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 devices
2. Ensure that the patient understands the contents of the notice required
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 equipment.
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.