US Food and Drug Administration: reprocessing update; medical device reporting; electrosurgery; dual electrode placement; human factors

AORN Journal,  Feb, 2005  by Sharon Giarrizzo-Wilson

• E-mail
• Print
• Link

QUESTION: Our OR has been using a third-party reprocessor for opened and unused disposable trocar systems. Last week, the vendor removed our entire reprocessed inventory. Staff members were told that trocars and some other single-use devices (SUDs) would no longer be reprocessed. Have the US Food and Drug Administration (FDA) guidelines for reuse of SUDs changed? Wit[ this affect previous patients who had surgeries during which these products were used? Should we disclose this information to those patients?

ANSWER: On Nov 2, 2004, the FDA announced that it no longer would allow commercial distribution of a number of previously approved and legally marketed reprocessed SUDs. (1) As part of the Medical Device User Fee and Modernization Act of 2002, reprocessors of certain types of SUDs that were previously cleared for reprocessing were required to submit additional cleaning, sterility, and functionality validation statistics to the FDA to determine if these SUDs continued to meet reprocessing guidelines. (2) Reprocessors whose reprocessed SUDs were determined to be unsatisfactory according to the FDA's reprocessing regulations may submit a new application demonstrating that the reprocessed product is substantially equivalent to the original manufacturer specifications. (2)

The decision to disclose information to patients regarding the use of reprocessed SUDs and the FDA's latest decision is best handled through your facility's risk management department. Specific information related to the FDA's decision to disallow reprocessing of select SUDs has not been made public, and AORN cannot take a position regarding why certain reprocessed SUDs no longer are marketed. The affected reprocessor will have specific data related to the product's validity testing and FDA reports and can be contacted for more information.

Patients who have experienced an intraoperative or postoperative adverse event directly related to the use of a reprocessed SUD (eg, device failure, infection) should be monitored and treated as directed by physician orders. Documentation and reporting of the event, including all pertinent information related to the occurrence, should be done according to facility and regulatory guidelines. More information related to medical device reporting can be obtained from the FDA's Medical Device Reporting web site at http://www.fda.gov/cdrh/mdr.

QUESTION: I was involved in a procedure during which an endoscopic stapler did not function property. The stapler partially discharged and became trapped on the tissue being ligated. An incident report was completed because the patient required additional anesthesia time. My supervisor also wanted the defective unit and its packaging information. The patient did not experience any untoward effects. Was my supervisor's request necessary? Why was the packaging information needed if the defective stapler was available?

ANSWER: Securing the involved device and packaging materials helps identify important manufacturer information related to the stapler's production and handling. By requesting these items, your supervisor was initiating the first step in the FDA's Medical Device Reporting (MDR) regulation. Since 1996, MDR regulations have required facilities using medical devices to notify the device manufacturer and / or the FDA within 10 days of any device-related event contributing to or causing patient death, injury, or serious illness. (3) The Medical Device Reporting regulation, which is a component of the Safe Medical Device Act (SMDA) of 1990, is an active monitoring and reporting system that results in improved product enhancements to protect patients, their family members, visitors, and health care staff members. (4,5)

The Federal Food, Drug, and Cosmetic Act [21 USC 321(h)] classifies a medical device as

   ... an instrument, apparatus,
   implement, machine
   contrivance, implant, in
   vitro reagent, or other similar
   article.... intended
   for use in the diagnosis of
   disease or in the cure, mitigation,
   treatment, or prevention
   of disease....  or
   intended to affect the
   structure or any function
   of the body.... (6)

Items recognized as medical devices include such items as computer software, gloves, joint implants, laboratory solutions, and surgical staples. The FDA does not have a traditional reservoir of safety data for all postmarket items because certain devices were grandfathered into the 1996 MDR regulation. These items still are monitored through periodic FDA requests for manufacturers' safety data and postmarket event (eg, malfunction) reports. Responses are limited because postmarket reporting is voluntary.

In an expanded attempt to increase surveillance and reporting of postmarket adverse device events, the FDA established the Medical Product Surveillance Network (MedSun) to encourage consumer reporting for all types of device compromise. (7) User facilities openly report atypical device responses and reactions to the MedWatch data collection reporting center located at https://www.medsun.net/about.html. The primary goals for MedSun are to identify, clarify, and share information with vendors and user facilities regarding identified medical device problems. (7) Table 1 describes how problems identified through MDR systems are placed into one of the three problem groups (ie, device, user, clinical). (4)