Well, leave it to the FDA to come up with a new approach for inspecting medical device manufacturers (that is, new to the medical device industry). But, in fact the use of HACCP it is an old concept that was initially instituted by the FDA for the food industry in the early 1970s. Actually, the HACCP approach was originally used by NASA to assure that the Astronaut’s food supply would be safe. But, most recently the FDA had adopted this HACCP approach for the Seafood Industry, making it a regulation similar to the GMPs. Again, this was to provide some assurance for a safe supply of seafood products.

But, why is the FDA now looking to implement a policy, that was strictly used for the food industry, for the medical industry? If I am correct, I don’t think that these industries have anything in common? I can assure you that if you ever get a chance to attend a Seafood HACCP course you would learn that they have nothing in common. But, as you will see, the use of the HACCP approach could easily be applied to the manufacturing of medical devices.

Before going into the reasons behind the FDA evaluating this inspectional approach, having an understanding of HACCP would be appropriate.

HACCP is an acronym for Hazard Analysis and Critical Control Points. When used properly, the HACCP approached of evaluating your medical products and the production process could provide you some assurance that you have determine the hazards associated with the device and its processes as well as determining the critical control points and that you are able to control them in some manner.

HACCP is a preventive, not a reactive, management tool used to assure that the manufacturing process addresses all potential hazards of the device. HACCP is not a zero-risk system but is designed to minimize the risk of potential hazards.

There are seven principals to HACCP:

1. Conduct a hazard analysis and identify preventive measures. (Prepare a list of steps in the process where significant hazards occur and describe the preventive measures.)

2. Identify critical control points (CCP) in the process.

3. Establish critical limits for preventive measures associated with each CCP identified.

4. Monitor each CCP. (Establish procedures for using monitoring results to adjust the process and maintain control.)

5. Establish corrective actions to be taken when a critical limit deviation occurs.

6. Establish a record keeping system.

7. Establish verification procedures that the HACCP system is working correctly.

The basic use of this approach is to evaluate each step of your manufacturing process, from your receiving of components until distribution and determine if that process has a potential hazard to the finished device related to any one of these three areas: Biological, Chemical or Physical.

The HACCP guide, which was written for the Seafood Industry, but is presently being applied to the medical device industry, has forms used to perform the Hazard Analysis. Once you have determined your Critical Control Points (CCP) you then use the HACCP Plan form to look at each CCP, come up with the Critical Limits for each preventive measure, outline What – How – Frequency and Who will monitor these CCPs, define your Corrective Actions in the event that the Critical Limits are deviated from, how the information will be Recorded and finally how the CCP will be verified.

If you think about it any good medical device manufacturer has already performed this exercise in some form.

At a recent HACCP training course, held in Indianapolis by the FDA, mainly for the Seafood Industry, where HACCP is mandatory, there were several medical device manufacturer who were interested in learning more about this HACCP inspectional approach, its benefits and to hear more on why the FDA wants to implement this for the device industry.

Initially sitting in of this session with a bunch of fish processors was a real experience. The whole HACCP approach is geared to that industry. All the experiences and examples by the speakers concerned how to deal with seafood as it related to safety. The device people felt like a "fish out of water," if I could be so succinct.

But, then the attendees from the medical industry finally got a chance to breakout and meet together with the FDA representative. Here we learned how this HACCP approach was to be used to inspect medical companies. During the course we had to conduct a Hazard Analysis and out line a HACCP Plan. The example that was used was a manufacturer of low protein, non sterile, latex examination gloves. Once the plan was completed it was determined that there were only three CCPs for this operation. One could surmise from this exercise that it a company who made these type of gloves and if the operations was already in GMP compliance, it would not change the operations or record keeping system.

So what is the drawback to this system. Well if you decide to use this system, it would provide the FDA with a clear detailed map of where the critical control points of your operations are and what the company was doing to assure that these points were being monitored and what would be done in the event that these points were deviated from.

