Reprocessing Single-Use Devices:

January 1, 2001

Reprocessing Single-Use Devices:
Choosing a Third-Party Reprocessor for a Given Single-Use Device

By Richard Radford

How will your hospital respond to the sweeping changes the FDA has mandated
for the reprocessing of single patient use devices? The two seemingly opposite
mandates of cutting costs and preserving the quality of patient care appear to
hang in the balance when making this choice. Single-patient use devices (SUDs)
have provided convenience, apparent cost savings, and an assurance that
infection control standards would be maintained for over 30 years. But now, at a
time when vital services are being challenged with budget concerns, new thinking
is required.

The FDA has been looking at the SUD issue for several years. Hospitals,
device manufacturers, and the FDA have been in serious debate attempting to find
the "middle ground" that would reconcile the opportunity for cost
savings and the safe reuse of SUDs. The most obvious opportunity for cost
savings was found to be devices that were categorized as "critical
devices" because they came into contact with blood, were invasive, or both.
Diagnostic cardiac catheters, forceps, orthopedic burrs, and others were the
likely candidates. These devices were very expensive and could offer hospitals
thousands of dollars each year in savings. However, a question remained
regarding the safety of this practice.

Independent studies, FDA reviews, and the history of third-party reprocessors
over the years have demonstrated the risks of reprocessing many of these devices
is equivalent to a device's first use when reprocessed under highly-controlled
processes. In fact, the FDA inspected Third Party Reprocessors (TPR) and applied
the same level of audit processes they utilize for the original manufacturer (OGM).
The FDA found that all of the TPRs could improve their documentation and other
issues of quality control. But this is a young industry, with standards of
practice that could only be improved by this process. And the TPR industry
responded with quality improvements in much the same manner that all medical
device manufacturers respond when they are bringing new products to market. The
good news in the development of this new reprocessing industry is the FDA has
not been able to detect any significant patient risk issues during the emergence
of the third-party reprocessing industry.

But, as this new industry has been forming, it has become clear that patient
safety cannot be jeopardized with a "two-tier" system of quality
regulation. That is to say, reprocessors are in effect offering back a device
that has been re-manufactured for the next single-patient use. If patient safety
is to be assured, the same quality processes needs to be maintained by both the
reprocessor and the OEM. Given this logic, the FDA has established the position
that a reprocessor is a manufacturer (remanufacturer) for the next patient use,
and therefore must comply with all of the requirements of the OEM. This standard
becomes effective January 1, 2001.

What does this mean for your hospital? A great deal if you intend to
reprocess SUDs. Hospitals are considered manufacturer's under these new
standards and must register with the FDA as such. This also means they must
establish and maintain the same processes of quality that other manufacturers
do. The standards required by the FDA are known as QSRs (quality systems
regulations). The QSRs are similar but not the same as those typically found in
healthcare i.e., JCAHO. They are tailored to produce
"objects/devices" in a uniform and repeatable manner. Is this what
healthcare is about? Is this a core competency your hospital requires to achieve
its mission? These are questions each institution must face as it deals with the
operational issues related to reprocessing under the new FDA guidelines.

Finding the Right Provider

If your choice is to focus on healthcare and not manufacturing, then
utilizing third-party reprocessors to achieve the significant cost savings
through SUD re-use is a good approach. A good deal has appeared in the popular
press and various journals, which offer guidance on how to best select a vendor.
Noticeably missing, however, from many of the vendor selection guidelines is the
development of a long-term plan for reprocessing SUDs in your hospital. This
planning is critical because the landscape of potential products has changed
significantly beyond the initial few device options offered by most TPRs. The
total number of devices that offer savings opportunities now exceeds 500
products and is growing. And the breadth of the reprocessing technologies, basic
science, engineering, and manufacturing processes required are beyond the
current capabilities of any single reprocessor.

Given this, the recommendations found in industry journals to select a
"full-service provider" become problematic because there are none
available. Given the growing volume of product types, which are labeled as
single patient use, and the fact that no current reprocessors have the
manufacturing depth that spans this gamut of devices, what policies can a
hospital develop to resolve this issue?

