While resterilization and reprocessing may not give anyone pause, the third type – reuse – raises eyebrows for a variety of reasons, be they clinically, ethically or fiscally based. Reactions typically hinge on the point of view of the objector and supporter. Certainly, the battle lines have been drawn over reuse of selected SUDs.

Third-party reprocessors (TPRs) support it, of course, as well as a growing number of healthcare providers who view it as an expense management strategy and tactic so long as patient safety, device composition and performance and healthcare quality aren’t compromised. On the flip side, the original equipment manufacturers (OEMs) oppose it on the grounds of patient safety, device composition and performance and healthcare quality. TPRs contend, however, that OEMs merely are protecting their revenue stream because the Food and Drug Administration has established federal guidelines and regulations for the practice that must be followed, which TPRs and providers consider a tacit acknowledgement and legal blessing to do it.

The bottom line is that reuse seems to be a fact of life within the nation’s healthcare provider organizations – whether it’s done openly or secretly, and regardless of association, federal or state guidelines. And it’s a relatively booming business.

Healthcare Purchasing News Senior Editor Rick Dana Barlow reached out to the key executives at the two market-leading TPR companies to explore the industry segment’s development over the years – from a practice performed "behind closed doors" to "coming out of the closet" to dealing with the industry and public aftershocks, including efficacy and safety, as well as what to tell patients. Rick Ferreira, chief operating officer, Ascent Healthcare Solutions, Phoenix, and Brian Sullivan, CEO and president, SterilMed Inc., Maple Grove, MN, pulled no punches with their diplomatic assessment of their business but remained optimistic that the groundwork they’ve paved in the last decade will smooth out any rough edges on the road going forward.

Inspecting surgical blades: Devices undergo multiple inspections and functional tests,
including visualization under lighted magnification.

FERREIRA: I am glad we have this opportunity to correct the record on a number of fronts. First, there are not a ‘handful’ of states with laws that hold TPRs accountable and liable if a reprocessed SUD fails. Under both federal law and regulation, TPRs — which the FDA regulates as manufacturers — are already fully liable and responsible for the devices they reprocess. The FDA has ruled that reprocessed cleared SUDs are substantially equivalent to new devices.

Second, the Association of Medical Device Manufacturers (AMDR) has stated that, to the best of their knowledge, no AMDR members have ever been sued for harm to a patient caused by improper reprocessing or from a reprocessed device. Moreover, the FDA has stated unequivocally that SUDs have caused zero patient deaths. None.

Despite this situation, only one state, Utah, passed unprecedented legislation in 2005 that gives OEMs immunity from liability for their own device failures or omissions merely because the device may have been reprocessed. The Utah law, which the OEMs spearheaded and backed through an intensive propaganda campaign, forces the TPR to ‘assume the liability associated with the original manufacturing’ of the device. This actually obliges us to shoulder OEM design flaws and defects. The law also eliminated the ability of patients in Utah to look to OEMs for recompense for injuries that OEM devices caused. Aftermarket reprocessors, in effect, have become the guarantors of original device manufacturers, forced to pay for injuries that they did not cause.

The Utah legislation was a way for manufacturers to prevent hospitals from using safe, effective, low-cost reprocessed devices and instead force them to buy new SUDs. It has nothing to do with patient protection, but is a blatant act to protect OEM revenue.

SULLIVAN: According to the FDA, SterilMed is considered the manufacturer of reprocessed devices.  As such, we are as accountable as any manufacturer (including Original Equipment Manufacturers (OEMs)) for product safety, effectiveness, labeling claims, liability and warranty. This applies to all states.  

 SterilMed develops and provides validated processes, reviewed and cleared by the FDA, to ensure we provide a reprocessed product considered to be substantially equivalent to a new product. This includes ensuring 100 percent documented sterility. Our processes are far more thorough and controlled than those performed in central sterile departments in hospitals. For example, each sterility cycle has biologic indicators which are verified sterilized before any product is released for shipment. Many central sterile departments use a tape which simply indicates the presence of EtO gas with no certainty of sterility.

FERREIRA: All we can do is continue to provide the facts, inconvenient as they may be to the OEMs that are behind most legislation that attacks reprocessing. Historically, when all the facts have been considered, lawmakers have acted responsibly and have not passed anti-reprocessing legislation.

