By Kris Ellis
The practice of reprocessing single-usemedical devices (SUDs) has been subject to increasing amounts of scrutiny andregulation in recent years. This trend continued in 2005 with the introductionof Massachusetts Senate Bill No. 1321, An Act Relative to a Patients Rightto Know of the Reuse of Certain Medical Devices Manufactured for Single Use.The bill was first introduced to the Massachusetts Joint Committee on PublicHealth on Jan. 26, 2005, and a public hearing on the bill was conducted onOct.19, 2005. Senate Bill 1321 was pending before the Joint Committee as ofDecember 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 duringtheir surgery could have been used before in another procedure. I believe thisis information that should be shared with patients.
The legislation stipulates that, except as specified, ahealthcare provider may not use a reprocessed SUD on a patient. Some of theconditions outlined in the bill are as follows: A healthcare provider may not use a reprocessed single-usemedical device on a patient without the patients consent as evidenced by asigned written notice required under this section which shall be a permanentmedical record of the patient.
A healthcare provider shall provide each patient on admissionor registration a written notice that describes: 1. The practices of thehealthcare provider regarding reprocessed single-use medical devices, includingthe circumstances under which such reprocessed single-use devices are used andthe safeguards taken by the healthcare provider to ensure the safety of thepatient under those circumstances; and 2. The potential risks of using reusedsingle-use medical devices generally and in the specific application.
The patient would have an opportunity to provide or refuseconsent to the use of reprocessed single-use medical devices on the patient, anda patients refusal to consent shall not in any way limit the patientsaccess to health care, including with use of an original device.
The notice would be separate from all other documents providedto the patient and would provide a place to indicate the patients refusal toconsent if the patient so chooses. The signed notice would then be made part ofthe permanent medical record of the patient.
Additionally, the patients attending physician or theattending physicians designee would be required to:
1. Describe verbally the contents of the notice to the patient, including the patients opportunityto provide or refuse consent to the use of reprocessed single-use medicaldevices
2. Ensure that the patient understands the contents of the noticerequired
3. If necessary, arrange for an interpreter to facilitate the patientscomprehension of the notice required in this section.
If a healthcare provider has admitted or registered a patientin compliance with this section, the healthcare provider is not required tocomply with this section during subsequent admissions or registrations of thesame patient so long as the healthcare provider verifies that the patientsprovision or refusal of consent to the use of reprocessed SUDs is recorded inthe permanent medical record of the patient and unless the patient revokesconsent 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 reconditionsor reprocesses any SUD shall be liable for the safety and effectiveness of anyreprocessed single-use device, except that a healthcare provider who fails tofulfill the informed patient consent requirement under this section shall alsobe held liable. In no event shall an original manufacturer be held liable forthe use, safety, or effectiveness of a reprocessed single-use device, accordingto the bill, unless such original manufacturer has expressly and specificallyconsented to the use of the reprocessed device in that specific instance.
Notification to the department must occur whenever a personperforming the reuse, recycling, reprocessing, refurbishing for reuse, orproviding for the reuse of a single-use medical device, reconditioning, orrebuilding a single-use medical device becomes aware of information thatsuggests that a single-use medical device that was reused, recycled reprocessed,refurbished, reconditioned or rebuilt by a person or entity may have: (a) causedor contributed to a death or serious injury or; (b) malfunctioned and thesingleuse medical device or a similar device that would be reused, recycled,reprocessed, or refurbished by a hospital or other entity on behalf of thehospital, would be likely to cause a death or serious injury if the malfunctionwere to recur.
The bill notes that failure of a reprocessor or healthcareprovider to comply with its provisions is prima facie evidence that thereprocessing of the device alone has rendered a reprocessed single-use deviceunreasonably dangerous and unfit for its intended use.
Violation of these provisions would result in a fine of notless than $10,000 for a first offense and not less than $20,000 for a second orsubsequent offense.
MassMEDIC brought this matter to the attention of theMassachusetts State Legislature, after the issue of patient safety and thereprocessing of single-use devices was raised by numerous MassMEDIC members, says Thomas J. Sommer, president of the MassachusettsMedical Device Industry Council (MassMEDIC). MassMEDIC is an organization thatrepresents the interests of Massachusetts medical device community.
