Medical Device & Diagnostic Industry Magazine
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An MD&DI September 1999 Column

MATERIALS HANDLING

John E. Lincoln

The generation, control, transportation, and disposition of hazardous biocontaminated material is a growing environmental concern. A good deal of attention has been focused on how hospitals dispose of body fluids, the decontamination or disinfection of reusable medical devices,^1–3 the disposal of packaging and spent devices in-house or through commercial services, and the effect on the environment. However, one area that has received relatively little attention is the control of product that is suspected or known to be biologically contaminated, primarily with blood or body fluids, and is returned to a manufacturer for failure investigation. Procedures should be established at both ends of the supply chain for the shipping, handling, processing, and disposition of such product.

DEVELOPING A COMPANY POLICY

Developing policies and procedures to adequately address the control of potentially contaminated returned product should be done to minimize liability and increase public, environmental, and employee safety. Device manufacturers might best be served by establishing a policy that discourages the casual return of any potentially contaminated product.

Sometimes the difficulty is getting the product returned at all. This situation puts the manufacturer at a disadvantage because there are times when the cause of the failure cannot be discovered by any means other than product review—product history review, work order documentation evaluation, simulation, etc.—necessitating the return of the contaminated device for investigation. Unfortunately, many end-user facilities, primarily hospitals, have internal requirements or protocols for the destruction of used single-use medical devices, making it difficult, if not impossible, to obtain such product for an investigation.

When a manufacturer or distributor decides to develop a policy regarding the handling of returned contaminated product, an evaluation must be done on its impact on various departments and functions within the company. Flow charts showing both the old and new process cycles can help people understand the changes.

The newly proposed process should be evaluated against the quality system regulations.^4,5 At a minimum, the new procedures should apply to quality assurance—especially complaint handling—as well as receiving, marketing, sales, R&D, and engineering. Other company personnel or departments coming in contact with actual or suspected contaminated product also need to be aware of and follow such procedures.

All returns from the field, especially from hospitals and clinics, should be handled as potentially contaminated product unless conclusive evidence exists to the contrary. Such material should be treated under a universal precautions protocol, which can be developed using this article as a guideline.⁶

Ideally, devices returned to a company should have been decontaminated or sterilized by the user before shipment and certified or labeled as such. Sometimes it is not possible or desirable to decontaminate or sterilize the product when doing so might mask the cause for the product's rejection. In any event, a manufacturer should never assume that a product has been decontaminated or sterilized before it was returned.

Employees should be given access to and training in these procedures. If no procedures are already in place, appropriate written instructions such as a copy of a standard operating procedure (SOP) may be provided as necessary to the customers or end-users for the handling, decontamination, and shipment of devices that require servicing or that need to undergo a failure investigation.

The written instructions for safe handling and return should include information regarding whom to contact at the company for assistance, the method of decontamination to be used and any limitations associated with it, precautions that should be taken to avoid the inadvertent destruction of evidence pertaining to the product's failure or malfunction, directions for the documentation that should accompany the device, and instructions for packaging, labeling, and shipping.

The company may choose to provide return kits, on request, that contain written instructions, data forms, shipping containers, and manufacturer-address and biohazard-symbol labels. Supplying these materials is not only convenient for the customer but helps to provide consistent conformance to regulatory requirements and validation of the protection offered by the packing and labeling that is provided.

Universal precautions demand that patient care items are assumed to be contaminated. When it is necessary to have a contaminated device returned to a manufacturer or distributor, the device should be placed in a securely sealed and leak-resistant primary container, and clearly identified as contaminated material. The package should be labeled and shipped in accordance with company instructions and those of whichever major carrier will be used (See Table I).

Table I. Key shipping and handling requirements for biologically contaminated product.

OSHA has its own set of requirements and standards for employee communication, awareness, training, and documentation regarding workplace hazards and their mitigation, which are required by law to be implemented and reported. For more information, review 29 CFR 1910.1030, "Bloodborne Pathogens," and 29 CFR 1910.132, "Personal Protective Equipment Standard," and include pertinent elements in the company SOPs for the handling of contaminated material.

AIR TRANSPORT

Any transport by air of hazardous or contaminated product is subject to the dangerous goods regulations⁹ (replacing the old restricted article regulations) of the International Air Transport Association (IATA). IATA coordinates its work with the International Civil Aviation Organization and its technical instructions, and the U.N. Committee of Experts on the Transportation of Dangerous Goods.

The IATA dangerous goods (DG) regulations require review of each DG article or substance and its acceptability for air transport. Some articles or substances may be forbidden, or forbidden unless granted specific approvals from the states concerned. If the products are allowed to ship, elements that must be taken into account include considerations of cargo versus passenger transport, packaging (with quantity considerations), training, proper declaration of dangerous goods by the shipper, and proper reporting of incidents. The air carrier should be contacted for further specific information.

