FDA, AAMI Examine Medical Device Reprocessing Issues

Reprocessing medical devices is an intricate, complicated task, and lapses in infection prevention practices can lead to poor patient outcomes and infections. Cognizant of these implications and the role that medical device preprocessing plays in the larger healthcare arena, last summer the Food and Drug Administration (FDA) launched a coordinated effort focusing on improvements in device design, reprocessing procedures and validation methodologies, and healthcare facility quality assurance practices.

By Kelly M. Pyrek

Editor's note: This article originally appeared as part of the 2012 Regulatory Update in the January 2012 print issue of ICT. To access a slide show presenting the highlights of the 2012 Regulatory Update, CLICK HERE.

Reprocessing medical devices is an intricate, complicated task, and lapses in infection prevention practices can lead to poor patient outcomes and infections. Cognizant of these implications and the role that medical device preprocessing plays in the larger healthcare arena, last summer the Food and Drug Administration (FDA) launched a coordinated effort focusing on improvements in device design, reprocessing procedures and validation methodologies, and healthcare facility quality assurance practices. In June 2011, the FDA's Center for Devices and Radiological Health (CDRH) held a two-day public workshop, and in October 2011, the FDA and the Association for the Advancement of Medical Instrumentation (AAMI) held a joint two-day summit -- all with the express purpose of discussing factors affecting the quality of reprocessing of reusable medical devices and then soliciting public comment, sharing information and experiences and defining an agenda for the work to follow.

These events are part of the FDA's ongoing effort to address patient exposure to inadequately reprocessed reusable medical devices with the overall goal to reduce the risk of infection. (This effort focuses on medical devices that are intended for reuse after reprocessing and does not include third-party reprocessing of single-use-only medical devices.)

It's a timely effort, judging by the continuing news of outbreaks related to improperly cleaned, disinfected and sterilized surgical instruments, as well as the FDA's receipt of a number of reports of patient exposure to inadequately reprocessed medical devices and subsequent healthcare-associated infections (HAIs). Several reports contained evidence suggesting that inadequate reprocessing may have been a contributing factor in microbial transmission and subsequent infection. The FDA says that, "A definitive causal relationship between reusable device reprocessing and any patient infection is difficult to establish, because inadequate reprocessing is not often investigated as a cause when an HAI is diagnosed. Ensuring adequate reprocessing of reusable medical devices could reduce the incidence of HAIs associated with the use of a reprocessed medical device. This will decrease the public health burden of HAIs in terms of morbidity, mortality and cost."

The FDA adds that, "The adequate reprocessing of reusable medical devices is a critically important factor in protecting patient safety. Inadequate reprocessing between patients can result in the retention of blood, tissue and other biological debris (soil) in reusable medical devices. This soil can allow microbes to survive the high level disinfection or sterilization process, potentially resulting in Healthcare-Associated Infections (HAIs) or other adverse patient outcomes."

The agency has been informed about problems in all steps of medical device reprocessing, including cleaning, disinfecting and sterilizing, and says that manufacturers, healthcare facilities, healthcare professionals, and the FDA all have a role in reducing the risk of inadequately reprocessed medical devices. These very stakeholders have been coming together recently to discuss a number of key points, including:
- The nature, scope and impact of reusable medical device reprocessing problems that have been observed and the causes of these problems
- Factors which facilitate reprocessing that should be considered when designing reusable medical devices and how the design process can be improved to better incorporate cleanability as a design endpoint
- Criteria that should be considered when developing reprocessing instructions and validation protocols for devices to be used in various healthcare environments, based on the draft guidance document, "Processing/Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling"
- Factors that should be considered by a healthcare facility when developing reusable device reprocessing procedures and quality assurance processes
- How problems with reusable medical device reprocessing should be identified, reported and acted upon by industry and users

At the June 2011 workshop, Michelle McMurryHeath, associate center director for science at the FDA, explained that, "FDA has received scattered reports of improperly cleaned reprocessed medical devices. We particularly noticed difficulty in cleaning some endoscopes, arthroscopic shavers, and reusable devices with specific design features such as lumens, hinges, interior channels, and devices that cannot be easily disassembled, so we took action."

 McMurryHeath explained that in 2007, these reports led to an increased concern within the FDA after news about contamination of reprocessed endoscopes in the Veterans Affairs medical system surfaced. In 2008, the FDA collaborated with the VA and CDC to try to address these concerns. In 2009, the FDA issued two safety communications on reprocessed devices, one on endoscopes and one on arthroscopic shavers, and a VA conference on this topic was held. In April 2011, the FDA launched its initiative, the Reusable Medical Device Improvement Initiative, which was accompanied by new draft guidance, the aforementioned "Processing/Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling."