Our interest in supporting this legislation is directlyrelated to patient safety. Our desire is to inform patients and to have themapprove or prohibit the use of reprocessed SUDs in a surgical procedure.
According to Sommer, patients and clinicians should beconcerned about the use of reprocessed SUDs because these devices were notdesigned or manufactured for multiple uses and re-sterilization. Originalequipment manufacturers (OEMs) cannot guarantee their safety after one use.
Thomas E. Tremble, director of government and regional affairsfor the Advanced Medical Technology Association (AdvaMed), echoed this sentimentin an Oct. 12, 2005 letter in support of Massachusetts Senate Bill 1321. Because of the health risks inherent in using a reprocesseddevice that was intended for a single use, patients and clinicians should havethe right to know whether a medical device that has already been used on anotherpatient will be used in their surgery or other medical care, he said. Theyare not designed to undergo the rigors of cleaning and resterilization as aresult their functionality may be severely compromised.
Single-use devices are designed for optimal performance andsafety under their intended conditions of use. Among the inherent risks ofreprocessed single-use devices:
As a result of recent legislation, the federal Food andDrug Administration (FDA) is responsible for regulating the reprocessing ofsingle-use devices, Tremble continued in the letter. However, FDA reviewsthe validation data for only a small fraction of reprocessed devices, therefore,significant steps must be taken to ensure consumer and patient safety and fullyrealize congressional intent.
Passage of this legislation would be an important step ineducating consumers on the presence of reprocessed devices. Additionally, thislegislation would clearly establish that liability for the safety andeffectiveness of reused single- use devices rests with the entity thatreprocesses the device.
While the reprocessing provisions contained in the MedicalDevice User Fee and Modernization Act of 2002 (MDUFMA) represent a notable firstattempt at better regulating reprocessed SUDs, MassMEDIC believes that MDUFMAdoes not go far enough to protect patients from potential contamination andinjury from reprocessed SUDs, Sommer said in testimony before the Joint Committee on PublicHealth in the Massachusetts State Legislature on Oct. 19, 2005. Specifically,MDUFMA does not require:
Single-use devices, particularly those that pierce the skinor that enter the body or bloodstream, are manufactured and designed for use ona single patient, Sommer continued in his testimony. After that they areconsidered medical waste. They are not designed to withstand repeated cleaningand sterilization. Many of these SUDs often have unique features such as narrow lumens, acute angles, crevices, coilsand joints, reinforcing meshes and rough, porous, or occluded surfaces that makeaccess difficult, create barriers to cleaning, and provide a surface on whichblood, tissue and other organic matter can accumulate. Common sterilizationtechniques used in reprocessing may be incapable of penetrating and removingthis biological tissue residue, leaving potentially pathogenic bacteria,viruses, proteins, and other microorganisms on the devices which may betransferred to another patient on reuse.
While healthcare institutions appear to have adopted theuse of reprocessed SUDs, primarily in an effort to reduce costs, MassMEDICsuggests that such savings may come at the price of jeopardizing patient safety,Sommer continued. Patients and clinicians remain uninformed about these risksand are not given the opportunity to accept or reject the use of a reprocessedsingle use medical device.
The Reprocessors Perspective
We saw similar legislation in Utah earlier in 2005 and late2004, says Dan Vukelich, deputy executive director of the Association ofMedical Device Reprocessors (AMDR). AMDRs members include Alliance Medical Corporation,SterilMed Inc., and Vanguard Medical Concepts Inc. From our perspective, thisis an organized campaign by original equipment manufacturers (OEMs) to do at thestate level what they couldnt do federally, which is to put reprocessors outof business. The legislation in Utah didnt all the provisions werethe same as in Massachusetts but the only provision that passed in Utah was theliability provision, and the other portions did not prevail.
Utah Senate Bill 110, in its final form, requires areprocessor of a critical SUD to assume liability associated with the originalmanufacturing and the reprocessing of the critical single-use medical device.The bill amends the Utah Judicial Code to establish that a reprocessor of acritical SUD assumes all liability related to the original manufacturing andreprocessing of the critical SUD.