It's important to remember that the Centers for Disease Control and
Prevention (CDC) has designated three device classifications for various levels
of reprocessing intensity:

  • Critical devices (contact with blood) require sterilization
  • Semi-Critical devices (contact with mucous membranes) requires high-level
    disinfection
  • Non-Critical devices (Contact with skin or less) requires low-level
    disinfection/cleaning

The science, technology and manufacturing expertise for reprocessing each of
these product types are different and the CDC classification may be the
appropriate construct to begin a vendor selection process. If hospitals were to
develop a multiple vendor approach based on the CDC reprocessing types, a more
powerful selection criteria set could be developed to address the specifics of
any given SUD to be reused.

However, this approach is contrary to the notion of minimizing and
consolidating vendors. In this case, choosing multiple vendors reflects the
immensity of product opportunity for the reprocessing of SUDs. No purchasing
agent expects to buy EP catheters, diagnostic forceps, sequential compression
devices, oxymeter probes, anesthesia circuits, resuscitation bags, cooling
blankets, and ventilator circuits from the same vendor. These products represent
a wide spectrum of product types falling into several reprocessing technique
categories. No single manufacturer produces all of these products and it is
unreasonable to expect a single TPR to have developed the deep science and
reprocessing techniques necessary to offer a complete reprocessing product line.
Establishing specific reprocessing vendor type criteria will assist in focusing
the selection process and assure the best reprocessing techniques are applied to
the specific SUD in question.

Over the past two years a great deal of information regarding the
reprocessing of critical devices and the TPR's who perform this service has
prevailed. The sterilization technique used by these companies is EO, which is
regarded as an industry standard. These devices experience the same
sterilization process the OEM uses prior to the first patient use. This industry
is well understood and the quality practices in place give the clinician a
significant level of assurance their patients will be safe from an infection
control standpoint. The issues outstanding in critical device vendor selection
relate to the cleaning, performance testing, records management, and level of
service when preparing the device for reuse. Critical devices, however,
represent a minor segment of the large array of SUDs, that a hospital can
benefit from by reprocessing. The largest segment of waste stream reduction and
cost savings will be derived from the reprocessing of semi-critical and
non-critical devices.

Using Right Sterilization Technology

Semi-critical and non-critical devices do not do well when subjected to steam
or EO. Many of these devices are manufactured utilizing various plastic
compounds, and the physical conditions of sterile reprocessing techniques
degrade plastic materials and alter their physical performance, limiting the
life cycle capabilities of the device. With these changes in the device, both
clinical and economic benefits are jeopardized. The optimum reprocessing
technique for reprocessing semi-critical devices must be determined on a
device-specific basis, given the large variation in the materials used and the
construction and the manufacturing processes used. For these reasons, a set of
device-specific questions should be posed to assist in selection of a TPR for
the semi-critical/non-critical devices.

The historical methodologies used to high-level-disinfect (HLD),
semi-critical and non-critical devices include a number of approved liquid or
cold disinfectant solutions (glutaraldehyde, phenolics, alcohol, etc.) and
pasteurization. Both the CDC and the FDA recognize these technologies as safe
and appropriate for this classification of devices. Over kill with sterilization
for these devices adds no known benefit to infection control, adds to the cost
and "turn time" of the reprocessing cycle, and stresses the devices,
reducing their useful life. Each of the HLD technologies has benefits and
disadvantages on a device specific basis. In general, it is not a
one-size-fits-all solution. Basic scientific research on chemical and physical
changes to the plastic and the device's clinical performance is required. A TPR
needs to have the capability to develop this data to ensure clinical safety and
device performance after each use of the reprocessed device.

When beginning to reprocess single-use devices, recognize that the science of
reprocessing is young and each hospital needs to understand the capabilities of
their reprocessing partner to gain the savings.

Selecting a TPR vendor based on their specific reprocessing technologies and
individual products reprocessed is the safest approach at this stage of the
development of the reprocessing industry. Assuming any TPR to be a full-service
reprocessor may limit the savings opportunity to the technical growth and
capacity of a single company. Begin with an understanding of the vast
differences in the reprocessing technologies and cost savings opportunities
between Critical and Semi-Critical devices. Then develop your selection criteria
based on the best fit for your hospital's long-term commitment to cost savings
and reduction of medical waste.

Richard Radford is the President of ClearMedical in Bellevue, Wash.

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