The Challenge of the Unknown

Although some data exists as to the number of reports of outbreaks associated with medical devices, there is a paucity of information that can directly link devices to infections or reprocessing failures. Melissa Schaefer, MD, a medical officer in the Division of Healthcare Quality Promotion of the Centers for Disease Control and Prevention (CDC), addressed this issue in her presentation at the June 2011 workshop. "How often are lapses in reprocessing occurring? I think the answer here is we really don't know," Schaefer said. "The reports that we hear about ... are likely the tip of the iceberg. The reason I say that is because the information we get requires facilities to actually recognize that there is an issue with reprocessing in their facility. And that requires them to proactively be monitoring the practices of the surgical techs or those that are in charge of reprocessing to make sure that they're adequately trained, and assess adherence to process measures. I don't think that that's reliably occurring in most healthcare facilities, particularly not in outpatient facilities where there's less infection control infrastructure and less oversight. Also, there's difficulty in linking outcome measures or clusters in infections to issues with reprocessing. You may see infections, but it's a number of steps to get back to the reprocessing issue, to put the links between the two. And then even if facilities see that they have an issue with reprocessing, it requires them to recognize that that issue may be a threat to their patient and to report the issues that are identified. Providers may not know what to report, where to report, or when to report. So how often do lapses in reprocessing result in infection? Again, this is a question that we really don't know the answer to, and it likely depends on a number of factors. As I have said, it's difficult to link outcome measures to issues with reprocessing."

Schaefer added, "I think the bad news is that we are continuing to hear about lapses in reprocessing of reusable medical devices, which is why we're all here today ... The good news is that these are preventable, and our sense is that the majority of the problem would be solved if the manufacturer's labels and instructions were followed, and that if people were adequately trained and educated on the importance of adequate reprocessing and the steps that need to be followed so that they don't cut these corners. The smaller proportion may require improvements to instructions or device design, but this is still a really critical component, because the issues with device design or inadequate instructions have national or international implications, because these devices are in facilities all across the world. Again, it goes back to our knowledge of the issues relying on the reports from the providers. We can't address the problem. We can't fix the problem if we don't know what the problem is. And so through these outbreaks, through the reports that are filed, it helps us learn from the users what the challenges are so that we can tackle them and focus our efforts."

The Sterile Processing Challenge

At the June 2011 workshop, Linda Condon, RN, head of sterile processing and a central sterile supply educator at Johns Hopkins Hospital in Baltimore  who has 27-plus years of experience working in the preoperative and perioperative environment, discussed the numerous challenges faced by professionals working in the sterile processing department (SPD). She pointed out the rapid advancements in surgical instrument design that required professionals to stay on top of the evolving processes required to clean, disinfect and sterilize them properly, and then transport them to the operating suites in a timely manner to meet a hospital's throughout demands. As an example, Condon explained that at her facility, which has 38 operating rooms, the SPD sees about 500 sets a day, with each set containing approximately 75 instruments. In addition to that, there are individual instruments that come through that must be packaged individually, therefore adding another 200 or so instruments. "So, basically, you've got about 40,000 instruments that are coming through a CS, at least in our hospital, on a daily basis," Condon said. "We did an inventory about three years ago, and just for our sets, not the vendor sets, not the sets that are used to implant screws and plates and everything else, we had 14,000 different instruments. That's incredible."Condon acknowledged that even though AAMI standards are what SPD professionals are expected to follow without exception, she noted that in the real world, sterile processing professionals face challenges relating to outdated, incomplete or overly complex and confusing instructions for use from manufacturers. She also pointed to a lack of standardization in manufacturers' reprocessing instructions that may leave it open to interpretation by sterile processing personnel and result in cleaning, disinfection and sterilization inconsistencies that jeopardize patient outcomes. At the October 2011 summit, sterile processing managers, technicians, regulatory affairs professionals, clinicians, nurses, clinical engineers, industry representatives and regulators prioritized the challenges to safe reprocessing. The challenges included high technician turnover, poorly designed devices, and what many described as complicated instructions for use (IFU) from manufacturers regarding cleaning."We are asking people who could make more at Burger King to do high-risk, highly technical and challenging processes under adverse conditions with little training, and little support," says Ramona Conner, manager of standards and recommended practices with the Association of periOperative Registered Nurses (AORN). Conner was among the numerous individuals at the October 2011 summit who explained the real-world sterile processing challenges that must be taken into consideration when medical device manufacturers design their instruments. Sterile processing departments are required by the Joint Commission and other accreditation organizations to clean and disinfect a reusable device per the manufacturers IFU. But that is a lot harder than it looks, some speakers said at the October summit."Some of these instructions are quite cumbersome," says Susan Klacik, corporate director of the International Association of Healthcare Central Service Materiel Management (IAHCSMM) and manager of central services at St. Elizabeth Health Center in Youngstown, Ohio. 