Thats fine obviously we take responsibility for thedevices we put out, Vukelich says. The problem is with the way itscrafted it says once its reprocessed, the reprocessor assumes fullresponsibility. That changes things because what if its an inherent designflaw? Im not saying we shouldnt take responsibility, but we should takefair responsibility. For example, Vukelich notes that if a device failure wasrelated to excessive reprocessing, responsibility should indeed fall on thereprocessor. However, an error in the manufacturing or design of a device thatbecomes apparent only after it is reprocessed should result in some type ofshared responsibility as opposed to all liability falling on the reprocessor.We just want fair treatment we want whatever percentage of responsibilitywere actually responsible for, Vukelich concludes. That provisionsucceeded in Utah so its going to make things interesting there. Its really unprecedented to let an OEM completely off thehook for their product once a device is reprocessed, so it may discouragereprocessors from operating in Utah.
In terms of the informed consent provision of Massachusetts SB1321, Vukelich agrees that circumstances which result in increased risk dowarrant consent on the part of patients. However, nobody can point to anyevidence that reprocessed devices have a higher risk than original equipment,he says. In fact, the evidence that we have may suggest thatreprocessed devices have a lower failure rate than original equipment, forexample with trocars.
From the hospitals perspective, this is just moreneedless regulation, Vukelich continues. They know what belongs in those informed consent forms.Patients are worried enough going into surgery, so you should inform them ofreal risks. Thats why I think hospitals by and large are not supportive, because they dontwant legislators telling them how to practice medicine. We, as an association,support the idea of informing patients. Patients should have as much informationas possible, because I think the most educated patients are best, so werecomfortable and happy educating people about what reprocessing is and how theindustry works.
Vukelich notes that informed consent means informing patientswhen an increased risk is present, but he contends that there is no increasedrisk for these reprocessed devices. In fact, if we want to start informingpatients about this, then suddenly the bar has been reset, he says. Vukelichthinks this type of scenario would then call for patients to be informed aboutnew, non-reprocessed OEM devices that have been subject to recalls and/or FDAenforcement action. Patients ought to know about that because that seems tome like a real safety issue, he says.
Theres some data to indicate that these devices havefailed and I dont think anybody wants to go down that path because they feelregulations are adequate, but thats our counter-argument Great, letsinform patients of the risks, but youre not going to find them with ourdevices youre going to find them with the OEM devices. Were happyto look at the safety record and be able to communicate with legislators and saytheyre barking up the wrong tree if theyre trying to tell you theres asafety issue with reprocessing. If anything, we should be looking at originalequipment.
Vukelich also notes that much of the general public may not beaware that other types of products such as saw blades and blood pressure cuffsare labeled for single use by manufacturers. You have to realize that thereare no FDA requirements on those single- use labels, he says. I think ifsomeone spends 15 minutes on the issue, at least enough to learn both sides, itbecomes a non-issue and you see that its economically motivated. At leastthats our hope.
To the non-clinician, it would seem counter-intuitive thatreprocessed SUDs might actually be safer, but it actually makes sense becausethe device was used once and it worked, Vukelich explains.
Oftentimes if original equipment fails, it fails right outof the package. Secondly, our entire industry tests or inspects 100 percent ofour devices. Thats different because if youre a major OEM and you make sawblades, you cant do that, but we give individual scrutiny to every singledevice, and thats part of whats made hospitals very comfortable andwilling to sign up with our companies is they know that every device hasreceived individual scrutiny. Plus thats all we do. When hospitalsreprocessed, they had a lot of competing priorities, but all we do is thecleaning of the devices, so we do it best. A lot of variables like that havecontributed to our safety record.
The single use label is not anFDA requirement, said Pamela J. Furman, Esq., executive director of AMDR inher testimony before the Joint Committee on Public Health in the MassachusettsState Legislature on Oct. 19, 2005. Rather it is a designation that is chosen by themanufacturer, and that choice is frequently made for marketing reasons as away to sell more devices not for patient safety reasons. The truth is that amanufacturer 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. Infact, some OEMs offer hospitals the option of reprocessing the OEMs own single-usedevices, which demonstrates clearly that, in some cases, the label single usedoes not mean, even in the manufacturers own estimation, that the device isnot suitable for reprocessing and re-use.