Session 1: FDA and legal Implications

Sponsored by ASTM Committee F04 on Medical and Surgical Materials and Devices

Reprocessing of Reusable Medical Devices: an FDA Perspective

Pamela Scott, Daniel McGunagle, FDA, Silver Spring, MD

Ineffective reprocessing of reusable medical devices continues to present a public health risk and reports to FDA from numerous facilities highlight problems with contamination and debris retention. The FDA believes that the incidents can be prevented through approaches including (but not limited to): (1) improved labeling and cleaning practices, (2) rigorous validation of the reprocessing instructions, (3) design features that facilitate cleaning and (4) user facilities implementing strong quality assurance programs. The recently published «Safety Communication from FDA, CDC and the VA: Preventing Cross-Contamination in Endoscope Processing» is one example of specific actions to reduce risk. At this workshop, FDA staff will discuss best practices for the reprocessing of all reusable medical devices.    

The FDA actively works with manufacturers, facilities and health care professionals to improve the reusable medical device landscape and to strengthen standardized practices for reprocessing. Drawing on clinical standards and FDA guidance, FDA staff will touch on key program areas where there are opportunities to improve the effectiveness of reprocessing of reusable medical devices.

The Legal Implications of Medical Device Cleanliness Standards

Steve Bennett, John Schlafer, Baker & Daniels, LLP, Fort Wayne, IN

The question «How clean is clean enough?" has been approached and answered in different ways in the legal world. Some focus on a manufacturer's validated cleaning process; others on one specific result, the absence of residue. The discussion and debate over cleanliness standards and contamination have been and will continue to be played out against the backdrop of product liability litigation, product recalls, and patient safety concerns. Therefore, the development of cleanliness standards by the ASTM will have legal implications for stakeholders in the medical device field.

An industry standard for cleanliness that defines acceptable residue limits, as well as appropriate testing methods for certain residues, will impact the defect analysis in product liability litigation. An ASTM cleanliness standard could become the guidepost for determining whether a specific explanted medical device contains a manufacturing defect, i.e., a deviation from the intended design specification. Accordingly, consideration should be given to the utility of such a standard in the context of explant analysis for contaminants.

A cleanliness standard also could be used as a legal framework for determining the adequacy of a manufacturer's cleaning and quality assurance processes.  Inconsistencies between a manufacturer's cleaning process and an ASTM cleanliness standard might expose a manufacturer to the claim that a medical device is defective. On the other hand, an ASTM standard could be used by a manufacturer to defend its validated cleaning process as «state of the art» or in conformance with industry standards.

Consideration also should be given to the interplay between an ASTM cleanliness standard and the requirements of regulatory bodies. For example, the FDA's Good Manufacturing Practices regulations require manufacturers to have procedures «for the use and removal of such manufacturing material to ensure that it is removed or limited to an amount that does not adversely affect the device's quality.» 21 C.F.R. § 820.70(h). The regulations do not define specific residues, residue limit values, or methods for testing. A medical device industry standard that provides those definitions may have an impact on cleanliness regulations or the legal interpretation of the regulations.  

This presentation will touch on all of the above legal ramifications of defining or not defining acceptable residue limits. Case examples will be presented, and litigation, regulatory, and risk management considerations will be addressed.

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