SULLIVAN: Our industry’s need to respond to these attacks is no different than what the generic drug manufacturers withstood from Big Pharma at the genesis of their industry. We don’t think the OEM attacks will prevail over the long term because they have no basis for their position. The fact that all four state legislatures – Virginia, Rhode Island, Massachusetts and Utah – that have considered patient consent legislation, rejected it, supports this point. These bills were rejected after the legislators had an opportunity to review the regulatory framework in which reprocessors operate. In addition, once they understood that patient consent is intended to address non-FDA cleared procedures, devices or drugs, they recognized that it was inappropriate to apply it to the use of FDA-cleared reprocessed devices. Finally, since reprocessors have a spotless safety track record – no recorded injuries or deaths proven to have been caused by reprocessing – legislators saw through the OEM’s sponsorship of the legislation and understood it for what it was – an attempt to protect them from lower priced competition. The law that Utah did pass is one that departs from mainstream tort law and is, we believe, unconstitutional.

FERREIRA: Patient consent is a separate issue from liability. The U.S. Food and Drug Administration (FDA) has never required a physician to obtain informed consent for medical devices that the FDA has cleared, which perform exactly the same as new devices. There is no legal, medical or ethical basis for it, and the entire healthcare system suffers if we don’t trust our doctors and nurses to make decisions on the tools they use. That was the case long before reprocessors came along.

Having lost their battles to cripple reprocessing in the regulatory and legislative arenas where science and evidence triumphed, OEMs are using the issue of informed consent as a red herring because they believe it would frighten patients into demanding brand-new devices. But if the push for informed consent were truly aimed at protecting the public, the principle should apply equally to new OEM devices, some of which have recently experienced serious safety problems, including deaths. Before operating, should surgeons warn their patients about new devices that have failed and caused injuries? I don’t think you will see the OEMs advocating informed consent along those lines.

SULLIVAN: The informed consent process is defined by FDA regulations (21 CFR) as a means of informing patients of the use of investigational and/or experimental drugs or devices. Reprocessed devices are mandated by legislation to be cleared by FDA and therefore, in no way, represent an investigational device. They are substantially equivalent to new devices.

We currently are held to the same ‘responsibilities’ as any other manufacturer. Last September, the FDA reiterated that reprocessed devices are as safe and effective as new ones. Patient consent is really an attempt by the OEMs to get patients to choose their devices over others. This would only serve to confuse the patient and ask them to make a decision that their healthcare provider is responsible for making. This would be like Ethicon trying to get patients to give consent to use a Boston Scientific device (instead of the ‘preferred’ Ethicon brand products) under the opinion that Ethicon devices are safer or more effective. Proposed patient consent bills regarding reprocessed devices are designed to scare patients by implying that they are less safe.

FERREIRA: Reprocessed devices do not pose a safety risk, and Ascent does not reprocess any implantables or devices that can cause serious injury. We would support informed consent about the use of all medical devices. Unfortunately, OEMs want to isolate reprocessed devices as a way to instill unjustified concern among patients. Any device-related informed consent should also require disclosure of potential complications, deaths and questions about efficacy linked to new devices. And Ascent accepts liability for all devices it reprocesses.

SULLIVAN: To reiterate, informed consent does not apply to cleared or approved devices. The mere fact that reprocessors are considered manufacturers means that liability and accountability rest with the reprocessor to the extent mandated by law.

FERREIRA: The TPR industry vigorously promotes and welcomes greater transparency in important ways. But let’s explore a little history first. Before third-party reprocessing existed as an industry, most devices were reusable. However, in the 1970s when OEMs arbitrarily changed the designation of many devices to ‘single use’ within the U.S. (the devices often remained reusable in other countries) without changing the devices, hospitals were suddenly faced with significant additional costs. Some chose to partner with a commercial reprocessor to help control expenses.

Even today, it is the OEMs themselves that decide to label their devices as ‘single use only;’ this is not a government mandate. Naturally, the manufacturers stand to make much more if their devices are discarded after a single use. This is planned obsolescence at its most egregious, and I would not call that behavior transparent; I would call it deceitful.

The fact is that some devices can be reprocessed safely multiple times. Reusing them saves hospitals millions of dollars per year and promotes a greener environment. In fact, each year Ascent eliminates 10,000 tons of material from landfill space. Reprocessing has also forced some OEMs to charge much less for their devices, reflecting their true market value. Partly as a response, OEMs have moved toward ‘price bundling,’ in which some devices are sold in packaged pricing along with other devices and components. This helps conceal the cost of the individual device.

Other things should be transparent, too. Consumers concerned about rising healthcare costs should know the lengths the OEMs have gone to in protecting their market share. Through their well-funded lobbying efforts, they have tried to kill the reprocessing industry, largely through scare tactics and front organizations such as PatientGUARD in New Jersey.

