly, the Association for the Advancement of Medical Instrumentation (AAMI), the American National Standards Institute (ANSI), ASTM International, and DIN (the German Institute for Standardization) have launched the Medical Device Standards Portal to help manufacturers "make the right decision."

Medical Device Site for Health Care Providers 

In addition to helping manufacturers, the FDA provides a number of resources for consumers and health care providers to keep up on the latest information about medical devices.

Specifically, the FDA Medical Devices site for health care providers includes:

  • General information on safety, including device recalls, alerts and other information
  • Medical Product Safety Network (MedSun) - a collaborative partnership between FDA and the clinical community to identify adverse events for medical devices
  • FDA Patient Safety News - a televised video series for health care professionals on medical devices, drugs and other FDA-related issues
  • Public health notifications regarding risks or problems with specific devices
  • Mammography information about facility certification and quality standards Information on quality standards for laboratory testing to ensure the accuracy, reliability and timeliness of patient test results

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