By Binseng Wang, ScD, CCE; Matthew Baretich, PE, PhD, CCE; and Tim Ritter, CBET, CCE

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 In the November 2012 “Soapbox,” Eliezer Kotapuri, PEng, CCE, presented several thought-provoking arguments in favor of the Interpretive Guidelines revised by CMS in December 2011. He claimed that, “There are advantages this directive may bring to the clinical engineering field,” and this directive “seems to have the right potential to revolutionize the clinical engineering field … ” Since the increase in costs nationwide has been estimated in the range of $1 to $5 billion per year, we carefully examine his arguments here so readers can decide whether there are benefits to be derived from such a massive investment.

Underbidding: Kotapuri stated that the directive will “breed consistency and continuity” and force everyone to “adhere to set standards,” thus thwarting underbidding and wanton cost cutting. This statement ignores more than 30 years of experience with the accreditation practices of both The Joint Commission (TJC) and the American Osteopathic Association (AOA). In fact, over this period AOA followed verbatim the prior CMS mandate of maintaining equipment per original equipment manufacturer (OEM) recommendations, while TJC gradually allowed hospitals to determine maintenance schedules and procedures. Yet, there is no evidence that hospitals accredited by AOA are safer in terms of equipment maintenance than those by TJC. A recent analysis of TJC 1999-2011 sentinel event data concluded that maintenance omission would, in the worst case, cause 0.14 to 0.74 events in 2011, or .00011 to .0006 per million equipment uses.1

Data collection, accuracy, and quality of data: Kotapuri argues that, “Hospitals will be forced to collect/review data before making decisions to alter any maintenance schedules for nonlife support equipment,” and collect accurate inventory and service history data. In the first meeting held with TJC representatives, CMS officials clarified that hospitals do not have to rely only on their own data but can use data provided by similar organizations elsewhere. So data collection and review will not have to be better everywhere, but only at certain hospitals used as reference. This is analogous to well-established evidence-based medicine practices that allow physicians to base patient treatments on existing clinical trial data instead of conducting new trials on every single patient.

Critical equipment: Kotapuri states, “This directive will force hospitals and their clinical engineering departments, internal or external, to come up with a list of critical equipment.” The benefit of having such a list is unclear, as a maintenance strategy alone and does not ensure reliability and safety.2

Capital acquisition: Kotapuri states that the increase in maintenance costs will “discourage hospitals from buying more or extra equipment, ‘just in case.’ ” This belief ignores the fact that total clinical engineering expense in any hospital is only about 1% of the total hospital operating expense.3 The only realistic deterrent of excessive equipment purchases is the reduction of reimbursements for unnecessary procedures and underutilized equipment.

OEM work: Kotapuri argues that the CMS directive will prompt clinical engineering staff to “more frequently question and scrutinize the work performed by OEM service technicians.” Other than verifying that OEMs perform scheduled maintenance at their recommended frequency, it is impractical to monitor closely how well they follow their maintenance procedures. Many OEMs decline to provide service manuals that allow such detailed monitoring. And, this will require even more clinical engineering staff time, over and above the workload increase mandated by the directive. If clinical engineering staff are proficient to scrutinize OEM service, why is it necessary to pay the OEM to perform this service in the first place?

OEM protocols: Kotapuri states that the directive will cause the OEMs to “be questioned at greater lengths about the PM schedules and procedures before receiving a 510(k) clearance.” Actually, the FDA does not require the submission of service documentation in premarket approval (PMA),4 and only “proposed directions for use” are required for premarket notification 510(k).5 While service is covered in the Quality Systems regulation (21 CFR 820), it is scrutinized only when the OEM is audited or a high number of patient incidents suggest inadequate maintenance. The public debates that followed the FDA’s initial attempt to regulate equipment servicers in 1997 (62 FR 67011) convinced the FDA that maintenance omission is extremely rare and does not warrant further regulatory scrutiny. While some OEMs do occasionally revise their service manuals, it is not a FDA requirement or a common practice. 

We are, therefore, hard pressed to find any silver lining in the CMS directive, especially considering the undisputable fact that all health care organizations are being forced to become more efficient and productive due to the continual decrease of reimbursements and increase of patient demand. The reaction of the clinical engineering community is a genuine concern for wasting precious, limited resources without any evidence of the need or benefits of the directive. The lack of cohesiveness and constant debates on maintenance strategy are misunderstood by Kotapuri as a sign of weakness, instead of a true demonstration of the community’s pursuit of continual improvement for the benefit of our clinical users and safety of the patients. 24×7 Soapbox Column, April 2013

Binseng Wang, ScD, CCE; Matthew Baretich, PE, PhD, CCE; and Tim Ritter, CBET, CCE. The views expressed in this article are those of the authors and do not represent the views of their employers. For more information, contact [email protected].


1. Wang B, Rui T, Balar S. An estimate of patient incidents caused by medical equipment maintenance omissions. Biomed Instrum Technol. 2013;47(1):84-91. Paper presented at: AAMI Annual Conference; June 2-4, 2012; Charlotte, NC.

2. Wang B. What is critical equipment, and how should it be maintained? 24×7. 2012;17(8):54.

3. Wang B, Rui T, Fedele J, et al. Clinical engineering productivity and staffing revisited: How should it be measured and how can it be used? J Clin Eng. 2012;37:135-145.

4. US Food and Drug Administration. Medical Devices. PMA Application Contents.Accessed March 14, 2013. 

5. US Food and Drug Administration. Medical Devices. How to Prepare a Traditional 510(k). Accessed March 14, 2013.