SULLIVAN: No impact. With rising healthcare costs, there is a societal need to ensure that quality medical care is affordable and that hospitals can operate in a financially stable manner. By definition, informed consent for reprocessed devices is not contrary to any belief that healthcare should be more transparent. Transparency is not useful if it leads to confusion. The mere act of requesting a patient’s consent to use an FDA-cleared reprocessed device suggests it is not equivalent; if it was, why would a patient need to consent to it? Since these devices have been found by the FDA to be equivalent, no purpose is served by informing them, and the result would only be confusion on the patient’s part.

FERREIRA: A TPR should be held liable for a failed device because it is the manufacturer. This fact sometimes gets lost in anti-reprocessing hype. For any device Ascent reprocessed, we take on all the responsibility and stand behind the product, backed by liability insurance of up to $25 million per occurrence.

FERREIRA: When a lawsuit is filed, judges and juries ultimately decide which parties are responsible for a bad medical outcome and apportion blame and damages accordingly. We stand behind all our products and if an Ascent device was found to be at fault, we would accept liability just as the hospital or a physician would be liable if they were found to have contributed to the outcome.

Sharper imaging:
Certain edges require precision manual honing and deburring, as with this arthroscopic shaver.

FERREIRA: I think there is some confusion here, so let’s clarify the state of modern reprocessing. Commercial reprocessing, which is a high-tech, science-based business with formidable entry barriers, operates with more regulatory oversight than the OEMs face. Furthermore, hospitals do not reprocess medical devices because they are not qualified to do so. Currently, no hospitals are registered with the FDA as manufacturers, the first step required before one can reprocess devices.

SUDs must successfully undergo a number of reprocessing steps to ensure cleanliness, sterilization and the ability to function identically to the new device. This requires a huge investment in human and financial resources. Reprocessing facilities must also comply with the FDA’s Quality System Regulation (QSR) and are inspected regularly. Our employees are highly trained and certified. And remember, while batch inspections of OEM equipment are the standard, each and every reprocessed SUD has been individually inspected to ensure it will function properly. Given the choice, I would rather have a surgeon use a device reprocessed by Ascent, not a new one, on me and my family members.

Hospitals understand these issues and that’s why they partner with responsible TPRs like Ascent rather than reprocess in-house. Also, we are not aware of any U.S. hospitals that reprocess SUDs. It would be illegal for them to do so.

SULLIVAN: Reprocessing regulations (MDUFMA) mandate that all reprocessors of ‘single use’ devices, including hospitals, have to comply with validated cleaning, sterility and functional testing processes. So hospitals are held to the same standard. Most of the items used in surgery are reused. The hospital needs to ensure they are effectively cleaned and sterilized. Hospitals can’t reprocess SUDs without clearance from the FDA. 

FERREIRA: Actually, we just continue to do our jobs. AMDR helps TPRs with educating the public and legislators, but for the most part the association is kept busy reacting to intensive and widespread OEM efforts to discredit the industry. For our part, I invite anybody to visit our website, ascenths.com, to learn more about our business practices. You will also see testimonials from respected hospital officials and the scientific community. Interviews like this also help with education.

That said, decision-makers in hospitals and healthcare organizations must be guided by facts and science, not fear or intimidation. At the microscopic level, we can prove our devices are sterile — in fact, we can sometimes prove our equipment is more sterile than even brand new OEM devices.

SULLIVAN: The general public normally isn’t involved in the hospitals choice of manufacturers, whether that is Smith & Nephew, Stryker or SterilMed. Given unlimited resources, buying everything new would be everyone’s choice. The truth is that this isn’t reality and the hospitals have to make the decisions to buy cost effective devices which perform as intended. The OEMs have attempted to manipulate public opinion in the past, and it fell flat because it was ultimately found to have no basis in fact. With a safety track record as good as our industry’s, the OEMs are forced to rely on innuendo and falsehoods. Patients have not demanded only new SUDs for procedures, and we do not anticipate this to occur within the structure of health insurance coverage. Health insurance companies are major advocates of cost-savings efforts such as ours.

FERREIRA: Unlike OEM equipment, all reprocessed devices in this country are completely traceable. In fact, federal law requires not only that all reprocessed medical devices be marked on their packaging, but also marked on the devices themselves, either with an indelible imprint, or, when that is not feasible, an attachment to that device. This is a greater degree of traceability than the OEMs provide, which also applies to the earlier question about transparency in healthcare.

