By Larry Hertzler, Senior Vice President for Clinical Engineering and Special Projects

February 6, 2020

Recently, there has been a push to further regulate the Healthcare Technology Management industry. This push is based on claims by certain organizations that some Independent Service Providers (ISOs) provide inferior and unsafe service quality.    

In September of 2019, The Alliance for Quality Medical Device Servicing (the Alliance) submitted feedback to the Federal Trade Commission after attending a workshop on the Right to Repair debate called “Nixing the Fix”. The feedback provided included proposed industry naming conventions to provide clarity around existing confusion. Some additional thoughts on those conventions are presented here. 

Regulatory requirements are identical for any business providing a comprehensive clinical engineering program. Since 1990, the Safe Medical Devices Act (21 CFR 803.32 (c)) requires reporting all incidents in which a medical device or user error may have caused or contributed to the serious illness, injury or death of a patient. If the hospital or health system receives payment from federally funded Medicare or Medicaid programs, it must be accredited through The Joint Commission (TJC), DNV or Healthcare Facilities Accreditation Program (HFAP), which are all governed by The Centers for Medicare and Medicaid Services (CMS)Because each hospital or health system is regulated, all clinical engineering service providers to these organizations must comply with the same regulations. This includes Self-Op programs as well as ISOs and OEMs (Original Equipment Manufacturerswhen they’re providing clinical engineering programs. And while a Food and Drug Administration (FDA) report¹ concluded there was insufficient data to indicate that safety issues exist as a result of using an ISO for preventative maintenance and repair of medical equipment, debate continues.   

What is clear, however, is that confusion exists surrounding the various servicing entities within this industry and the terminology used to define each.  From the name of the profession to the names of functions and departments, a variety of terms are used inconsistently. For example, terms for servicing entities are used interchangeably, making it difficult to understand which is being referenced.  

With this in mind, the Alliance included naming conventions in its letter to the FTC² based on three classifications of servicing entities. 

Servicing Entity Classifications 

The primary three categories of servicing entities are Original Equipment Manufacturers (OEMs), Internal Hospital Employees (Self-Op), and Independent Service Organizations (ISOs). Most clinical engineering programs use a combination of these three to service a hospital/system. 

OEM: Most OEMs only service their own equipment and are governed by FDA 21 CFR. OEMs that service other OEM equipment are technically considered an ISO with regard to that service. A few of these OEMs also provide clinical engineering programs. To more easily identify each type, OEMs may be divided into two groups: 1) OEM when providing service on their own equipment, and 2) OEMmvs (OEM Multi-Vendor Service) when providing clinical engineering programs. 

Self-Op: These programs vary as to which services are provided by a hospital or health system’s employees and which are provided by ISOs or OEMs. All three must follow the same regulatory requirements. As hospital employees, they’re the “hospital” with regard to the CMS, TJC and DNV GL Healthcare requirements.  

ISO: This diverse group includes companies that service only a single brand or type of deviceothers that service many brands and types of devices, and some providing clinical engineering programs. ISOs that provide clinical engineering programs are subject to the same regulations as the Self-Op programs likely having legal agreements with hospitals/systems to operate as their agents.  

Proposed Naming Conventions 

Based on the above definitions of industry service entities, these standardized naming conventions are proposed 

Self-Op for a healthcare delivery organization with its own staff operating a clinical engineering program. 

OEM for a company that’s providing service on its own equipment. 

OEMmvs for an OEM that’s providing comprehensive clinical engineering services. 

ISOpgm³ (ISO Program) for an independent organization that’s providing clinical engineering programs. 

ISO for an ISO that provides medical equipment service but not clinical engineering programs. 

Conclusion 

As we join many within the industry looking to dispel misconceptions surrounding the quality and safety of services provided, we believe the use of consistent references to the provider types will bring clarity to the conversation. We look forward to furthering this conversation and welcome your comments and suggestions on the proposed naming conventions. You can submit your feedback directly to us at info@trimedx.com. 

¹FDA FDARA Report 

²The Alliance for Quality Medical Device Servicing – FTC Response on Right to Repair – 13 Sep 2019 

³ISO Rationale: As more ISOs provide limited services than clinical engineering programs, it seems practical for ISOs offering these programs to add “pgm” to the ISO designation. It also makes sense that a company would prefer to add “pgm” to its designation rather than “limited.”