Editor’s Opinion: Using Our Devices to Weigh In on Devices

  This issue of Ostomy Wound Management contains three original contributions that aim to increase understanding of currently available medical device technologies. The concerns addressed range from safety (pulsatile lavage) to the pros and cons of use (hyperbaric oxygen) to factors that should be considered when making appropriate product selections (support surfaces). At first glance, clinicians may wonder how this information might affect their practice until they realize these articles all contain crucial, fundamental guidance on providing safe and effective care.   The vast majority of medical devices used by our readers to prevent and manage wounds, position and transfer patients, manage or treat incontinence, and care for stomas are cleared, not approved, for marketing by the United States Food and Drug Administration (FDA). The program used to clear these devices has been in place for 35 years. Most devices are cleared for marketing based on their essential equivalence to products marketed before 1976. A review¹ of the historical and legislative history of this program shows it was never designed to provide assurance of safety or effectiveness. Of course, medical technology also was far less advanced at that time, and the establishment of a few device categories (high risk, moderate risk, and low risk) was a step in the right direction for patient safety. The 1997 Food and Drug Modernization Act eliminated the requirement for low-risk devices (most wound care products) and many moderate risk devices to obtain FDA clearance. At the same time, the FDA is charged with, among other responsibilities, “protecting the public health by assuring the safety, efficacy and security of medical devices”² while also dealing with chronic funding shortages.¹

  With this background and during a time of unprecedented technological advances — more than 15,000 medical devices entered the market place between 2003 and 2007 — it is not surprising there are issues. High-profile problems (artificial hips, surgical mesh, medical tubing connectors) drew attention to the fact that perhaps a program that has been in place for more than 35 years needs to be brought into the 21st century. To that end, the Institute of Medicine (IOM) provided a number of recommendations for pre-market review changes — especially for moderate risk devices — as well as for the development of a more robust post-market surveillance program.¹

  The FDA’s proposal to strengthen medical device post-market surveillance currently is available for public comment.³ Because the proposal directly affects the products we use on a daily basis and plays a substantial role in our professional obligation to do no harm and safeguard the public, clinicians are encouraged to share their opinions with the FDA.³ In addition, stay up-to-date by reading the journal as researchers try to do their part by conducting post-market studies to help us understand how and why currently marketed products may work and how we can use them safely.

 This article was not subject to the Ostomy Wound Management peer-review process.

1. Institute of Medicine. 2011. Medical Devices and the Public’s Health. The FDA 510(k) clearance process at 35 years. Washington, DC. National Academies Press. Available at: http://books.nap.edu/openbook.php?record_id=13150&page=R2. Accessed February 16, 2013.

2. United States Food and Drug Administration. 2012. About FDA. Available at: www.fda.gov/aboutfda/whatwedo/default.htm. Accessed February 16, 2013.

3. Center for Devices and Radiological Health. United States Food and Drug Administration. (2012). Strengthening our National System for Medical Device Post Market Surveillance. Available at: www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHReports/UCM301924.pdf. Accessed February 16, 2013.