A SAMPLE APPROACH

The requirements allow for several different approaches, and they each could be right as long as the regulatory requirements are met. It is important to consider each aspect of those requirements, evaluate current company practices, and develop a system that best blends the two. The discussion that follows involves only one possible approach (Figure 1).

Start with some type of formal returned-goods authorization (RGA) system. At a minimum, the RGA system should require that any end-user, anticipating a product return, must obtain approval for the return from the manufacturer or distributor prior to shipment, and that an RGA number be assigned. The RGA number should be prominently displayed on the outer container of the shipment. The manufacturer's or distributor's SOP should include a sequential numbering system and a log or forms to document the customer contact, product description, lot number (if available), quantity, reason for return, etc. The RGA should have a provision for review and inclusion in the company's complaint system. This RGA system would then serve three key functions. It would:

On receipt at the device manufacturer's site, the package containing the potentially contaminated device should be immediately routed, unopened, to a defined holding area, possibly under plant quality assurance control. All suspect product should be regarded the same—as if it's contaminated—and treated with universal precautions. Consequently, all receiving and returned-product handling personnel must be trained in company procedures regarding the disposition of suspect product—usually all opened product received back from a customer, unless specific information to the contrary is known.

The responsible receiving department will ensure that the device is properly and clearly identified and that it is handled and stored segregated from acceptable or other quarantined product. The department will then ensure that the device is decontaminated according to written procedure (whenever possible), prior to examination or evaluation. This step can be delayed if decontamination or sterilization would hamper the investigation; it can also be eliminated if it can be verified that the sender followed established protocol in having already completed the process.

Quality assurance routes the product—either in the container it was mailed in or in a more suitable box, labeling it as "engineering test sample," "contaminated," or "biohazard"—and routes or hand carries it to material handling. There, the product should undergo a predefined sterilization process validated to worst-case conditions. Independent test labs have protocols using lab soils that could form the basis of a contaminated-product disinfection, decontamination, or sterilization protocol.^10–12

If the product is included in a company's sterile load, an analysis or validation of the product's effect on the load's configuration and bioburden should be added to the appropriate documentation—most likely, the sterilization validation package. The method or methods chosen for decontamination, disinfection, or sterilization should allow the device to be safe for contact regardless of which type or types of pathogens might have contaminated it.

The method of decontamination should be documented, as well as the involved agents or personnel and the date and time. If sterilized, the item should be logged in the sterilization batch record, including the information mentioned above. When the product is returned, it is routed by the material handling department back to quality assurance, where it is either scrapped, placed in a new container, or labeled. The container or label should indicate that decontamination has been performed. However, personnel handling or testing the sterilized product should, to the degree possible, treat it as suspect. Quality assurance personnel should route the decontaminated product to the proper department for analysis.

PREDECONTAMINATION EVALUATION

If the decontamination process or chemicals could affect the investigation results, the product might have to be evaluated prior to decontamination. In such cases, evaluating personnel must wear appropriate protective attire and follow procedural and engineering controls, validated and defined by SOPs, prior to handling any contaminated product. After the evaluation is completed and prior to disposal, the product must be decontaminated or treated as hazardous, red-bag waste.

EMPLOYEE SAFETY MEASURES

Personnel must be trained in all safety measures. Protective attire, consistent with the degree of risk, should be worn by anyone involved in handling or investigating the product, including housekeeping and waste-disposal personnel. Such attire includes gloves, gowns, lab coats, head and foot coverings, face shields or masks, and eye and respiratory protection. Reusable items require a validated cleaning procedure after each use. Such attire should periodically be checked, repaired, or reconditioned as needed, or retired from use. Records of protective-attire safety checks and their results should be maintained. If items need to be custom-fitted, such as a sealed face mask or respirator, a documented, periodic fit test, along with training, should be conducted with the specific individual who uses the device.

A company should develop a program that allows employees who risk coming in contact with suspect or contaminated product to receive a hepatitis vaccine. Those employees who wish to decline should do so in writing so that their instructions can be filed in their personnel records.

Hand-washing facilities or antiseptic towels must be provided in the area or areas where contaminated-product handling occurs. Eating, drinking, the use of cosmetics or lip balm, and the handling of contact lenses are all prohibited in these designated areas. Wipe-down procedures are also required.

Product capable of generating potentially infectious aerosols must be transported in leakproof, sealed containers and evaluated in biological safety cabinets or physical-containment devices. Such evaluations should only be performed in closed-door work areas with restricted access, generally a biological lab or R&D area. Such area doors are marked with a universal biohazard symbol.

Routine investigations should be conducted in the restricted-access area, with an additional area, approximately three feet in radius from the work surface or sink, delineated by cones or roped off when in use and prior to decontamination. After the investigation is completed, the sink and surrounding work surfaces must be washed with an approved disinfectant. Any surfaces exposed to the contaminated product must also be treated as if they were contaminated until they are decontaminated or disinfected. The cleaning procedures should be validated and periodically reviewed, reverified, revalidated, and documented. Proper disposal of disinfecting solutions should also be practiced. This may involve review by the cognizant local water/sewer district, which should also be documented.