Just a little more on that point: With all the pressure the OEMs have leveraged to drive TPRs out of business, do you find it odd that the OEMS haven’t surfaced any evidence, in decades of reprocessing, that reprocessed SUDs lead to an increased risk of infection in the U.S.? No such evidence exists. How would you react if Tylenol claimed that Advil kills you, without offering anything but allegations? Would you be appalled? To suggest, without any evidence, that your competitor is putting people at risk is irresponsible and wrong.

SULLIVAN: Reprocessing legislation (section 301 of MDUFMA) requires that all devices are either marked with the reprocessor’s name or logo, or otherwise bear a peel-away label that may be attached to the patient’s chart. Hospitals thus can effectively trace whether or not a reprocessed device has been used. To date, there has not been one case of a patient death linked to the use of a reprocessed device. All devices reprocessed by SterilMed are sterilized under a validated process to ensure sterility. This is no different than is required of an OEM. You are as likely to get an infection from a new device as a reprocessed one.

An infection can originate from a new device, a reused SUD, a surgeon’s mistake, improperly processed reusable devices or even the patient reacting to something done to him/her on the OR table. One has to make a giant leap of conjecture to rule reprocessing as the specific cause of an infectious outcome.

FERREIRA: The markings that identify all devices reprocessed by Ascent are linked to a comprehensive, detailed order history file that tracks and monitors every step in the reprocessing process, such as when the independent third-party lab verified the device’s sterility, allowing for its release to the hospital. We believe our hospital partners would act in an ethical manner, but this system would make it very difficult to use us as a scapegoat.

FERREIRA: Actually, Ascent and SterilMed make up about 95 percent of the TPR industry in the U.S. It’s not accurate to say there are ‘countless’ others, but you might want to check with the FDA on the exact number; it is probably a mere handful. Also, AMDR requires all members to meet extremely high quality standards.

SULLIVAN: SterilMed and Ascent represent nearly 95 percent of the market. There are only a few others that are registered with the FDA to market reprocessed devices.  

FERREIRA: In the last nine years, for a variety of reasons, including the high cost of complying with stringent regulatory and legislative oversight, the reprocessing industry has seen dramatic consolidation. The Ascent lineage has elements of seven former companies: SRS, Orris, AMT, Paragon, MIT, Alliance and Vanguard, most of which were AMDR members. There are also some small niche-market vendors, such as those that perform high-level disinfection, which is different from full reprocessing.

We are not aware of any companies illegally ‘reprocessing’ and can’t imagine that any hospital would put itself at risk by doing business with such an organization. The FDA monitors reprocessing closely and would take immediate action to close down any such operation.

SULLIVAN: AMDR is attempting to solidify and identify all reprocessors into one representative group. Stringent FDA audits completed on a bi-annual basis (twice as often as occurs with OEMs) as well as ISO certification more than guarantees the legitimacy of reprocessing companies and their validations. Hospitals and surgery centers are well aware they need to work with a reprocessor that is regulated by the FDA.

Careful detailing: Trocar inspections identify the most exiguous problems.

FERREIRA: We estimate that only 2 percent of all types of SUDs can be safely reprocessed. These include compression sleeves, EP catheters and external fixation devices. Ascent is quite conservative in the range of SUDs it will even consider, because some classes of SUDs cannot be safely returned to their original functional state.

Every hospital or facility considering reprocessing goes through a multi-step research phase. It typically involves many parties, including surgeons, nurses, infection-control specialists and administrators. Often, hospitals form a committee to look into all the implications of reprocessing, and we present a great deal of information to them, including a comprehensive tour of our reprocessing facilities. No question goes unanswered.

Virtually all hospitals are under pressure to reduce costs where possible, which is why they consider reprocessing in the first place. Typically, each device they reprocess saves them 50 percent vs. the cost of buying the same device new. A hospital’s savings will depend on its size and the comprehensiveness and efficiency of the reprocessing program – the more reprocessed devices, the greater the savings.

A great thing about hospitals is that they are science and safety oriented. For every claim we make, we have to back it up with evidence. Many of the leading hospitals in the country, including 13 of the 14 U.S. News & World Report ‘Honor Roll’ hospitals in 2006, ask us to reprocess some of their devices.

SULLIVAN: Reprocessing is absolutely for every organization that wants to avoid foolishly spending their patient’s money. SterilMed reprocesses over 8,500 unique part numbers in 15 major device categories. The best way to determine which devices to do is to send us the SUD purchase data.