Whether that could be considered good or bad will have to be determined by each company.

Basically, the FDA feels that if a company was to used this approach of conducting a Hazard Analysis, come up with a HACCP plan on how they will control their Critical Control Points, then the FDA will key in on these points during future inspections. When the FDA investigator feels that the company is controlling these critical areas the inspection will be over. If done correctly and the FDA sticks to this policy of reviewing the CCP only, the inspectional time at the facilities could be reduced by more than half. That is the main reason for the FDA to look into this approach, to reduce the inspectional time and thus being able to use their staff more efficiently.

One has to remember that this system is not a stand alone system. In order to assure its success, HACCP must be built on a strong GMP program. If violations are found the FDA will fall back on the GMP regulations to take action. But, the main reason for this approach is that it will be used by the FDA to focus their attention on the parts of the process that are most likely to affect the safety of the product. By being allowed to do this the FDA would be able to forego all the unnecessary learning process involved with each inspection and key into the PLAN that would be supplied by the company.

Many questions were brought up by the medical device attendees that they feel the FDA has to address to be able to get their full support. Some of the more pertinent ones were:

• What is a Critical Control Point for a medical device?
• What would be the difference between a CCP and a Control Point (CP)?
• What would be the value to the company?
• Will HACCP be accepted by the EU now that many of the medical device companies are also ISO certified?
• Will the GMP be put aside during a HACCP inspection and if we take this approach how would we be sure that it would be followed by the agency?
• In that HACCP is safety related only, will the FDA inspect our changes for intended use also?
• Will complaints still be reviewed?
• Will the Hazard Analysis work sheet have to be shown to the FDA?
• Will a CCP disagreement with the Agency result in an FDA 483 point?
• Will this approach be mandatory or voluntary?
• How costly will it be to set up the HACCP plan?
• How many companies are already looking into this plan?
• Does the plan work to assure device safety?
• Who is on the FDA HACCP evaluation team?
• Will there be a written structure to the HACCP inspection i.e. the Design control regulations?
• WHY SHOULD WE DO THIS?

Not all these question could be answered. The FDA is in an evaluation mode trying to get volunteers from the industry to try this process. The companies that want to be part of this experiment would have to prepare a HACCP Plan, send that Plan to the FDA and they will audit the company to see how the plan worked. Once the FDA learns more about this process, how hard it would be for companies to address this program, and the problems associated with conducting the inspections, the FDA will then determine if they will make this a mandatory inspectional strategy or keep it voluntary.

Not all FDA’ers are leaning to this approach, though Dr. Burlington is. As a matter of fact there is another FDA inspectional approach that is being brought up from the recent past. It is call the SEVEN SUB-SYSTEMS. This was first brought up in the early 90’s and was supposed to be used for conducting inspections.

These Seven Sub-Systems are:

• Corrective and Preventative Actions
• Design Control
• Production & Process Controls
• Management Controls
• Documents, Records & Change Controls
• Facilities & Equipment Controls
• Material Controls

Basically, it would require a full FDA inspection to review all these areas. More information on this approach will be coming out of the FDA in the near future.

Will it or could it work, it will depend on several factors:

1. Will the industry see a real benefit to going through this exercise and using it?

2. Will the FDA keep their part of the bargain and actually reduce on site inspectional time?

3. Will providing the FDA with a detailed road map of your areas of concern be a potential time bomb?

4. Since you are already doing most of this in controlling your operations, what is the real concern of providing the FDA a road map if they will be able to travel it faster and stick to the designated routes?

Let me say this, on the whole the HACCP approach is one that is of great value to any company and should be used whether it is provided to the FDA or not. It makes you take a critical look at your operations and to determine what you will have to control and what you will be done in the event a failure occurs. But, can an industry that just went through the traumatic experience of dealing with the new GMP requirements including Design control now be expected to deal with a new FDA inspectional approach? I am not sure that this is a good time for the FDA come up with more changes, especially for the small medical device manufacturer.