Infection Control Today magazine's 2002 virtual roundtable on medical device reprocessing
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Infection Control Today: What is the reasonable margin of safety that patients and healthcare personnel should expect from reprocessed medical devices?
ClearMedical: Patients and healthcare personnel can and should expect the same level of safety from a device reprocessed by ClearMedical as they would from a new device. Under new FDA guidelines, reprocessors of single-use devices (SUDs) are considered manufacturers and must comply with regulations established for original equipment manufacturers (OEMs). In addition, reprocessors must follow FDA standards known as Quality Systems Regulations (QSRs), which are tailored to produce "objects/devices" in a uniform and repeatable manner. All reprocessors, third-party reprocessors (TPRs) and hospitals must comply with the same quality and safety requirements as the OEM.
Infection Control Today: Is reprocessing still considered to be good science and why?
ClearMedical: Reprocessing is most certainly a proven science. Independent studies, FDA reviews and historical data have demonstrated that the risk of using a reprocessed SUD is equivalent to using that device for the first time. The FDA has applied the same level of oversight and regulatory processes to reprocessors as it utilizes for OEMs. What's more, new FDA enforcement guidelines requiring pre-market 510(k) submissions has expanded the review process to a 'product-by-product' approval process.
Infection Control Today: What steps is your company taking to ensure that the original equipment manufacturers' specifications are met when reprocessing medical devices?
ClearMedical: ClearMedical has a fully functional, state-of-the-art test lab staffed with both engineering and FDA regulatory specialists. Every device that we consider reprocessing is thoroughly tested for compatibility with our reprocessing procedures. Our acceptance criteria are the same as the OEM's specifications.
First, we establish the device's "characterization" by researching available information such as FDA submissions, product inserts and original labeling, and ask our Clinical Advisory Board and partner hospital staff for actual conditions of use for the product. Next, we conduct tests on new devices to determine their physical properties, and compare those properties to our reprocessed devices to verify that they are identical. We ensure that the original functionality and safety of every device is preserved before we return it to a customer for reuse.
For example, many devices that we reprocess require the ability to hold or apply air pressure. Our research will indicate the amount and duration of the pressure that will be applied. Our engineers may also conduct tests to determine such factors as the elasticity of the air bladder, the strength of the connectors and material shrinkage. All of the findings are analyzed to determine the appropriate quality tests to employ. ClearMedical tests every device it reprocesses before shipping.
Infection Control Today: Obviously hospitals are trying to cut costs by turning to third-party reprocessing, while OEMs are lobbying hard against this practice; in this battle over dollars and sense, can patient safety be safeguarded while free enterprise is protected?
ClearMedical: ClearMedical promotes "The Responsible Reuse of Medical Devices." Furthermore, we are a healthcare partner committed to providing scientifically based and environmentally sound reprocessing solutions. Both the goal and mission of ClearMedical are consistent with safeguarding patient safety while promoting financial stewardship.
We are firm believers in the safety of our reprocessed devices. It's important to note that reprocessing is not just about saving hospitals money; additional benefits of the practice are becoming widely apparent. In addition to creating considerable savings for the hospital, other benefits of reprocessing include the outsourcing of regulatory compliance and reporting issues, acquiring scientific expertise, reducing risk and realizing efficiencies by using the focused expertise of a specialist in medical device reprocessing, and reducing medical waste.
Hospitals are well aware that a major risk factor associated with outsourcing SUD reprocessing is the loss of control over the activity. While critical to any business, loss of control for hospitals and systems is a serious issue, as hospitals cannot, for the most part, outsource patient responsibility. Nevertheless, when partnering with a TPR for reprocessed SUDs, hospitals assume no more risk than they would if they purchased the SUDs from the OEM. All parties--hospitals, TPRs and OEMs--are held to the same quality standard and bear the same associated risks.
Infection Control Today: Can those high-risk, Class III devices ever be safely reprocessed, and should patients be told prior to a medical procedure that reprocessed instruments and devices will be used?
ClearMedical: We believe that for Class I and II devices, ClearMedical's high-level disinfectant (HLD) reprocessing process is the right solution; while Class III devices can be safely reprocessed with EtO sterilizers.
To us at ClearMedical, the question of whether patients should be notified that a reprocessed item will be used is a non-issue. To others, it may be an ethical, philosophical and even political question that should be handled at the discretion of the physician, medical professional or healthcare provider. The bottom line is, and the facts are, all reprocessed devices must be in the same condition as they were before they were first used. When all FDA submissions (510(k)) and rules are followed, including Quality Systems Regulations (QSRs), all devices are as safe for the next single-patient use as they were for the first patient-use. If any concerns or flaws arise during testing, the devices are rejected long before they reach patients.
Infection Control Today: How closely are you, as a third-party reprocessor, going to monitor adverse events in hospitals related to malfunctioning reprocessed devices, and how will your company address such an event in case it occurs?
ClearMedical: We are not aware of any adverse events in the history of reprocessed devices and we don't anticipate any in the future. But like any medical device, the items that we reprocess are closely monitored according to strict regulations. ClearMedical has established procedures, in accordance with medical devices reporting (MDR) regulations, for documenting and notifying interested parties including the FDA in the event of any serious injury or death that may have been caused or contributed to by one of our marketed devices and/or any malfunction of one of our devices which, if it were to recur, would be likely to cause or contribute to a death or serious injury. These guidelines extend to those of the Medical Devices Vigilance System as established by the European Economic Community (EEC) Directive for Medical Devices (MDD).
Infection Control Today: What is the most common misconception about the reprocessing of medical devices and how do you address it?
ClearMedical: It is not widely understood that the same process is not necessarily appropriate for every class of device, and journals such as this one can certainly help educate end users to that fact. We believe that for most devices, ClearMedical's HLD process is ideal, while sterilization is more appropriate for some Class III devices.
The current number of reprocessible devices that offer savings opportunities now exceeds 500 devices, and medical industry journals and the popular press have written extensively on criteria for selecting a reprocessing specialist. We feel that inherent in the decision to choose a specific TPR is the question of strategy. Hospitals must establish specific reprocessing vendor type criteria for CDC Class I, Class II and Class III devices, and consider such issues as the long-term plan for reprocessing SUDs in the hospital.
The breadth of the reprocessing technologies, basic science, engineering and manufacturing processes required are beyond the capabilities of any single reprocessor. For example, non-critical and semi-critical (Class I and Class II) SUDs do not reprocess well when subjected to steam or Ethylineoxide (EtO) gas reprocessing, the most common form of sterilization. The impact of EtO gas sterilization on the compounds degrades the plastic material and alters their physical performance, thereby limiting their life cycle and potential savings to the hospital. For these devices, a high-level disinfectant (HLD) reprocessor, such as ClearMedical, is the right solution. On the other hand, EtO sterilizers can be good solutions for critical (Class III) devices.
It is important for each hospital to understand the capabilities of different reprocessors so they can select the right partners with the correct technologies and product focus. Just like selecting vendors for the original product--it is not a one source that meets all needs and maximizes savings.