Massachusetts Bill Considering Patient Consent Law forReprocessed SUDs Fuels Further Debate

February 1, 2006

Massachusetts Bill Considering Patient Consent Law for
Reprocessed SUDs Fuels Further Debate

By Kris Ellis

The practice of reprocessing single-use
medical devices (SUDs) has been subject to increasing amounts of scrutiny and
regulation in recent years. This trend continued in 2005 with the introduction
of Massachusetts Senate Bill No. 1321, An Act Relative to a Patients Right
to Know of the Reuse of Certain Medical Devices Manufactured for Single Use.
The bill was first introduced to the Massachusetts Joint Committee on Public
Health on Jan. 26, 2005, and a public hearing on the bill was conducted on
Oct.19, 2005. Senate Bill 1321 was pending before the Joint Committee as of
December 2005.

I filed this as a consumer protection measure, says Massachusetts state Sen. Susan C. Tucker (D-Andover), who introduced the bill. I do not think most patients know that a device used during
their surgery could have been used before in another procedure. I believe this
is information that should be shared with patients.

The legislation stipulates that, except as specified, a
healthcare provider may not use a reprocessed SUD on a patient. Some of the
conditions outlined in the bill are as follows: A healthcare provider may not use a reprocessed single-use
medical device on a patient without the patients consent as evidenced by a
signed written notice required under this section which shall be a permanent
medical record of the patient.

A healthcare provider shall provide each patient on admission
or registration a written notice that describes: 1. The practices of the
healthcare provider regarding reprocessed single-use medical devices, including
the circumstances under which such reprocessed single-use devices are used and
the safeguards taken by the healthcare provider to ensure the safety of the
patient under those circumstances; and 2. The potential risks of using reused
single-use medical devices generally and in the specific application.

The patient would have an opportunity to provide or refuse
consent to the use of reprocessed single-use medical devices on the patient, and
a patients refusal to consent shall not in any way limit the patients
access to health care, including with use of an original device.

The notice would be separate from all other documents provided
to the patient and would provide a place to indicate the patients refusal to
consent if the patient so chooses. The signed notice would then be made part of
the permanent medical record of the patient.

Additionally, the patients attending physician or the
attending physicians designee would be required to:

1. Describe verbally the contents of the notice to the patient, including the patients opportunity
to provide or refuse consent to the use of reprocessed single-use medical

2. Ensure that the patient understands the contents of the notice

3. If necessary, arrange for an interpreter to facilitate the patients
comprehension of the notice required in this section.

If a healthcare provider has admitted or registered a patient
in compliance with this section, the healthcare provider is not required to
comply with this section during subsequent admissions or registrations of the
same patient so long as the healthcare provider verifies that the patients
provision or refusal of consent to the use of reprocessed SUDs is recorded in
the permanent medical record of the patient and unless the patient revokes
consent in a subsequent written document provided to the healthcare provider,
any written revocation shall be deemed effective regardless of its form.

The bill also specifies that a reprocessor that reconditions
or reprocesses any SUD shall be liable for the safety and effectiveness of any
reprocessed single-use device, except that a healthcare provider who fails to
fulfill the informed patient consent requirement under this section shall also
be held liable. In no event shall an original manufacturer be held liable for
the use, safety, or effectiveness of a reprocessed single-use device, according
to the bill, unless such original manufacturer has expressly and specifically
consented to the use of the reprocessed device in that specific instance.

Notification to the department must occur whenever a person
performing the reuse, recycling, reprocessing, refurbishing for reuse, or
providing for the reuse of a single-use medical device, reconditioning, or
rebuilding a single-use medical device becomes aware of information that
suggests that a single-use medical device that was reused, recycled reprocessed,
refurbished, reconditioned or rebuilt by a person or entity may have: (a) caused
or contributed to a death or serious injury or; (b) malfunctioned and the
singleuse medical device or a similar device that would be reused, recycled,
reprocessed, or refurbished by a hospital or other entity on behalf of the
hospital, would be likely to cause a death or serious injury if the malfunction
were to recur.

The bill notes that failure of a reprocessor or healthcare
provider to comply with its provisions is prima facie evidence that the
reprocessing of the device alone has rendered a reprocessed single-use device
unreasonably dangerous and unfit for its intended use.

Violation of these provisions would result in a fine of not
less than $10,000 for a first offense and not less than $20,000 for a second or
subsequent offense.

