Looking back over the week, one of the events of note was the issuance of an alert by FDA that warned contact lens wearers of the possibility of fusarium keratitis, a fungal infection that can occur in the eye and cause serious damage. The FDA has set up a separate hot topic page that overviews and updates the current situation complete with links to get more information about the condition, report an adverse event, advice for patients and more. It is very thorough and complete.
The manufacturer at the center of the issue is Bausch & Lomb and their site has also been updated to reflect the most recent information. They also took out full page advertisements in major daily newspapers this weekend.
The incident made me think about the key steps in any medical product crisis. I’m not evaluating Bausch & Lomb’s response in doing so, I’m merely providing my own approach. (No outsider can effectively evaluate the actions being taken in an on-going crisis because all of the facts are not at one’s disposal.) Here’s my checklist.
- The minute you learn of a crisis, you are behind the curve. Your immediate communications objective is to get ahead of it.
- Get outside help. No matter how well-intentioned you are, your judgments are likely to be clouded by your business interests. Outsiders are there to clear away the fog and help you make informed decisions.
- If there is a problem with a product, move quickly to understand the problem and its ramifications.
- Until you speak, the environment is probably being informed more by rumor and innuendo than by fact. It is essential to create a concise checklist of the facts – those already well known and those that are obscure and need to be known. To that end, take a 360 degree evaluation of the environment and assess the accuracy of what is being said versus the reality of the situation. Look at the gaps and decide the best way to address those gaps.
- Once you know the gaps, separate them into two camps – those about which you can do something and those about which you can’t. For those about which you can do something, prioritize them and match them to your available resources.
- Do not try to avoid the bad news. Get it out there and then very clearly state what the problem is, state what it is not. Clarify the environment with the facts.
- Assess who your allies, their credibility, their willingness to help and the best way to utilize them. Assess any foes.
- Communicate, both directly and through credible third parties three key elements: (i) what you have done since you found out about the problem; (ii) what you are currently doing about the problem, and (iii) what you are going to do in the future.
- To the extent you can, use facts, not opinion to make a case.
- Do not waste time – the more time that goes by, the more work you have to do to inform the environment.
Manufacturers of medical products need to understand that they are operating in a time when public opinion of the industry is running pretty low. That puts all the more onus on a company during a crisis to move quickly, with transparency, with the facts, and with good help.