Comments on: A Matter of Semantics: Defining ‘Medical Equipment’ https://24x7mag.com/maintenance-strategies/alternative-equipment-maintenance/prevailing-attitudes/defining-medical-equipment/ 24x7 Magazine offers in-depth coverage and the latest news in Healthcare Technology Management, serving as the premier resource for HTM professionals seeking industry insights and updates. Thu, 22 Aug 2019 21:14:59 +0000 hourly 1 https://wordpress.org/?v=6.8.1 By: William Hyman https://24x7mag.com/maintenance-strategies/alternative-equipment-maintenance/prevailing-attitudes/defining-medical-equipment/#comment-310026 Wed, 22 May 2019 14:38:09 +0000 http://www.24x7mag.com/?p=52547#comment-310026 There has long been a recognized difference between what is inventoried for equipment management purposes and what is inventoried for financial management purposes. Cost is not helpful as a criteria for safety concerns. Things that cost less than $2500 can still hurt you.

]]>
By: James Russell https://24x7mag.com/maintenance-strategies/alternative-equipment-maintenance/prevailing-attitudes/defining-medical-equipment/#comment-309994 Wed, 22 May 2019 00:20:34 +0000 http://www.24x7mag.com/?p=52547#comment-309994 Amazing isn’t it. 45 years later and we still can’t define what Medical Equipment we as HTM technicians and managers are responsible for. It seemed pretty ludicrous when I attended my first SMDA briefing that they were worried about tongue depressors and cotton swabs to high-end medical devices. Of course, it shouldn’t be surprising since FDA and CMS are involved.

]]>
By: Rick Schrenker https://24x7mag.com/maintenance-strategies/alternative-equipment-maintenance/prevailing-attitudes/defining-medical-equipment/#comment-309969 Tue, 21 May 2019 16:00:43 +0000 http://www.24x7mag.com/?p=52547#comment-309969 I get the significance of the business issues represented in the article, but it continues to seem to me that the field is always in reactive mode to regulatory requirements that are reactive to industry-driven changes. When it comes to safety, this seems backwards to me. I suggest that HTM reflect on that.

And I already know the comeback: “When you’re up to your ears in alligators, it’s difficult to attend to draining the swamp”. I’ll still suggest HTM leadership look at some of the safety engineering models being used for more complex systems.

A set of such models that have earned a lot of respect across many domains are laid out in Nancy Leveson’s “Engineering a Safer World” , a PDF for which can be found at https://mitpress.mit.edu/books/engineering-safer-world .

If you read nothing else from the book, at least read the first chapter, “Why Do we Need Something Different?” It’s only three pages long. Humor me. Read them.

If you then want to go further, jump right into chapter two, “Questioning the Foundation of Traditional Safety Engineering”. Forewarned: It does a pretty good job of challenging the adequacy of the Domino and Swiss Cheese models to model accidents in complex systems. It’s a much longer chapter, but a quick summary can be found in Table 2.1 on page 57, “The basis for a new foundation for safety engineering”.

Read whatever you want after that …

The models that have derived from Leveson’s work can be rather complex, and applying them to systems under the control of HTM may not always, or even generally, worth the expense. But other models exist, e.g., assurance cases, lightweight versions of which can be developed (and which Leveson has been known to criticize; this remains a developing field).

Is there a role and/or place within HTM to be aware of the palette of options for risk management? Can HTM respond with critiques grounded in formal analysis to arguably inconsistent and/or incoherent challenges from regulators like the ones laid out in this article? Or is the field destined to play a never ending game of regulatory Whack-A-Mole governed by 20th century perspectives on the nature of safe systems?

]]>
By: Matt Baretich https://24x7mag.com/maintenance-strategies/alternative-equipment-maintenance/prevailing-attitudes/defining-medical-equipment/#comment-309910 Mon, 20 May 2019 15:30:20 +0000 http://www.24x7mag.com/?p=52547#comment-309910 This is an important commentary. You’d think we would have a solid working definition for medical devices and medical equipment. I have no objection to HTM programs covering a wide variety of equipment — that’s a business decision — but when it comes to regulatory and standards compliance, we need clarity. This is another opportunity for the HTM community to develop a consensus and work with the regulators to implement it.

]]>