MassMEDIC brought this matter to the attention of the
Massachusetts State Legislature, after the issue of patient safety and the
reprocessing of single-use devices was raised by numerous MassMEDIC members, says Thomas J. Sommer, president of the Massachusetts
Medical Device Industry Council (MassMEDIC). MassMEDIC is an organization that
represents the interests of Massachusetts medical device community.

Our interest in supporting this legislation is directly
related to patient safety. Our desire is to inform patients and to have them
approve or prohibit the use of reprocessed SUDs in a surgical procedure.

According to Sommer, patients and clinicians should be
concerned about the use of reprocessed SUDs because these devices were not
designed or manufactured for multiple uses and re-sterilization. Original
equipment manufacturers (OEMs) cannot guarantee their safety after one use.

Thomas E. Tremble, director of government and regional affairs
for the Advanced Medical Technology Association (AdvaMed), echoed this sentiment
in an Oct. 12, 2005 letter in support of Massachusetts Senate Bill 1321. Because of the health risks inherent in using a reprocessed
device that was intended for a single use, patients and clinicians should have
the right to know whether a medical device that has already been used on another
patient will be used in their surgery or other medical care, he said. They
are not designed to undergo the rigors of cleaning and resterilization as a
result their functionality may be severely compromised.

Single-use devices are designed for optimal performance and
safety under their intended conditions of use. Among the inherent risks of
reprocessed single-use devices:

  • Single-use devices often have small crevices, coils, and
    joints that are difficult to effectively clean and resterilize.
  • Studies on the reuse of single-use devices have determined
    instances of lack of sterility, contamination with tissue, or bodily fluids, and
    lack of functionality.
  • One recent study of reused arthroscopic shaver blades
    found the blades to be contaminated with DNA and protein. AdvaMed is the
    worlds largest medical technology association representing manufacturers of
    medical devices, diagnostic products, and medical information systems.

As a result of recent legislation, the federal Food and
Drug Administration (FDA) is responsible for regulating the reprocessing of
single-use devices, Tremble continued in the letter. However, FDA reviews
the validation data for only a small fraction of reprocessed devices, therefore,
significant steps must be taken to ensure consumer and patient safety and fully
realize congressional intent.

Passage of this legislation would be an important step in
educating consumers on the presence of reprocessed devices. Additionally, this
legislation would clearly establish that liability for the safety and
effectiveness of reused single- use devices rests with the entity that
reprocesses the device.

While the reprocessing provisions contained in the Medical
Device User Fee and Modernization Act of 2002 (MDUFMA) represent a notable first
attempt at better regulating reprocessed SUDs, MassMEDIC believes that MDUFMA
does not go far enough to protect patients from potential contamination and
injury from reprocessed SUDs, Sommer said in testimony before the Joint Committee on Public
Health in the Massachusetts State Legislature on Oct. 19, 2005. Specifically,
MDUFMA does not require:

  • Validation data for all classes of critical SUDs;
  • Institutions to establish a tracking system for
    reprocessed SUDs; and
  • Disclosure to patients on potential use of a
    re-processed SUD.

Single-use devices, particularly those that pierce the skin
or that enter the body or bloodstream, are manufactured and designed for use on
a single patient, Sommer continued in his testimony. After that they are
considered medical waste. They are not designed to withstand repeated cleaning
and sterilization. Many of these 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 provide a surface on which
blood, tissue and other organic matter can accumulate. Common sterilization
techniques used in reprocessing may be incapable of penetrating and removing
this biological tissue residue, leaving potentially pathogenic bacteria,
viruses, proteins, and other microorganisms on the devices which may be
transferred to another patient on reuse.

While healthcare institutions appear to have adopted the
use of reprocessed SUDs, primarily in an effort to reduce costs, MassMEDIC
suggests that such savings may come at the price of jeopardizing patient safety,
Sommer continued. Patients and clinicians remain uninformed about these risks
and are not given the opportunity to accept or reject the use of a reprocessed
single use medical device.

The Reprocessors Perspective

We saw similar legislation in Utah earlier in 2005 and late
2004, says Dan Vukelich, deputy executive director of the Association of
Medical Device Reprocessors (AMDR). AMDRs members include Alliance Medical Corporation,
SterilMed Inc., and Vanguard Medical Concepts Inc. From our perspective, this
is an organized campaign by original equipment manufacturers (OEMs) to do at the
state level what they couldnt do federally, which is to put reprocessors out
of business. The legislation in Utah didnt all the provisions were
the same as in Massachusetts but the only provision that passed in Utah was the
liability provision, and the other portions did not prevail.