Speakers said that most IFUs are more than 75 pages long, and sometimes give conflicting or confusing instructions. "We should have standard definitions, standard soaking times, brushing, and rinsing directions," says Condon. "Make the cleaning instruction simple and concise.

"Stakeholders speaking at and attending the October 2011 summit created a list of priorities that will serve as the foundation of all future conversations and standards development by AAMI. The priorities include:

- Creating standardized, simple instructions and processes for sterile processing that are achievable and repeatable

- Addressing the inability to disassemble/reassemble some instruments and devices and the impact on reprocessing/patient outcomes

- Elevating the training, education and professional development of sterile processing personnel

- Better defining what is "clean" in terms of sterile processing- Addressing validation issues and the types of test soils/challenges used by manufacturers

- Examining the accountability of stakeholders and the role they play in medical device reprocessing

AAMI has released its post-summit publication; to access this document, CLICK HERE.

Medical Device Design

Much of the dialogue at the June 2011 workshop and the October 2011 summit focused on what constitutes and contributes to good medical device design. Devices have become more complex and harder to clean, says Victoria Hitchins, a research microbiologist at the Office of Science and Engineering Laboratories in FDAs Center for Devices and Radiological Health, who spoke at the October 2011 summit. "Today, you cant see if the inside of the device is visibly clean due to long and/or narrow, opaque lumens and hinges."

IAHCSMM's Klacik said that manufacturers also need to engage with sterile processing on how a device should be cleaned, just like they do with clinicians on how it should be used. "A lot of times sales reps come in and talk to surgeons and nurses but forget to come down to central services," she says. "Some of the sales reps that do come to the department dont know the care and cleaning of the instrumentation." One industry executive urged healthcare personnel to talk to manufacturers about these issues. "If there are challenges in the field, please bring it to the manufacturer," says Vana Poovala, manager of regulatory affairs for Philips Electronics North America. "Communication, feedback is very important to us to improve our processes. Sometimes we dont hear from the customers about what their issues are."

At the June 2011 workshop, the FDA's McMurryHeath said that the agency's goals are to improve the design and innovation of design of problematic medical devices, improve reprocessing techniques and the validation of those techniques, and improve healthcare facility quality assurance processes. She said that the FDA uncovered a number of themes: "Contamination is often found in unexpected sections of the device. Sometimes following the labeling instructions did not seem to adequately clean the device, and sometimes manufacturers included unclear and confusing reprocessing instructions."McMurryHeath emphasized that all stakeholders needed to work together to address this issue, and explained, "For the manufacturers, this role includes device designs that actually promote disinfection, cleaning, and sterilizing. They need to provide clear and complete and easytofollow instructions and ways to follow those instructions very easily. They need to do adequate validation of their cleaning instructions so that we can be assured that they work. Meanwhile, healthcare facilities need to establish appropriate quality assurance programs for reprocessing and make sure that their employees are well trained in how to clean, disinfect and sterilize, as well as store these reusable devices. As well, we are depending upon them to report problems, both to the manufacturer and to FDA. Meanwhile, the FDA has an important role to play as well, to provide clear regulatory requirements, to promote good labeling and manufacturing, and to increase user awareness of this issue. We're working to fulfill this role with the draft guidance and this newlylaunched initiative. Both are designed to increase awareness of the issue and improve labeling clarity. But we also see our role as one to promote medical device innovation to meet that challenge. And to that end, we are calling on manufacturers to study reprocessing design and improve the design of these devices."

McMurryHeath continued, "For example, we've discovered that several features might be beneficial in making these devices easy to clean smooth surfaces, particularly in the interior lumens area of reusable medical devices, easy disassembly, noninterchangeable connectors for critical connection points, disposable components for hardtoclean areas some areas, you just can't get clean clear identification of connecting accessories, and a clear indication of which components must be discarded after each patient use and cannot be reused, and finally, designs that consider the hydrodynamic properties to prevent debris buildup. Despite these collaborative efforts, challenges remain and will remain for some time. These are complex devices and we're always going to have to take the human factors into account, no matter how clear the labeling is. And we need to be aware that there might be user error, and do what we can, particularly through the quality assurance programs, to minimize that error. And we need to make sure that even though the labeling may be detailed, that it is clear enough to follow and easy enough for a range of different types of healthcare facilities to follow."

