The HTM community found itself in a form of collective disbelief in December 2011, after CMS released a memo that mandated following manufacturer-recommended maintenance schedules for most medical equipment. In one fell swoop, CMS declared evidence-based maintenance inconsequential.
While that by-product of the ruling was most likely unintentional, the reaction was not. Many shops’ efforts to service equipment more efficiently, based on collected evidence demonstrating known functionality and failures, became irrelevant. Accompanying budgetary considerations were thrown out the window at the same time.
In response to the CMS directive, AAMI and the American Society for Healthcare Engineering (ASHE) gathered 244 pages of data to enlighten the federal agency on the merits of the evidence-based approach. AAMI and ASHE made that data available to CMS after a June 2012 meeting. The data highlighted current HTM practices to determine maintenance frequencies, including the use of ECRI Institute’s Sample Device Inspection Procedure, risk assessment models and other methods to make the case for current practices.
The package of information also raised several key points. Among them, AAMI and ASHE explained that manufacturer recommended maintenance activities “are developed before the devices have any history of utilization in the clinical care environments”and that “manufacturer procedures are more typically developed for testing activities during initial assembly and may not be appropriate for periodic testing activities.”
Additionally, the package pointed out that there is no “independent oversight or analysis process to validate the effectiveness or necessity of the recommended procedures.” Within the substantial document’s analysis were points about the importance of techs working with users instead of simply performing routine equipment checks, as manufacturers recommend. Industry standards have kept pace with technology, the package explained, and efficient practices discovered by short-handed departments should not be overlooked.
What has happened since the directive and the subsequent meeting? “We found your submitted information most helpful, and we are working on an updated memo.” That was the CMS response to the initial information package submitted to CMS, according to Patrick Bernat, Director of Healthcare Technology Management at AAMI.
“Since the meeting, those of us who attended the meeting have remained in contact with the CMS staff members who also attended, and we have provided additional information as requested by CMS. Our most recent packet of info was sent to CMS in early December — much smaller than the 244-page packet. It was in response to a specific question,” Bernat says.
The AAMI and ASHE group consisted of Bernat, AAMI president Mary Logan, president of RHS Biomedical Engineering Consulting Robert Stiefel, ASHE’s executive director Dale Wooden and Karen Waninger.
“We all felt very pleased after that meeting,” Bernat says. “You can’t predict the future. You can’t predict exactly what CMS is going to do, but we all felt good after that meeting. We felt we established a good rapport with them and we established a good working relationship so that subsequent email exchanges have been very pleasant and constructive.”
“I don’t think that they were trying to do any harm to hospitals or the HTM field. They just needed to be educated on some areas.”
Consistency across the country
The government, whether federal or state, is big on standardization. The preference for standard practice is evident in airline safety requirements, road and highway requirements, and in building construction and environmental regulations. The standards set by the government are mandatory.
Departments in the federal government such as the Food and Drug Administration, Environmental Protection Agency and the Department of Housing and Urban Development have volumes of standards that affect all Americans.
So it should come as no surprise that CMS, a government agency, would prefer to see standardization across the country for the maintenance of medical equipment. But standards are traditionally intended to streamline processes, and are typically based on best practices. If the HTM community can make a compelling case for evidence-based programs, then CMS might just find a way to standardize that approach.
After the June meeting, AAMI president Mary Logan said, “It was clear in the June meeting with CMS that they didn’t realize the depth of the detailed policies and schedules used by the hospital in-house and independent service organization models. It was obvious that CMS is looking for standardization. It’s heartening that they are willing to consider the detailed data provided by the field to re-evaluate what standardization they can accept.”
“What kind of standardization makes sense for everybody involved? Standardization for the sake of standardization doesn’t really accomplish anything. That’s where the AAMI standards work comes into play,” Bernat says. “During Standards Week (in early December 2012), the new work item proposal related to equipment maintenance was approved, so work will move forward in the coming year on that.
“Really, I think that the goal of that project is to take the concept of standardization and the concept of evidence-based maintenance and bring them together so that we can accommodate not only CMS’s interest in standardization, but standardization for the good of the field as well.”
“But, without taking the decade’s worth of evidence-based maintenance that hospitals have perfected over the years and throwing it in the garbage. What we know at this point is that work was approved during Standards Week in Florida. Our hope is this is something that we can present to CMS and say look we understand your interest in standardization, and we feel that standardization is a good thing too. And here is an option for standardization that also incorporates evidence-based maintenance into the model,” Bernat says.
“This can really make everybody happy. It can accomplish standardization and still not abandon the principles of evidence-based maintenance, which are really part of the foundation of healthcare technology management. If you remove evidence-based maintenance, you are removing a major piece of the profession.”
“Bernat says AAMI had to pull together documentation to address many subtle areas of questions and concerns CMS still had. “The nature of evidence-based maintenance was something they needed more information on — how hospitals arrive at their policies for maintenance. That was a part of what we sent them,” he says.
“Standardization on an evidence— based maintenance approach is a large undertaking, and as a profession we need to achieve that,” says Karen Waninger, CBET, MBA, Clinical Engineering Director at Community Health Network and a member of AAMI’s Technology Management Council. “If we had been more cohesive in the past, we could have presented a more immediate complete alternative to the manufacturer recommendations.”
“As it is, there are many solid programs with similar characteristics for the use of actual equipment histories as the basis for different maintenance strategies,” she says. “The AAMI equipment maintenance standards committee will hopefully be able to present some recommendations toward this desired standard.”
Clarification and analysis
The 244-page document that AAMI and ASHE presented to CMS stated: “This document is the first response to questions that were raised by CMS representatives during the June 28 meeting. Through ongoing direct communication between our organizations, we expect to bring further clarity to the remaining points of concern.”
The document also addressed the importance and prevalence of evidence-based programs. “These types of evidence-based maintenance programs (EBM) have been widely utilized across the United States for decades, and have become an integral part of quality improvement processes within HTM. Some aspects of this approach have been adopted by most health care organizations in the United States, regardless of size, ownership or mission. While there is variation among the programs currently being used, two basic elements are evident: equipment risk analysis and EBM strategies.”
“Bernat says CMS has also met with other groups. They are getting input from various sources. There are several things that are promising. It’s promising that they are working on a revised memo,” he says.
One of those meetings was an April 2012 summit with George Mills of The Joint Commission, a landmark meeting in which CMS began clarifying its intent. Many in the HTM community worried CMS would require departments to purchase manufacturer brand-name tools or calibration. The agency confirmed through Mills that any calibration tools would be allowed as long as the calibration was performed correctly.
Talking: it’s a start
Perhaps the most important development since the 2011 directive and the subsequent June 2012 meeting is the channel of communication that has been created. “The follow-up materials that we sent them, the 244-page material, and other smaller inquiries that they’ve sent via email that we have responded to – everything that we’ve sent, they’ve been pleased with,” Bernat says.
“There hasn’t been any case where we’ve supplied something and they [CMS representatives] have turned around and said, ‘This doesn’t answer our question.’
They confirmed that they reviewed that material and [that] it was mosthelpful. They’ve acknowledged receipt of everything that we have sent, whether it’s the 244-page document or the answer to a simple question. I think we have developed a very positive and productive relationship with them. We can’t dictate their timetable, and that’s one of the things I find myself repeating often when people ask questions about where things are or what will happen next.”
CMS followed up to the 244-page document with some clarification questions. Their questions may or may not give a clue as to the content of the next memo to the field. Bernat gave a couple of examples of the follow-up questions that CMS asked.
“They had questions about manufacturer recommendations. They had questions about how often manufacturer recommendations are updated and whether those updates are communicated to hospitals,” he says.
Other questions, according to Bernat, included:
- If the manufacturer of a piece of equipment updates its recommendations, how will those responsible for servicing the equipment be notified of the update?
- How are those updates communicated to the field?
- Is the field comfortable withhow accessible that information is?
“From the HTM side, a common concern is that manufacturer recommendations are not updated to keep up with the times,” Bernat says. He says hospital biomeds wanted to make clear the distinction between updates resulting from FDA action and regular updates designed to keep up with changes in the field.
While the goal of standardization has become clear, some questions remain. The original directive applied to “critical equipment,” a category that was vaguely defined at best.
“CMS did not define critical equipment with any more clarity than they did in the original memo and did not agree that it was the same as life support equipment,” the most common interpretation in the field, Waninger says. “They did indicate they would consider discussions around aligning the terminology in the future to help eliminate confusion. When those discussions will occur remains to be seen. Since CMS did not provide a list detailing what qualifies as critical equipment, many organizations have released statements declaring their own interpretation, including that the terms “critical equipment” and “life support equipment” are interchangeable.
Bernat believes that a model for standardization will eventually have positive effects. “I think the desire is to have some basic parameters, but still give hospitals flexibility to use their experience and intelligence. I don’t think we are as far from CMS as it may seem. I think that almost everybody sees some value in standardization.”
“It has great potential because we are bringing the concept of standardization together with evidence-based maintenance,” he explains. “So it’s got great potential to do something good for the field, not only to meet the needs of CMS and their interest in standardization, but… for the credibility of the field, to say that we all follow an accepted approach.”
Bernat says the original directive was unintentionally stifling. Since learning from AAMI, ASHE and other interestedgroups about the potential effects of only using manufacturer-recommended practices, CMS representatives have worked to understand the issue more thoroughly. “They don’t claim to know everything. They need input from interested parties and experts,” Bernat says. “I think we have developed a productive relationship with them.”
Still, there’s a lot of red tape to pass through before a revised directive is published. “If they put out a revised memo, it’s going to go through a lot of internal reviews at CMS. One thing that they have been very clear on, from the time we’ve met with them until now, is that they cannot make promises about when something will be revised or when something will happen. They move deliberately, and there are a lot of people involved.” In other words, don’t hold your breath.
“It is my opinion that much thought and deliberation is being directed toward the topic of manufacturers’ recommendations, and the CMS team is becoming aware of many unintended interpretations of their statement,” Waninger explains. “I expect they will elaborate more when they believe they have fully explored the varying opinions and strategies.” It will take time, but it’s best that CMS fully explores the evidence at hand before deploying a standard with such sweeping impact for the profession. Don’t you agree?