The healthcare industry faces more regulations each year and a more aggressive enforcement environment. Healthcare technology management (HTM) services enforce their own requirements with the vendors they partner with. Because of the broad scope of services provided by HTM departments and the evolution of clinical technologies, compliance issues can flare up in minutes in the HTM space. This did not seem like such a big deal in the past—it was OK to deal with issues in a reactive manner. Not anymore!
HTM services exert great influence on the availability of and access to patient care services, and are therefore highly visible to executive and senior leadership. That alone is a major reason to establish an HTM compliance program. Taking a 30,000-foot overview, the HTM compliance program offers three main benefits:
- It provides a well-documented, current, and accurate program that could be referred to at any time when federal, state, or other accreditation inspection agency knocks on your door.
- It keeps HTM services and its employees in compliance and avoids trouble.
- It allows services to operate smoothly and reasonably when responding to changes in the industry and regulatory environment.
Developing an HTM compliance program is not a one-time act! Even when you have an established program, the challenges continue. You will be looking for ways to reenergize the program and asking yourself if your program is effective. Before establishing an HTM compliance program, have your leadership team decide on the degree of accountability, resources, alternatives, escalation criteria, and services encompassed in the program. As you start with this new development, make sure key details of the program are not missed, such as:
- Controls that prevent and detect wrongdoing with medical device management.
- Processes that manage the risk of noncompliance, are proactive, and react appropriately to problems when they occur.
- Assurances to internal (senior and executive leadership) and external (regulators) stakeholders that the department is doing what it can to manage the risk.
- Educating the HTM employee base to know what they need to do in their jobs to avoid compliance problems.
I believe that a dedicated HTM compliance professional is critical for this effort. For those who disagree, consider this—do your directors, supervisors, lead clinical engineers, or even corporate compliance professionals have the time, resources, expertise, and patience to do what this role warrants? Maybe or maybe not. Wouldn’t it be nice to have someone who will oversee aspects of the program that worry your leadership?
Here are some of the initiatives that a dedicated HTM compliance professional may work on:
- Policies, procedures, and guidance document management
- Purchasing and service contract management
- Medical device recalls and alerts management
- Medical device-related events and incidents management
- Medical device cybersecurity management
- Standardization of medical devices across the system (for an integrated delivery network or a large health system)
- HTM internal audit and periodic assessments
- Education and awareness of risks in medical device management
The HTM compliance professional, in my opinion, must be a clinical engineer. Better yet, a certified clinical engineer (CCE) who is well-versed with the broad range of HTM services, regulations that govern medical device management, and fosters commonality in communication between the information technology, HTM, supply chain, corporate compliance, legal, and privacy worlds. Even better if this person can speak the same language as organizational compliance, legal, and privacy. This is hard to get in one person, but it is not impossible! No one is going to be shovel-ready for this role. It takes education and training and comes with a wealth of experience on wide variety of projects in the medical device landscape.
We run into challenges with any new development. As an HTM professional working in compliance, I have learned that there can be some tough obstacles to an effective compliance program implementation, such as a lack of buy-in from management, too few resources, communications issues, resistance to change, juggling dual roles for the compliance professional, and more. It is essential that these obstacles are visible to the leadership teams and there is a plan in place to overcome them.
I wrote this blog post to provide readers with a brief overview of what an HTM compliance program may seem like. Due to multiple requests at industry events, I will also be sharing key insights for implementation in a future article in BI&T.
Priyanka Upendra is a clinical engineering compliance manager at Intermountain Healthcare in Salt Lake City, UT. She is an active member of AAMI, the National Health Information Sharing and Analysis Center, and the American College of Clinical Engineering.