Reprocessing Medical Devices Cleared or Approved by FDA for One Use Only

 

Risks of Reprocessed SUDs

Prior to the enactment of MDUFMA, many, including physicians, nurses, industry organizations, and even Congress, concluded that the FDA’s regulation of reprocessed SUDs was inadequate to address the potential risks associated with their reprocessing and reuse. SUDs are designed to be effective and practical for a use on a single patient. They are not designed to facilitate cleaning and sterilization. As a result, SUDs often have unique features such as narrow lumens, acute angles, crevices, coils and joints, reinforcing meshes and rough, porous or occluded surfaces that make access difficult, create barriers to cleaning and allow for the collection of blood, tissue and other organic matter. Commonly used sterilization techniques used in reprocessing may be incapable of penetrating this biological tissue residue, leaving potentially pathogenic bacteria, viruses and other microorganisms on the devices which may be transferred to another patient on reuse. Indeed, independent laboratories have conducted tests on reprocessed low or moderate risk (Class I and Class II) SUDs that break sterile or mucosal barriers that were on hospital shelves ready to be used. In some instances, over 90% of the products tested positive for the presence of residual tissue, and more than 60% of the reprocessed products fell far below sterility standards established by the FDA. Moreover, methods traditionally used to destroy human and animal pathogens do not appear to destroy prions, the causative agent for spongiform encephalopathies such as Creutzfeldt-Jakob disease, raising particular concern regarding the reprocessing of devices used for invasive neurological or opthamalogic procedures. Even if sterility can be ensured, organic residue may still remain on reprocessed devices due to inadequate cleaning. Such sterile pyrogens, blood, tissue and other organic residue can trigger potentially fatal immune reactions.

Additionally, the reprocessing of devices intended for only one use can diminish the device’s effectiveness by threatening the functional integrity of the used SUD. An SUD is designed for optimal single-use performance rather than ease of cleaning, and its structural integrity may be seriously compromised or destroyed by sterilization. For example, reprocessing can decrease rigidity and increase the incidence of balloon tip catheter rupture; weaken structural integrity of PVC esophageal stethoscopes; structurally damage blood pressure transducer domes; misalign biopsy jaws so that they fail to open and close properly; and decrease the sharpness of arthroscopic knee surgery blades. The diminished efficacy of reprocessed SUDs represents a significant risk to patient care.

Although the risks of reprocessed SUDs are obvious, they have historically been difficult to track because of the inability to trace the identity of the reprocessor or the number of times the device had been reprocessed. Once the outer packaging of a reprocessed device is removed and discarded prior to its use, there is no way to link the device to its reprocessor or even to identify the device as having previously been used. If a device-related event occurs, it is generally attributed and reported to the OEM with whom the device would most obviously be associated. Frequently, the original contains a trademark, or other identification for branding purposes that remains after the product is reprocessed. As a result, although some experts have blamed reprocessing for a rise in the rate of infections and disease contracted in hospitals, the connection was impossible to prove because of poor patient tracking and labeling of reprocessed devices. See Dana Hawkins, News You Can Use: Risky Recycling, U.S. NEWS & WORLD REPORT (Sep. 20, 1999).

MDUFMA Mandates New Controls

Realizing that patients were not being adequately protected, Congress enacted MDUFMA to strengthen FDA regulation of reprocessed devices with five specific directives.

  • First, Section 302 required FDA to develop a list of reprocessed devices that would be subject to enhanced section 510(k) requirements to ensure that they remain substantially equivalent to the predicate device after a specified number of uses. This premarket submission and review of validation data on maximum number of uses was a significant new requirement for reprocessed products. Prior to enactment, reprocessors were subject to only self-imposed limits. The deadlines for submitting enhanced 510(k)s was January, 2004.
  • Second, Section 302(B) required FDA to review and determine the continued viability of the existing premarket exemptions for Class I and Class II reprocessed “critical” SUDs within six months after enactment and to review “semicritical” reprocessed SUDs within eighteen months. If the FDA terminated the exemption for a device or type of device, reprocessors would be required to submit an enhanced 510(k), including validation data demonstrating the number of times the device can safely and effectively be reprocessed.
  • Third, MDUFMA required reprocessors of Class III devices to file reports under section 515 of the FDCA, essentially identical in scope to the premarket approval required for the original device. Significantly, however, reprocessors are not required to submit design control data for the original product.
  • Fourth, Section 303 required FDA to modify the MedWatch (Medical Device Report) mandatory and voluntary reporting forms that are used to report patient injuries to FDA. This change intended to achieve more accurate reporting of patient injuries caused by reprocessing, including accounting for injuries appropriately attributed to the reprocessor instead of the original equipment manufacturer (“OEM”).
  • Fifth, to fill a gap in FDA’s post marketing system, Section 301 required reprocessors and original equipment manufacturers attach directly to the device a label that “prominently and conspicuously” identifies the manufacturers of the device.

To Ensure Patients are Protected - FDA Must Fully Enforse Congress' Mandates


FDA has taken several steps to implement MDUFMA.  For example, on April 30, 2003, the FDA published a list of devices that would be subject to enhanced 510(k) requirements and a list of “critical” devices that, when reprocessed, were no longer exempt from premarket submissions. FDA has also modified the MedWatch forms. Reprocessors had nine months, until January 2004, after the list was published to submit the enhance 510(k)s with the additional validation data for those previously-cleared devices. For devices not cleared prior to the April 30, 2003, notice, the enhanced 510(k) requirements were effective immediately. Reprocessors of critical devices for which an exemption was removed have until July 2004 to file 510(k)s with validation date for those devices.  To fully satisfy MDUFMA’s requirements and goals, however, much work must still be done.