Utah Senate Bill 110, in its final form, requires a
reprocessor of a critical SUD to assume liability associated with the original
manufacturing and the reprocessing of the critical single-use medical device.
The bill amends the Utah Judicial Code to establish that a reprocessor of a
critical SUD assumes all liability related to the original manufacturing and
reprocessing of the critical SUD.

Thats fine obviously we take responsibility for the
devices we put out, Vukelich says. The problem is with the way its
crafted it says once its reprocessed, the reprocessor assumes full
responsibility. That changes things because what if its an inherent design
flaw? Im not saying we shouldnt take responsibility, but we should take
fair responsibility. For example, Vukelich notes that if a device failure was
related to excessive reprocessing, responsibility should indeed fall on the
reprocessor. However, an error in the manufacturing or design of a device that
becomes apparent only after it is reprocessed should result in some type of
shared responsibility as opposed to all liability falling on the reprocessor.
We just want fair treatment we want whatever percentage of responsibility
were actually responsible for, Vukelich concludes. That provision
succeeded in Utah so its going to make things interesting there. Its really unprecedented to let an OEM completely off the
hook for their product once a device is reprocessed, so it may discourage
reprocessors from operating in Utah.

In terms of the informed consent provision of Massachusetts SB
1321, Vukelich agrees that circumstances which result in increased risk do
warrant consent on the part of patients. However, nobody can point to any
evidence that reprocessed devices have a higher risk than original equipment,
he says. In fact, the evidence that we have may suggest that
reprocessed devices have a lower failure rate than original equipment, for
example with trocars.

From the hospitals perspective, this is just more
needless regulation, Vukelich continues. They know what belongs in those informed consent forms.
Patients are worried enough going into surgery, so you should inform them of
real risks. Thats why I think hospitals by and large are not supportive, because they dont
want legislators telling them how to practice medicine. We, as an association,
support the idea of informing patients. Patients should have as much information
as possible, because I think the most educated patients are best, so were
comfortable and happy educating people about what reprocessing is and how the
industry works.

Vukelich notes that informed consent means informing patients
when an increased risk is present, but he contends that there is no increased
risk for these reprocessed devices. In fact, if we want to start informing
patients about this, then suddenly the bar has been reset, he says. Vukelich
thinks this type of scenario would then call for patients to be informed about
new, non-reprocessed OEM devices that have been subject to recalls and/or FDA
enforcement action. Patients ought to know about that because that seems to
me like a real safety issue, he says.

Theres some data to indicate that these devices have
failed and I dont think anybody wants to go down that path because they feel
regulations are adequate, but thats our counter-argument Great, lets
inform patients of the risks, but youre not going to find them with our
devices youre going to find them with the OEM devices. Were happy
to look at the safety record and be able to communicate with legislators and say
theyre barking up the wrong tree if theyre trying to tell you theres a
safety issue with reprocessing. If anything, we should be looking at original

Vukelich also notes that much of the general public may not be
aware that other types of products such as saw blades and blood pressure cuffs
are labeled for single use by manufacturers. You have to realize that there
are no FDA requirements on those single- use labels, he says. I think if
someone spends 15 minutes on the issue, at least enough to learn both sides, it
becomes a non-issue and you see that its economically motivated. At least
thats our hope.

To the non-clinician, it would seem counter-intuitive that
reprocessed SUDs might actually be safer, but it actually makes sense because
the device was used once and it worked, Vukelich explains.

Oftentimes if original equipment fails, it fails right out
of the package. Secondly, our entire industry tests or inspects 100 percent of
our devices. Thats different because if youre a major OEM and you make saw
blades, you cant do that, but we give individual scrutiny to every single
device, and thats part of whats made hospitals very comfortable and
willing to sign up with our companies is they know that every device has
received individual scrutiny. Plus thats all we do. When hospitals
reprocessed, they had a lot of competing priorities, but all we do is the
cleaning of the devices, so we do it best. A lot of variables like that have
contributed to our safety record.

The single use label is not an
FDA requirement, said Pamela J. Furman, Esq., executive director of AMDR in
her testimony before the Joint Committee on Public Health in the Massachusetts
State Legislature on Oct. 19, 2005. Rather it is a designation that is chosen by the
manufacturer, and that choice is frequently made for marketing reasons as a
way to sell more devices not for patient safety reasons. The truth is that a
manufacturer could label an operating table as single use, if it wanted to
if it really thought a hospital would throw the table out after one use. In
fact, some OEMs offer hospitals the option of reprocessing the OEMs own single-use
devices, which demonstrates clearly that, in some cases, the label single use
does not mean, even in the manufacturers own estimation, that the device is
not suitable for reprocessing and re-use.