Breaking Down 2013’s Top Health Tech Hazards: A Chat with ECRI Institute’s James P. Keller

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In 1964, a Philadelphia boy died as a result of a poorly preserved defibrillator. The event spawned the Emergency Care Research Institute, or ECRI, a non-profit organization that evaluates the safety of medical procedures, processes, drugs, products and systems via applied scientific research methods.

We believe ECRI’s thought leadership is imperative to the way we conceive of certain technologies within the health IT industry. Case in point: James P. Keller, Jr., ECRI’s VP of Health Technology Evaluation and Safety, sat down with us last year to discuss the annual “Top 10 Health Technology Hazards” list, detailing why data loss was excluded from the final group despite ranking prominently in 2011.

Power Your Practice brought Mr. Keller back for a second round this year. We discuss why patient/data mismatches in EHRs and interoperability rank as threats in 2013, and outline preventive measures physicians and their practices can take.

1. What criteria do you use to compile each year’s list? What kind of research is involved?

Each of the ten hazards on our list met one or more of the following criteria:

  • It can harm or kill someone.
  • It has frequently occurred.
  • It can affect a large number of individuals.
  • It’s had a high profile, for example, from widespread coverage in the news.

Another factor that determined if an item made our list is that there must be clear steps for hospitals to take now to minimize the risk.

Some of the research we used to help come up with our Top Ten list includes (1) review and analysis of problem reports submitted to ECRI Institute and other organizations like FDA, (2) review of our technology-related accident investigation files, (3) review of technology-related concerns covered in the clinical literature and lay press, (4) discussions among our clinical and technical experts and with those from other organizations, and (5) monitoring trends for how health technology is being used.

2. What factors come into play with patient/data mismatches in EHRs? What are some of the immediate dangers?

ECRI Institute’s research and testing show that patient/data association errors with health IT systems do occur.  With the rapid adoption of health IT systems from the government’s meaningful use-related incentives, there’s a significant risk that there will be many more of these errors.

3. What are some tips for addressing said dangers?

Carefully consider how all the connected technologies facilitate placing the right patient data into the right record.  Options may include choosing a patient from a picklist or scanning the bar code on a patient’s wristband.

4. Preventive measures? 

Fully test IT systems before installation or after significant software changes.  Include test procedures that look for patient and data disassociation errors.

5. Why is interoperability with medical devices and health IT systems such a huge hurdle for the industry? 

Interoperability between medical devices and health IT systems adds a new level of complexity to these systems so that they are effectively interdependent.  Without connectivity, a device problem can only affect the device itself.  With connectivity, the problem can potentially cascade to many devices and systems.

6. Can vendors integrate their EHRs by following, say, the “network of networks” model used by the banking industry? Would that increase security? 

The integration definitely needs to follow the network of networks model.  And if done right, that should increase security.  However, the devil is in the details and there is no plug-and-play way to apply the network of network principles for hospital systems today.  A good way to move in that direction though is for hospitals to adopt the IEC 80001 standard on the Application of risk management for IT networks incorporating medical devices.

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Breaking Down 2013’s Top Health Tech Hazards: A Chat with ECRI Institute’s James P. Keller