At the June 2011 workshop, Sheila Murphey, a medical officer in the Infection Control Devices Branch at the FDA's CDRH, noted the difficulties clinicians face that should be taken into consideration by medical device manufacturers: "Successful reprocessing starts with a device thats properly designed for that purpose ... The design needs to take into account the stresses for the device, for the user and ultimately for the patient. Regarding the staff who are going to be charged with the reprocessing of the device, the institution has to make sure theyve been educated properly to do what they need to do, that they receive the support and supervision to continue to do it properly.  We have to commit to doing the same thing the same way on the same high level every day. People have to understand the needs of the device and the resources of the users to put it all together to do it successfully."

Murphy added, "Clear and feasible instructions for use are critical to helping make sure that things are done properly. Staff have to be educated. All the tools that can be provided by industry, by professional organizations, by other interested parties, by accrediting organizations, are very useful in supporting the effort and the level of excellence that are going to be needed. We've made a very big deal about Instructions because they can be a source of salvation or a source of problems. They may not be available. They may be incomplete or confusing. They may be difficult to follow properly, tempting the user to not follow them properly. They may be outdated because a device has been updated. The user may not know whether or not theyve got the relevant instructions for the relevant model. And for some devices, weve got a lot of models out there. It can be confusing both to the person at the original manufacturers site whos trying to help the user and the user themselves. The facility can also be a source of problems. Is the space adequate? Is adequate equipment available, adequate utilities available, adequate personnel, and are the personnel given the training and the time to do the workload that they are required to do? Errors in use do happen, and everything that we can do both in terms of checking on people, checking on devices, checking on instructions can help to avoid that."

Medical Device Validation

Validation of medical devices was another topic of considerable interest at the workshop and the summit, with users grappling with whether manufacturers' protocols for the validation of cleaning processes match up with real-world scenarios in which the medical device is actually used. AAMI TIR30:2011: A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices, is a source of information for stakeholders needing clarification on medical device validation issues.

 As the document notes, "In the past, a device was considered 'clean' if the person who was performing the cleaning task observed no visible foreign material. Today, however, more devices have long or narrow opaque lumens, crevices, hinges, acute angles, serrated edges, junctions between insulating sheaths, coils, or other designs that make it difficult or impossible to rely on the traditional visual endpoint. In addition, visual observation might not be adequately sensitive to detect levels of soil that could interfere with subsequent reprocessing."

The document states further, "Manufacturers of reusable medical devices must provide instructions on how to reprocess their devices between patient uses. Three types of risks are associated with the reuse of a medical device: (a) the risk of disease transmission from one patient to another or from environmental sources to a patient; (b) the risk of inadequate or unacceptable device performance following reprocessing; and (c) the risk of occupational exposure to bloodborne pathogens and other potentially infectious materials. Reprocessing involves several steps, including cleaning, testing for device performance, disinfection, and/or sterilization."

AAMI TIR30:2011 points out that, "There are few tests that can be used to verify cleaning. To verify cleaning of a given device, one must have a test soil and a quantitative test method for detecting residual soil after cleaning. If cleaning protocols that could be used for verification were in wide use today, they could help ensure that adequate cleaning is accomplished so that a device can be reliably disinfected and/or sterilized before it is used on the next patient."

According to the standard, "The manufacturer must validate the instructions for reprocessing a reusable device before marketing it. In addition, manufacturers must consider: a) that exposure to chemicals, such as cleaning agents, could alter the material used in the device; b) whether the materials of construction will absorb or adsorb chemical agents, which could then gradually leach from the material over time; c) how cleaning processes could affect the function of the device; and d) that cleaning processes and tools must be able to contact all areas of the device that could become contaminated.Medical device manufacturers must comply with quality system regulations in order to mitigate the risk associated with the manufacturing process, a component of the FDA medical device  approval process.

Patrick Weixel, an FDA consumer safety officer, explained at the June 2011 workshop that, "The bottom line is it's the manufacturer's responsibility to take into considerations things like the risks presented with the device, the extent that the activities are going to be incorporated into their manufacturing processes, and the complexity of the device. So with reusable devices, it means making sure that it can be adequately cleaned."It may take a village to do so, according to Eamonn Hoxey, vice president of regulatory compliance for Johnson & Johnson medical devices and diagnostic companies and a member of the executive committee and board of directors of AAMI.

