Avinash Konkani: Improving Manufacturers’ Response Time in Correcting Problems

As healthcare technology management (HTM) professionals, we understand how challenging it is to manage medical device recalls, perform field safety correction, and advise affected customers. All three of these notifications (i.e., recalls, field safety correction, customer advisory) from manufacturers are categorized as “urgent.” We follow up with internal customers about these notifications, undergo the required short-term solution, and then wait for the manufacturer’s response describing the action needed to actually correct the problem.

The response time from manufacturers in providing guidance to correct the problem can vary from weeks to months. Such lengthy response times do not seem to match up with the level of urgency stated in the original notification. Even though we have taken a temporary action (education to raise awareness of the problem, in most cases), this temporary action is not strong enough to sustain us for weeks or months.

Manufacturers need to work on improving their response times in correcting problems. After they correct the problem, they should send the completion report to us for documentation, with proper reference to the recall/safety correction/advisory addressed.

What bothers me considerably is that sometimes, we see that we have more than one recall on the same model and make of the device, but we continue using the device for which a planned corrective action is forthcoming. When a medical device has yet-to-be-revealed deficiencies, how safe can it be to continue using?

In recent years, we see more software-related recalls and safety advisories that are mostly “invisible” deficiencies of the device and that the manufacturer will correct with a software upgrade. Some are corrected remotely, while others require intervention by the on-site field service technician. How well are these recalls managed by manufacturers and communicated to us?

I encourage the HTM community to share their thoughts on this topic in the comments section below.

Avinash Konkani, PhD, AHFP, is senior clinical engineer at the University of Virginia Health System in Charlottesville, VA, and a member of the BI&T Editorial Board.

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2 Comments on “Avinash Konkani: Improving Manufacturers’ Response Time in Correcting Problems”

  1. Alan Lipschultz Says:

    I have been involved as an expert witness in several cases where the delay in a fix reaching the field has been a crucial issue. This vantage point has also enabled me to also understand the manufacturers’ internal debates regarding recalls for reported problems. Based on my experiences, I think most manufacturers do try to do the right thing. The FDA however has recognized that the overall system needs improvement. If you’ve not already read it, I suggest reading AAMI’s 2015 white paper, “Risk Principles for Postmarket Medical Devices” and FDA’s 2016 Guidance Document for manufacturers, “Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions.”

    The first significant delay, especially for rare non-obvious problems, is that it takes time to gather enough data “dots” before the manufacturer can “connect the dots” to even suspect that there is a problem. One of the problems faced by manufacturers is that many problems never get reported to the manufacturer, and even if they are, often the data provided is ambiguous. Often hospitals report a problem, but never return the problem device to the manufacturer for a failure analysis.

    Some manufacturers have a more robust “listening” process and others to look for patterns in the problem reports coming into them. Increasing the volume of well-documented reports to the manufacturer will help. In my experience, HTM can also play a roll in “pushing” the manufacturer, especially if the problem is happening frequently enough within one organization to be a discernible pattern within that organization. When a manufacturer tells you “we’re not having any other organization report similar problems”, challenge the manufacturer to send an engineer to your organization to work with HTM to try and get to the root of the problem. I have seen times where the root problem did end up being something unique to the reporting hospital because of process or the use a device from another manufacturer interacting with the “problem device.” It takes patience to figure out these patterns, but the manufacturer should be willing to work with you.

    Once the manufacturer has recognized there is a problem, there will be another delay for the manufacturer to figure out the root issue causing the problem, and another delay to figure out what is the appropriate action. The FDA’s 2016 guidance document should be part of their internal discussion about the best way to respond. As an HTM organization who may be a major customer of the manufacturer, don’t be afraid to ask their permission for your hospital’s clinicians to be part of that internal debate as to communicate the issue to all of their customers. In order to encourage the manufacturer to accept the help from your organization, offer to sign appropriate non-disclosure forms; it would not be appropriate for your clinicians to be talking to their peers who are not part of the non-disclosure agreement.

    Reply

  2. William A Hyman Says:

    Even before HTM hears about it, there is the issue of how long did the manufacturer know about the problem before reaching a decision to act, and then move that action to the point of notification. Problem identification might involve an accumulation of reports (above some “acceptable” level), opening an investigation (CAPA), moving that investigation along, finding an answer, and then creating a fix. And when do they stop selling the suspect device?

    Reply

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