 |
Slippery SUDs: Understanding FDA Regulations on the Reuse of Single-Use Medical Devices
By John Latsko  The unregulated practice of
reusing medical devices that are either labeled or otherwise
intended for use on a single patient began more than 25 years ago
as a way for hospitals to reduce cost and waste. From these early
efforts, an entire third-party reprocessing industry has evolved to
assist hospitals with surgical and endoscopic device reprocessing.
With the enactment of the Medical Device Amendments of 1976 to the
federal Food, Drug, and Cosmetic Act (FD&C), the original
equipment manufacturers (OEMs) were subject to heavy federal Food
and Drug Administration (FDA) regulations when marketing new
medical devices. The refurbishers and reprocessors of those
devices, however, went unregulated.
Under the FD&C, reprocessing of single-use devices (SUDs)
was permissible, but it raised questions regarding device safety,
informed consent, ethics of reprocessing, proper refurbishing,
incident reporting, and accurate labeling practices. OEMs were
often subjected to criticism and threatened with liability for the
SUDs they manufactured and labeled for single use, but which were
later refurbished and marketed, both properly and improperly, for
patient use by others. This changed several years ago when the FDA
subjected SUD reprocessors to virtually the same regulatory
standards as OEMs when it issued guidance titled "Enforcement
Procedures for Single-Use Devices Reprocessed by Third Parties and
Hospitals."
So what does this have to do with O&P? Prosthetic SUDs are
sometimes offered for resale through various sources. Many of these
devices were FDA-approved SUDs when their OEM initially sold them.
While the device may be labeled or intended for single use only, it
can be used legally by other patients. A reprocessed SUD is defined
as an original device that has previously been used on a patient
and has been subjected to additional processing and manufacturing
for the purpose of an additional single use on a patient. Becoming
a reprocessor for SUDs by virtue of marketing SUDs creates many
obligations on the part of the reprocessor. An SUD may be lawfully
reused if it is adequately refurbished so that it is safe and
effective, and if its quality and integrity are maintained in
accordance with FDA guidelines. Under current federal regulations,
any third-party reprocessor, an OEM that refurbishes its own
devices, or a hospital that refurbishes its devices, is required to
meet the same requirements as the OEM. That means a reprocessor
must meet the same FDA regulations as the OEM did when it first
marketed the device.
The FDA is responsible for overseeing the safety of all medical
devices. FDA enforcement actions and sanctions for failure to meet
its standards include issuance of health alerts and warning
letters, ordering mandatory recall and seizure, obtaining
injunctions, imposing civil money penalties up to $1 million per
proceeding, and criminally prosecuting offenders for serious
violations. In addition, violations of FDA regulations could result
in banishment from federal programs such as Medicare. While the
regulations and sanctions related to SUD reprocessing might seem
harsh in certain circumstances, they are meant to assure the public
of the safety of the refurbished SUD. The level of regulation and
oversight of reprocessed SUDs is determined by the FDA device
classification and the risk associated with use of the refurbished
device. Most external-limb prostheses are classified by the FDA as
Class II or "medium risk non-critical" along with other medical
devices such as powered wheelchairs and intravenous catheters.
Class II non-critical SUDs do not need an FDA clearance order to be
marketed. There is not yet an established industry to reprocess
prosthetic SUDs like there is in the hospital industry, and there
may never be.
Regulations related to reprocessing are complicated, and
compliance is expensive. Except for hospital SUDs, generally only
OEMs reprocess SUDs. Anyone who intends to market refurbished
prosthetic devices for reuse must fully acquaint themselves with
the FDA regulations related to obtaining an FDA marketing clearance
order.
SUD reprocessing is controversial in both hospital and
non-hospital settings. While possibly the most qualified to
refurbish SUDs, many OEMs resist SUD reprocessing for many reasons,
including the fact that they believe the device is for a single
use, and reuse has an adverse impact on new product sales.
Supporters of reprocessing, such as hospitals, focus on lower cost.
Everyone's concern, of course, is the safety and integrity of
reprocessed SUDs. Someday, reprocessing could become more the norm
in prosthetics as it is with hospital surgical devices. Until then,
take care should you ever consider using and marketing reprocessed
SUDs.
John Latsko is a partner in the health law practice of
Schottenstein, Zox & Dunn, Columbus, Ohio. He can be contacted
at 614.462.2329; jlatsko@szd.com 
Table Of Contents - July 2007
|
|
