Many medical devices that are manufactured for single use are eventually
refurbished (or 'reprocessed') and used again. At a minimum, this means
sterilizing a previously used medical device, a popular technique employed
by hospitals. But third-party reprocessors have recently found that there is
also a high demand for more thorough cleaning and refurbishing of medical
devices. Biopsy needles, surgical scissors, forceps, and cardiac catheters
are among the single-use devices commonly reprocessed by third parties. The
impetus for reprocessing is purely economic, and the practice is becoming
more widespread as devices become more complex and expensive, and hospitals
seek to reduce costs. While economically effective, reprocessing raises
serious questions about safety, and, consequently, questions about legal liability.
The reprocessing of devices that were intended for single use raises several
issues, the first of which is patient safety. The practice has traditionally
drawn heavy criticism from device manufacturers, who are concerned that their
products are being used in unanticipated ways that may not be safe for
patients. One major concern is the effectiveness of resterilization and the
possibility that a reprocessed device will remain contaminated. This concern
is growing as medical devices are becoming smaller and more complex, making
them more difficult to clean effectively. Another concern is device failure,
particularly when components or materials in devices are not designed to
withstand multiple uses. Apart from such safety concerns, device manufacturers
also have an economic incentive to manufacture disposable products that will
be consumed in larger quantities. But in any case, it is fair to say that
questions of safety remain unresolved.
These safety issues, in turn, raise questions about tort and contract
liability. The tort law theory of joint and several liability allows multiple
parties in the manufacturing supply chain to be sued. Who is responsible for
injuries resulting from an improperly reprocessed device? Although Food and
Drug Administration (FDA) regulations do not give individuals a private right
of action for injuries from medical devices, such injuries may still give rise
to claims in tort under strict liability or negligence, or in contract under
breach of warranty. And because an original manufacturer's name still appears
on a device after it has been reprocessed, the manufacturer is likely to be
named as a defendant, although it may have specified the device for single
use only. Another view holds that doctors may be particularly vulnerable in
liability cases because of the learned intermediary doctrine. According to
this theory, manufacturers of medical devices (a category that might also
encompass device reprocessors) pass information to doctors, who in turn
decide which risks to take, and which information to pass on to patients.
Patients usually have the least information about such practices and are
almost always unaware that the devices being used to treat them may be
reprocessed, which raises problems of informed consent.
The issue of FDA regulations is an interesting one, because the agency
has been slow to regulate reprocessing. The FDA is the body authorized by
Congress to regulate the manufacture, sale, and use of medical devices, so
one might expect to see this topic addressed in FDA regulations. In theory,
the same regulations that apply to manufacturers of new devices are applicable
to reprocessors. Moreover, the FDA could simply impose a blanket ban on the
use of reprocessed medical devices if it so chose. But the agency has been
reluctant to do this, and in effect, there is little direct regulation of reprocessing.
The FDA recently responded to criticism from industry and the public by releasing
draft enforcement guidances for the reprocessing of single-use devices, a move
suggesting that the agency views the practice as requiring more oversight. In
September 2001, the FDA announced that it would begin inspections of hospital
(but not third-party) reprocessors.
Little long-term research has been done on the risks of reprocessing, and the
net effect is that all parties involved-doctors, manufacturers, reprocessors,
and certainly patients-are operating in the dark with regard to questions of
safety and legal liability. With more data on the risks and benefits of reprocessing
different kinds of devices, the FDA will be better positioned to regulate such
activities. Addressing the question of patient safety will clearly be a necessary
first step in regulating the practice, and this should in turn inform courts'
approaches to legal liability issues. The future of reprocessed devices is
uncertain, but the topic will remain an area of interest in both law and the
device sector because of its far-reaching legal, technological, and medical implications.
Links:
http://www.fda.gov/cdrh/reuse/
http://devicelink.com
http://www.advamed.org/publicdocs/doc_02n_0456.pdf
http://www.ecri.org/documents/448908.htm
Further reading:
Emil P. Wang, Regulatory and Legal Implications of Reprocessing and Reuse of Single-Use Medical Devices, 56 Food Drug L.J. 77 (2001).
Janice M. Hogan & Thomas E. Colonna, Products Liability Implications of Reprocessing and Reuse of Single-Use Medical Devices, 53 Food Drug L.J. 385 (1998)
