The new AAMI BMET Apprenticeship Program is off and running thanks to Jackson, Tennessee-based ReNew Biomedical Services.
ReNew signed on with the Association for the Advancement of Medical Instrumentation (AAMI) in April to become its first official partner in the one-of-a-kind program, which combines online and classroom education with up to 6,000 hours of on-the-job learning time. Program partners hire apprentices directly and provide them with training – and paid work experience – at their own facilities.
Participants in the two-year program can earn three industry-recognized credentials: AAMI’s CABT and CBET candidate status; and the ITF+ certification. Upon successful completion of the apprenticeship, they also receive a journeyman certificate from AAMI and the U.S. Department of Labor.
Program employers, on the other hand, become eligible for grants from the federal government that can offset the costs associated with training. But more importantly, says Mark Taylor, one of the three managing partners at ReNew Biomedical, they gain access to potential “biomed talent” that most would probably agree is in very short supply.
“Fortunately for us,” Taylor says, “we’ve been growing exponentially. But hiring has been difficult, to say the least. It’s been hard to find people who even know what HTM is.”
ReNew offers biomedical field services in all 50 states. The company has 18 full-time employees, including 13 technicians, and has five vehicles that cover the country serving as mobile biomed workshops.
“We literally work on anything and everything except for large imaging machines,” Taylor says.
A few years ago, as the company was expanding, Taylor and his partners approached a local community college about creating a trade program for students who were interested in healthcare technology management (HTM). That idea sputtered out when they realized how little people knew about the field, but later they managed to bring it back to life as the “ReNew Biomedical Training Academy.”
“We’d contacted AAMI right before COVID to figure out how we were going to reach people,” Taylor says. “And then almost overnight, our problem got even bigger with all the equipment facilities suddenly needed to handle the surge of sick patients.”
The academy was created shortly thereafter, with financial assistance from the Tennessee Department of Labor and a curriculum AAMI had just developed for its fledgling BMET Apprenticeship Program.
The association’s goal with the program, says Danielle McGeary, CHTM, AAMI vice president of HTM, is to provide anyone who wants to enter the field with the hands-on experience required to get started. “It could be someone who’s ready for a career change, or it could be someone just out of high school. This is intended to bridge that gap to get them the training they need to be successful.”
Employers who take part in the program, McGeary adds, benefit from having entry-level workers on their payroll they can train to their equipment and service specialties. “When they’re finished, if you want them to stay, they’ll already be up to speed – they won’t need retraining.”
“To be honest,” Taylor says, “our involvement is self-serving – we’re a business that needs trained biomeds. At the same time, though, programs like this are for the greater good of the future of HTM.”
He encourages other employers who may be interested in apprenticeships to contact them to hear more about their experience.
More information on how to become a BMET Apprenticeship partner can be found at www.aami.org/training/bmet-apprenticeship.
An overhauled technical information report from AAMI may change how device designers and industry consider risks associated with intravascular medical devices.
The extensive 2021 update to the Technical Information Report (TIR) 42, Evaluation of particulate associated with vascular medical devices, comes more than 10 years after the previous version debuted. According to project lead Eleni Whatley, biomedical engineer at the FDA’s Center for Devices and Radiological Health (CDRH), the AAMI document has kept its primary purpose of providing recommendations for determining the source of harmful particulates, establishing particulate limits and defining appropriate test methods to achieve these goals. However, the new version also thoroughly explores clinical risk assessment.
“By providing much more specific details and in-depth discussion points about the benefit-risk analysis, the TIR is enabling individual manufacturers to take their specific device and their specific treatment scenario and consider strategies to lower risks related to particulate introduction into the vascular system,” Whatley said.
TIR42:2021 focuses on intravascular medical devices – those that are used within a blood vessel – as opposed to long-term implants such as pacemakers. This latter group of complex implantable devices have their own standards, but the acute tools and devices that facilitate the surgeries to implant permanent devices also come with their own risks that should be accounted for. If any one intravascular medical device sheds particulates into the bloodstream, it can be a serious and unforeseen threat to a patient.
The AAMI working group that developed the updated TIR was co-chaired by Dinesh Patwardhan, material scientist at CDRH, as well as Terry Irwin, a distinguished quality engineer with 25 years of industry experience.
“Over the last 10 years, there was a significant advance in these kinds of technologies. The benefits versus risks for each have to be thoroughly evaluated by the industry and by reviewers,” explained Patwardhan. “Because these technologies are changing, it becomes important to figure out where to draw the boundary. A ‘catch all’ standard may have limited utility for stakeholders, so this TIR includes very specific criteria for what this document and these methods apply to.”
For example, the document touches on specific benefit-risk analysis scenarios for particles from intravascular catheters or guidewires but will not account for the risks posed by particles from the operating room, such as lint from a gown or gauze. And while the document could not outline specific particulate limits due to the vast number of different devices, diseases, and vascular territories, it does include a comprehensive discussion for how individual manufacturers can go about developing these specifications.
According to Cliff Bernier, director of standards at AAMI, it is thanks to the contributions of a diverse cast of professionals – including physicians, researchers, industry and regulatory representatives – that the updated document can build upon existing knowledge while also providing a new level of clarity.
“If somebody who is not 100% familiar with particulate assessment takes a look at this technical information report, it is written in a way that they can still follow,” he said.
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