By K. Richard Douglas
The world could not run without benchmarks. In engineering, science, drafting, quality control, manufacturing and in environmental regulations, benchmarks provide a standard that can be used as a point of reference in evaluating a level of quality.
A standard can emerge from a consensus of stakeholders and can often provide a target or comparison that provides a good measuring stick for how something can be assessed.
There is a set pattern to the development of a standard. This is how one organization approaches the task.
According to the Project Management Institute, standards development follows six steps.
A standard development team is assembled and subject matter experts are solicited as first reviewers. During meetings, over several months, team members draft and refine the new standard. The draft version is then presented to the subject matter experts for review, feedback and possible changes.
The revised draft is made available for public comment. After this period, if there are compelling comments that would make revisions necessary, those revisions are made. The new standard then goes to a standards consensus committee for approval. This committee is made up of independent volunteers. If the committee votes to approve the new standard, it is adopted.
While standards can go through a very deliberate and calculated development process, there are also times when standards may need to be modified or relaxed.
During the spread of the SARS-CoV2 coronavirus, the FDA issued several authorizations of guidance to address the extraordinary circumstances that the pandemic has posed to health care workers and facilities.
Examples include information published by the agency on the use of blood antibody tests to identify exposed persons, and emergency use authorization that recognized the insufficient supply of face masks. They also announced a program that would “move new treatments to patients as soon as possible.”
These standards have been modified in response to the rapidly changing needs and requirements caused by the coronavirus pandemic.
AAMI Standards of HTM
While there haven’t been any updates to standards impacting the HTM community in recent months, there has been activity with regards to standards that impact medical device manufacturers.
There also has been some temporary easing of standards because of the coronavirus pandemic.
There remain a number of standards that regulatory agencies and surveyors review when visiting a health care facility and these standards have been developed to protect patients, standardize procedures and maintain baselines.
There are approximately 17 organizations that can accredit hospitals, many with “deeming” power for Medicare and Medicaid. The Joint Commission accredits more than 4,000 hospitals. The FDA regulates medical device manufacturers.
Many standards that HTM professionals are familiar with, especially quality standards, have broad application across several industries. The ISO 9001 standard is an example.
AAMI has worked to help formulate a definition, in conjunction with the FDA, that sets a standard for terms used in HTM; specifically defining servicing versus remanufacturing.
According to AAMI, their EQ – Medical Equipment Management Committee develops standards on aspects of medical equipment management for healthcare technology managers.
Further, AAMI’s website states that “AAMI’s standards committees and working groups develop and maintain all AAMI standards, technical information reports (TIRs), consensus reports and other guidance documents. These committees and associated working groups also provide input into international (ISO/IEC) standards.”
Also, AAMI’s website explains the significance of an American National Standard. The website states, “An American National Standard (ANS) is a document that has been sponsored by an ANSI-Accredited Standards Developer (e.g., AAMI), achieved consensus, met ANSI’s Essential Requirements, and been approved by the Institute. AAMI may choose to submit its standards or TIRs to ANSI to be designated as an American National Standard (ANS).”
According to The Joint Commission, “all medical equipment is required to be on the medical equipment inventory,” if the facility is accredited through The Joint Commission.
The original ANSI/AAMI EQ56:2013 Standard has been in a process of revision, although that process has been slowed because of the impact of the coronavirus pandemic on the workplaces of many of the committee members involved with the EQ documents, according to AAMI. For instance, a scheduled meeting of the EQ-Medical Equipment Management committee that was scheduled for June 10 and 11, 2020 had to be postponed. This meeting would have been just ahead of the 2020 AAMI Exchange, which was cancelled.
A call for comments by AAMI on EQ56 were due by early January. Committee members are reviewing those comments and that feedback will be considered as part of the updating process when the committee is able to reconvene and return to its work.
In our July 2019 story about the current state of standards, we looked at an update of AAMI’s progress on the standard at that time.
At the time, AAMI’s Director of HTM Standards, Patrick Bernat, shared an update. “The scope of the previous EQ56 did not include quality management principles or processes. Recently, the FDA report on device servicing recommended that service providers adopt quality management principles and systems. This NWIP is proposing to include these principles in the new standard’s scope, including an effort to align with concepts in ISO 20000,” Bernat said at the time.
“Additionally, the EQ Committee conducted a gap analysis to identify other gaps that need to be addressed in an EQ56 revision. As a result of that exercise, the EQ Committee is also proposing to address the items below in a revision,” he added. At that time, Bernat outlined six “critical gaps in the existing EQ56 document.” He also outlined five additional “secondary gaps” which needed additional attention.
These updates are still in the process of being revised and bringing the EQ56 Standard to a place where it recognizes current technology and the convergence of IT and HTM.
AAMI released the original EQ56 standard, “Recommended practice for a medical equipment management program,” in 2013. That is when the recommended practice was developed by the AAMI Medical Equipment Management Committee and then approved by the American National Standards Institute Inc.
At that time, the standard, a baseline for medical equipment management programs, had been in the works for three years.
Stephen Grimes, principal consultant with Strategic Healthcare Technology Associates LLC, says that COVID has slowed the progress on standards recently. Grimes has served on the AAMI committee updating EQ56 since the original 2013 version was developed.
