Medical Device Recalls - How Laboratories Must Respond

Julie McDowell:

The laboratory director has a legal obligation to follow up with all recalls that impact any test components or blood components used in the laboratory. While blood bankers are already on high alert for all blood component recalls, the impact from a medical device recall can be just as serious as a blood component recall. Per the CAP Laboratory General Checklist, GEN.20340, the laboratory manages notifications from vendors of defects, or issues with reagents, supplies, instruments, equipment, or software that may affect patient care and, or client services. For example, there was a recent recall on waived blood lead testing lot numbers. The recall was classified as level 1 because the use of the impacted lot numbers might have led to falsely low lead results. In this CAPcast, Dr. Matthew Krasowski, Chair of the CAP Toxicology Committee discusses the laboratory's role in medical device recall, such as this recent incident, and how both CAP-accredited laboratories and inspectors should respond to recalls. Dr. Krasowski, can we start with some background on why it's so important for laboratories not to overlook a medical device recall, such as the recent one involving waived blood lead tests?

Dr. Matthew Krasowski:

Yeah, certainly. So I think it's first helpful to just do a brief overview of the risk definitions to identify where Level 1 fits into the scheme. So according to the FDA website, when the FDA learns of a company's correction or removal action, it reviews the strategy the company proposes to address the problem. Addresses the health hazard presented by the product, determines if the problem violates FDA law, are there any potential violations of FDA requirements. And if appropriate, assigns the recall or classification, which is either 1, 2, or 3 to indicate the relative degree of risk.

A risk Level of 1 is the most serious and it's defined as a situation when there is a reasonable chance that the product can cause serious health problems or death. This is where the lead testing recall fell in. A risk Level of 2 is defined as a situation where a product may cause a temporary or reversible health problem, or where there is a slight chance it will cause serious health problems or death. And then lastly, the lowest level will be a risk Level of 3 is the least serious and is defined as a situation where a product is not likely to cause any health problem or death. In the case of the lead testing recall, there's a possibility that you'd have erroneous results and that you might not recognize lead poisoning for example, and that could lead to medical problems. So that one was classified a risk Level of 1.

Julie McDowell:

Now, how do laboratories know when there's a recall?

Dr. Matthew Krasowski:

So recall notices are issued directly for manufacturers, typically in the form of a conspicuously marked first-class letter to impacted customers. It will generally have some language like urgent medical device recall. The FDA also posts summaries of the information about the most serious medical device recalls in its medical device recall database. You can find that on the fda.gov website under medical device recalls. Laboratories, laboratory directors may also find out about this through electronic notifications as well, but the official recall notice is typically in a first-class letter.

Julie McDowell:

Now I'd like to talk a little bit about laboratory response. How should laboratories respond to recall?

Dr. Matthew Krasowski:

So laboratories should aim to respond in a timely manner. The notice that the manufacturer sends will contain the reason for the recall, the risk to health, and the actions to be taken by the customer, or user. For example, it may direct to discontinued use of the product to retest impacted patients. The challenge is that there's a fair amount of extrapolation with these instructions. For example, if the manufacturer tells you to retest impacted patients, you need to have a mechanism for identifying the patients that would have been impacted. You need to be able to contact those patient providers and then have a method for retesting. So this may involve multidisciplinary collaboration within the institution.

Julie McDowell:

And how should all this be documented?

Dr. Matthew Krasowski:

So laboratories must have a written policy that addresses who receives recall notices, and how they're handled. Actions after recall must always be documented. If your laboratory received a recall notice but never had any of the affected products or lots on the recall, then you must still clearly document that you confirmed your laboratory was not impacted by the specific recall. If your laboratory did have inventory of impacted products, then you must document how you verified your patient results if applicable, and how you notified providers if applicable or took other actions as deemed necessary.

Julie McDowell:

Let's talk a little bit about how inspectors should respond. What questions do they need to be asking?

Dr. Matthew Krasowski:

So first and foremost, during inspection, inspectors should request and review the written policy for the handling of recalls. Additionally, inspectors should ask the following questions, have you had any recalls since the last inspection? If so, what actions were taken? When does the investigation need to be completed, if it's not completed already. Where is the documentation on this? How are recalls incorporated into non-conforming events documentation, and are recalls considered in the quality management system or QMS? If alternative products or alternative means of testing were implemented because of recall, how were those validated and implemented? And then how are the staff educated about handling recall notifications? So inspectors should aim to look at the policy for addresses, how recalls are handled, records of any recalls received, and then documentation of actions taken for a specific recall.

Julie McDowell:

Finally, Dr. Krasowski, what should inspectors cite and when?

Dr. Matthew Krasowski:

So in the realm of transfusion medicine, the transfusion medicine checklist has three checklist items that are specific to recalls. So those requirements are in TRM.42120, that's the blood component recall and quarantine, and TRM.42135, that's the blood supplier notifications for handling recalls of products, and TRM.42170 for notification and counseling if a recalled product was already transfused to patients. However, the focus of this podcast is on medical device recall notifications. In addition to GEN.20340 a notifications from vendors, there are two other laboratory general requirements that may be applicable when investigating a recall, GEN.20310 is investigation of non-conforming events and GEN.20318 is corrective and preventive action.

In general, the CAP discourages what might be known as double dips on deficiencies. Unless there's a very good reason to cite multiple deficiencies for the same issue. There is usually one that would be the most appropriate and others that might be less so to the specific recall. If the laboratory does not have any policy or process related to recalls, the inspector should cite GEN.20340. If the laboratory has a policy, but on investigation and the inspection, you don't have documentation of a thorough investigation, the lab should cite GEN.20310. If the lab has a policy and does a thorough investigation but does not implement or document any specific corrective actions, the inspector should cite GEN.20318.

Julie McDowell:

Great. Well, thank you Dr. Krasowski. For more information, please visit the laboratory improvement section of cap.org.

Thank you for listening to this CAPcast. To listen to our other episodes, find us on the MyCAP app, available for CAP members, as well as SoundCloud, Apple Podcasts, Stitcher, Google Podcasts, Spotify, and Amazon Music. Just search for CAPcast from the College of American Pathologists on these apps. Once you find our podcast, be sure to click the subscribe button so you don't miss new CAPCast episodes./

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