Patient Safety, FDA Requirements and an Effective Recall Process

Patient Safety, FDA Requirements and an Effective Recall Process

By Edwin Ross, BS, MS

For half of the last decade (1995-2000), awareness has been heightened concerning patient 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 protect patients.

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

On their Reuse Web Site (, the FDA states:

  1. 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.
  2. 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.
  3. 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).
  4. 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, for the next six months, collect, aggregate and report the aggregated data about the current practices of healthcare organizations concerning the reuse of SUDs.2 With that being the current state of affairs, it does not take much effort to determine what the future may hold for healthcare organizations that not only reprocess and reuse SUDs, but also process any items that may put a patient at risk.

Healthcare organizations may be required to have a manufacturing process that will mirror or replicate the requirements of QSRs used by medical device manufacturers for not only SUDs but also all processed items. This process will require standardized/validated cleaning and decontamination procedures, packaging criteria, labeling of items, loading of sterilizers, sterilization processes (i.e., equipment, sterilant quality, and quantity), controlled quarantine, transportation, storage sites, documentation of the above, and a method of recall if the manufacturing system fails.

Results learned from a study conducted in 1997, and subsequently published in Surgical Services Management in 1998, indicated that the best way to prevent a recall situation is effective quarantine and biological monitoring. The study showed that as the frequency of biological monitoring increased, the following 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 and operationally more effective to monitor every load with a biological indicator, which requires as little as a one to three-hour quarantine period, than to monitor daily or weekly.3 This is because the cost of every load monitoring with a rapid readout biological indicator and short term quarantining is less expensive than the costs associated with recall, healthcare-acquired infections and litigation.

However, monitoring is only one component of the complex scientific sterilization process. Each component of that process should be able to pass several challenges to its validity both as a stand-alone sub process and as a component of a larger system. In the future, the FDA may require the use of legally binding protocols or that the organization has a process that has demonstrated it is scientifically and operationally sound. While it is preferable for a healthcare organization to have its sterilization processing system working according to design, this does not always happen. Of all the sterile processing subsystems, the final safeguard and last chance to prevent patient harm is to have an effective recall system.

The FDA has specific guidelines for recalls:

  1. Recall is required if a product may cause serious adverse health consequences or death [FDA, Title 21, Part 7, Section 3 (m)(1)].
  2. 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)].
  3. 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 the product performance may affect the safe and efficacious use of the product. Because a medical device manufacturer uses a validated process and items are not released until all the testing indicates that the sterilization process was effective, a recall due to ineffective sterilization is rare in the medical device industry. In healthcare organizations, a recall is usually the result of concern over the sterility of the medical device.

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

These recommended practices clearly state that a healthcare facility must have written policies and procedures for the recall of supplies sterilized by the healthcare facility that are issued or stored. These policies should be in compliance with the Safe Medical Devices Act of 1900.9 This act requires that a healthcare facility establish a recall procedure to quickly retrieve processed medical devices that are suspected to be non-sterile and to ensure adequate follow-up with physicians and patients. These policies and procedures must be developed in cooperation with the infection control committee and risk management.

The recommended practices state that a healthcare organization should recall all medical devices processed in a sterilizer when there is a positive biological indicator or any monitoring controls such as the mechanical monitors, internal or external chemical indicators suggest that the load was not properly run or was questionable. In the case of a positive biological indicator (BI), all loads processed in the sterilizer in question should be recalled since the last negative biological indicator was obtained.4-8 Recall steps are listed in Table 1.10

In conclusion

Most healthcare organizations do not have the time, money, space or human resources 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 because the FDA, to this point in time, has not regulated hospital sterile processing systems that healthcare organizations have been allowed to claim that they are able to manufacture to the same level of patient safety assurance as medical device 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 consulting experience, is a lecturer and author and has special interest in patient safety, infection control, sterile processing, and regulatory requirements.

For references, visit

Solutions to Sterilization Problems

By Phillip Davis

One long and continuing problem encountered with steam and/or ethylene oxide sterilization is the presence of moisture associated with instrument and basin sets, which is commonly known as "wet packs." There are numerous factors 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: Steam Sterilization and Sterility Assurance, page 13 (1994), a towel or other absorbent material may be placed in the tray or between nested basins to facilitate drying. A new highly absorbent, lint-free foam Instrument Tray Liner and Basin Divider manufactured by General Hospital Supply Corporation in Wilton, Conn., is now available. This product can be used in a Closed Container System as well as an open Sterilizing Tray.

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

Gas Plasma Sterilization

There are generally three sterilization processes for use on surgical equipment: High-temperature steam, ethylene oxide, and low temperature hydrogen-peroxide gas plasma. For a number of reasons, hydrogen-peroxide gas plasma sterilization is becoming a preferred sterilization method by many technicians. For example, hydrogen-peroxide gas plasma sterilization has significantly less corrosive effect on metal surgical instruments and leaves no residue that may cause the sterilized surgical instruments to be irritating or toxic to patients.

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

A STERRAD® hydrogen-peroxide gas plasma sterilization system available from Advanced Sterilization Products of Irvine, Calif., for example, is designed to provide non-toxic, dry, low temperature sterilization in about one hour without toxic residues. However, the STERRAD system (at left) is not usable with cellulose-based products like linen or paper normally used in other sterilization processes.

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

General Hospital Supply Corporation manufactures a lint free foam Instrument Tray Liner, available to hospitals and surgicenters. This product is the only disposable tray liner that is "Sterrad" compatible and will sterilize lumen devices as well.

Phillip Davis is the president of General Hospital Supply Corporation and has 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:

  • Why are the medical devices being recalled?
  • Who authorized the recall?
  • Who is responsible for reporting the results of the recall?
  • Amount of product produced, time frame and where was distributed.
  • Which medical devices are to be recalled (include load label information-sterilizer number, load number, and processing date)?
  • Which products were not recalled because of usage?
  • To which persons or departments the order is addressed?
  • A method for recording the number and type of products recalled by location.
  • Who and when to return the recalled medical devices to sterile processing?

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.

  • Notify infection control so that follow-up surveillance of patients can be conducted, if need be, as determined by the healthcare facilities policy.
  • Try to determine the cause of the sterilization process failure.
  • Check other monitoring controls from the cycles before and after the load was run such as Bowie-Dick test results, mechanical monitors, chemical, and biological indicators.
  • Determine that the correct biological indicator and test pack was used for the load.
  • Check all areas of the process for possible errors; sterilizer performance, sterilant quality and quantity, packaging and loading technique, appropriate cycle parameters for the load, and relative humidity in the processing area.
  • If using spore strips that require sterile transfer to a media, subculture the biological indicator according to the manufacturer's instructions. If using self-contained biological indicators, subculture if you suspect that the biological indicator was not correctly activated and incubated.

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

  • For vacuum-assisted steam sterilizers run a Bowie-Dick type test pack in three consecutive empty cycles.
  • For all steam and low temperature sterilizers, run a biological indicator test pack in three consecutive empty cycles.
  • Place the sterilizer into routine use if all results indicate the sterilizer is functioning properly.

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

  • Time and date of questionable sterilization process.
  • Description of sterilizer and load (include load label information--sterilizer number, load number, and processing date).
  • The monitoring results of the questionable load (e.g., equipment control--mechanical monitors and pack control--internal chemical indicators).

Recall report must include:

  • Why the medical devices were recalled.
  • What the corrective action was to prevent recurrence.
  • Percentage of products actually located in the recall.
  • Verification that recalled items were destroyed or reprocessed.

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