Patient Safety, FDA Requirements and an Effective Recall Process

By Edwin Ross, BS, MS

Forhalf of the last decade (1995-2000), awareness has been heightened concerningpatient safety. Organizations such as Health Care Financing Administration (HCFA)and the Joint Commission on Accreditation of Healthcare Organizations (JCAHO)have added regulatory requirements and accreditation standards to protectpatients.

Recently another regulatory body, the FDA (Federal Drug Administration),announced that it would be conducting research concerning hospital practicesrelated to the reprocessing of single-use devices (SUDs). The main objective isto gather data about Class III Medical Devices that pose the highest potentialrisk for patients. 1

On their Reuse Web Site (www.fda.gov/reuse),the FDA states:

One of the goals of the FDA is to protect the health of the public by assuring that the practice of reprocessing and reusing single-use devices (SUDs) is safe and effective and based on good science.

The FDA has designed an approach that applies existing regulations for original equipment manufacturers (OEMs) to third parties and hospitals to minimize risks associated with reprocessed SUDs.

The public expects and the law requires all medical devices to be safe, effective, and manufactured in accordance with Good Manufacturing Practices (GMPs) now referred to as Quality System Regulations (QSRs).

Based upon an assessment of potential risk, the FDA plans to phase-in additional oversight to ensure those organizations that manufacturer or re-manufacture medical devices, to include SUDs, are in compliance with the FDA guidance.

JCAHO announced that the FDA selected them as the organization that will, forthe next six months, collect, aggregate and report the aggregated data about thecurrent practices of healthcare organizations concerning the reuse of SUDs. 2 With that being the current state of affairs, it does not take much effort todetermine what the future may hold for healthcare organizations that not onlyreprocess and reuse SUDs, but also process any items that may put a patient atrisk.

Healthcare organizations may be required to have a manufacturing process thatwill mirror or replicate the requirements of QSRs used by medical devicemanufacturers for not only SUDs but also all processed items. This process willrequire standardized/validated cleaning and decontamination procedures,packaging criteria, labeling of items, loading of sterilizers, sterilizationprocesses (i.e., equipment, sterilant quality, and quantity), controlledquarantine, transportation, storage sites, documentation of the above, and amethod of recall if the manufacturing system fails.

Results learned from a study conducted in 1997, and subsequently published inSurgical Services Management in 1998, indicated that the best way toprevent a recall situation is effective quarantine and biological monitoring.The study showed that as the frequency of biological monitoring increased, thefollowing occurred:

Patient safety increased through the potential reduction of healthcare-acquired infections.

Costs were reduced by controlling the risk of liability and minimizing the number of items that were to be recalled. Limiting the subsequent reprocessing associated with multiple load recalls further reduced cost.

Most difficult to objectively determine is the loss of confidence in the sterile processing system that is proportionate to the size of the recall conducted within the organization.

The conclusion of that study demonstrated that it was clinically andoperationally more effective to monitor every load with a biological indicator,which requires as little as a one to three-hour quarantine period, than tomonitor daily or weekly. 3 This is because the cost of every loadmonitoring with a rapid readout biological indicator and short term quarantiningis less expensive than the costs associated with recall, healthcare-acquiredinfections and litigation.

However, monitoring is only one component of the complex scientificsterilization process. Each component of that process should be able to passseveral challenges to its validity both as a stand-alone sub process and as acomponent of a larger system. In the future, the FDA may require the use oflegally binding protocols or that the organization has a process that hasdemonstrated it is scientifically and operationally sound. While it ispreferable for a healthcare organization to have its sterilization processingsystem working according to design, this does not always happen. Of all thesterile processing subsystems, the final safeguard and last chance to preventpatient harm is to have an effective recall system.

The FDA has specific guidelines for recalls:

Recall is required if a product may cause serious adverse health consequences or death [FDA, Title 21, Part 7, Section 3 (m)(1)].

Recall is required if a product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote [FDA, Title 21, Part 7, Section 3 (m)(2)].

Recall is required if a product associated with a situation in which use of or exposure to a product is not likely to cause adverse health consequences [FDA, Title 21, Part 7, Section 3 (m)(3)].

For medical device manufacturers, the reasons for recall are very broad.Product maybe recalled because of questionable sterility but also because theproduct performance may affect the safe and efficacious use of the product.Because a medical device manufacturer uses a validated process and items are notreleased until all the testing indicates that the sterilization process waseffective, a recall due to ineffective sterilization is rare in the medicaldevice industry. In healthcare organizations, a recall is usually the result ofconcern over the sterility of the medical device.

When and how to recall medical devices processed in a healthcare facility isdefined by the recommended practices published by the Association for theAdvancement of Medical Instrumentation (AAMI). 4-7

These recommended practices clearly state that a healthcare facility musthave written policies and procedures for the recall of supplies sterilized bythe healthcare facility that are issued or stored. These policies should be incompliance with the Safe Medical Devices Act of 1900. 9 This actrequires that a healthcare facility establish a recall procedure to quicklyretrieve processed medical devices that are suspected to be non-sterile and toensure adequate follow-up with physicians and patients. These policies andprocedures must be developed in cooperation with the infection control committeeand risk management.

The recommended practices state that a healthcare organization should recallall medical devices processed in a sterilizer when there is a positivebiological indicator or any monitoring controls such as the mechanical monitors,internal or external chemical indicators suggest that the load was not properlyrun or was questionable. In the case of a positive biological indicator (BI),all loads processed in the sterilizer in question should be recalled since thelast negative biological indicator was obtained. 4-8 Recall steps arelisted in Table 1. 10

In conclusion

Most healthcare organizations do not have the time, money, space or humanresources required to document such high standards as required by QSRs. In fact,most organizations do not have processes that would minimally meet QSRs.Therefore an effective recall system is needed. Additionally, it is only becausethe FDA, to this point in time, has not regulated hospital sterile processingsystems that healthcare organizations have been allowed to claim that they areable to manufacture to the same level of patient safety assurance as medicaldevice manufacturers without proving it. This should be coming to a stop.

Edwin Ross is Chief Executive Officer of Applied Healthcare Research,Inc., Santa Clarita, Calif. He has extensive operational and consultingexperience, is a lecturer and author and has special interest in patient safety,infection control, sterile processing, and regulatory requirements.

For references, visit www.infectioncontroltoday.com .

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