“We’ve made some progress in EQ56, incorporating some additional elements that align us more effectively with other QMS and IT service standards (necessary because we’re more often dealing with hybrid medical and information technology systems). With reduced frequency of meetings and cancellation of the on-site meeting this month, I’m not sure where we are in developing a version for ballot,” he says.
Grimes has proposed that the HTM field adopt its own QMS standard. He outlined his proposal in a 2019 AAMI Biomedical Instrumentation and Technology (BI&T) article.
“The point I raised about the need for a QMS, and the absence of a health technology related quality management system for the CE/HTM community, I believe remains a major issue. Our community needs a QMS standard appropriate for the spectrum of work we do – servicing is currently the concern of FDA and manufacturers, but there remain many other things we do in technology life cycle management that should be represented in a relevant QMS,” Grimes says.
Can the national standards of a regulatory body be waived or modified? The short answer is; yes.
Sometimes a temporary adjustment to a standard is required based on extraordinary circumstances. The coronavirus pandemic created a national crisis that required an extraordinary response by health care facilities nationwide.
Hospitals could not wait casually on the sidelines in order to respond to the growing threat of overflowing ICUs and ERs, but needed the regulators to work with them to address the unique circumstances that they faced. This included the ad-hoc erection of additional patient ICU beds or beds for displaced non-COVID patients to accommodate a surge in hospital admissions nationwide.
As a result, many federal agencies that publish standards for health care responded quickly with changes to established standards.
According to CMS, “under section 1135 of the Social Security Act, [the HHS Secretary] may temporarily waive or modify certain Medicare, Medicaid, and Children’s Health Insurance Program (CHIP) requirements.”
CMS also states; “When there’s an emergency, sections 1135 or 1812(f) of the SSA allow us to issue blanket waivers to help beneficiaries access care. When a blanket waiver is issued, providers don’t have to apply for an individual 1135 waiver. When there’s an emergency, we can also offer health care providers other flexibilities to make sure Americans continue to have access to the health care they need.”
It would be a temporary adjustment to a standard based on the Medicare Conditions of Participation or the Emergency Medical Treatment and Labor Act (EMTALA) waiver. These waivers recognize the increased necessity for services like telemedicine and allow clinicians who may not have been eligible to bill Medicare for telehealth services.
Also, the waiver allows hospitals to screen patients offsite to prevent the spread of COVID-19. Rules related to verbal orders are waived. Reporting requirements on patients in ICUs who require soft wrist restraints have been waived and requirements for providing medical records, patient visitation of patients in isolation and seclusion, in high impact areas, are waived.
Another waiver, that recognized the limited supply of PPE, allows “used face masks to be removed and retained in the compounding area to be re-donned and reused during the same work shift in the compounding area only.”
The Centers for Disease Control and Prevention (CDC) issued its “Crisis Standards of Care Decontamination Recommendations” which address the reuse of respirators and suggested decontamination methods, which include ultraviolet germicidal irradiation, vaporous hydrogen peroxide and moist heat.
Medical staff, who previously may have been restricted from practicing at a hospital because their privileges will expire or the requirements of a new physician to begin practice at a hospital without governing board review, are waived so that doctors can more easily treat COVID-19 patients.
“On April 29, 2020, CMS issued a formal communication granting 1,135 blanket waivers that permit health care facilities to adjust scheduled inspection, testing, maintenance frequencies, and activities for facility and medical equipment,” says Mike Busdicker, CHTM, FACHE, system director of Clinical Engineering at Intermountain Healthcare in Midvale, Utah.
“Utilization of the waiver allows an organization, like Intermountain Healthcare, to evaluate current pandemic status and adjust PM frequencies to reduce disrupting patient care and reduce possible exposure/transmission of COVID-19. Implemented changes need to be formally documented along with any deviations and recovery plans,” Busdicker says.
To some degree, with a viral pandemic, a waiver has to be flexible because, unlike a hurricane or tornado, where the duration of the event is predictable, the lifespan of a viral pandemic is unknown. This is also true for geographic areas.
The National Fire Protection Association (NFPA) has had to modify many standards because of the many temporary structures or non-traditional spaces that were hastily erected to respond to the coronavirus pandemic and the expected surge of COVID patients.
In an NFPA press release, the organization explained; “At NFPA, we fully recognize that it will be impossible to modify or construct spaces in strict compliance with fire and life safety codes while getting ready to treat critically ill patients with the best possible care,” said Robert Solomon, PE, fire protection engineer at NFPA. “At the same time, there are measures that can be taken to help keep people safe from fire in light of the current situation.”
This waiver of a standard by NFPA is in line with another waiver by CMS which stated: “CMS will permit facility and non-facility space that is not normally used for patient care to be utilized for patient care or quarantine, provided the location is approved by the state (ensuring that safety and comfort for patients and staff are sufficiently addressed) and is consistent with the state’s emergency preparedness or pandemic plan.”
New standards will be available to the HTM community in the near future to better define a medical equipment management program. There may be modifications to standards that HTM professionals recognize, that result from the coronavirus pandemic. Both will impact the field in ways that are either anticipated or unknown. Maybe a new QMS standard will emerge as well.
For now, a pandemic has put efforts on hold and reshaped the health care landscape into the foreseeable future.
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