He noted at the June 2011 workshop that all stakeholders -- the device manufacturer, the manufacturer of the equipment that's used for reprocessing reusable devices, and the healthcare facility -- "have a common responsibility to have trained and adequate personnel, to have the right resources, be it people, infrastructure, buildings, equipment, utilities that allow the reprocessing to be operated effectively, to have quality systems in place, and to maintain adequate records. But the device manufacturer takes the lead on the design of the device to enable it to be reprocessed, for providing the reprocessing instructions, for the verification of validation of the device, and the instructions for use that are provided with that device, and making sure that the device is compatible with the specified reprocessing conditions."

Hoxey added, "The reprocessing equipment manufacturer is designing their equipment for reprocessing, and that equipment needs to be suitable for the device that they intend to reprocess in that piece of equipment. They need to verify and validate that reprocessing equipment for those specified devices they're going to reprocess. And they have to provide adequate instructions for installation, for use, and for maintenance and ongoing preservation of the performance of that equipment over time. Healthcare facilities have to select devices and reprocessing equipment that go together. Those are chickenandegg situations. You can't buy a device that you don't have the equipment to reprocess won't work, and buying reprocessing equipment for devices that you don't have doesn't make a lot of sense. So there's a purchasing responsibility there for having compatible equipment and devices. Having the right utilities, the quality of water, the electricity supply, steam supply for sterilizers, all of those utilities need to be to the right standard to allow the equipment to work."

How Clean is Clean?

One of the biggest issues explored at the June 2011 workshop and at the October 2011 summit was defining how clean is clean when it comes to reprocessing medical devices. At the June 2011 workshop McMurryHeath noted, "To date, we still need to discern how clean is clean. We've learned that following existing reprocessing instructions is not necessarily enough and that some design features contribute to the problem. But we still don't fully understand the actual link between soil and retained debris and infection. We need to understand that connection more closely."

At the June 2011 workshop, Stephen Spiegelberg, PhD, president and cofounder of Cambridge Polymer Group, who chairs task groups in ASTM on the cleanliness of biomedical devices, shared his perspectives on the issue and outlined some considerations for the device manufacturing process: "When manufacturers are designing components with cleaning in mind, the first question is, is this a single-use component either for permanent implantation or for single-use and disposal or is it going to be reusable because the approach to cleaning is going to be very different. What materials are being used in the device? Is it purely plastics, purely metal, a combination of the two or do you have some kind of active component in there as well? What manufacturing materials will be used that could potentially leave residues? And by this I mean manufacturing residues, polishing compounds, lubricants, etc. The FDA is very interested in cleaning considerations as part of the design input process. We shouldnt be thinking about this when were throwing this from research into manufacturing or even further down the line. It should be a design consideration, a design input from the very beginning. So, really, we should be designing to minimize cleaning as much as possible. It makes it much easier to clean and makes it more cost efficient to clean. And the first step in that is to design the components for simple, effective cleaning -- minimizing blind spots, trying to minimize the use of mixed materials whenever possible so they can use one type of cleaning agent and making it for easy disassembly for reusable parts. We also want to design components for the simplest manufacturing process as possible. The fewest number of manufacturing steps also means the fewest number of processing compounds that will be introduced into the device. Finally, when youre designing your components, you want to be designing with cleaning validation in mind; how do you assess how clean your components are."

Michelle Alfa, PhD, FCCM, of St. Boniface Hospital Research Centre in Winnipeg, MB, Canada, addressed how clean is clean enough in reprocessing surgical instruments. "You should start thinking about whats in that tray set thats going through this process every time," she suggested. "What are the post-cleaning residuals that may be relevant? Certainly, viable microorganisms that may be left on the instruments from either the previous patient or from a water source would obviously be of concern because they hold the potential risk of, if theyre not removed or killed, of causing infection in the next patient they get exposed to. The other part of it is the organic residues, secretions from the previous patient. Theres organic residues in the water thats used for washing these devices. The detergents themselves, particularly if they are enzymatic, thats a proteinaceous solution, and thats got organic material in it. And then the other part is whether the washer or the instrument actually have biofilm on them. Those all represent the residuals that might be relevant on a surgical instrument after cleaning."

Alfa adds, "So whats out there in terms of information? Certainly, there are bioburden measurements that have been taken, and there is a smattering of information on assessments made on surgical instruments that have been used for a period of time. It begs the question, what level of residuals are acceptable after completion of cleaning. So, how clean is clean enough?" She reported on a study to evaluate instruments used on patients to examine the residuals pre- and post-cleaning. The researchers selected a plastic surgery instrument set used in the emergency department for trauma patients, chosen for its relatively reduced complexity as compared to an orthopedic surgical tray set. "What we did was determine the five most commonly used instruments in the tray sets in that department," Alfa explained. "These tray sets are reprocessed using an automated instrument and washer in our central processing department. Our question was, whats the level of soiling after a patient procedure before cleaning? And then we wanted to compare that to the impact that the automated washer disinfectant had on those residual levels. Each instrument had a defined area on 10 them which represented one square centimeter in that same location, and we tried to make those locations the ones where we had identified most of the visible soil present on those instruments. That was the site that was sampled, and we evaluated 10 patient procedures. Five instruments from each patient were pre-cleaning, and five of those patient procedures were where we took five instruments from the tray set, and that was post-cleaning. We then swabbed these devices and quantitatively assayed for protein, hemoglobin and carbohydrate. We also decided to put LPS or endotoxin in our assay method as well. Because they were surgical set instruments that were used in procedures, we wanted to have an idea of whether there was endotoxin issues there, which is difficult to assess." 

Alfa reported that from five instruments from five different patient procedures, the researchers found before cleaning an average of 97.9 micrograms per centimeter squared. After coming out of the automated cleaning process, the researchers found .9 micrograms per square centimeter. For hemoglobin, the level went from 26.9 micrograms per square centimeter to.1 per square centimeter. "For carbohydrates, we had higher levels after cleaning than we had before cleaning, and that was a shock," Alfa said. "Its worrisome because cleaning should remove residuals, not contribute to them. And if you look at the endotoxin levels, we started off with an average of about 18, which is not too unexpected, but we went up -- the average was 13,000. The range is quite big. It was as low 13 per square centimeter, all the way up to 25,000 endotoxin units per square centimeter. That is mindboggling." Alfa said that the suspected culprit could have been the final rinse water. "Our facility was using deionized water for their final  rinse, and although we werent able to analyze the rinse water in a timely matter to get the conclusive data, we feel it was likely that the rinse water actually had biofilm in the tubing or the environment and the final rinse was probably contributing to increasing the amount of endotoxin there. It leads to the question of biofilm in the lines and the water in the holding tank and in any of the components. The take-home message is that residuals remain and consideration has to be given to the final water rinse thats used -- you must ensure that it is maintained in a way that prevents you from putting more bugs in the final rinse than afterward. Sure, you might put an instrument through a steam sterilization process, and then youre going to end up with sterile crud, as I call it. And even though that instrument might look visibly clean, if youve got endotoxin there. Endotoxins ability to elicit inflammatory responses in the human body is not completely eradicated by steam sterilization. The proteins are denatured, but if theyre there, they still can be antigenic. So, do residuals from reprocessing contribute to adverse patient reactions? I would put to you that I think from our data the possibility is there, but the issue is we need more scientific data."

At the October 2011 summit, participants also wrestled with the definition of "clean," in an attempt to define the steps needed to ensure that contaminants are removed or reduced so that the instrument or device is safe for disinfection, sterilization and eventual use on the patient. The FDA's Victoria Hitchens acknowledged that in the past, "visibly clean" was sufficient, but today's advanced instrument design complicates the cleaning process and so the level of cleaning efficacy must be elevated. Hitchens emphasized the importance of manufacturers validating the cleaning process in a way that reflects the ability for users to replicate it under real-world conditions in the SPD. 

The Future

The discussions to this point have established a path for the future that standards-making committees will continue to define. "Finally the issues, problems and concerns of safe reprocessing of reusable medical devices is getting some much needed national attention," says Rose Seavey, RN, BS, MBA, CNOR, CRCST, CSPDT, president and CEO of Seavey Healthcare Consulting and a member of several AAMI working group committees. "It was good to see representatives from all the interested parties and disciplines including regulatory agencies, manufacturers, professional organizations and clinical staff all in one room focusing on this critical issue. Going forward I hope that all the considerations raised get addressed. For instance, all reusable medical devices need to be designed with reprocessing as a priority. IFUs need to be consistent, simple, repeatable, concise and readily available. Vendors need to be knowledgeable of their validated reprocessing steps. Those who do the reprocessing must be better educated. Standardized educational requirements (beyond certification) for anyone responsible for reprocessing reusable medical devices. The increased educational requirements and responsibility is going to demand higher pay for people in the sterile processing profession. This is not going to happen overnight, but I am extremely encouraged that these issues are being put under the national spotlight so we can work on them together."

Q&A with Ramona Conner, MSN, RN, CNOR

By Kelly M. Pyrek

ICT spoke with Ramona Conner, MSN, RN, CNOR, manager of standards and recommended practices for the Association of periOperative Registered Nurses (AORN), about her impressions of the AAMI/FDA summit on medical devices.