Can Class III SUDs Be Safely Reprocessed?

Congress has recognized that reprocessed Class III SUDs present significant risks that can be identified only through rigorous premarket review. FDA must ensure that Premarket Reports for a Reprocessed Class III SUDs include adequate clinical data, processing information, device characterization and validation data to demonstrate its safety and effectiveness up to a maximum number of reuses. MDUFMA requires a reprocessor to demonstrate the safety and effectiveness of its reprocessed Class III SUD by submitting and obtaining approval of a Premarket Report (PMR) that meets the same stringent requirements that are currently applicable to the Premarket Application (PMA) for the original single-use product, except that the PMR need not include certain design control information available only to the original device manufacturer. To compensate for the absence of design control information for the original SUD, the PMR for the reprocessed device must fully characterize the device to be reprocessed, and identify and validate the criteria and benchmarks for ensuring its continued safety and effectiveness after each cycle of reprocessing and reuse. The device characterization must include methods to identify and compensate for changes to the original device after it was approved for marketing, as well as to reflect the conditions and effect of prior use. Reprocessors must also develop and submit data from clinical trials to demonstrate the safety and effectiveness of the reprocessed SUD for each cycle of cleaning, sterilization and reuse up to the maximum number of intended reuses.

Validation Data Must Be Submitted to Demonstrate the Continued Safety and Effectiveness or Substantial Equivalence of Each Reprocessed SUD After Each Successive Cycle of Reprocessing and Reuse.

PMRs and enhanced 510(k) submissions for reprocessed SUDs must include validation data to ensure the devices continued safety and effectiveness on reuse. For devices subject to the enhanced 510(k) requirements, the reprocessor must demonstrate that, after each successive cycle of reprocessing and reuse, the device remains substantially equivalent to its single-use predicate. Because SUDs are not designed for reprocessing, FDA must require reprocessors to develop extensive characterization data for each original device model and make that it intends to reprocess before attempting to validate the cleaning, disinfection, sterilization and performance of the reprocessed device. At a minimum, the FDA should require that the following testing should be included in any validation program:

  • Cleaning and sterilization characterization;
  • Microbiocidal effectiveness;
  • Product design considerations;
  • Validation of cleaning, disinfection and sterilization processes;
  • Installation, operation, and performance qualification;
  • Review and approval of validation;
  • Revalidation and equipment maintenance;
  • Safety, bioburden, and particulate testing;
  • Pyrogen validation testing;
  • Routine pyrogen testing;
  • Routine monitoring and control of processes; and
  • Product function testing.

FDA Must Take Enforcement Action Against Reprocessors Who Have Not Complied With the January 2004 Deadline For Submitting Enhanced 510(k)s.

Reprocessors who have not submitted the required validation data are now in violation of federal law and their products are now misbranded if they are still being sold to customers. Because of the severity of risks associated with these devices, FDA should take immediate action to protect the public health from any violative reprocessed SUDs. FDA’s response should include a Public Health Notification warning the public of the risks, seek injunction action to prevent noncompliant reprocessors from selling these products, preventing these devices from further distribution by seizing or pulling non-compliant devices from the market, or by ordering an immediate recall.

FDA Should Require A Separate Premarket Submission for Each SUD Make, Model and Design to be Reprocessed.

FDA should prohibit the bundling of devices made by different OEMs and different models and designs of devices made by a single manufacturer to ensure an accurate assessment of each reprocessed SUD.  Each OEM uses a unique design, and different materials, manufacturing processes, and engineering processes to make its device and a single OEM may incorporate different materials and designs into different models of its own device. Different materials, components and design features present in different makes and models of devices may react differently to the harsh agents often used to reprocess them and may present different barriers to their cleanability and functional performance. Reprocessors must submit data to specifically and reliably characterize the used, incoming SUDs with respect to their physical, functional and compositional characteristics in order to demonstrate and validate that its reprocessing methods adequately clean and sterilize the device without compromising its safety, integrity and functionality. This cannot be done adequately if multiple device makes and models are bundled in to a single premarket submission. FDA must therefore prohibit bundling of different devices in a single submission and require instead a separate PMR or 510(k) submission for each.

Section 301 Should Only Apply to Reprocessors in Order to Fulfill Section 301’s Original Intent.

Section 301 of MDUFMA was enacted to address the wide spread underreporting of patient injuries and product malfunctions attributable to reprocessed SUDs and to ensure that users know that the SUDs they are using were previously used and reprocessed and by whom. By applying the device labeling requirements to both OEMs and reprocessors of single-use devices, however, the requirement has created an unnecessary administrative burden that threatens to undercut this provision entirely. There has generally been little difficulty in identifying the OEM of a particular SUD. Therefore, there is no need to identify the OEM on a label attached directly to the device. In contrast, it is incredibly difficult to identify a reprocessed device once it has been removed from its packaging and is on a tray ready for use on a patient. Without a label a reprocessed is likely to be associated with the OEM which is why an appropriately identifying label is required. Reporting patient injuries and product malfunctions to FDA is a cornerstone of FDA’s postmarketing surveillance system, and if the user can not identify that a product was reprocessed, the user can not accurately report malfunctions to FDA. The labeling requirement should be limited to reprocessors of used SUDs to address the significant underlying problem of identifying whether, how many times and by whom the device was reprocessed in order to tracking and account for injuries associated with reprocessed SUDs.