Patient Safety, FDA Requirements and an Effective Recall Process

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 (,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.2With 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.

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Solutions to Sterilization Problems

By Phillip Davis

Onelong and continuing problem encountered with steam and/or ethylene oxidesterilization is the presence of moisture associated with instrument and basinsets, which is commonly known as "wet packs." There are numerousfactors that can contribute to this problem, such as:

  • Excessive weight in instrument trays or basins

  • Boiler or plumbing changes

  • New or different sterilizers

  • Staff changes and/or new personnel

  • New medical devices

  • Changes in seasons

  • New rigid containers or wrap material

As indicated in the ANSI/AAMI ST46-1993: Good Hospital Practice: SteamSterilization and Sterility Assurance, page 13 (1994), a towel or otherabsorbent material may be placed in the tray or between nested basins tofacilitate drying. A new highly absorbent, lint-free foam Instrument Tray Linerand Basin Divider manufactured by General Hospital Supply Corporation in Wilton,Conn., is now available. This product can be used in a Closed Container Systemas well as an open Sterilizing Tray.

In conclusion, there is no easy solution to the continuing "wetpack" problem that exists during the sterilization process at present;however, identifying the causes and improving techniques is a step in the rightdirection.

Gas Plasma Sterilization

There are generally three sterilization processes for use on surgicalequipment: High-temperature steam, ethylene oxide, and low temperaturehydrogen-peroxide gas plasma. For a number of reasons, hydrogen-peroxide gasplasma sterilization is becoming a preferred sterilization method by manytechnicians. For example, hydrogen-peroxide gas plasma sterilization hassignificantly less corrosive effect on metal surgical instruments and leaves noresidue that may cause the sterilized surgical instruments to be irritating ortoxic to patients.

In addition, hydrogen-peroxide gas plasma sterilization produces no toxicby-products and requires no special ventilation or aeration.

A STERRAD® hydrogen-peroxide gas plasma sterilization systemavailable from Advanced Sterilization Products of Irvine, Calif., for example,is designed to provide non-toxic, dry, low temperature sterilization in aboutone hour without toxic residues. However, the STERRAD system (at left) is notusable with cellulose-based products like linen or paper normally used in othersterilization processes.

A tray liner is then needed to cushion articles such as fiber opticendoscopes, laser handpieces, power drills, and ophthalmic devices as they areplaced in a hydrogen-peroxide gas plasma sterilization system. Preferably, thetrayliner should have low absorbency, yet will allow the passage of plasmatherethrough such that an article can be effectively sterilized in the system.

General Hospital Supply Corporation manufactures a lint free foam InstrumentTray Liner, available to hospitals and surgicenters. This product is the onlydisposable tray liner that is "Sterrad" compatible and will sterilizelumen devices as well.

Phillip Davis is the president of General Hospital Supply Corporation andhas been in the medical industry since 1972. Mr. Davis has worked for Aesculap,J. Sklar and V. Mueller in the past. For more information, call 1-800-548-1004.

Table 1:

Positive biological indicator--recall steps to take

Recall all medical devices processed in that sterilizer since the last negative biological indicator was obtained. To speed up the process, call the departments first to ensure notification of the recall.

Issue a written recall order that outlines:

Quarantine all recalled medical devices until completion of the investigation, then reprocess. If not practical, reprocess immediately. When opening packs, check all internal chemical indicators and record any that do not reach their end point response.

Correct the identified problem. Retest the sterilizer before returning to routine use:

Verbally report results to your supervisor and file a written report. The information should include:

Recall report must include:

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