Precautions should be taken against spills or other accidents. When an accident does occur, the potentially infectious materials must immediately be cleaned up. There are commercial kits that help increase the safe handling of such spills and aid in the collection and disposal of the material.

RECORDING INVESTIGATIVE DATA

Investigators working on contaminated product should record their observations and findings into nonhandheld recorders or dictate to a second person, in order to prevent the contamination from being circulated to other departments.

DISPOSAL

Prior to disposal, all contaminated product should be decontaminated or sterilized. Items coming in contact with such contaminated product, such as sponges, utensils, and cloths, must also be decontaminated or sterilized prior to disposal (or reuse) unless a provision exists or is implemented for commercial red bag waste handling. Companies should check with state-specific agencies for disposal guidelines and document the findings.

Any contaminated, biohazardous spills should be treated as a hazardous material incident, to be handled per an applicable SOP. Such procedures include cleanup using absorbent or adsorbent material designed to soak up, bind, gel, or solidify the liquid, followed by disinfection using a bactericidal, viricidal, and fungicidal disinfectant proven effective against HIV, hepatitis B, and herpes I and II.

Hazardous material spills should be reported to the plant safety officer, senior quality system or regulatory affairs manager, or other designated senior management person. Information on the containment and corrective action taken should be fully documented. Disposal of such spills and associated medical devices should always be in accordance with state-specific guidelines as to approved treatment technologies.

PRODUCT DESIGN

Effective decontamination and sterilization requirements should be considered during product design or redesign. Such considerations, as part of design input, should include configuration, materials, clean surfaces, biocompatibility of the disinfectant or sterilant, and the principles of risk analysis and FMEA.

TRAINING

Mandatory training in procedures to use for contaminated product must be included in the company's periodic training programs, with the agenda and attendance documented. A multitiered system could be used in which personnel are informed that the company could, at any time, receive contaminated product from the field, whether it is clearly identified or not. Those who would logically receive or transport such product, whether real or suspect, should receive more intensive training. The most thorough training should be provided to those involved in the investigation, testing, cleaning, decontamination, sterilization, and final disposition of the product.

Written procedures should not eliminate the need to follow procedures dictated by common sense and caution or replace those rules mandated by other agencies when specific biohazards are involved.

CONCLUSION

The training and equipping of personnel, as well as the authorization for shipment, receipt, handling, storage, decontamination or sterilization, investigation, disposal, and documentation of suspect or actual contaminated product, is a serious company responsibility. This responsibility is heightened as more medical devices reach a global market and new and more resistant forms of pathogens appear. Companies must implement or refine their existing systems. To delay only places their employees and the environment at needless risk. In cases in which systems are not currently in place, personnel can take it upon themselves to practice universal precautions and develop their own procedures for handling contaminated product.

REFERENCES

1. Designing, Testing, and Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities: A Guide for Device Manufacturers, AAMI TIR 122 (Arlington, VA: Association for the Advancement of Medical Instrumentation, 1994).

2. AF Booth, "The Manufacturer's Role in Safe Reuse," Medical Device & Diagnostic Industry 19, no. 5 (1997): 127–134.

3. E Arscott, et al., "Validating Reusable Medical Devices: An Overview," Medical Device & Diagnostic Industry 18, no. 1 (1996): 210.

4. Code of Federal Regulations, 21 CFR 820.60, 820.75, 820.80, 820.90, 820.100, 820.140, 820.150, and 820.198.

5. Quality systems - Model for quality assurance in design , ANSI/ISO/ASQ[C] QS9001 (New York City: American National Standards Institute, 1994).

6. Code of Federal Regulations, 29 CFR 1910.132, 1910.1030, and booklet 3127, "Occupational Exposure to Bloodborne Pathogens."

7. Domestic Mail Handling, USPS Section 124.35 (Washington, DC: United States Postal Service).

8. Code of Federal Regulations, 49 CFR 170-178, HM 126, and HM 181.

9. Dangerous Goods Regulations (Geneva: International Air Transport Association, 1999).

10. Safe Handling of Biologically Contaminated Medical Devices in Non Clinical and Clinical Settings, AAMI TIR 10 (Arlington, VA: Association for the Advancement of Medical Instrumentation, 1993).

11. RR Reich, "How Design Controls Affect Sterilization Process Development and Validation," Medical Device & Diagnostic Industry 19, no. 10 (1997): 107-111.

12. SL Barbee, et al. "Susceptibility of Crytospuridium paruum in Disinfection and Sterilization Processors" (paper presented at the Eighth Annual Meeting of the Society for Healthcare Epidemiology of America, Orlando, Florida, April 5-7, 1998).

John E. Lincoln is principal of J.E. Lincoln and Associates (Tooele, UT).

Illustration by James Schlesinger

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