FDA initiated a new effort to make infusion pumps, medical devices that deliver fluids including drugs, safer and more accurate. The initiative shows the attention that FDA is paying to patient safety. It includes a new draft guidance document released for comment. There have been a number of articles commenting about the infusion pumps that refer to “requirements” being issued by FDA. An example is from Medpage Today. There is a link at the bottom of the post to their article. However, this isn’t exactly the case. A “draft guidance document” is basically a preliminary recommendation. FDA is not issuing a “proposed rule” that would become a regulation that FDA can actually enforce. Please see the link to the Blog Compliance Zen at the bottom of this post that also discusses this issue.
This specific draft guidance document does in fact reference medical device regulations. However, it manages to use the words “recommend” and “must” (as in requirement) in the same paragraph describing information needed by FDA to evaluate the medical device:“We recommend you identify your device by the regulation and product code described in Section 3, Scope. You must provide information on how your device is similar to and/or different from other products of comparable type in commercial distribution, accompanied by data to support the statement, as required by 21 CFR 807.87(f). Side by side comparisons, whenever possible, are desirable.”
These are some of the issues involved with developing an “Artificial Pancreas” that the blog has discussed in previous posts:
For hospitalized patients, diabetics, and those with chronic pain this isn’t a moot point. The question of infusion pump safety can quite literally be a question of life or death.Is this the best approach? Will an infusion pump manufacturer need to follow this recommendation? Or will it lead to confusion on what is actually required and allow inadequate descriptions of the infusion pumps in a medical device 510(k) application. The 510(k) application does not carry the same extensive requirements as an investigational device exemption (IDE) application.
There are a number of things that can go wrong with infusion pumps. Many are controlled with software. FDA issued these comments about potential software problems:
“Unfortunately, in some cases, the software does “go wrong” and compromises patient safety. Because software is inevitably complex, abstract, and intangible, design errors can be difficult to detect. Users and patients should expect infusion pump software to be free from errors. The occurrence of a software error should be a highly unusual event.”I am glad that FDA is giving attention to the issue of infusion pumps. There is a good deal of information besides the draft guidance document that will benefit consumers who need to pay attention to infusion pumps. Again, I notice that FDA begins a major consumer protection initiative on a Friday, when it will receive the least attention. They did the same thing in announcing issues with Simvastatin (see previous post). FDA has also decided to take on this issue with a guidance document, not a regulation. Many of FDA’s regulations are antiquated and in serious need of updating. What to do about software and computer validation is certainly one of the issues that FDA needs to take on.
Part 11- Electronic Records; Electronic Signatures, has been in limbo since 2003. Part 312, the investigational new drug (IND) regulations haven’t had a major review since the 1980s. And the medical device regulations in Part 812 and 814 have received substantial public criticism.
Public health initiatives are a very good thing. Sometimes, however, you need a regulation that can be enforced.
UPDATE: Here is a link to Compliance Zen that has an excellent post by John Avellanet on “Regulation by Guidance” that discusss this issue. Compliance Zen was recently selected as one of the top 50 blogs for biotech students (see Blogroll).
Here is the article from Medpage Today
UPDATE: You can now “Like” the Blog on Facebook. They no longer have fans, which I think is an improvement: