Efforts to Address Medical Device Reprocessing Encompass Design, Human Factors


Following a two-day summit convened by the FDA and AAMI in October 2011, AAMI released a post-event publication in December 2011 that captured the essence of the summit, outlined the priorities, and established a path forward.

For a related slide show on medical device design and cleanability, CLICK HERE.

By Kelly M. Pyrek

Editor's Note: ICT first reported on efforts by the Food and Drug Administration (FDA) and the Association for the Advancement of Medical Instrumentation (AAMI) to examine the state of medical device reprocessing in our 2012 Regulatory Update in January. This is an update on the issues.

Following a two-day summit convened by the FDA and AAMI in October 2011, AAMI released a post-event publication in December 2011 that captured the essence of the summit, outlined the priorities, and established a path forward. 

In a prologue in the publication, "A Clean Start: Priority Issues from the AAMI/FDA Medical Device Reprocessing Summit," AAMI president Mary Logan and Pamela Scott, senior science advisor for reprocessing of reusable medical devices for the FDA, note, "Several attendees mentioned that the healthcare community has been talking about reprocessing issues and the challenge of following complex reprocessing instructions for almost 40 years. While we have made significant progress along the way, some of the frustrations and issues raised at the summit were obviously longstanding. We commend the willingness of healthcare and industry professionals to come together to address these important issues."

It is a formidable task, and one that will require immense collaboration, communication and perseverance if the end goal is to be achieved -- better reprocessing of reusable medical devices and improved patient outcomes. As Logan and Scott add, "Healthcare organizations which have experienced challenges associated with reusable medical devices, including the Veterans Administration, Tulane Medical Center, and Victoria General Hospital, join countless other hospitals and surgical centers in our recommitment to solving these old frustrations and issues because of their desire to prevent future patient events. On a more personal level, the countless patients who have been potentially or actually exposed to contaminated instruments resulting from inadequate reprocessing would fervently urge us to do something now. To do something now is exactly why we co-convened this important event. AAMI standards committees already are making plans and setting priorities on what can be addressed now and by whom. The FDA continues to seek out and capitalize on opportunities to improve the reprocessing of reusable medical devices through regulatory science. Working together, AAMI and the FDA will facilitate collaboration with other organizations, companies, and individuals to take the lead on different areas of the reprocessing challenge. No one group can do this alone, and the answer is not as simple as 'more standards' or 'more regulations.'

The AAMI publication (2011) explains that the summit "crystallized a compendium of challenges and priority actions for delivering on patients basic expectation of cleanliness for reusable medical devices. Indeed, this 'patient safety first' focus with the ideal of ensuring that reprocessing is done correctly every time was a recurring message from summit participants. So, too, was the overarching challenge for all stakeholders to deepen knowledge and eliminate confusion about reprocessing requirements and to pay closer attention to human and environmental challenges."

AAMI's Seven Clarion Themes
1. Gain consensus on how clean is clean and on adequate cleaning validation protocols for reprocessing reusable medical devices.
2. Create standardized, clear instructions and repeatable steps for reprocessing whenever possible.
3. Pay early, iterative, and comprehensive attention to reprocessing requirements throughout the device design process.
4. Make human factors and work environment factors priorities when developing reprocessing requirements.
5. Improve information collection and sharing to broaden the use of best practices in reprocessing.
6. Improve reprocessing competencies by strengthening training, education and certification.
7. Create a greater sense of urgency and understanding throughout the healthcare community about the consequences of inadequate reprocessing.]

Let's review the seven clarion themes in more detail.

1. Gain consensus on how clean is clean and on adequate cleaning validation protocols for reprocessing reusable medical devices.
Summit attendees pointed to an overall lack of understanding and lack of a consistent definition for the meaning of clean  for reprocessed medical devices, so there must be more research on the essential factors to be considered when defining clean for handling and reprocessing medical devices. Also needed is a common definition or explanation of clean for reprocessed medical devices. Summit attendees noted a lack of specific criteria and endpoints for measuring whether a device is clean, so the goal is to define acceptance criteria and analytical endpoints for determining how clean is clean enough for specific clinical uses of medical devices. Summit attendees emphasized a lack of standardization of clinically relevant test soils for validating the effectiveness of reprocessing methods, therefore there must be standardized test soils for validating the reprocessing of specific types of medical devices.

The variability in how "clean" is defined across standards and recommended practices further complicates matters. A dictionary such as Merriam-Webster defines clean as being free from contamination or disease, a definition that makes sense in the healthcare community, but this can be much too vague when validation of cleaning and decontamination processes are considered. For example, here's a look at various definitions from industry standards:
- AAMI TIR 30 (a compendium of processes, materials, test methods and acceptance criteria for cleaning reusable medical devices and intended for manufacturers) defines clean as "Removal of contamination from an item to the extent necessary for further processing or for the intended use.
- ANSI/AAMI ST79 (a comprehensive guide to steam sterilization and sterility assurance in healthcare facilities intended for reprocessing personnel) defines it as: Removal of contamination from an item to the extent necessary for further processing or for the intended use. In healthcare facilities, cleaning consists of removal, usually with detergent and water, of adherent organic and inorganic soil (e.g., blood, protein substances, and other debris) from the surfaces, crevices, serrations, joints, and lumens of instruments, devices, and equipment by a manual or mechanical process that prepares items for safe handling and/or further decontamination.
- AS/NZS 4187 (cleaning, disinfecting, and sterilizing reusable medical and surgical instruments and equipment, and maintenance of associated environments in healthcare facilities) defines it as Removal of soil and a reduction in the number of microorganisms from a surface, by a process such as washing with detergent solution without prior reprocessing.
- ASTM E2314 (standard test method for determination of effectiveness of cleaning processes for reusable medical instruments using a microbiologic method defines it as Removal of foreign materials, including organic soil (for example, protein) and microorganisms from medical instruments.

Defining clean is essential because the device manufacturer must provide validation of the reprocessing method, and the end user must provide verification  to measure the effectiveness of reprocessing methods. Summit presenter Trabue Bryans, vice president and general manager at WuXi AppTec, a contract research firm, explains the distinction between the two processes:
Validation of the efficacy of reprocessing: If I clean the device this way, will it be acceptable for use?
End-user verification: Did I clean the device to the acceptable level?
What the testing lab does is different than what end users do, Bryans says in the AAMI publication (2011). Validation of efficacy does not have to be user-friendly, quick, or easy. Validation does have to be sensitive (able to be measured to a specific level) and thorough (able to be correlated to complete recovery of soil).

The general procedure for validation (measuring cleaning efficacy) can be described as including the following steps:
- Soil the device
- Allow soil to simulate worst-case conditions (e.g., allow soil to penetrate lumens, allow soil to dry)
- Clean the device according to the manufacturers instructions for use (IFU)
- Extract the cleaned device with elution fluid or other solvents, or measure soil directly on the device (i.e., the radionuclide method for cleaning validation)
- Test the extracted fluid for residual soil

Compounding this validation-studies issue is the challenge of determining the appropriate test soils that represent the soils from actual use for appropriate verification assays by end users. As the AAMI publication (2011) notes, "According to the Draft Guidance for Industry and FDA Staff: Processing/Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, which is not for implementation, the FDA recommends the use of a quantitative test method capable of measuring meaningful levels of clinically relevant soil to meet a related, predetermined cleaning endpoint. When choosing a test method, consideration should be given to the chemical constituents that the device is expected to come in contact with during actual clinical use, which should be adequately represented in the artificial soil. The FDA generally requests that at least two quantitatively measured components of soil be assayed as part of cleaning validation protocols."

Bryans adds that definitive biomarker guidance is needed to establish which markers are actually appropriate; ensure that the markers selected are measurable to appropriate levels; ensure test results are reliable and reproducible; standardize testing (e.g., soil) for categories of devices; and standardize test criteria across laboratories. Not only does Bryans question whether microbial markers should be eliminated completely or used in conjunction with other markers to allow for correlation of results, he also says that "Scientific data is needed to determine the levels of a marker that are considered clean, the lower limits of detection and variability of markers, and the cost of marker assays versus the value of the data." (AAMI, 2011) The FDA is aware of these challenges, says Steven Turtil, a biologist in the agency's Division of Surgical, Orthopedic, and Restorative Devices. Weve tried to identify, for ourselves, what is clean, Turtil says. The core issue is direct measurement of clinically relevant soil. Turtil says the FDA is interested in exploring more standardized methods for validation of cleaning instructions. (AAMI, 2011)

2. Create standardized, clear instructions and repeatable steps for reprocessing whenever possible.
Summit attendees said that complicated reprocessing instructions -- and many different sets of instructions for many medical devices -- for clinical and reprocessing staff with a wide variety of skills were a challenge. For the future, steps for improvement include taking clinical and reprocessing staff into account when developing reprocessing instructions and obtain their input; conducting usability testing; making instructions clear; writing reprocessing instructions for clinical and reprocessing staff instead of for engineers or regulators; making instructions available electronically for reprocessing sites with access to computer technology; and taking a few of the most commonly used and current reprocessing practices and validating to all of these practices so that reprocessing steps are repeatable in the real world.

According to the AAMI publication (2011), "The single purpose of reprocessingrendering reusable medical devices safe for the next patientis often obfuscated by manufacturers IFU. The IFU at times add confusion and conflict with standard processing methods, summit participants said. Inadequately reprocessed reusable medical devices are the unintended consequence of the demand to reprocess thousands of medical devices, with many distinct and complicated requirements set forth in lengthy IFU that may be inaccessible. Some IFU recommend specific cleaning, disinfection, or sterilization parameters that cannot be followed, are not consistent with AAMI standards, or are unintelligible to reprocessing staff.

Problematic IFUs are a concern to numerous sterile processing departments across the country, but in particular at large institutions that turn over an enormous number of instruments daily. For example, Johns Hopkins Hospital reprocesses approximately 37,000 instruments every day, including 500 instrument sets (with about 75 instruments per set), and 200 individual instruments. Linda Condon, an educator in the Central Sterile Processing Department there, says the total hospital inventory of different instruments requiring reprocessing tallies as high as 14,000. Right now, it is impossible to follow manufacturers instructions for use, Condon says, as reported in the AAMI publication (2011). She cites a lack of standardized cleaning processes as the major culprit and adds,  There are like instruments with different instructions, processes, and tools. There are complicated instructions with too many steps that are unreasonable, with too many variables. There is minimal repetition of tasks. Device IFU do not specify the brush size needed to clean specific devices. Staff have to work from memory or hearsay. IFU expect people to read an awful lot, in an environment that is not conducive to do such. Nobody reads. It is easier to ask a neighbor or see what someone else is using.

Condon says that standardization is needed for soaking time, brushing, rinsing and ultrasonic cleaning, and adds further, "Cleaning instructions should be simple, concise, and repeatable. Mechanical cleaning instructions should be specific, but broad enough to be used with any FDA-cleared washer. Echoing Condon's sentiments is Sue Klacik, central sterile supply manager at Humility of Mary Health Partners and the AAMI representative for the International Association of Healthcare Central Service Materiel Management (IAHCSMM). "There are multiple IFU for all products, [including instructions] for inspecting, cleaning, function testing, and protective packaging, Klacik says, as reported in the AAMI publication (2011). "For every instrument, you have to consult a different IFU. Reprocessing of nine devices would take about an eight-hour day, but there is absolutely no consistency in the IFU. Klacik points out inconsistencies between IFU and AAMI standards, including ANSI/AAMI ST 79:2010 and A1: 2010, Comprehensive guide to steam sterilization and sterility assurance in healthcare facilities and AAMI TIR12:2010, Designing, testing, and labeling reusable medical devices for reprocessing in healthcare facilities: A guide for medical device manufacturers. Of 22 different manufacturers IFU for stainless steel, non-lumened, hand-held devices that she reviewed, 41 percent omitted the use of a washer-disinfector, 50 percent omitted the process of using a sonic cleaning method, and 86 percent omitted the use of a lubricant. These are standardized processes, discussed in AAMI documents, but omitted in IFU, Klacik says. IFU dont meet standards. (AAMI, 2011)

Sometimes IFU are difficult to access, let alone understand. Rose Seavey, president of Seavey Healthcare Consulting, LLC, has experienced first-hand the difficulties associated with procuring specific IFUs from medical device manufacturers who believe that the onus is on the end user. Seavey says that it is important for the Joint Commission, the Centers for Disease Control and Prevention (CDC) and the Centers for Medicare and Medicaid Services (CMS) to  reference AAMI and Association of periOperative Nurses (AORN) standards for reprocessing in their guidance documents because these are the documents that clinical and reprocessing personnel follow, and because they are specific, comprehensive, and evidence-based. Seavey makes these recommendations  for IFU:

- IFU must be readily available, clear and specific to the device (especially for complicated devices), and cover categories of instruments
- Design considerations, FDA labeling, and like categories should be standardized
- Healthcare professionals and reprocessing personnel should be notified of updates or modifications to IFU in a consistent and timely manner
- Vendor representatives should be knowledgeable about current, published standards and provide accurate information; they should also provide specific IFU in writing
- Healthcare professionals should make an effort to obtain the specific IFU that they need, and use MedWatch to report any obstacles

3. Pay early, iterative and comprehensive attention to reprocessing requirements throughout the device design process.
Summit attendees pointed out that reprocessing is often an afterthought in device design and that there is a lack of guidance for medical devices that must be disassembled and reassembled for reprocessing. The solution may lie in manufacturers making effective reprocessing a priority from the very beginning of device design development, and whenever possible, minimizing features such as lumens, channels, articulated surfaces, and/or finishes and materials that are difficult to clean. Manufacturers are being asked to take into account the reprocessing capacity of healthcare facilities and the reprocessing staff who will conduct reprocessing. In addition, they are asked to consider all potential soil types, locations and surfaces on devices when validating cleaning methods for the most difficult to clean areas. Ultimately, if a device cannot be cleaned effectively, manufacturers could be asked to redesign it. Devices should be designed to minimize the need to disassemble and reassemble them for reprocessing; however, if disassembly and reassembly are needed for reprocessing, manufacturers should provide clear instructions, with guidance on when in the process the device should be disassembled and reassembled (i.e., before or after cleaning and disinfection/sterilization).

Thomas Gilmore, senior manager of product development for cleaning, disinfection, and sterilization, Olympus America, Inc. says that device designers have made improvements to devices that make them easier to clean, and more changes are planned for the future. For example, a single-channel flexible bronchoscope that is resistant to heat and pressure and can withstand steam sterilization was introduced in 2006. Changes in device materials can also improve durability against oxidizing agents. Improved design geometry can eliminate stepped surfaces, sharp corners, and abrupt surface changes, which are particularly problematic in internal spaces. Devices should also be designed to avoid dead-end cavities that are hard to clean. Improvements to automated reprocessing equipment, and recent and significant advances in chemistry, are reducing reprocessing time and the need for contact with chemicals, increasing efficacy, and providing more environmentally friendly cleaning products. Chemistry plays a fundamental role in the cleaning and reprocessing of reusable medical devices, Gilmore says. The two fundamental design criteria for chemistry are efficacy and material compatibility. (AAMI, 2011)

4. Make human factors and work environment factors priorities when developing reprocessing requirements.
Summit attendees were concerned about the lack of understanding about the human factors and the environmental work factors that affect reusable medical device reprocessing. What could alleviate these issues is validating that personnel can reprocess medical devices effectively, taking into consideration personal characteristics and professional conditions, such as demanding workloads, as well as validate that medical devices can be reprocessed effectively in the real-life conditions of reprocessing departments. An additional consideration is the clinical demands for reusable medical devices in reprocessing instructions. Too often, the time to complete the reprocessing steps according to the instructions exceeds the time constraints of clinical need for reprocessed reusable devices.

In order to better understand performance in the sterile processing department, it is essential to consider that many SPDs have limited resources and/or staff, and the reprocessing environment can be isolated, noisy, humid and poorly lit -- all factors that can hinder job function. In addition, the workflow can be complex, with high volumes, peak periods, rush jobs, and constant interruptions, and time for adequate reprocessing can be limited by clinical demands, workforce availability or equipment cycles. On top of all of this, sterile processing personnel have different cognitive and physical capabilities and limitations, knowledge and skills, and preferences that can impede job performance.

5. Improve information collection and sharing to broaden the use of best practices in reprocessing.
Summit attendees emphasized a lack of documentation and data to analyze what works and what doesnt work in reprocessing, and so a potential solution may be a registry that collects information about best practices and challenges in reprocessing in real clinical environments. Another challenge is lack of communication and sharing of best practices and challenges in reprocessing, and so "feedback loops" among reprocessing staff, clinical staff, manufacturers, and regulators about reprocessing experiences is proposed. Additionally, summit attendees on the clinical side cited difficulty bringing reprocessing issues to the attention of medical device manufacturers, and it is hoped that a complaint procedure cane be developed, making it easy to submit a complaint on a company website so that a timely response can be issued.

As the AAMI publication (2011) notes, " There is a considerable amount of anecdotal evidence about experiences with reprocessing, but little solid documentation and data to conduct meaningful analysis, summit participants said. Better ways to collect and share information, and learn from challenges and best practices, are needed. At some facilities, part of the problem is that instrumentation is purchased without the input of central sterile managers. Only when it is sent for reprocessing and the IFU reviewed is it discovered that the necessary equipment is not availableand reprocessing staff are blamed when instrumentation, which can be very expensive, cannot be used.

6. Improve reprocessing competencies by strengthening training, education and certification.
Summit attendees cited ongoing inadequate knowledge among reprocessing staff and manufacturers, and uneven reprocessing competencies in the field. This can be mitigated by providing training and education on a continual basis, assessing core competencies and targeting areas for improvement. It is also recommended that managers encourage education of reprocessing staff at the national level through a two-year degree program. The significant challenge is that sterile processing departments suffer from high turnover and low pay for reprocessing staff; summit attendees recommended that facilities create career ladders with increased compensation for additional education, and that they compensate certified reprocessing staff with pay that reflects required competencies.

Presenters at the summit, AORN's Ramona Conner, IAHCSMMs Sue Klacik, APIC's Marilyn Hanchett, and Eileen Young, clinical nurse educator at Olympus America, called for greater staff training and competencies as well as mandated certification for reprocessing personnel. They emphasize that resource limitations and personnel issues -- including adequate education, pay, and responsibilities -- are barriers to competencies. They say that mandated certification should provide a consistent, baseline education in standard practices for reprocessing reusable medical devices, as well as deliver higher competency levels and require critical thinking skills.


Certification Can Address Inadequate Reprocessing

Josephine Colacci, JD, government affairs director for the International Association of Healthcare Central Service Material. Management (IAHCSMM), shares her thoughts on clarion theme No. 6, "Create a greater sense of urgency and understanding throughout the healthcare community about the consequences of inadequate reprocessing":

There have been plenty of examples in the news in the last couple of years that should have created a greater sense of urgency and understanding throughout the healthcare community about the consequences of inadequate reprocessing.  Drawing attention to these cases should create a greater sense of urgency:

- In Florida, problems arose when irrigation tubing used in endoscopy procedures was rinsed, but not disinfected.
- In Tennessee, workers misassembled endoscopic equipment, somehow replacing a one-way valve designed to allow only clean fluids into the tubing with a two-way valve that didnt offer the same protection.
- The Florida and Tennessee errors led to nearly 10,000 patients being notified that they may have been exposed to hepatitis and HIV.

If these errors dont create a sense of urgency in the healthcare community, then nothing will.  While drawing attention to these cases, it opens the door to the discussion of the vital role that sterile processing professionals play in the delivery of safe, quality patient care, the disciplines many contributions continue to be overlooked and underestimated by some healthcare organizations and state health officials.

Central sterile supply professionals in every facility throughout the nation must receive ongoing, formal training and become certified in order to perform their daily duties safely, effectively and consistently. New Jersey is the only state that requires certification for central sterile supply professionals. The frightening reality is that in some facilities across the country, central sterile supply professionals are performing this essential function in the absence of any formal training and certification requirements.

These cases of errors can lead to positive public policy changes. IAHCSMM is leading efforts to have states pass laws requiring certification of central sterile supply professionals.


7. Create a greater sense of urgency and understanding throughout the healthcare community about the consequences of inadequate reprocessing.
An overwhelming majority of summit attendees expressed a lack of awareness about the potential patient safety risks from inadequately reprocessed medical devices. As Young notes, "A root cause of many reprocessing challenges is a lack of recognition of the importance of infection control across the industry. Infection prevention is everybodys business." She says that clinicians and reprocessing personnel will be more attentive to the procedural steps and details of reprocessing if they understand why they are important: Inadequate reprocessing can have adverse patient events. As the AAMI publication (2011) emphasizes, "An understanding of the fundamentals of infection control and prevention must begin with top-level administrators and risk managers in healthcare organizations who can allocate resources to this challenge. 'We need to create a business case for infection prevention -- the more you process people safely through the system, the more you will be reimbursed,' Young says."


An Insider's Thoughts on AAMI's Seven Clarion Themes

Sue Klacik, CRCST, CHL, FCS, ACE, CSS manager at St. Elizabeths Healthcare and a board member of the International Association of Healthcare Central Service Material. Management (IAHCSMM), shares her thoughts on priorities coming out of the FDA/AAMI Summit on Reprocessing Medical Devices held in October 2011. 

1. Gain consensus on how clean is clean and on adequate cleaning validation protocols for reprocessing reusable medical devices.
Microbiologists and medical device testing labs to address.

2. Create standardized, clear instructions and repeatable steps for reprocessing whenever possible.
AAMI has started a new working group to start a Technical Information Report TIR The purpose of this TIR is to provide standardized cleaning processes that manufacturers can use in their instructions for use (IFU) for medical devices. These standardized IFUs will be consistent with the recommended practices in ANSI/AAMI ST 79 Comprehensive guide to steam sterilization and sterility assurance in health care facilities which are the best practices used by healthcare re-processors. Membership on this committee includes medical device manufacturers, healthcare users, professional organizations such as IAHCSMM, AORN, APIC, government regulators, the FDA and medical device testing labs, using the experience and knowledge from these stakeholders the document will address the needs of all stakeholders to provide standardized instructions for use that will meet best practice.  A task group met Feb. 15, 2012 to begin work on the document. Further work will continue with the full committee during the AAMI Sterilization Committee Meetings in May of this year.

3. Pay early, iterative, and comprehensive attention to reprocessing requirements throughout the device design process.
Medical device manufacturers can incorporate reprocessing into their device design with new products coming into the market.  Through these Summits users microbiologists and the FDA voiced their concerns that the ability to thoroughly clean the device should start at the beginning of the device design and not as an afterthought. Complex medical devices should have IFUs that are complete, easy to understand and achievable.

4. Make human factors and work environment factors priorities when developing reprocessing requirements.
AAMI has begun a new work project to address the human factors issues. This too is a TIR; the membership includes medical device manufacturers, healthcare users, professional organizations IAHCSMM, AORN, APIC, government regulators, the FDA and medical device testing labs. The group is using documents provided by the FDA and AAMI to develop a Human Factors document for medical device manufacturers to refer to as they develop new instrumentation. A task group met on Feb. 16, 2012 to begin work on the new document.  The document will be discussed during a full committee meeting during the next AAMI meeting on May 21, 2012 in Alexandria, Va.

5. Improve information collection and sharing to broaden the use of best practices in reprocessing.
Professional associations such as IAHCSMM, AORN and APIC provide a venue for sharing information. 

6. Improve reprocessing competencies by strengthening training, education and certification.
During the summit the need for educational materials provided by manufacturers to users was voiced by the users. Some manufacturers are beginning to make their training materials in more detail and more understandable. Certification needs to be mandated.

7. Create a greater sense of urgency and understanding throughout the healthcare community about the consequences of inadequate reprocessing.
    The issues raised need to be discussed at professional conferences and articles placed in professional journals.


The Next Steps

The system-wide issues outlined in the seven clarion themes will require the whole healthcare community to work together as a team, AAMI emphasizes. AAMI president Mary Logan says that AAMIs Sterilization Standards Committee leadership is committed to sustaining the momentum from the summit with an action plan for addressing the priorities. At the November 2011 AAMI Sterilization Standards Committee meetings, three new technical information reports were discussed -- endoscope reprocessing; standardized cleaning instructions for use; and human factors for device reprocessing -- and work on these reports began at task group meetings held in February. AAMI also will convene a small group of stakeholders to review the clarion themes and determine which organizations will take the lead on various issues that cannot be addressed with standards alone.
We asked individuals working in sterile processing and in the medical device industry to share their insights on these issues and present their insights to further spark dialogue within the infection prevention community.

Our roundtable participants are:

From sterile processing:
- Linda Condon, RN, MBA, CRCST, head, sterile processing department, Johns Hopkins Hospital
- Russell Gilbert, RN, CNOR, CRCST, perioperative/sterile processing educator, surgical services, CoxHealth
- Sue Klacik, CRCST, CHL, FCS, ACE, CSS manager, St. Elizabeths Healthcare                                             
- Rose Seavey, RN, BS, MBA, CNOR, CRCST, CSPDT, principal, Seavey Healthcare Consulting

From industry:
- Ralph Basile, vice president, Healthmark Industries
- Chuck Hughes, general manager, SPSmedical

ICT: What issues in the seven clarion themes that came out of the summit meeting are the easiest to tackle and the hardest to address, and why?

Ralph Basile: The easiest is to monitor the cleaning process. While there is no clear consensus as to "what is clean," in the real world "clean" means that contaminating soils are removed below the level of detection. There are various methods, including directly testing instruments for residual soils and challenge devices that provide feedback on the performance of cleaning equipment.  The most difficult is designing devices that meet the competing masters -- performance in use and simplicity in cleaning.

Linda Condon: Of the seven themes, No. 6 is the easiest to address: "Improve reprocessing competencies by strengthening training, education and certification." We are already geared with a lot of training, we just need to continue and make sure that we are capturing the right audience. Of the seven themes, No.  2 is the hardest to address: "Create standardized, clear instructions and repeatable steps for reprocessing whenever possible."   Although AAMI has convened a working task group and is in the process of creating an IFU template, this will take a while to develop and spread the word. In addition, what do you do for IFUs that are already out there?

Russell Gilbert: Two of the themes should be relatively easy to tackle. Those are the ones for improvement of information collection and sharing, and the one for improvement of reprocessing competencies through training, education, and certification. It seems like most hospitals that I have communication with are trying to improve their information collection and sharing. They are doing this by increasing the technology that is available to the technicians doing the hands on processing of the instruments. If hospitals and even surgery centers do not have instrument tracking systems in place to help monitor their instruments then it seems that they have a plan in-place to implement a system. Some of these instrument tracking systems have added features showing the cleaning instructions from the IFUs provided by the manufacturer. Many facilities have available for the technicians websites that operate a data base for manufacturer IFUs. AAMI has started its Benchmarking Solutions web-based application which will allow hospitals to compare themselves with other similar hospitals. Improvement of reprocessing competencies are steps that each sterile processing department can accomplish, the technicians that do this job want to be professional. They do try to do things the correct way; its just that in the past the correct instructions may not have been available to them to use. We as an industry are getting better at disseminating the correct education to our staff. Mandatory certification would be one of the biggest steps forward for instrument processing; I think we will eventually see this happen. Unfortunately it seems that it may end up being driven by bad press images on national TV instead of through the recognition of hard-working individuals. I believe that the hardest summit theme to address is to create standardized, clear instructions and repeatable steps for reprocessing. There are too many wheels in motion that cant be changed, meaning that, for the instruments that are already on the market, their IFUs wont change. Issues that technicians are currently dealing with will stay the same, but we can at this point and from here forward, work with manufacturers to standardize their IFUs.

Chuck Hughes: The easier to tackle of the seven clarion themes are 1, 3, 5, 6 and 7, as these primarily require staff education through sharing knowledge of reprocessing best practices. SPSmedical has a long history of taking a leadership role in education by contributing to sterilization standards (AAMI and CSA), speaking at conferences and seminars, creating webinars and publishing articles, along with the thousands of one-on-one conversations each year with customers. The other themes require a commitment to resources by medical device manufacturers and healthcare facilities which has long been needed. And while proper reprocessing of reusable medical devices has always been a patient safety issue, it appears that recent media attention has motivated our industry to a have a greater sense of urgency and understanding about the consequences of inadequate reprocessing.

Rose Seavey: None of these is going to be easy. There is no low-hanging fruit in these seven clarion themes, however, as an independent consultant the one that I think I can help tackle is No. 7: "Create a greater sense of urgency and understanding throughout the healthcare community about the consequences of inadequate reprocessing." As I meet, network and lecture to colleagues in the OR, GI, sterile processing, infection prevention, manufacturing, administration, etc. I emphasize that we all have a part in this and we need to get on board and make sure the resources are available and we need to keep reprocessing under the spotlight. The hardest in my opinion will be No. 2: "Create standardized, clear instructions and repeatable steps for reprocessing whenever possible." Right now reprocessing is all over the board, there is no standardized processes, training, education equipment etc. and not enough resources to provide it. We can create standardized policies and procedures, but it leadership in not holding people accountable for following it or if they do not provide enough resources (human and financial)  than the policies are only as good as the paper they are written on.    

ICT: What -- in all honesty -- will it take to move these mountains?

Ralph Basile: There is no single answer. Guidelines from regulatory and standards writing bodies; greater focus and improved design by device manufacturers; advances in cleaning technologies; improved performance by healthcare providers through a commitment to education and measurement of performance.

Linda Condon: The things that stand out to me weigh heavy on the FDA making some changes in how it does business. There are many products out on the market that have been cleared by the FDA that have poor, inadequate and/or incomplete instructions for use.  In addition, there are products on the market that have parameters outside the normal minimum standards recommended in AAMI ST 79.  These products have been cleaned and are now creating a problem for hospitals and manufacturers alike. Manufacturers that have not validated their products and/or have products that are validated outside the minimum standards should re-validate. If this is not done voluntarily, then the FDA should step in and set some sort of timeframe. The FDA should streamline the process so it is not so cumbersome for the manufacturers and is timely. The FDA needs to provide training to hospitals on the FDA approval process; maybe some webinars could be held. Hospitals need to understand the difference between Class I, II and III devices. They also need to understand the process. There are a ton of forums in which the FDA could provide these educational opportunities, including professional meetings such as AORN Congress or the annual IAHCSMM meeting,  etc. Unfortunately, many FDA employees are not allowed to travel. 
The FDA should also publicize the use of MedWatch. Hospitals are afraid to use for various reasons such as time constraints, relationships etc. The FDA should visit hospitals so they can see what happens in a central sterile processing department.  The agency is approving/clearing products and does not always understand the constraints found in the hospital system. I have offered Hopkins several times! The FDA should create a new position for someone with processing experience to review IFUs for clarity, reasonableness, etc.  Recently cleared devices are still showing up with inadequate IFUs. There should be some guideline as to how consumers are alerted when an IFU is updated. There should also be guidelines established on when companies merge how IFUs can be changed to reflect the acquired line. For example, Biomet purchased EBI but they were distributing the generic Biomet IFU for the EBI instruments. A position statement should be developed.
If manufacturers make caution statements there should be available documentation as to why the caution statement was made.  For example, Stryker Orthopedics has two cautions statements on their IFU:
1. Warning: Stryker Orthopaedics does not recommend the use of rigid containers for steam sterilization. This configuration could limit steam penetration and prevent effective sterilization of the instruments.
2. Caution: Stryker Orthopaedics does not recommend the use of flash sterilization for re-usable instruments.
Well, hospitals do not recommend flash either but does this mean we cant use immediate use sterilization in an emergency situation? Are these statements supported by testing that was unsuccessful? Random statements should be validated for appropriateness and  AAMI/AORN/FDA should provide a position statement on how to resolve discrepancies with IFUs.  We all know that discrepancies exist and everyone across the country is dealing with them differently.  There should be consensus.  Why do we have three temperatures listed in the AAMI ST 79?  Why not just 250 and 270? Manufacturers have an option to use 270 or 275 and this creates another cycle for sterilizers, hospitals etc.

Russell Gilbert: People. It will take all kinds of people willing to stand up and say that we can no longer tolerate the infection rates we are seeing. These are the people that will have the ethics to see to it that the right things are being done. This includes the technician processing the instruments, the supervisors making sure processes are being done correctly, and it will require a realization from the hospital executive administration that cutting hours out of the sterile processing department staffing is actually helping drive up the infection rate. Perhaps a heightened awareness in the community will help increase the pressures to make a change.

Chuck Hughes: Continued media attention, stricter reprocessing surveys, and the FDA encouraging device manufacturers to validate to a standardized procedures in their instructions for use. Law firms now have websites that focus attention on suing over dirty instruments. Survey organizations such as the Joint Commission, the Centers for Medicare and Medicaid Services (CMS) and AAAHC, have come out saying they will be looking closer at reprocessing procedures, and we are seeing the FDA holding manufacturers more accountable in their product submissions.

Sue Klacik: Certification should be mandated by law. Survey organizations should ask if the personnel performing the reprocessing of reusable instrumentation are certified.

Rose Seavey: Government intervention, mandatory resources, public involvement?  For instance the Feb. 22, 2012 episode, TODAY Investigates: Dirty surgical instruments a growing problem in the OR and the follow up report  Filthy surgical instruments: The hidden threat in Americas operating rooms certainly got the attention of a lot of lay people.  Perhaps we need more stories like this?    

ICT: Has there been a higher level of interest and engagement in these issues since the AAMI summit and the publication of the post-summit paper? How can the profession capitalize on these dynamics?

Ralph Basile: There is no doubt that there has been greater interest in these issues. Numerous articles have been published online and in print. AAMI and other standards-writing bodies have taken up efforts to address the issues raised from the summits. The recent story on The TODAY Show brought the topic to the general public, further increasing interest and discussion. One major step to capitalize is mobilizing state legislatures to pass laws mandating certification for sterile processing professionals.

Russell Gilbert: There has been an increase in interest since the summit. Many publications have had mention of the summit meeting since that time. I have received e-mails referencing the summit meeting; all of this is keeping the goal of better patient care as the center of focus. This attention will lead to better processes.

Chuck Hughes: SPSmedical attended and presented at the summit, as well as helped sponsored the post-summit report.  We have seen significant discussions about the summit with a large number of customers receiving the report. The turnout was good and many organizations have reported on the events. Continued referencing of the summit at seminars and discussing the issues in articles such as this, will help all parties to capitalize on these dynamics.

Sue Klacik: Yes, users are looking at the IFUs more closely. The processing personnel are becoming involved in the purchase decision.  Their role is to state if they have the capabilities to reprocess the medical device. More healthcare facilities need to involve CSSD in the purchase decision of medical devices. Healthcare facilities are looking closer at the training and competencies of their staff. Certification demonstrates competency and more hospitals are requiring certification for their CSSD staff.   

ICT:  Is the onus for proper sterile processing practices shared equally by clinicians, sterile processing personnel and manufacturers? What are the roles they must play?

Ralph Basile: Sterile processing personnel are the tip of the spear. In the final analysis, it is the person handling the instruments during reprocessing that is the final arbiter of whether or not an instrument is suitable for the next step in the process. These are the professionals that must be empowered to make critical decisions about the devices they are handling. It remains for the rest of us, manufacturers, hospital administrators, clinicians, regulatory agencies and standards groups -- to support the efforts and effectiveness of the sterile processing personnel.

Russell Gilbert: The main thing that I picked up from the summit was that everyone wants the same thing. They all want a positive outcome for the patient. Where the disconnect seems to come from is in the understanding of the needs of the technician trying to process the instrumentation for the patient. Staffing for sterile processing departments seems to be shrinking, and at the same time the instruments that they are responsible for are becoming more difficult and time consuming to process. In addition to this no two sterile processing departments are alike; some are using older generation equipment than others. Some processing departments dont even have all of the equipment listed on an IFU to correctly process some of the instruments. I think that everyone needs to continue to be an advocate for the best patient outcome. I think sterile processing staff needs to keep striving for mandatory certification of the profession, and to see that their departments are up to date with current processing equipment. The manufacturers are going to have to strive to make products that are as simple and easy to process as possible.

Chuck Hughes: I feel the onus on proper reprocessing has been on the backs of sterile processing personnel for many years.  Operating room, infection control, materials management and medical device manufacturer's reps rarely demonstrate any appreciation for the complexity of reprocessing complex medical devices and the resources CSSD needs to comply with validated instructions for use.  Not because they do not care, but because they do not know. And because sterile processing has been neglected for so long, many facilities lack proper space, environmental controls, equipment, certified staff or the time to properly reprocess the growing number of complex devices. For those sterile processing personnel who do have the support and respect of other departments, great things are being done. Unfortunately, many in healthcare still see sterile processing as the pots and pans department.  Most facilities have an unreasonable demand for instrument turnover, which creates the need for shortcuts to get the instruments to the operating room on time.  Since knowledge is power, we need to educate all healthcare professionals (users and manufacturers) as to the many challenges of properly reprocessing complex medical devices.

Sue Klacik: Yes, the onus is equally shared by clinicians, central sterile service (CSSD) personnel and manufacturers. We all have a role to play in medical device safe use and re-processing. Clinicians need to use the device for its intended purpose, CSSD personnel need to follow the manufacturers IFUs and the manufacturers need to provide devices that can be safely and effectively re-processed., including having IFUs that are understandable and practical in a common healthcare setting. All of the stakeholders need to follow the AAMI standards and recommended practices.

Rose Seavey: We all own a piece of infection prevention. I would add to that administration.

ICT: Keeping up with the state of the art in reprocessing is challenging for those who develop standards and guidance documents -- how are new developments and new thinking brought to bear on existing standards, and how best can standards address real-world challenges like those discussed at the summit?

Ralph Basile: First and foremost, to empower the sterile processing professional with the knowledge, technological tools and the decision-making power to insure that instruments they handle are ready for the next step in the process. Device manufacturers must consider "cleanability" as a critical measure of function of their device. Tools must be developed that better clean medical devices and make it easier to identify the cleanliness of instruments after reprocessing.

Russell Gilbert: It can easily be seen that there is difficulty in keeping standards current with what is taking place in the working environment. I think in order to do this you have to have planned review of all changes that are taking place and the effects that they have on the current standards. Once the review has been done, any changes made to standards need to be implemented in as rapid and streamlined of a process as is possible. I think that it then falls to the inspection agencies for hospital accreditation to be making sure that standards are being implemented. I do also believe that these inspection agencies are becoming more aware of the role that they play in driving the use of those standards by making their hospital inspectors better aware of what happens within a sterile processing department.

Sue Klacik: It is the stakeholders responsibility to stay updated on standards and guidance documents. Professional organizations keep members apprised on the new standards and guidance documents.  The standard organizations need input from users. Users are encouraged to participate in standard and recommended practice as they are updated.

Chuck Hughes: SPSmedical contributes to writing sterilization standards as a corporate member of AAMI and CSA. I feel these organizations have done a great job documenting best practices with recommendations that are considered reasonable for healthcare facilities to comply with.  For example, standards have stressed for a long time the importance of having and following manufacturers' validated instructions for use in order to proper reprocess devices; however, many healthcare facilities fail to do this.  During sterilization audits, I find the few facilities that do have all the manufacturers' IFUs, do not make them accessible in each of the areas where they are needed.  Even before a device is purchased, standards recommend the healthcare facility review the reprocessing IFU to see if they have the resources to comply; however, this is rarely done.  Instead, sterile processing personnel find out about a new device only after it was purchased. They then have to struggle to secure the IFU and/or an in-service from the manufacturer's representative. As a testing laboratory, we do confront manufacturers who seem to not recognize the importance of ease of cleaning and validating to a standard sterilization process. We clarify many misconceptions they have regarding sterile processing, i.e., every facility has an ultrasonic cleaner and steam sterilizers can easily be adjusted, so it does not matter what exposure time gets validated.

ICT: What are the next steps for the committee in terms of supporting steps already taken by the  FDA and by AAMI to study the practices relating to reprocessing of medical devices?

Ralph Basile: I think that some of these steps are already in motion, including new work items dealing with the critical issues of standardized IFUs, flexible endoscope reprocessing and consideration of human factors in device reprocessing. The publication of the newest version of the FDA's Device Reprocessing Instructions for Manufacturers will also help to improve the state of the art. State legislatures passing laws mandating certification for sterile processing staff. Finally, the healthcare facilities, beginning with hospital administration, must commit themselves to delivering clean, safe-to-use instruments to patient care. The oft quoted truism, "we improve what measure," certainly applies here. "Clean" is a process of 'man and machine' (and water, and detergents and temperature, etc.). All processes are subject to error and even failure. By measuring and documenting performance, cleaning outcomes will be improved.

Linda Condon: Hospitals should be invited to participate in a study and be surveyed about their practices.  Maybe this could be something that is added to the Med Sun group; these hospitals are all ready participating in voluntarily reporting of adverse events.  For example, in most hospitals across the U.S., CS only uses a few sterilization cycles (four cycles on average) This means that they are rounding up the multiple extended cycles. For example, anything greater than 4 minutes is sterilized for 10 minutes.  Technically these hospitals are not following the IFU.  If the Joint Commission,  CMS and the CDC are saying follow the IFUs, why are these hospitals not being cited?  This goes back to critical thinking skills. How did we stray so far?  We should be able with scientific data to make sterilization generalizations to help hospitals standardize practice and create a safe environment.  Sterilization validation should include a maximum temperature  for durability.  Somehow we need to get hospital administrators on board with the state of many CS departments.  Most administrators do not appreciate the work being performed in the CS departments.  Many CS departments are lacking necessary resources.  Administrators are aware of the Med Sun group and I really think the this group could be helpful is spreading this important message.

Russell Gilbert: When I first arrived at the summit meeting it seemed that the solutions would be very simple and that the problems we currently have in sterile processing would be an easy fix. I felt I had a good knowledge as to how the process would work and everything would fall into place. Once in the summit meeting though I quickly became aware of how vastly complicated things really are. There are many agencies involved, many other standard organizations that must be considered both international and European, and that there are lots of issues to be addressed from the manufacturers engineering side. It all should seem so simple: I just need a device that I can use on a patient then I can take to decontamination and clean in a rapid and uncomplicated manner that will be available to use on the next patient. It seems simple doesnt it, you use the instrument, you clean and sterilize the instrument, and it is ready to use again. It was apparent at the summit that the goal of AAMI and the FDA is to improve care throughout all hospitals and for all patients, if this wasnt their goal then this summit wouldnt have taken place and they would not be continuously working to bring all sides together to resolve issues and move forward. Two great opportunities have been presented from this summit that I see will play an important part in resolving some of the issues we face, these are the development of work groups to look at human factors and also standardization of manufacturers' instructions for use. It will take time to put this information into practice, but there are no overnight solutions for us to choose from.

Sue Klacik: AAMI has already begun three new working groups that being the Standardized Instructions for Use, Human Factors and a new TIR on endoscope reprocessing.  AAMI has published a report on the 2011 summit to inform stakeholders of the Summit.  AAMI is also publishing a magazine on the issues from the AAMI 2011 summit.  AAMI has developed and published a list of 10 Things Your Organization Can Do Now to Improve Reprocessing. Healthcare can use this tool to begin resolving reprocessing issues facing healthcare facilities.  
The FDA would be better to address this issue.  However, my understanding is that the FDA has taken the lessons learned at the AAMI/FDA Summit and comments submitted on the new FDA Draft Guidance for Industry and FDA Staff Processing/Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling to update this document.  The International Association of Healthcare Central Service Materiel Management (IAHCSMM) has worked with AAMI to inform its members of the summit and also updates its members.

Manufacturer Roundtable

ICT asked representatives from manufacturers for their perspectives on key issues relating to device design and cleanability, as well as manufacturers' instructions for use (IFU).

Our roundtable participants are:

- Gregg Agoston, associate director, Protection 1 Services, KARL STORZ Endoscopy-America, Inc.

- Brent Geiger and Terry Mistalski, Minntech Corporation, Medivators Business Group

- Marcia Frieze CEO, Case Medical

- Sharon Hadley, BSN, RN, CNOR, CSPDM, CHL, vice president for clinical operations, IMS

- Bruce Hoadley, executive vice president of Vikon, an IMS division

- Derek Lashua, Spectrum Surgical 

Device Design  
How do you define the concepts of "clean" and "cleanibility"?

Agoston: I define clean as an item that has  had all visible organic and inorganic material removed from the devices surfaces; this includes surfaces on the exterior and within lumens.  Failure to properly clean an item begins a cascading effect that can eventually result in sterilization failure. Disinfection is a separate step  following cleaning and should be performed to render a device safe to handle through the elimination of many or all pathogenic  microorganisms, with the exception of bacterial spores on inanimate objects.  Cleaning is the process by which visible gross debris is removed. An item is rendered clean by using a thorough cleaning process with  appropriate chemicals and cleaning accessories for the particular device The disinfection process consists of either mechanically or  chemically removing, inactivating or destroying bloodborne pathogens to the point where they are no longer capable of transmitting  infectious particles and the item is considered safe to handle, use or dispose of. (AAMI)  Cleanability refers to the ease with which a particular device can be cleaned to remove gross debris. All devices should be manufactured  with a goal of ease of cleaning in mind.

Geiger and Mistalski: There has been much recent discussion around just  exactly what clean is and how it is defined, and it seems like a straightforward question, but it is actually very complex and difficult. For the purposes of endoscope cleaning, we have defined clean by using established quantitative endpoints for residual protein, carbohydrate and  hemoglobin. The endpoints used for these markers are based on AAMI TIR 30 and published research by Michelle Alfa, PhD.  It is also important to consider that "clean" must be defined relative to an established baseline, so any cleaning validation studies must  include and account for negative controls to be meaningful.  

Frieze: All items, including medical devices, can be cleaned and should be cleaned before and after each use to  render them safe for handling and prior to further sterilization or disinfection. However, whether the device can be effectively cleaned is  another issue. Cleanability means that the item can be effectively disassembled, that the materials are compatible with the cleaning agents  and maintain their integrity if reusable throughout the useful life of the product and that adherent soil can be removed from surfaces and  crevices of the device. In order for a device to be cleaned clear and accessible reprocessing instructions must be provided to the user.

Hadley: According to ANSI/AAMI ST79:2010 & A1:2010,  Section 2.17, cleaning is defined as the removal of contamination from an item to the extent necessary for further processing or for the  intended use. For cleaning to occur, the item must be "cleanable." "Cleanability" is adversely affected as  instrumentation becomes more complex.  Cleanability of instruments can be a design issue, and it is a patient safety issue.  With more sophisticated devices, additional time may be needed to ensure that items are indeed clean and safe to handle prior to further  processing. (Manufacturers instructions for use should be available and must be followed to ensure devices are properly cleaned.) Proper point-of-use care and handling (post-operative or post-procedure) is a critical component of cleanability. Blood and other bioburden is more difficult to remove when allowed to dry on the surface and in the joints and crevices of devices.

Lashua: A clean instrument is visually free of blood and bioburden.  Cleanibility is the level of ease that an instrument can be cleaned

Do you believe that your medical device(s) is/are easy to disassemble, clean, disinfect, sterilize and assemble?

Agoston: Yes, assuming that the sterile processing department (SPD) staff follows the manufacturers guidelines for each device as described in our IFU. If the device is not disassembled completely, brushed and flushed, soaked and rinsed as described in the IFU, the device will not have been properly cleaned prior to sterilization, invalidating the sterilization process. In the average community hospital setting, however, the challenge for healthcare workers is that the inventory of medical devices within the facility can number in the thousands. Each device will have its own instructions for cleaning, disinfection and sterilization. Combine this with the fact that most SPDs are not staffed adequately to allow for specialization, e.g., orthopedics, laparoscopy, urology, etc., and that only one state, New Jersey, requires certification for SPD workers, and the task of following manufacturer guidelines becomes almost impossible for any particular device. As a result, the SPD staff generally resorts to processing devices in a manner that is least likely to cause damage to the items. This leads to instruments not being properly cleaned or disinfected prior to sterilization. It is usually the high-cost specialty instruments that require hand cleaning that are the issue, such as telescopes, video cameras and power equipment such as saws, shavers and drills, and instruments with lumens. Often the hand-washed instruments are improperly processed. We have witnessed on a regular basis failures to follow manufacturing guidelines for such items, such as not submerging in enzymatic solution those items approved for such. Devices with lumens are often not cleaned appropriately, and due to costs associated with damage to such items, processes are frequently changed to reduce damage. At a major teaching hospital, we witnessed OR staff wiping off gross debris from rigid scopes in the OR without using any chemical or enzymatic agent. Staff then separated the scopes from the instruments, which then went through a decontamination process while the scopes were carried into the clean side of reprocessing and placed in a bin to be reunited with the instruments after they came out of the washer. When we questioned why they were doing this, the response was that they had been experiencing high damage rates with the scopes, so to avoid damaging them during the decontamination process, they skipped that step. Fortunately, upon our visit, this practice was changed by hospital administration.

Frieze: Our SteriTite container was designed specifically to be easy to disassemble, clean and reassemble for its intended use; organizing, packing and sterilization of reusable devices. There are only three standardized parts in the SteriTite sealed container that need to be disassembled and reassembled for use: the lid, the base, and the filter retention plate(s). Each part is interchangeable with others of its type. Our IFUs demonstrate how the components can be disassembled and reassembled with text and photographs. All of our containers, trays and inserts are anodized and passivated for corrosion resistance. This process protects the metal surfaces of our devices from deterioration and corrosion making them safe for re-processing and their intended use. We also developed a pH neutral line of instrument chemistries designed for instrument processing and to address concerns and issues with caustic cleaners.

Hoadley: The Vikon Quick Release Kerrison is designed so that assembly and  disassembly are intuitive for SPD and OR personnel. Because the Vikon Quick Release Kerrison does not completely come apart, parts  cannot be lost or mismatched during sterilization and reassembly. In addition, the Vikon Quick Release Rongeur has been validated for  sterilization in both the assembled, or closed, position, and the open position.

Lashua: Yes, we constantly strive to  offer products that improve patient safety such as Spectrum's Clear Flush Kerrisons and Clear Flush Laparoscopic Instruments.  These devices are  unique in the industry because they are the only design that have been independently validated that they can be properly decontaminated.

Do you support the FDA and AAMI's efforts to encourage device design that better facilitates sterile processing?

Agoston: Yes, we support this initiative, and encourage SPD personnel through training and education to follow the IFU for reprocessing. Good design alone will not solve the problem or improve the outcome; it has to be combined with good reprocessing/cleaning.

Geiger and Mistalski: Yes, patient-contact device design is a fundamental consideration for successful sterile processing, however given the huge number of different reusable medical devices available, it is incredibly complex task to try to influence manufacturers device design. FDA and AAMI efforts may have some general success in increasing awareness of better design for processing, but I think it will be very difficult for FDA and AAMI to make a major impact on specifics of fundamental device design. Clarifying that our devices are not used on patients, our devices clean and disinfect flexible endoscopes, TEE probes and esophageal dilators.

Frieze: Case Medical absolutely supports efforts to design devices that better facilitate sterile processing. Many medical devices are way too complex and were never designed with cleaning, reprocessing, reassembly and disassembly in mind. An example would be complex orthopedic sets with multiple layers, screw caddies and power equipment with hard to reach areas such as narrow lumens and open crevices where microorganism can readily proliferate. Some medical devices require extended reprocessing times. Had these items been designed differently, compliance with standard hospital cycles could be achieved. In the rare case that a device is so complex or dense that an extended processing time is required, this item should be labeled as such and removed from the instrument set and placed in a separate container for processing. A spare or duplicate item can be sterilized and packaged separately prepared while all the other items in the set can be processed in the standard cycle. Medical device manufacturers typically interface with surgeons on device designs. They should be open to obtaining information and feedback from sterile processing and infection prevention personnel during the design phase to incorporate cleanability and reprocessing input from users.

Hoadley: Yes. Some current instrument designs make it extremely difficult for OR and SPD personnel to properly clean them. Proper cleaning, along with sterilization, are important in preventing Surgical Site Infections, which can have a serious impact on patient outcomes. According to a 2009 study published in the American Journal of Infection Control, SSIs have been estimated to extend the average length of stay by 9.7 days and increase costs by $20,842 per hospital admission. The study estimated the total economic impact of SSIs, including extended stays and treatment costs, at $1.6 billion.

Lashua: Yes.  These efforts will result in improved patient safety

Do you believe that these efforts represent a substantial cost to device manufacturers?

Agoston: Possibly. If the device was not adequately designed at the first place, the modification would be costly; if they were designed for easy cleaning, there should be no additional costs. Nevertheless, we support these efforts to improve patient and healthcare worker safety. These efforts will fall short, however, unless hospitals also make a substantial investment in their SPD personnel through higher pay rates, certification, allowances for specialization, investment in space and equipment, and continuous education and training. Without these things, the current state will not change and there will be high turnover in the departments, making it almost impossible for managers to ensure that IFUs are followed. Prior to creation of the SPD, the same nurse who assisted the surgeon also was responsible for the cleaning and sterilization of the instruments. The nurses thorough knowledge of the instruments resulted in a higher level of accountability and lower damage rates. To address product flow and standardization, this functional model was replaced by creating the SPD. At the same time, instrumentation also changed from typical open instruments to minimally invasive designs and power equipment, bringing a new level of complexity to cleaning and sterilization requirements. For many years, hospitals have been cost shifting; that is, although keeping costs low for manpower, they are paying higher rates for instrument damage and HAIs associated to improperly processed instruments.

Frieze: Although the costs associated with better design efforts such as R&D, compatibility testing and acquiring premium raw materials, quality manufacturing processes, and validation testing may be significant, they are necessary as these factors yield a superior product that is safe for the patient, staff and environment.  Durable, reusable products that comply with cleanability efforts may be costly for the device manufacturer and for the user but this is an  investment that is worthwhile as we are investing in product safety and efficacy which could translate to patient safety and sustainability for  future generations.

Hoadley: There may be some short-term production costs incurred by manufacturers, but these will be far outweighed by improved patient outcomes, as well as long-term cost savings for facilities and the entire healthcare system.

Lashua: In many cases yes. The instrument has to be redesigned to be able to be disassembled for cleaning or validated that it can be cleaned

Do you receive negative feedback about the cleanability of your device(s) from users? If so, what are the chief complaints?

Agoston: Complaints are not directed toward any one item, but they are directed toward the large number of manufacturers instruments in the hospitals inventory and the variety of requirements each manufacturer has for cleaning, maintenance and sterilization, all of which makes the SPD staffs job very difficult.

Geiger and Mistalski: Difficulty cleaning long, small lumens of devices that are reprocessed in our endoscope reprocessor is a complaint. 

Frieze: We have not received any negative feedback regarding the cleanability of our devices. We caution users to only use pH neutral cleaners and non-abrasive products to clean our anodized aluminum cases, trays and inserts.
Hoadley: No. The need for a more cleanable rongeur was the impetus for the development of the Vikon Quick Release Kerrison.  Its known in the SPD community that it is virtually impossible to remove bioburden from a Kerrison rongeur unless it is disassembled, which is very difficult with a standard Kerrison design.

Lashua: We try to offer  the users more than one option based on their preference.  For example, we offer a take apart kerrison rongeur that allows for effective  cleaning.  For those who don't care for this design, we offer the Clear Flush Kerrison which is a non-take apart but can be flushed and is validated that bioburden has been removed.

Do you believe that your device validation studies are designed to reflect real-world conditions in the SPD and are reprocessing steps able to be replicated easily by SPD technicians?

Agoston: Yes, validation should reflect real-world conditions, and yes, our sterilization validation reflects the real world.

Geiger and Mistalski: Yes, cleaning validation studies are performed using the automated cleaning cycle of our AER, so the cycle is automatic and all cleaning steps controlled. Since cleaning is automated, replication of cleaning reprocessing steps by technicians is not a concern. However, it is important to recognize that manufacturers must make certain assumptions in validation studies, and the assumptions need to be valid and supported by scientific data, clinical experience or established clinical practice.

Frieze: All of our validation testing is designed to reflect real-world conditions. While other container manufacturers use simulated shelf life testing using an abbreviated shelf life study based on contact lens solution shelf life testing, They state a one year shelf life, but actually tested for a maximum of 63 days. Case Medical provides the actual real time of such a study with simulated handling events, not an artificial construct.

Lashua: Yes, otherwise the validation is useless.
Do you support the FDA's draft guidance that provides greater clarity on how to scientifically validate the reprocessing instructions that are part of device labeling -- Why or why not?

Agoston: FDAs draft guidance is not clear enough for us to follow and we are currently experiencing unreasonable questions to our scientifically sound cleaning studies, such as suitable test soil, physical marker end points. We support due diligence work but expect the guidance to provide greater clarity on directions and requirements and be clear enough for the device manufacturer to follow.

Geiger and Mistalski: Yes. Medivators devices are designed specifically for automatic reprocessing, so therefore we have been scientifically validating endoscope reprocessing with our AERs for more than 10 years. We have established procedures for validation and formal validation programs, so the recommendations in the FDA guidance document are nothing new. 

Frieze: Case Medical supports this effort because by doing so, it will help eliminate the confusion users often face when there are unclear reprocessing instructions and/or dissimilar labeling parameters. By clarifying the scientific data included on the labeling, medical device manufacturers can present a clear snapshot of data that is easy to understand and follow.

Lashua: Yes.  The manufacturers and the FDA must work together so the users can have the validated cleaning instructions.

Manufacturers' IFU
Do you believe that your IFU are clear and easy to understand?

Agoston: Yes. For any one device, our IFUs are written to be understood easily by the reader and to meet the FDA requirements for the device. Multiply this by the tens or hundreds of different items in any one hospital and it becomes easy to understand why there is so much confusion in the SPD and OR on proper care and handling for any one device. Even with clear-to-understand and easy-to-follow IFUs, it does not guarantee that all instructions will be followed adequately.

Geiger and Mistalski: Yes, our basic endoscope connection instructions are simple, they are at most a only one page with double sided content, they include pictures and diagrams and have been evaluated by numerous lay people for clarity and ease of understanding. Reprocessor DFUs are necessarily longer and more complex. 

Frieze: We developed our IFUs based on feedback from end users. Our IFUs go through each step point by point, illustrating a clear guideline for users to follow. We include photographs or illustrations identifying each step for decontamination, cleaning, assembly, inspection, sterilization parameters and point of use.

Hoadley: Yes. Our IFUs were written specifically for the Vikon Quick Release Kerrison, showing step-by-step instructions on the sterilization process. We have seen many IFU that are very general, attempting to cover a broad range of instruments in single document.

Lashua: We are continually improving our IFUs.  As an AAMI member, I attend the  meetings to learn the most up-to-date guidelines.
Do you receive negative feedback about your IFU from users? If so, what are the chief complaints?

Agoston: The challenge for users is the vast number of instruments and devices in the hospitals inventory, each often having specific instructions for care, handling, cleaning, sterilization and storage. In addition, some items such as power equipment and devices with small, long lumens require special handling that requires longer processing times. The SPD often is not staffed adequately and/or the hospital does not have sufficient inventory to support longer processing times. As a result, the SPD staff does not follow the recommended procedures for processing, thus placing patients at risk of exposure to a device that was improperly cleaned, sterilized or maintained.

Geiger and Mistalski: There are literally thousands of different endoscope/AER connection combinations and we do not yet have DFUs to cover all connection types. The main complaints are that visual diagrams for all possible connections are not yet completed or available.

Hoadley: No. We have worked with a number of SPD professionals to ensure that IFU for the Vikon Quick Release Kerrison are clear and easy to follow.

Lashua: Users are now asking specifics about cleaning brush size for example. We listen and add these into the IFUs.

Are you currently revising or do you plan to revise your IFU to make them easier to understand?

Agoston: We regularly review our IFU and update them as needed. IFU are also updated as we gain additional product use and sterilization approvals and clearances.

Geiger and Mistalski: Revision of IFUs is a never-ending, ongoing process. They are always being improved and updated.

Lashua: Yes.  AAMI and the FDA are helping guide us in this process. 

How do you make your IFU available to users?

Agoston: IFUs are provided in the package with each new product purchased and also upon request by contacting our Technical Support Department.

Geiger and Mistalski: They are available on our website at www.medivators.com, and are also on our unique database listing of endoscope/AER connections found at wwwminntech.com/medivators/HookupLookup.

Frieze: We provide a hard copy of our IFUs with each product sent. We have our IFUs and MSDS documents easily accessible to all on our website, www.casemed.com.

Hoadley: IFU for the Vikon Quick Release Kerrison are available in package inserts and electronically.

Lashua: In electronic format and with the products.

What kind of technical assistance do you offer to users?

Agoston: KARL STORZ offers 24/7/365 phone support by our highly qualified Technical Support Department. All of our Field Representatives are highly trained in their respective surgical specialties to assist our customers. We also offer Field Service Technicians free of charge in most metropolitan areas and, for a fixed fee, we even place trained KARL STORZ On-Site Endoscopic Specialists (OES) in facilities. Being a resident expert, one of the primary roles for the OES is to ensure that KARL STORZ devices and instruments are properly cleaned, sterilized and maintained so that they are always in optimum working condition and ready for each patient use.

Geiger and Mistalski: We provide live technical phone support 6 a.m. to 10 p.m. CT Monday through Friday. On www.medivators.com, users can access many product bulletins that answer a wide array of questions.

Frieze: We have product/technical specialists available by phone and on line through email. We provide on-site in-services, education and training at no charge to the end user upon request or post install. We also offer assessment and installation services at no charge to customers pre- and post-purchase. In addition, we have IFU power points that go through the process step by step as well as instructional videos available online.  We have a team of product and clinical specialists available to answer questions and provide on-site or remote education and in-service.

Hoadley: We offer a complete in-service program for SPD and OR personnel, covering care, handling, and sterilization issues. We also provide care and handling posters for the Vikon Quick Release Kerrison.

Lashua:  In-person education, webinars, and written guidelines. 

Do you believe that manufacturers should work harder at improving the communication/complaint process from users?

Agoston: Yes, and we always try and reach out to the end users of our product to solicit their feedback for continuous quality improvement.

Geiger and Mistalski: We cant speak for other manufacturers, but we have a very diligent complaint handling team who manage to resolve most issues quickly.

Frieze: Users often complain about the lack of information or guidance provided to them for reprocessing. In addition, they may not know whom to consult with for information, where to find the information, some of which is not readily available and may find many IFUs to be unclear or too complex for practical application. There should be a common language shared amongst all manufacturers such that the IFUs for similar products should correspond with similar terminology, description, and template with clear illustrations so that users can become familiar with the information and be able to easily extrapolate as needed.  Case Medical strives to improve its communication and complaint process. We have a formal complaint process for both internal and  external users managed by our quality control team of scientists and engineers. We send out regular newsletters and communications  regarding product information and make all of our documentation readily available and easy to access.

Lashua: Yes, it can always be improved.  As an ISO facility, we are required to document concerns and put a corrective action plan in place.



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