FERREIRA: We will only take on devices that can be cleaned, sterilized and tested to ensure that they’re functionally equivalent to the original device. Implantables and Class 3 devices will never be candidates for reprocessing by Ascent. Currently, Ascent has 77 510(k) device clearances — the most in the industry.

SULLIVAN: Those which can’t be cleaned or ensured to be functionally equivalent to new devices. As a current policy, we will not reprocess Class III implantable devices. Other non-implantable Class III devices may be reprocessed in the future. However, Class III devices are subject to FDA PMA approval requirements, which are much more onerous. 

FERREIRA: We would also not reprocess anything with a medicinal coating, so that is not a concern for us or our hospital partners. Of course, we research devices that might qualify in the future. Only after thorough review and testing procedures do engineers develop device-specific protocols for cleaning, function testing and sterilizing every device that is deemed suitable for reprocessing. But the overriding point here is that the FDA independently validates our processes and issues a 510(k) clearance for each device we reprocess.

SULLIVAN: As a part of our analysis to determine whether devices are reprocessable, SterilMed conducts comprehensive tests to ensure that reprocessed devices are compatible with cleaning agents, are biocompatible and are not degraded. Our analysis compares the new and reprocessed devices to ensure that the materials are not altered during reprocessing. Devices made of any new raw materials would undergo this same analysis as part of our new product review.

FERREIRA: Medical device reprocessors are already way ahead of the general industry when it comes to medical device traceability. As the FDA moves to require a UDI system for all medical devices, the medical-device industry should look to our experience and to the mechanisms we have used for some time now.

SULLIVAN: As the FDA considers SterilMed the manufacturer after we reprocess the devices, we will follow the same UDI that any other medical device manufacturer would follow. Any changes would have the same impact on a third-party reprocessor as any other medical device manufacturer.

FERREIRA: Whatever controversy has occurred over medical device reprocessing has been about profits, not patients. OEMs have suggested, based on zero evidence, that reprocessing poses a risk to patients. Reprocessors have proven otherwise and meet all the same regulatory requirements, and even more, as the OEMs.

Perhaps a different question is what the OEMs should have done a decade ago to be good corporate citizens and responsible players in the drive to reduce healthcare costs. Hospitals have roughly a 2 percent profit margin. Collectively, the OEMs’ margin is in the 80 percent range. Big difference.

Reprocessing is part of the solution hospitals need, and, if you’re not part of the solution, you’re part of the problem. By continuing to oppose, rather than embrace, reprocessing, the OEMs are contributing to mountains of medical waste and rising healthcare costs. They are doing a tremendous disservice to patients who are entitled to sound, scientifically accurate information about their care.

SULLIVAN: Hospitals could have resisted the pressure from OEMs and clinicians reacting to misinformation, and instead relied on facts and FDA’s regulation surrounding reprocessing. Hospitals should consider the facts that reprocessing SUDs is proven safe, has 10 years of positive clinical history and is stringently regulated by the FDA and cost effective. 

FERREIRA: I’m not sure. I do know that we do business in a highly regulated atmosphere, meeting the most stringent quality requirements day in and day out, working for America’s leading hospitals. As I mentioned, we receive assistance from the AMDR, but it has a microscopic budget compared with the billion-dollar-a-year anti-reprocessing lobby, which is funded by huge device manufacturers devoted to smearing reprocessors.

SULLIVAN: The problem is not with the general public. The problem is that there has been misinformation which has been used to instill doubt and fear. We are part of the healthcare solution. OEMs are driving up costs, waste, and unfounded scare tactics to drive their sales, and to drive out their competition. OEMs should be asked why they chose, and continue choosing, to drive up healthcare costs and not embrace this practice. Reprocessors need to keep trying to educate our customers by providing the facts. 

FERREIRA: Reprocessors have now built up a 20-year track record of success, based on the many themes we’ve already discussed: sound scientific practices, proven cost savings for hospitals, environmental stewardship and even price competition from the OEMs. I could go on. But this track record clearly has OEMs worried about profits, which is exactly why they like to whip up the controversy and the volatility you mention.

SULLIVAN: ‘Volatility’ has been manufactured by OEMs who are seeing an impact on their bottom lines. Healthcare costs are rising. Reimbursements are decreasing. This forces healthcare providers to find cost effective ways to provide their services. This leads them to SterilMed. More business for SterilMed means less profit for the OEMs. They create fear and apprehension regarding the safety and effectiveness of reprocessed devices.

