Total Recall: Med Device Makers Protected & Your Recall Process Primer

A top story this morning is the Supreme Court ruling shielding medical device makers from litigation in the course of a recall. ("Supreme Court Shields Medical Device Makers").

In an 8-1 ruling, the Court decided medical device manufacturers with FDA approved devices will be immune from personal injury litigation. If a device is made improperly (violates FDA specs), individuals may still bring suit.

This litigation will have lasting impacts on our industry, but navigating exactly what will happen, and how hospitals should include recall procedures in strategic planning, is a bit tricky.

How do the long term effects of this ruling, combined with recent Heparin syringe and balloon catheters, affect hospitals?

Patients, insurance firms, and hospitals will be left, once again, holding the tab...for removal recalls, patients will come back to the hospital for replacement of faulty parts, which requires another surgery and compounds their risk.

Duplicate surgeries due to med part recalls also, of course, significantly compounds the costs of original procedures.

Must hospitals start forecasting a certain amount of recalls per year and projecting costs accordingly? Should future budgets include extra OR time, plus additional surgical, scrub nurse, and anesthesiologist fees to cushion the bottom line in case of a massive recall?

But I'm getting ahead of myself -
let's take a look at how recalls actually work.

According to the FDA, a recall can encompass different types of actions, including:

  • Inspecting the device for problems
  • Repairing the device
  • Adjusting settings on the device
  • Re-labeling the device
  • Destroying device
  • Notifying patients of a problem
  • Monitoring patients for health issues

To see recalls for the past 5 years or so, click here to access the FDA Center for Devices and Radiological Health Medical Device Recalls List (Class I Recalls).

On this list, the FDA posts "
information about the most serious medical device recalls. These products are on the list because there is a reasonable chance that they could cause serious health problems or death."

Recalls are placed into 3 categories, according to "potential risk to public health: "

Class I = High risk
Class II = Less serious risk
Class III = Low risk

A recall is either a call for "correction" or a call for the dreaded "removal." (From the FDA site):

Correction - Addresses a problem with a medical device in the place where it is used or sold.

Removal - Addresses a problem with a medical device by removing it from where it is used or sold.

Here is the action a medical device manufacturer issuing a Class I Recall must take, according to the FDA. Language has been pulled directly from their "how to" guide.

Please note the lack of tight guidelines about who is specifically responsible for contacting involved patients and paying for repair/replacement procedures.

"A Class I recall is the most serious type of recall. In a Class I recall, there is a reasonable chance that the product will cause serious health problems or death.

In a Class I recall, the company:

  • notifies their customers (i.e. distributors or vendors), and directs them to notify the intended recipients of the device (i.e. other vendors, hospitals, nursing homes, outpatient treatment facilities, doctors, or individual patients). The notification usually contains the name of the device being recalled, identifying lot or serial numbers, the reason for the recall, and instructions about how to correct, avoid, or minimize the problem. It should also provide a telephone number for questions related to the recall.
  • issues a press release to notify the public, if appropriate to minimize health consequences.

FDA may also issue its own press release or public health notice."

A separate list contains 'all' medical device recalls of FDA approved medical devices (including the less severe Class II and Class III recalls). You can search the database here.

This doesn't feel like very thorough coverage, and it isn't.

For medical device manufacturers, the FDA has published a more extensive "Guidance for Industry" brief (DOP: 11/3/2003), detailing what to do to set a recall in motion. It also details the exact responsibilities a medical device manufacturer holds in the instance of a recall, including how it must communicate with customers, i.e. hospitals and patients.

You should read it, especially if your title starts with a C or your professional license reads "MD." So should the hospital's legal eagle team. So should the Board. So should the marketing and communications department, the surgical director, etc.

With the FDA data above, hospital teams still need to take significant planning steps to determine how a recall will be handled and minimize its overall effects on patient care, while maximizing the benefits of services available to individual at-risk patients.

Food for thought:
  • How many recalls should executive teams reasonably predict? One a year for cardiac devices, one a year for ortho, one a year for 'other' med devices?
  • Have your leadership teams met to discuss what they feel the hospital's responsibility should be in a recall scenario? Remember this is an important ethical issue, and physicians & nurses will have strong and valuable input. You might also consider asking patients (trustees or interested volunteers) to weigh in.
  • Are your current quality control, Six Sigma, purchasing, and OR teams keeping track of the number of recalls that affect its patients annually and tracking this trend's impacts on the organization?
  • Does your organization have an FDA contact person responsible for tracking recalls? *Subscribing to the FDAs Class I recall list is an easy way to get started. In addition, this person should be in contact with the FDA Recall Coordinator for your state - find them here.
  • Is the position responsible for tracking recalls logically housed in the QCI department and has an action plan of internal communication and coordination been established that goes into effect when a recall is announced? (i.e. FDA Coordinator calls VP of Communications, CEO, who calls BOD Chair, etc.)
  • If your staff deems it a responsibility within the scope of your mission, who in your hospital is specifically responsible for contacting all patients identified as being at risk after a recall? (the treating physician? the surgeon? the patient services office?)
  • Is the hospital tracking how many patients affected by medical device recalls respond to notification and report to the hospital for device repair/replacement?
  • Will the hospital need to start tracking how many patients do NOT seek medical care following a recall but require a later procedure due to a faulty FDA-approved device?

The closest business case parallel I can think of is the automobile industry.

When a part for our Honda Accord is recalled, we receive a notice (addressed to us personally) and we take the car in to a licensed Honda dealer for repair/replacement.

This dealer has entered into an agreement with Honda that means they receive incentives for selling the brand, and can better cover the staff and facility costs associated with a recall.

But what about hospitals?

Our industry has not traditionally entered into exclusively 'licensed' deals with a single med maker or equipment provider - you don't see "Licensed Ogee Ortho Pain Pump Hospital" signs up in the lobbies of our finest hospitals, for example.

Med device makers don't control hospital branding the same way automobile manufacturers drive branding in the auto industry, thank goodness. Medical device makers don't 'own' hospitals - we aren't their exclusive dealerships.

We have tended to use devices our purchasing departments, surgical chiefs, and administrators select for utility, rather than to accelerate branding/marketing aims.

However, this doesn't mean some hospitals aren't already quietly negotiating licensed deals with medical device makers, as they do with insurance companies.

This also doesn't mean the opportunity to create such relationships may, in some instances, bring to bear a very attractive cost efficiency - if a hospital orders scalpels from only one provider for instance, or participates in a group purchasing plan like the PRIME program offered by the Maryland Hospital Association.

Imagine, for example, if your facility only purchased stents from one firm, and entered into a licensing agreement to provide their product exclusively.

This firm orders a recall. All the hospitals 'licensed' with this med device maker must call patients back and deal with the administrative, scheduling, cost, and communication challenges that significantly alter each affected individuals continuum of care.

All the hospitals who entered into an agreement with a competing maker can breathe easy - they're safe...this time.

It's the implications of escaping "this time" and the larger picture that's important for hospital administrators to consider.

More medical devices in play on the market means better quality of life for many, but also means hospital teams will face an increasing incidence of recalls.

As a patient, I'd like to know my hospital/surgical team is going to work harder to notify me of a recall that affects my health than my car dealer will when something in my Honda needs fixin'.

As a consultant, I'd like to know hospitals are proactively establishing procedures that they'll put into place in a recall situation.

As a future hospital administrator, I'd like to know if your hospital is entering into licensed agreements with medical device manufacturers that contractually details who bears the cost burden in case of a recall.

What is your team doing to get ready for an era of Total Recall?

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