Q: The AAMI meeting on medical devices was quite lively in its discussions -- what were your general impressions of the dialogue?

A: I think that this was an exciting opportunity to bring together all the stakeholders who effect medical device reprocessing. As you say, the dialogue was lively and the participants were engaged in the discussions.  The summit provided an opportunity for open dialogue that will help all stakeholders identify barriers and seek solutions to some very complex and challenging issues. I was especially pleased with the interest the participants from the FDA had in the discussion. I was impressed with their interest in working with the manufacturing and healthcare provider communities to improve the current state of medical device reprocessing.

Q: Did you receive any interesting reactions to your presentation at the summit? 

A: I dont believe anything that I said was a surprise to those who interact with hospitals on a daily basis.  I do think that the session did raise awareness of the difficulties facing healthcare organizations challenged with providing training and maintaining competency of a diverse and ever-changing work force.

Q: Do you believe that the priorities that came out of the summit are the right ones?

A: Yes, I agree with the identified themes.

Q: Would you add anything to the existing list of priorities?

A: I dont have anything to add, as I think that the list encompasses the primary issues. The challenge will be in developing meaningful solutions and taking action to address these issues.

Q: Focusing on perioperative practice, what can this sector add to the ongoing dialogue, especially relating to working with the SPD and manufacturers?

A:  AORN will continue to work closely with AAMI to participate in seeking solutions to the identified issues.

Q: What are the next steps you would like to see be taken moving forward and how can momentum from the meeting be maintained?A: I would like to see development of an action plan to begin to address these areas of concern and to continue the multidisciplinary dialogue that has been initiated by this summit.

Maintaining Momentum, Addressing Clarion Themes: A Q&A with AAMI President Mary Logan

By Kelly M. Pyrek

Following an October 2011 summit on reprocessing of medical devices, the Association for the Advancement of Medical Instrumentation (AAMI) will create a comprehensive action plan focusing on priorities that were outlined by participants at the event held by AAMI and the Food and Drug Administration (FDA). During that summit, stakeholders debated the key challenges to reprocessing reusable medical devices, and now the AAMI Sterilization Standards Committees will begin to discuss clarion themes which include:

- Gaining consensus on how clean is clean

- Creating standardized, clear instructions and repeatable steps for reprocessing

- Taking human factors into account when developing reprocessing requirements

- Making effective reprocessing a priority from the very beginning of device design planning

- Improving information collection and sharing to broaden the use of best practices in reprocessing- Improving reprocessing competencies by strengthening training, education and certification

ICT spoke with Mary Logan, JD, CAE, to discuss what happens next following the AAMI/FDA Medical Devices Summit and how AAMI is moving forward with standards development to address emerging themes and priorities from the summit.

Q: Now that a list of priorities has been established, what are the next steps that AAMI is taking to advance the agenda?

A: The first step AAMI took was to produce a post-summit publication that summarizes the event and lays out a roadmap for the work that needs to be done. We have already started three new projects within our sterilization standards committees, which draw from a very vibrant, diverse  community of experts. These new projects consist of technical information reports (TIRs). One is on reprocessing endoscopes; one is on standardized cleaning instructions, which was a big issue at the summit. And one is on human factors-related issues for reprocessing instructions. For example, if there are 35 steps to reprocessing that require five hands at the same time, then something needs to be simplified and the reality of the human interface needs to be better taken into consideration. We are also talking about setting up a small steering committee comprised of stakeholders from different communities and professional societies to assess what else can be done that cannot be addressed through standards development. We would like other organizations to consider committing to implementation of the recommendations coming out of the summit. Since AAMI is taking the lead on the standards, we are hoping other organizations will be willing to work with us as part of an interdisciplinary group to address the other issues. AAMI is happy to take the lead on coordinating projects, but this is a team effort that requires everyone on the team to play a part in order for real change to occur.

Q: Dialogue between stakeholders at the summit was spirited when it came to the issue of accountability, so how can AAMI continue to ensure that ongoing conversation and debate is constructive?

A:In the standards community the dialogue is often as heated and rich as you heard at the summit and that's what we like. We want to keep that dialogue going until people achieve consensus on their own. One of the things that is so lovely about standards-setting is that the community continues to work together until they can achieve agreement on a path forward. Sometimes it takes a long time to get there because perspectives are so different. That's one of the reasons why we think these three projects are good ones because the community has agreed to work on them.  I can't speak for the FDA, but  based on the regulatory commitment to these issues that I have observed, I have to believe that if the FDA, the Joint Commission, the state regulatory bodies and the Centers for Medicare and Medicaid Services (CMS) don't see significant progress in the healthcare stakeholders groups that they each govern and regulate, someone is going to ratchet up the non-voluntary aspects of this process. All of these regulatory bodies have made it clear that they are committed to reducing healthcare-associated infections. And, no one wants to  see more letters go out to thousands of patients saying they have been exposed to hepatitis B or C from a  device  that wasn't reprocessed correctly. That alone is a strong driver for keeping the constructive conversation going and the projects moving forward.

Q: The list of priorities that came out of the summit is quite extensive, so at what point could these issues be resolved?

A: Our experience with  sterilization and high-level disinfection in general is that there isn't an endpoint . Technology becomes more prevalent and more  complex, the material that  devices are made of continue s  to evolve, and the  products  available to address high-level disinfection and sterilization continue to advance. And each time there is an advancement, you must step back and look at whether standards adequately address that advancement. Also,  each new advancement requires a re-assessment of whether reprocessing professionals in healthcare organizations  need to have updated training to be able to take on the new or different or more advanced  reprocessing for new technologies. And, so the cycle continues as the science evolves. 

Q: The issues discussed at the summit require big changes in culture, resourcing, funding, research -- how can healthcare facilities cope with these significant expectations?

A:  I think the biggest challenge related to  reprocessing  are the competing high priorities in healthcare organizations that are so resource-stretched. It would be great if someone would take on a research project to assess the cost of prevention versus the cost of  "clean-up"  when there's a mess.  It would be great for infection control and central sterile processing professionals to have data to show senior management that it costs more to fix these problems after the fact than to do it right the first time with the right resources and commitment. Infection control and sterile processing professionals  care deeply about solving these issues and would like to make the changes a priority. Data on the cost of an outbreak versus the cost of prevention would help them make this a priority in their organizations. This type of data is especially needed in  the  healthcare environment today where the push is to cut short term costs, which can ultimately result in greater costs over the long haul.   

Q: There is an emphasis on all stakeholders -- users, manufacturers, etc. -- sharing accountability for improving medical device reprocessing, but at the summit, some participants felt the onus was more on manufacturers. What's the reality?

A:  There has to be a balance. Everyone has to do their part. One of the things that is great about standards development in addition to having a multidisciplinary process with everyone at the table working toward consensus, is that it's also a very good alternative to a more punitive type of regulatory process. Oftentimes, the FDA will adopt standards as a part of its regulatory process. It's much better for industry and for users if they've had a say in the process of developing a standard that gets adopted as part of the regulation, than if the FDA simply creates a regulation on its own without going through the consensus process. So to the extent that the  expectations for  industry can be addressed through standards, rather than through some new regulation, it's obviously better for everybody because the process comes from people working together to get to the end result rather than having that end result  imposed upon them. The FDA participates in our standards-setting process, so there are FDA staff who sit on the various AAMI committees and who will be part of the process for the development of those three technical information reports  that I mentioned earlier .  It's much better all the way around  if they can achieve their goals through  standards. There is no single solution to these complex issues. Industry alone doesn't "own" the problems and healthcare organizations alone don't "own" the problems. Devices that are easier to clean will help. Better and standardized instructions for reprocessing will help. Improved training, more support for staff, and stronger quality processes in healthcare organizations will help. A clear answer to the question, "How clean is clean," will help. And so on. The whole community together "owns" the problems and has to be accountable to solve them together.

Q: Issues such as "how clean is clean" are tough ones that force professionals to rethink everything they know. Can they eventually be conquered?

A: These are big, complex issues, and some of them have been around for a very long time without a lot of progress having been made. I think the summit helped rejuvenate the profession and energize people about making a renewed commitment to tackle some of these issues. What I like to do when something is so complex it seems overwhelming is to break it down into parts that are more manageable. And that is what I hope people will do when they consult the post-summit publication -- the clarion themes are divided into priority issues under each of those themes and organizations can take any one of those topics and tackle them, either on their own or together within the larger community. So, "how clean is clean" is big but it can be broken down into parts. It's one area where we need more research and I hope that the summit will have challenged the healthcare community to push for more research that would help us have a better handle on that important issue. We break down these big issues into manageable parts, we tackle those parts and then we reassess how we are doing and if we are making a difference. Then we ask ourselves if we need to recalibrate or redefine the priorities in some way, and whether there are additional parts we missed.   It's an evolving conversation where we check off the manageable priorities and then figure out what to do with the barriers which feel as though they can't be overcome. I tend to be optimistic but I think any progress we make, any patients that we can save from receiving a letter saying they have been exposed due to improper reprocessing of instruments, is well worth all of the effort.

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