FERREIRA: We will only take on devices that can be cleaned, sterilized and tested to ensure that they’re functionally equivalent to the original device. Implantables and Class III devices will never be candidates for reprocessing by Ascent. Currently, Ascent has 77 510(k) device clearances — the most in the industry.

SULLIVAN: Those which can’t be cleaned or ensured to be functionally equivalent to new devices. As a current policy, we will not reprocess Class III implantable devices. Other non-implantable Class III devices may be reprocessed in the future. However, Class III devices are subject to FDA PMA approval requirements, which are much more onerous. 

FERREIRA: We would also not reprocess anything with a medicinal coating, so that is not a concern for us or our hospital partners. Of course, we research devices that might qualify in the future. Only after thorough review and testing procedures do engineers develop device-specific protocols for cleaning, function testing and sterilizing every device that is deemed suitable for reprocessing. But the overriding point here is that the FDA independently validates our processes and issues a 510(k) clearance for each device we reprocess.

SULLIVAN: As a part of our analysis to determine whether devices are reprocessable, SterilMed conducts comprehensive tests to ensure that reprocessed devices are compatible with cleaning agents, are biocompatible and are not degraded. Our analysis compares the new and reprocessed devices to ensure that the materials are not altered during reprocessing. Devices made of any new raw materials would undergo this same analysis as part of our new product review.

FERREIRA: Medical device reprocessors are already way ahead of the general industry when it comes to medical device traceability. As the FDA moves to require a UDI system for all medical devices, the medical-device industry should look to our experience and to the mechanisms we have used for some time now.

SULLIVAN: As the FDA considers SterilMed the manufacturer after we reprocess the devices, we will follow the same UDI that any other medical device manufacturer would follow. Any changes would have the same impact on a third-party reprocessor as any other medical device manufacturer.

FERREIRA: Whatever controversy has occurred over medical device reprocessing has been about profits, not patients. OEMs have suggested, based on zero evidence, that reprocessing poses a risk to patients. Reprocessors have proven otherwise and meet all the same regulatory requirements, and even more, as the OEMs.

Perhaps a different question is what the OEMs should have done a decade ago to be good corporate citizens and responsible players in the drive to reduce healthcare costs. Hospitals have roughly a 2 percent profit margin. Collectively, the OEMs’ margin is in the 80 percent range. Big difference.

Reprocessing is part of the solution hospitals need, and, if you’re not part of the solution, you’re part of the problem. By continuing to oppose, rather than embrace, reprocessing, the OEMs are contributing to mountains of medical waste and rising healthcare costs. They are doing a tremendous disservice to patients who are entitled to sound, scientifically accurate information about their care.

SULLIVAN: Hospitals could have resisted the pressure from OEMs and clinicians reacting to misinformation, and instead relied on facts and FDA’s regulation surrounding reprocessing. Hospitals should consider the facts that reprocessing SUDs is proven safe, has 10 years of positive clinical history and is stringently regulated by the FDA and cost effective. 

FERREIRA: I’m not sure. I do know that we do business in a highly regulated atmosphere, meeting the most stringent quality requirements day in and day out, working for America’s leading hospitals. As I mentioned, we receive assistance from the AMDR, but it has a microscopic budget compared with the billion-dollar-a-year anti-reprocessing lobby, which is funded by huge device manufacturers devoted to smearing reprocessors.

SULLIVAN: The problem is not with the general public. The problem is that there has been misinformation which has been used to instill doubt and fear. We are part of the healthcare solution. OEMs are driving up costs, waste, and unfounded scare tactics to drive their sales, and to drive out their competition. OEMs should be asked why they chose, and continue choosing, to drive up healthcare costs and not embrace this practice. Reprocessors need to keep trying to educate our customers by providing the facts. 

FERREIRA: Reprocessors have now built up a 20-year track record of success, based on the many themes we’ve already discussed: sound scientific practices, proven cost savings for hospitals, environmental stewardship and even price competition from the OEMs. I could go on. But this track record clearly has OEMs worried about profits, which is exactly why they like to whip up the controversy and the volatility you mention.

SULLIVAN: ‘Volatility’ has been manufactured by OEMs who are seeing an
impact on their bottom lines. Healthcare costs are rising. Reimbursements are decreasing. This forces healthcare providers to find cost effective ways to provide their services. This leads them to SterilMed. More business for SterilMed means less profit for the OEMs. They create fear and apprehension regarding the safety and effectiveness of reprocessed devices.